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An Open-label Extension Study Evaluating the Safety and Efficacy of Upadacitinib (ABT-494) in Adults With Rheumatoid Arthritis (BALANCE-EXTEND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02049138
Recruitment Status : Completed
First Posted : January 30, 2014
Results First Posted : July 12, 2022
Last Update Posted : July 12, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: Upadacitinib
Biological: Pneumococcal 13-valent conjugate vaccine (PCV-13)
Enrollment 493
Recruitment Details

Participants must have completed a preceding rheumatoid arthritis (RA) upadacitinib randomized controlled trial (RCT), Study M13-550 (NCT01960855) or Study M13-537 (NCT02066389) to be enrolled in this long-term extension study.

Participants were enrolled at 113 study sites located in 17 countries (Belgium, Bulgaria, Chile, Czechia, Hungary, Israel, Latvia, Mexico, New Zealand, Poland, Russian Federation, Slovakia, South Africa, Spain, United Kingdom, Ukraine, and United States/Puerto Rico).
Pre-assignment Details

Participants were assigned to upadacitinib 6 mg twice-daily up to 30 days following the Last Visit (Week 12) of the preceding RCT. Participants may have been up-titrated to 12 mg BID and subsequently down-titrated per protocol-specified criteria. Efficacy results are reported by treatment sequence for each participant. Adverse event data are reported according to treatment received at the time of the event.

Participants may have enrolled in a vaccine substudy during the main study.
Arm/Group Title Upadacitinib Never Titrated Upadacitinib Titrated Up and Not Down Upadacitinib Titrated Up and Down
Hide Arm/Group Description

Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to a once-daily (QD) dose of 15 mg upadacitinib and remained on this dose throughout the study.

A subset of participants who opted-in to the vaccine substudy received a single-dose of 0.5 mL intramuscular injection of pneumococcal 13-valent conjugate vaccine (PCV-13).

Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to a once-daily dose of 30 mg upadacitinib and remained on this dose throughout the study.

A subset of participants who opted-in to the vaccine substudy received a single-dose of 0.5 mL intramuscular injection of pneumococcal 13-valent conjugate vaccine (PCV-13).

Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.

A subset of participants who opted-in to the vaccine substudy received a single-dose of 0.5 mL intramuscular injection of pneumococcal 13-valent conjugate vaccine (PCV-13).
Period Title: Overall Study
Started 306 149 38
Enrolled in Vaccine Sub-study 76 24 11
Completed 142 51 30
Not Completed 164 98 8
Reason Not Completed
Adverse Event             46             25             1
Withdrawal by Subject             57             21             5
Lost to Follow-up             18             5             1
Lack of Efficacy             10             26             1
Non-Compliance             15             6             0
Required Alternative / Prohibited Therapy             1             1             0
Coronavirus Disease-2019 (COVID-19) Infection             1             0             0
COVID-19 Logistical Restrictions             1             0             0
Other             15             13             0
Missing             0             1             0
Arm/Group Title Upadacitinib Never Titrated Upadacitinib Titrated Up and Not Down Upadacitinib Titrated Up and Down Total
Hide Arm/Group Description Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily (QD) dose of 15 mg upadacitinib. Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns. Total of all reporting groups
Overall Number of Baseline Participants 306 149 38 493
Hide Baseline Analysis Population Description
The open-label treated population consisted of all participants who had received at least one dose of open-label study medication. Baseline data are from the Baseline of the preceding RCT study (M13-550 or M13-537).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 306 participants 149 participants 38 participants 493 participants
55.8  (12.62) 56.0  (12.56) 53.7  (8.54) 55.7  (12.33)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 306 participants 149 participants 38 participants 493 participants
< 45 years
56
  18.3%
30
  20.1%
5
  13.2%
91
  18.5%
45 - < 65 years
174
  56.9%
76
  51.0%
28
  73.7%
278
  56.4%
≥ 65 years
76
  24.8%
43
  28.9%
5
  13.2%
124
  25.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 306 participants 149 participants 38 participants 493 participants
Female
246
  80.4%
117
  78.5%
29
  76.3%
392
  79.5%
Male
60
  19.6%
32
  21.5%
9
  23.7%
101
  20.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 306 participants 149 participants 38 participants 493 participants
Hispanic or Latino
76
  24.8%
40
  26.8%
7
  18.4%
123
  24.9%
Not Hispanic or Latino
230
  75.2%
109
  73.2%
31
  81.6%
370
  75.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 306 participants 149 participants 38 participants 493 participants
White
293
  95.8%
132
  88.6%
37
  97.4%
462
  93.7%
Black or African American
9
   2.9%
12
   8.1%
1
   2.6%
22
   4.5%
Asian
1
   0.3%
2
   1.3%
0
   0.0%
3
   0.6%
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
1
   0.3%
0
   0.0%
0
   0.0%
1
   0.2%
Multiple
2
   0.7%
3
   2.0%
0
   0.0%
5
   1.0%
Region  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 306 participants 149 participants 38 participants 493 participants
Western Europe
27
   8.8%
13
   8.7%
5
  13.2%
45
   9.1%
Eastern Europe
144
  47.1%
46
  30.9%
19
  50.0%
209
  42.4%
North America
90
  29.4%
78
  52.3%
10
  26.3%
178
  36.1%
South/Central America
42
  13.7%
5
   3.4%
3
   7.9%
50
  10.1%
Other
3
   1.0%
7
   4.7%
1
   2.6%
11
   2.2%
Duration of RA  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 306 participants 149 participants 38 participants 493 participants
9.34  (8.73) 9.61  (8.36) 7.66  (6.54) 9.29  (8.47)
Tender Joint Count   [1] 
Mean (Standard Deviation)
Unit of measure:  Joints
Number Analyzed 306 participants 149 participants 38 participants 493 participants
25.8  (14.49) 30.4  (15.90) 31.3  (15.67) 27.6  (15.17)
[1]
Measure Description: A total of 68 joints were assessed for the presence or absence of tenderness.
Swollen Joint Count   [1] 
Mean (Standard Deviation)
Unit of measure:  Joints
Number Analyzed 306 participants 149 participants 38 participants 493 participants
16.7  (10.45) 18.8  (12.03) 19.3  (9.53) 17.5  (10.92)
[1]
Measure Description: A total of 66 joints were assessed for the presence or absence of swelling.
Physician's Global Assessment of Disease Activity   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 298 participants 147 participants 38 participants 483 participants
64.4  (15.82) 65.6  (15.41) 65.0  (15.41) 64.8  (15.64)
[1]
Measure Description: The physician rated the participant's current global RA disease activity (independently from the participant's assessment) on a visual analog scale (VAS) from 0 to 100 mm, where 0 mm indicates very low disease activity and 100 mm indicates very high disease activity.
[2]
Measure Analysis Population Description: Participants with available data
Patient's Global Assessment of Disease Activity   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 305 participants 146 participants 37 participants 488 participants
62.4  (20.78) 67.4  (20.52) 66.5  (16.48) 64.2  (20.51)
[1]
Measure Description: The participant was asked to rate their current RA disease activity over the past 24 hours on a 100 mm VAS, where 0 mm indicates very low disease activity and 100 mm indicates very high disease activity.
[2]
Measure Analysis Population Description: Participants with available data
Patient's Global Assessment of Pain   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 305 participants 146 participants 37 participants 488 participants
63.8  (19.73) 67.2  (19.64) 66.5  (13.13) 65.0  (19.32)
[1]
Measure Description: Participants were asked to indicate the severity of their arthritis pain within the previous week on a visual analog scale from 0 to 100 mm. A score of 0 mm indicates "no pain" and a score of 100 mm indicates "worst possible pain."
[2]
Measure Analysis Population Description: Participants with available data
Health Assessment Questionnaire - Disability Index (HAQ-DI)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 304 participants 146 participants 37 participants 487 participants
1.4811  (0.6848) 1.6036  (0.6215) 1.5304  (0.4969) 1.5216  (0.6550)
[1]
Measure Description: The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.
[2]
Measure Analysis Population Description: Participants with available data
High-sensitivity reactive Protein (hsCRP)  
Mean (Standard Deviation)
Unit of measure:  mg/L
Number Analyzed 306 participants 149 participants 38 participants 493 participants
12.8968  (17.8329) 14.9212  (20.1890) 17.1232  (28.1184) 13.8344  (19.5179)
1.Primary Outcome
Title Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Hide Description

Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:

  1. ≥ 20% improvement in 68-tender joint count;
  2. ≥ 20% improvement in 66-swollen joint count; and

  3. ≥ 20% improvement in at least 3 of the 5 following parameters:

    • Physician global assessment of disease activity
    • Patient global assessment of disease activity
    • Patient assessment of pain
    • Health Assessment Questionnaire - Disability Index (HAQ-DI)
    • High-sensitivity C-reactive protein (hsCRP).
Time Frame Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label treated population with available data at each time point
Arm/Group Title Upadacitinib Never Titrated Upadacitinib Titrated Up and Not Down Upadacitinib Titrated Up and Down
Hide Arm/Group Description:
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
Overall Number of Participants Analyzed 306 149 38
Measure Type: Number
Unit of Measure: percentage of participants
Week 6 Number Analyzed 277 participants 143 participants 36 participants
87.7 73.4 77.8
Week 12 Number Analyzed 273 participants 141 participants 37 participants
89.0 73.8 75.7
Week 24 Number Analyzed 256 participants 131 participants 35 participants
91.8 73.3 88.6
Week 36 Number Analyzed 246 participants 125 participants 35 participants
90.2 83.2 82.9
Week 48 Number Analyzed 229 participants 117 participants 34 participants
90.0 82.1 88.2
Week 60 Number Analyzed 217 participants 105 participants 35 participants
95.4 83.8 85.7
Week 72 Number Analyzed 199 participants 101 participants 32 participants
93.0 84.2 90.6
Week 84 Number Analyzed 203 participants 97 participants 32 participants
94.6 76.3 96.9
Week 96 Number Analyzed 204 participants 93 participants 33 participants
92.2 86.0 90.9
Week 108 Number Analyzed 194 participants 91 participants 33 participants
94.8 85.7 87.9
Week 120 Number Analyzed 186 participants 86 participants 29 participants
96.2 89.5 96.6
Week 132 Number Analyzed 181 participants 80 participants 30 participants
93.9 87.5 96.7
Week 144 Number Analyzed 178 participants 75 participants 27 participants
94.9 88.0 88.9
Week 156 Number Analyzed 176 participants 73 participants 27 participants
92.0 87.7 92.6
Week 168 Number Analyzed 172 participants 71 participants 29 participants
91.9 88.7 82.8
Week 180 Number Analyzed 179 participants 67 participants 29 participants
93.9 79.1 86.2
Week 192 Number Analyzed 168 participants 70 participants 28 participants
93.5 87.1 92.9
Week 204 Number Analyzed 166 participants 69 participants 29 participants
94.0 81.2 86.2
Week 216 Number Analyzed 160 participants 64 participants 27 participants
92.5 85.9 85.2
Week 228 Number Analyzed 149 participants 55 participants 28 participants
96.0 83.6 92.9
Week 240 Number Analyzed 153 participants 61 participants 28 participants
92.8 85.2 89.3
Week 252 Number Analyzed 149 participants 58 participants 30 participants
94.0 87.9 86.7
Week 264 Number Analyzed 135 participants 54 participants 28 participants
93.3 81.5 89.3
Week 276 Number Analyzed 128 participants 52 participants 27 participants
93.8 84.6 81.5
Week 288 Number Analyzed 133 participants 50 participants 27 participants
94.7 88.0 88.9
Week 300 Number Analyzed 125 participants 50 participants 23 participants
94.4 82.0 87.0
Week 312 Number Analyzed 129 participants 49 participants 26 participants
92.2 87.8 88.5
2.Primary Outcome
Title Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Hide Description

Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:

  1. ≥ 50% improvement in 68-tender joint count;
  2. ≥ 50% improvement in 66-swollen joint count; and

  3. ≥ 50% improvement in at least 3 of the 5 following parameters:

    • Physician global assessment of disease activity
    • Patient global assessment of disease activity
    • Patient assessment of pain
    • Health Assessment Questionnaire - Disability Index (HAQ-DI)
    • High-sensitivity C-reactive protein (hsCRP).
Time Frame Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label treated population with available data at each time point
Arm/Group Title Upadacitinib Never Titrated Upadacitinib Titrated Up and Not Down Upadacitinib Titrated Up and Down
Hide Arm/Group Description:
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
Overall Number of Participants Analyzed 306 149 38
Measure Type: Number
Unit of Measure: percentage of participants
Week 6 Number Analyzed 275 participants 144 participants 35 participants
63.6 37.5 48.6
Week 12 Number Analyzed 275 participants 141 participants 35 participants
73.5 41.8 45.7
Week 24 Number Analyzed 251 participants 131 participants 35 participants
75.7 49.6 60.0
Week 36 Number Analyzed 245 participants 126 participants 34 participants
73.5 51.6 55.9
Week 48 Number Analyzed 229 participants 116 participants 36 participants
74.2 50.0 55.6
Week 60 Number Analyzed 213 participants 108 participants 35 participants
79.8 52.8 65.7
Week 72 Number Analyzed 201 participants 102 participants 33 participants
77.1 49.0 63.6
Week 84 Number Analyzed 203 participants 95 participants 33 participants
78.8 55.8 75.8
Week 96 Number Analyzed 202 participants 93 participants 33 participants
74.8 53.8 63.6
Week 108 Number Analyzed 194 participants 93 participants 34 participants
79.4 54.8 58.8
Week 120 Number Analyzed 187 participants 88 participants 29 participants
80.7 58.0 72.4
Week 132 Number Analyzed 178 participants 80 participants 29 participants
79.2 56.3 69.0
Week 144 Number Analyzed 178 participants 73 participants 28 participants
76.4 65.8 60.7
Week 156 Number Analyzed 176 participants 71 participants 26 participants
79.5 63.4 76.9
Week 168 Number Analyzed 173 participants 72 participants 29 participants
79.2 61.1 75.9
Week 180 Number Analyzed 178 participants 70 participants 29 participants
80.9 64.3 65.5
Week 192 Number Analyzed 166 participants 69 participants 26 participants
80.7 59.4 76.9
Week 204 Number Analyzed 163 participants 69 participants 29 participants
82.2 59.4 79.3
Week 216 Number Analyzed 158 participants 63 participants 27 participants
76.6 55.6 66.7
Week 228 Number Analyzed 149 participants 55 participants 28 participants
79.2 58.2 67.9
Week 240 Number Analyzed 152 participants 61 participants 28 participants
79.6 63.9 71.4
Week 252 Number Analyzed 148 participants 58 participants 30 participants
83.8 55.2 76.7
Week 264 Number Analyzed 133 participants 55 participants 28 participants
79.7 60.0 75.0
Week 276 Number Analyzed 129 participants 51 participants 27 participants
84.5 52.9 66.7
Week 288 Number Analyzed 135 participants 51 participants 26 participants
82.2 58.8 61.5
Week 300 Number Analyzed 127 participants 49 participants 23 participants
75.6 61.2 56.5
Week 312 Number Analyzed 127 participants 49 participants 26 participants
84.3 69.4 69.2
3.Primary Outcome
Title Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Hide Description

Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria:

  1. ≥ 70% improvement in 68-tender joint count;
  2. ≥ 70% improvement in 66-swollen joint count; and

  3. ≥ 70% improvement in at least 3 of the 5 following parameters:

    • Physician global assessment of disease activity
    • Patient global assessment of disease activity
    • Patient assessment of pain
    • Health Assessment Questionnaire - Disability Index (HAQ-DI)
    • High-sensitivity C-reactive protein (hsCRP).
Time Frame Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label treated population with available data at each time point
Arm/Group Title Upadacitinib Never Titrated Upadacitinib Titrated Up and Not Down Upadacitinib Titrated Up and Down
Hide Arm/Group Description:
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
Overall Number of Participants Analyzed 306 149 38
Measure Type: Number
Unit of Measure: percentage of participants
Week 6 Number Analyzed 273 participants 146 participants 37 participants
38.8 15.1 21.6
Week 12 Number Analyzed 274 participants 144 participants 37 participants
47.1 18.1 24.3
Week 24 Number Analyzed 253 participants 134 participants 35 participants
45.5 27.6 37.1
Week 36 Number Analyzed 243 participants 127 participants 35 participants
49.0 28.3 34.3
Week 48 Number Analyzed 226 participants 116 participants 36 participants
57.1 26.7 25.0
Week 60 Number Analyzed 211 participants 110 participants 35 participants
60.2 30.0 42.9
Week 72 Number Analyzed 204 participants 103 participants 33 participants
56.4 29.1 36.4
Week 84 Number Analyzed 204 participants 95 participants 33 participants
60.3 29.5 54.5
Week 96 Number Analyzed 199 participants 94 participants 33 participants
57.3 34.0 42.4
Week 108 Number Analyzed 192 participants 91 participants 34 participants
59.9 31.9 47.1
Week 120 Number Analyzed 187 participants 88 participants 29 participants
59.4 30.7 62.1
Week 132 Number Analyzed 178 participants 80 participants 29 participants
61.8 33.8 48.3
Week 144 Number Analyzed 172 participants 73 participants 28 participants
57.6 34.2 39.3
Week 156 Number Analyzed 173 participants 72 participants 27 participants
64.7 38.9 55.6
Week 168 Number Analyzed 170 participants 71 participants 29 participants
62.9 42.3 58.6
Week 180 Number Analyzed 176 participants 71 participants 29 participants
59.1 29.6 48.3
Week 192 Number Analyzed 163 participants 69 participants 27 participants
62.0 31.9 48.1
Week 204 Number Analyzed 163 participants 68 participants 29 participants
65.0 42.6 58.6
Week 216 Number Analyzed 159 participants 62 participants 28 participants
59.1 41.9 46.4
Week 228 Number Analyzed 150 participants 56 participants 28 participants
60.0 39.3 60.7
Week 240 Number Analyzed 151 participants 62 participants 28 participants
66.2 38.7 46.4
Week 252 Number Analyzed 143 participants 58 participants 28 participants
62.9 29.3 50.0
Week 264 Number Analyzed 135 participants 54 participants 28 participants
58.5 37.0 57.1
Week 276 Number Analyzed 127 participants 52 participants 25 participants
66.1 34.6 48.0
Week 288 Number Analyzed 132 participants 52 participants 27 participants
65.9 44.2 44.4
Week 300 Number Analyzed 125 participants 51 participants 23 participants
60.8 41.2 43.5
Week 312 Number Analyzed 130 participants 48 participants 27 participants
63.1 39.6 55.6
4.Primary Outcome
Title Percentage of Participants With Satisfactory Humoral Response to PCV-13 Four Weeks After Vaccination
Hide Description Satisfactory humoral response is defined as greater than or equal to 2-fold increase in antibody concentration from the vaccination Baseline in at least 6 out of the 12 pneumococcal antigens 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F).
Time Frame Vaccination Baseline (defined as the last non-missing observation on or before the date of receiving PCV-13 vaccination) and 4 weeks after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The sub-study full analysis set (FAS) included all participants enrolled in the sub-study who received PCV-13 vaccination and at least 1 dose of upadacitinib 15 mg or 30 mg after vaccination during the sub-study. Analysis includes participants with available data at the Week 4 visit of the sub-study.
Arm/Group Title Upadacitinib 15 mg + PCV-13 Upadacitinib 30 mg + PCV-13
Hide Arm/Group Description:
Participants receiving 15 mg upadacitinib QD were administered a single-dose of pneumococcal 13-valent conjugate vaccine (PCV-13).
Participants receiving 30 mg upadacitinib QD were administered a single-dose of pneumococcal 13-valent conjugate vaccine (PCV-13).
Overall Number of Participants Analyzed 83 23
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
67.5
(57.4 to 77.5)
56.5
(36.3 to 76.8)
5.Secondary Outcome
Title Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Hide Description

The DAS28(CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0 to approximately 10, where higher scores indicate more disease activity.

LDA is defined as a DAS28(CRP) score ≤ 3.2.
Time Frame Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
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Open-label treated population with available data at each time point
Arm/Group Title Upadacitinib Never Titrated Upadacitinib Titrated Up and Not Down Upadacitinib Titrated Up and Down
Hide Arm/Group Description:
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
Overall Number of Participants Analyzed 306 149 38
Measure Type: Number
Unit of Measure: percentage of participants
Week 6 Number Analyzed 279 participants 146 participants 37 participants
70.3 43.2 43.2
Week 12 Number Analyzed 272 participants 145 participants 37 participants
77.9 43.4 43.2
Week 24 Number Analyzed 255 participants 134 participants 36 participants
82.4 48.5 52.8
Week 36 Number Analyzed 246 participants 128 participants 36 participants
80.5 50.8 55.6
Week 48 Number Analyzed 228 participants 118 participants 37 participants
86.8 54.2 56.8
Week 60 Number Analyzed 218 participants 110 participants 36 participants
86.2 56.4 66.7
Week 72 Number Analyzed 203 participants 104 participants 33 participants
84.7 51.0 69.7
Week 84 Number Analyzed 207 participants 98 participants 34 participants
88.9 60.2 85.3
Week 96 Number Analyzed 205 participants 97 participants 34 participants
82.4 64.9 79.4
Week 108 Number Analyzed 195 participants 92 participants 34 participants
88.2 66.3 70.6
Week 120 Number Analyzed 185 participants 87 participants 31 participants
85.9 69.0 77.4
Week 132 Number Analyzed 167 participants 77 participants 31 participants
88.6 70.1 87.1
Week 144 Number Analyzed 169 participants 70 participants 28 participants
85.2 68.6 82.1
Week 156 Number Analyzed 166 participants 67 participants 29 participants
86.1 74.6 86.2
Week 168 Number Analyzed 160 participants 69 participants 30 participants
90.0 78.3 80.0
Week 180 Number Analyzed 178 participants 69 participants 30 participants
90.4 69.6 80.0
Week 192 Number Analyzed 169 participants 72 participants 27 participants
89.3 75.0 96.3
Week 204 Number Analyzed 166 participants 70 participants 30 participants
88.6 61.4 83.3
Week 216 Number Analyzed 159 participants 64 participants 28 participants
89.9 70.3 82.1
Week 228 Number Analyzed 151 participants 55 participants 29 participants
89.4 70.9 86.2
Week 240 Number Analyzed 153 participants 62 participants 29 participants
89.5 75.8 86.2
Week 252 Number Analyzed 145 participants 58 participants 31 participants
91.7 67.2 83.9
Week 264 Number Analyzed 130 participants 53 participants 28 participants
86.2 67.9 82.1
Week 276 Number Analyzed 121 participants 54 participants 25 participants
91.7 74.1 72.0
Week 288 Number Analyzed 106 participants 46 participants 25 participants
90.6 71.7 76.0
Week 300 Number Analyzed 101 participants 37 participants 20 participants
94.1 67.6 80.0
Week 312 Number Analyzed 116 participants 48 participants 27 participants
84.5 68.8 70.4
6.Secondary Outcome
Title Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Hide Description

The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0 to approximately 10, where higher scores indicate more disease activity.

Clinical remission is defined as a DAS28(CRP) score < 2.6.
Time Frame Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
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Open-label treated population with available data at each time point
Arm/Group Title Upadacitinib Never Titrated Upadacitinib Titrated Up and Not Down Upadacitinib Titrated Up and Down
Hide Arm/Group Description:
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
Overall Number of Participants Analyzed 306 149 38
Measure Type: Number
Unit of Measure: percentage of participants
Week 6 Number Analyzed 279 participants 146 participants 37 participants
53.0 21.2 29.7
Week 12 Number Analyzed 272 participants 145 participants 37 participants
56.6 25.5 27.0
Week 24 Number Analyzed 255 participants 134 participants 36 participants
60.8 31.3 38.9
Week 36 Number Analyzed 246 participants 128 participants 36 participants
65.0 35.2 50.0
Week 48 Number Analyzed 228 participants 118 participants 37 participants
66.2 36.4 35.1
Week 60 Number Analyzed 218 participants 110 participants 36 participants
72.9 38.2 50.0
Week 72 Number Analyzed 203 participants 104 participants 33 participants
69.0 35.6 51.5
Week 84 Number Analyzed 207 participants 98 participants 34 participants
72.0 36.7 52.9
Week 96 Number Analyzed 205 participants 97 participants 34 participants
71.7 45.4 52.9
Week 108 Number Analyzed 195 participants 92 participants 34 participants
74.4 42.4 47.1
Week 120 Number Analyzed 185 participants 87 participants 31 participants
74.1 49.4 45.2
Week 132 Number Analyzed 167 participants 77 participants 31 participants
73.7 40.3 61.3
Week 144 Number Analyzed 169 participants 70 participants 28 participants
71.0 44.3 60.7
Week 156 Number Analyzed 166 participants 67 participants 29 participants
74.7 50.7 65.5
Week 168 Number Analyzed 160 participants 69 participants 30 participants
77.5 49.3 66.7
Week 180 Number Analyzed 178 participants 69 participants 30 participants
75.3 44.9 56.7
Week 192 Number Analyzed 169 participants 72 participants 27 participants
76.9 47.2 55.6
Week 204 Number Analyzed 166 participants 70 participants 30 participants
77.1 47.1 76.7
Week 216 Number Analyzed 159 participants 64 participants 28 participants
79.2 56.3 53.6
Week 228 Number Analyzed 151 participants 55 participants 29 participants
80.8 49.1 69.0
Week 240 Number Analyzed 153 participants 62 participants 29 participants
75.2 50.0 69.0
Week 252 Number Analyzed 145 participants 58 participants 31 participants
80.7 44.8 58.1
Week 264 Number Analyzed 130 participants 53 participants 28 participants
73.8 39.6 67.9
Week 276 Number Analyzed 121 participants 54 participants 25 participants
76.9 50.0 52.0
Week 288 Number Analyzed 106 participants 46 participants 25 participants
74.5 47.8 48.0
Week 300 Number Analyzed 101 participants 37 participants 20 participants
75.2 43.2 55.0
Week 312 Number Analyzed 116 participants 48 participants 27 participants
72.4 45.8 63.0
7.Secondary Outcome
Title Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time
Hide Description

The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, and Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.

LDA is defined as a CDAI score ≤ 10.
Time Frame Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
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Open-label treated population with available data at each time point
Arm/Group Title Upadacitinib Never Titrated Upadacitinib Titrated Up and Not Down Upadacitinib Titrated Up and Down
Hide Arm/Group Description:
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
Overall Number of Participants Analyzed 306 149 38
Measure Type: Number
Unit of Measure: percentage of participants
Week 6 Number Analyzed 274 participants 142 participants 37 participants
65.3 35.2 35.1
Week 12 Number Analyzed 273 participants 141 participants 34 participants
71.1 39.7 32.4
Week 24 Number Analyzed 254 participants 133 participants 35 participants
80.3 46.6 51.4
Week 36 Number Analyzed 243 participants 126 participants 35 participants
77.8 44.4 57.1
Week 48 Number Analyzed 230 participants 118 participants 36 participants
83.0 50.8 38.9
Week 60 Number Analyzed 218 participants 107 participants 36 participants
85.8 58.9 63.9
Week 72 Number Analyzed 200 participants 104 participants 33 participants
85.5 46.2 60.6
Week 84 Number Analyzed 205 participants 97 participants 32 participants
84.4 52.6 75.0
Week 96 Number Analyzed 198 participants 96 participants 33 participants
81.3 63.5 57.6
Week 108 Number Analyzed 194 participants 86 participants 33 participants
85.1 67.4 54.5
Week 120 Number Analyzed 188 participants 88 participants 31 participants
87.2 67.0 77.4
Week 132 Number Analyzed 182 participants 80 participants 30 participants
87.4 72.5 76.7
Week 144 Number Analyzed 181 participants 75 participants 28 participants
88.4 68.0 78.6
Week 156 Number Analyzed 178 participants 71 participants 28 participants
88.8 73.2 71.4
Week 168 Number Analyzed 173 participants 73 participants 30 participants
90.8 82.2 83.3
Week 180 Number Analyzed 179 participants 69 participants 30 participants
88.3 73.9 76.7
Week 192 Number Analyzed 168 participants 70 participants 29 participants
88.1 70.0 79.3
Week 204 Number Analyzed 164 participants 70 participants 29 participants
89.0 71.4 82.8
Week 216 Number Analyzed 158 participants 64 participants 28 participants
88.6 70.3 78.6
Week 228 Number Analyzed 149 participants 56 participants 29 participants
89.3 67.9 79.3
Week 240 Number Analyzed 153 participants 62 participants 29 participants
87.6 72.6 75.9
Week 252 Number Analyzed 146 participants 57 participants 31 participants
89.0 73.7 74.2
Week 264 Number Analyzed 133 participants 54 participants 29 participants
83.5 63.0 75.9
Week 276 Number Analyzed 129 participants 53 participants 28 participants
87.6 67.9 67.9
Week 288 Number Analyzed 134 participants 51 participants 28 participants
90.3 74.5 75.0
Week 300 Number Analyzed 127 participants 50 participants 24 participants
89.8 72.0 70.8
Week 312 Number Analyzed 127 participants 47 participants 26 participants
86.6 70.2 73.1
8.Secondary Outcome
Title Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time
Hide Description

The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, and Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.

Clinical remission is defined as a CDAI score ≤ 2.8.
Time Frame Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
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Open-label treated population with available data at each time point
Arm/Group Title Upadacitinib Never Titrated Upadacitinib Titrated Up and Not Down Upadacitinib Titrated Up and Down
Hide Arm/Group Description:
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
Overall Number of Participants Analyzed 306 149 38
Measure Type: Number
Unit of Measure: percentage of participants
Week 6 Number Analyzed 274 participants 142 participants 37 participants
23.4 4.9 10.8
Week 12 Number Analyzed 273 participants 141 participants 34 participants
26.4 6.4 8.8
Week 24 Number Analyzed 254 participants 133 participants 35 participants
28.3 12.8 14.3
Week 36 Number Analyzed 243 participants 126 participants 35 participants
32.5 9.5 17.1
Week 48 Number Analyzed 230 participants 118 participants 36 participants
34.8 11.0 11.1
Week 60 Number Analyzed 218 participants 107 participants 36 participants
43.1 13.1 22.2
Week 72 Number Analyzed 200 participants 104 participants 33 participants
43.5 12.5 9.1
Week 84 Number Analyzed 205 participants 97 participants 32 participants
43.4 12.4 18.8
Week 96 Number Analyzed 198 participants 96 participants 33 participants
40.4 15.6 21.2
Week 108 Number Analyzed 194 participants 86 participants 33 participants
44.8 16.3 18.2
Week 120 Number Analyzed 188 participants 88 participants 31 participants
43.6 12.5 22.6
Week 132 Number Analyzed 182 participants 80 participants 30 participants
46.7 18.8 33.3
Week 144 Number Analyzed 181 participants 75 participants 28 participants
38.1 14.7 28.6
Week 156 Number Analyzed 178 participants 71 participants 28 participants
47.2 14.1 32.1
Week 168 Number Analyzed 173 participants 73 participants 30 participants
48.6 20.5 33.3
Week 180 Number Analyzed 179 participants 69 participants 30 participants
48.0 15.9 20.0
Week 192 Number Analyzed 168 participants 70 participants 29 participants
46.4 18.6 24.1
Week 204 Number Analyzed 164 participants 70 participants 29 participants
51.2 20.0 34.5
Week 216 Number Analyzed 158 participants 64 participants 28 participants
46.2 21.9 28.6
Week 228 Number Analyzed 149 participants 56 participants 29 participants
44.3 25.0 31.0
Week 240 Number Analyzed 153 participants 62 participants 29 participants
51.6 24.2 31.0
Week 252 Number Analyzed 146 participants 57 participants 31 participants
52.7 19.3 22.6
Week 264 Number Analyzed 133 participants 54 participants 29 participants
48.1 20.4 17.2
Week 276 Number Analyzed 129 participants 53 participants 28 participants
53.5 24.5 28.6
Week 288 Number Analyzed 134 participants 51 participants 28 participants
51.5 25.5 28.6
Week 300 Number Analyzed 127 participants 50 participants 24 participants
51.2 22.0 29.2
Week 312 Number Analyzed 127 participants 47 participants 26 participants
50.4 27.7 34.6
9.Secondary Outcome
Title Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time
Hide Description

The simplified disease activity index (SDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm and hsCRP (mg/dL). The total SDAI score ranges from 0 to 86 with higher scores indicating higher disease activity.

LDA is defined as a SDAI score ≤ 11.0.
Time Frame Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
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Hide Analysis Population Description
Open-label treated population with available data at each time point
Arm/Group Title Upadacitinib Never Titrated Upadacitinib Titrated Up and Not Down Upadacitinib Titrated Up and Down
Hide Arm/Group Description:
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
Overall Number of Participants Analyzed 306 149 38
Measure Type: Number
Unit of Measure: percentage of participants
Week 6 Number Analyzed 273 participants 142 participants 37 participants
54.2 25.4 32.4
Week 12 Number Analyzed 270 participants 141 participants 34 participants
61.1 33.3 23.5
Week 24 Number Analyzed 253 participants 133 participants 35 participants
66.8 33.1 48.6
Week 36 Number Analyzed 242 participants 126 participants 35 participants
67.8 34.9 48.6
Week 48 Number Analyzed 228 participants 118 participants 36 participants
73.7 38.1 41.7
Week 60 Number Analyzed 218 participants 107 participants 36 participants
72.9 41.1 61.1
Week 72 Number Analyzed 200 participants 104 participants 33 participants
71.5 36.5 51.5
Week 84 Number Analyzed 205 participants 97 participants 32 participants
74.6 40.2 62.5
Week 96 Number Analyzed 198 participants 96 participants 33 participants
71.2 45.8 51.5
Week 108 Number Analyzed 194 participants 86 participants 33 participants
75.8 51.2 54.5
Week 120 Number Analyzed 185 participants 87 participants 31 participants
74.6 55.2 64.5
Week 132 Number Analyzed 166 participants 76 participants 30 participants
77.7 43.4 66.7
Week 144 Number Analyzed 167 participants 70 participants 28 participants
70.7 44.3 67.9
Week 156 Number Analyzed 164 participants 65 participants 28 participants
75.0 58.5 64.3
Week 168 Number Analyzed 157 participants 69 participants 30 participants
75.8 59.4 66.7
Week 180 Number Analyzed 178 participants 68 participants 30 participants
78.7 55.9 53.3
Week 192 Number Analyzed 168 participants 70 participants 27 participants
76.2 52.9 66.7
Week 204 Number Analyzed 164 participants 70 participants 29 participants
71.3 52.9 79.3
Week 216 Number Analyzed 157 participants 64 participants 28 participants
79.0 56.3 57.1
Week 228 Number Analyzed 149 participants 55 participants 29 participants
77.2 56.4 69.0
Week 240 Number Analyzed 153 participants 62 participants 29 participants
74.5 50.0 69.0
Week 252 Number Analyzed 143 participants 57 participants 31 participants
79.0 52.6 61.3
Week 264 Number Analyzed 128 participants 52 participants 28 participants
71.1 51.9 67.9
Week 276 Number Analyzed 121 participants 53 participants 25 participants
78.5 56.6 56.0
Week 288 Number Analyzed 106 participants 46 participants 25 participants
74.5 56.5 68.0
Week 300 Number Analyzed 101 participants 36 participants 19 participants
78.2 50.0 63.2
Week 312 Number Analyzed 111 participants 45 participants 26 participants
72.1 48.9 65.4
10.Secondary Outcome
Title Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time
Hide Description

The simplified disease activity index (SDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm and hsCRP (mg/dL). The total SDAI score ranges from 0 to 86 with higher scores indicating higher disease activity.

Clinical remission is defined as a SDAI score ≤ 3.3.
Time Frame Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
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Hide Analysis Population Description
Open-label treated population with available data at each time point
Arm/Group Title Upadacitinib Never Titrated Upadacitinib Titrated Up and Not Down Upadacitinib Titrated Up and Down
Hide Arm/Group Description:
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
Overall Number of Participants Analyzed 306 149 38
Measure Type: Number
Unit of Measure: percentage of participants
Week 6 Number Analyzed 273 participants 142 participants 37 participants
15.0 4.2 2.7
Week 12 Number Analyzed 270 participants 141 participants 34 participants
17.8 2.8 5.9
Week 24 Number Analyzed 253 participants 133 participants 35 participants
18.2 6.0 11.4
Week 36 Number Analyzed 242 participants 126 participants 35 participants
23.6 4.0 8.6
Week 48 Number Analyzed 228 participants 118 participants 36 participants
25.9 7.6 8.3
Week 60 Number Analyzed 218 participants 107 participants 36 participants
32.6 12.1 13.9
Week 72 Number Analyzed 200 participants 104 participants 33 participants
31.0 9.6 9.1
Week 84 Number Analyzed 205 participants 97 participants 32 participants
32.2 8.2 12.5
Week 96 Number Analyzed 198 participants 96 participants 33 participants
28.8 13.5 18.2
Week 108 Number Analyzed 194 participants 86 participants 33 participants
31.4 10.5 12.1
Week 120 Number Analyzed 185 participants 87 participants 31 participants
33.5 8.0 12.9
Week 132 Number Analyzed 166 participants 76 participants 30 participants
33.1 10.5 20.0
Week 144 Number Analyzed 167 participants 70 participants 28 participants
26.3 5.7 14.3
Week 156 Number Analyzed 164 participants 65 participants 28 participants
33.5 7.7 28.6
Week 168 Number Analyzed 157 participants 69 participants 30 participants
31.8 11.6 26.7
Week 180 Number Analyzed 178 participants 68 participants 30 participants
33.1 10.3 13.3
Week 192 Number Analyzed 168 participants 70 participants 27 participants
32.7 12.9 14.8
Week 204 Number Analyzed 164 participants 70 participants 29 participants
37.2 11.4 24.1
Week 216 Number Analyzed 157 participants 64 participants 28 participants
32.5 10.9 10.7
Week 228 Number Analyzed 149 participants 55 participants 29 participants
30.9 16.4 24.1
Week 240 Number Analyzed 153 participants 62 participants 29 participants
34.0 14.5 10.3
Week 252 Number Analyzed 143 participants 57 participants 31 participants
39.9 12.3 16.1
Week 264 Number Analyzed 128 participants 52 participants 28 participants
32.8 11.5 7.1
Week 276 Number Analyzed 121 participants 53 participants 25 participants
35.5 17.0 20.0
Week 288 Number Analyzed 106 participants 46 participants 25 participants
35.8 19.6 8.0
Week 300 Number Analyzed 101 participants 36 participants 19 participants
34.7 16.7 26.3
Week 312 Number Analyzed 111 participants 45 participants 26 participants
30.6 15.6 26.9
11.Secondary Outcome
Title Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time
Hide Description The disease activity score-28-CRP (DAS28 [CRP]) assesses RA disease activity based on a continuous scale of combined measures of 28 tender joint counts (TJC28), 28 swollen joint counts (SJC28), C-reactive protein (CRP), and the patient global assessment of disease activity (measured on a visual analog scale from 0 to 100 mm). DAS28(CRP) scores range from 0 to approximately 10 where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
Time Frame Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
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Hide Analysis Population Description
Open-label treated population with available data at Baseline and each time point
Arm/Group Title Upadacitinib Never Titrated Upadacitinib Titrated Up and Not Down Upadacitinib Titrated Up and Down
Hide Arm/Group Description:
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily (QD) dose of 15 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
Overall Number of Participants Analyzed 305 146 37
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 6 Number Analyzed 278 participants 144 participants 36 participants
-2.9  (1.21) -2.4  (1.28) -2.5  (1.01)
Week 12 Number Analyzed 271 participants 143 participants 36 participants
-3.1  (1.14) -2.5  (1.27) -2.5  (1.03)
Week 24 Number Analyzed 254 participants 132 participants 35 participants
-3.2  (1.07) -2.7  (1.36) -2.7  (1.22)
Week 36 Number Analyzed 245 participants 126 participants 35 participants
-3.2  (1.20) -2.9  (1.11) -3.0  (1.17)
Week 48 Number Analyzed 227 participants 116 participants 36 participants
-3.4  (1.20) -2.9  (1.20) -2.8  (0.97)
Week 60 Number Analyzed 217 participants 108 participants 35 participants
-3.5  (1.15) -2.9  (1.07) -3.1  (0.98)
Week 72 Number Analyzed 202 participants 102 participants 32 participants
-3.5  (1.03) -2.9  (1.24) -3.1  (0.88)
Week 84 Number Analyzed 206 participants 96 participants 33 participants
-3.5  (1.06) -2.9  (1.28) -3.3  (0.62)
Week 96 Number Analyzed 204 participants 95 participants 33 participants
-3.4  (1.11) -3.1  (1.21) -3.2  (0.98)
Week 108 Number Analyzed 195 participants 91 participants 33 participants
-3.5  (1.09) -3.1  (1.24) -3.1  (0.94)
Week 120 Number Analyzed 185 participants 86 participants 30 participants
-3.5  (1.08) -3.1  (1.29) -3.2  (0.86)
Week 132 Number Analyzed 167 participants 77 participants 30 participants
-3.5  (1.02) -3.1  (1.23) -3.3  (1.02)
Week 144 Number Analyzed 169 participants 70 participants 27 participants
-3.4  (1.13) -3.0  (1.18) -3.4  (1.04)
Week 156 Number Analyzed 166 participants 67 participants 28 participants
-3.5  (1.13) -3.1  (1.11) -3.6  (1.00)
Week 168 Number Analyzed 160 participants 68 participants 29 participants
-3.6  (1.17) -3.2  (1.23) -3.6  (1.08)
Week 180 Number Analyzed 178 participants 68 participants 29 participants
-3.6  (1.10) -3.2  (1.24) -3.5  (1.13)
Week 192 Number Analyzed 169 participants 72 participants 26 participants
-3.6  (1.15) -3.2  (1.31) -3.6  (1.06)
Week 204 Number Analyzed 166 participants 70 participants 29 participants
-3.6  (1.13) -3.1  (1.32) -3.7  (1.13)
Week 216 Number Analyzed 159 participants 64 participants 27 participants
-3.6  (1.13) -3.2  (1.15) -3.5  (1.02)
Week 228 Number Analyzed 151 participants 54 participants 28 participants
-3.6  (1.12) -3.3  (1.37) -3.7  (0.91)
Week 240 Number Analyzed 153 participants 61 participants 28 participants
-3.7  (1.12) -3.2  (1.30) -3.5  (0.91)
Week 252 Number Analyzed 145 participants 58 participants 30 participants
-3.7  (1.20) -3.3  (1.18) -3.3  (1.04)
Week 264 Number Analyzed 130 participants 53 participants 27 participants
-3.5  (1.25) -3.1  (1.24) -3.4  (1.01)
Week 276 Number Analyzed 121 participants 53 participants 24 participants
-3.7  (1.01) -3.1  (1.22) -3.5  (0.90)
Week 288 Number Analyzed 106 participants 45 participants 24 participants
-3.7  (1.08) -3.3  (1.44) -3.2  (0.75)
Week 300 Number Analyzed 101 participants 36 participants 19 participants
-3.7  (1.00) -3.0  (1.38) -3.4  (0.81)
Week 312 Number Analyzed 116 participants 47 participants 26 participants
-3.5  (1.10) -3.2  (1.25) -3.2  (1.04)
12.Secondary Outcome
Title Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
Hide Description The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, and Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.
Time Frame Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label treated population with available data at Baseline and each time point
Arm/Group Title Upadacitinib Never Titrated Upadacitinib Titrated Up and Not Down Upadacitinib Titrated Up and Down
Hide Arm/Group Description:
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily (QD) dose of 15 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
Overall Number of Participants Analyzed 297 144 37
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 6 Number Analyzed 265 participants 138 participants 36 participants
-30.0  (12.49) -27.5  (13.54) -27.2  (11.42)
Week 12 Number Analyzed 265 participants 137 participants 33 participants
-31.6  (11.82) -28.4  (13.87) -27.9  (11.12)
Week 24 Number Analyzed 246 participants 129 participants 34 participants
-32.6  (11.81) -30.6  (13.59) -29.6  (11.45)
Week 36 Number Analyzed 236 participants 122 participants 34 participants
-32.2  (12.43) -31.4  (12.67) -29.6  (11.63)
Week 48 Number Analyzed 222 participants 114 participants 35 participants
-34.0  (12.84) -31.8  (13.35) -29.1  (10.82)
Week 60 Number Analyzed 210 participants 103 participants 35 participants
-34.7  (12.52) -32.4  (12.18) -32.2  (12.09)
Week 72 Number Analyzed 192 participants 100 participants 32 participants
-34.3  (11.71) -32.3  (13.33) -31.8  (10.88)
Week 84 Number Analyzed 197 participants 93 participants 31 participants
-34.9  (12.08) -31.0  (13.36) -33.5  (9.66)
Week 96 Number Analyzed 191 participants 92 participants 32 participants
-33.4  (11.71) -32.1  (12.37) -31.3  (10.86)
Week 108 Number Analyzed 187 participants 83 participants 32 participants
-34.5  (11.83) -32.4  (12.79) -32.3  (10.81)
Week 120 Number Analyzed 181 participants 85 participants 30 participants
-34.8  (11.87) -32.3  (12.94) -34.0  (10.75)
Week 132 Number Analyzed 175 participants 79 participants 29 participants
-35.0  (12.24) -32.7  (12.39) -34.5  (12.14)
Week 144 Number Analyzed 174 participants 74 participants 27 participants
-35.0  (12.21) -33.1  (12.67) -36.2  (12.03)
Week 156 Number Analyzed 171 participants 69 participants 27 participants
-35.6  (12.24) -33.6  (12.25) -36.1  (11.80)
Week 168 Number Analyzed 166 participants 70 participants 29 participants
-36.2  (13.01) -33.8  (12.97) -37.6  (13.08)
Week 180 Number Analyzed 172 participants 66 participants 29 participants
-35.5  (12.60) -34.0  (12.13) -36.9  (12.07)
Week 192 Number Analyzed 161 participants 68 participants 28 participants
-35.6  (12.25) -34.0  (12.89) -38.6  (11.76)
Week 204 Number Analyzed 157 participants 68 participants 28 participants
-36.0  (12.36) -33.8  (13.69) -37.9  (12.59)
Week 216 Number Analyzed 151 participants 62 participants 27 participants
-35.8  (13.19) -33.9  (11.87) -37.3  (11.62)
Week 228 Number Analyzed 143 participants 53 participants 28 participants
-35.6  (12.68) -35.5  (13.31) -37.9  (11.55)
Week 240 Number Analyzed 146 participants 59 participants 28 participants
-36.4  (12.95) -34.7  (13.02) -35.8  (11.07)
Week 252 Number Analyzed 139 participants 55 participants 30 participants
-35.9  (13.41) -35.3  (12.58) -34.3  (11.71)
Week 264 Number Analyzed 126 participants 52 participants 28 participants
-35.5  (13.66) -33.2  (12.38) -33.5  (12.49)
Week 276 Number Analyzed 122 participants 50 participants 27 participants
-36.5  (12.59) -33.6  (12.16) -34.7  (11.92)
Week 288 Number Analyzed 129 participants 48 participants 27 participants
-36.9  (13.22) -35.3  (14.34) -33.5  (10.25)
Week 300 Number Analyzed 120 participants 47 participants 23 participants
-36.0  (12.17) -32.9  (11.86) -34.6  (11.27)
Week 312 Number Analyzed 120 participants 44 participants 25 participants
-35.9  (12.43) -34.4  (12.63) -34.0  (11.62)
13.Secondary Outcome
Title Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time
Hide Description The simplified disease activity index (SDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm and hsCRP (mg/dL). The total SDAI score ranges from 0 to 86 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.
Time Frame Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label treated population with available data at Baseline and each time point
Arm/Group Title Upadacitinib Never Titrated Upadacitinib Titrated Up and Not Down Upadacitinib Titrated Up and Down
Hide Arm/Group Description:
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily (QD) dose of 15 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
Overall Number of Participants Analyzed 297 144 37
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 6 Number Analyzed 264 participants 138 participants 36 participants
-38.8  (25.57) -37.2  (27.36) -40.8  (29.76)
Week 12 Number Analyzed 262 participants 137 participants 33 participants
-40.6  (24.84) -38.6  (26.09) -41.7  (30.24)
Week 24 Number Analyzed 245 participants 129 participants 34 participants
-42.0  (23.35) -36.7  (43.09) -38.2  (33.62)
Week 36 Number Analyzed 235 participants 122 participants 34 participants
-41.8  (25.10) -41.6  (25.59) -44.5  (31.98)
Week 48 Number Analyzed 220 participants 114 participants 35 participants
-42.9  (23.24) -41.6  (25.26) -44.6  (29.09)
Week 60 Number Analyzed 210 participants 103 participants 35 participants
-44.3  (24.21) -42.5  (24.51) -41.4  (22.38)
Week 72 Number Analyzed 192 participants 100 participants 32 participants
-43.4  (24.62) -41.9  (27.31) -41.8  (21.19)
Week 84 Number Analyzed 197 participants 93 participants 31 participants
-42.7  (28.14) -39.0  (31.94) -44.7  (20.79)
Week 96 Number Analyzed 191 participants 92 participants 32 participants
-42.0  (18.50) -42.4  (27.17) -43.2  (22.39)
Week 108 Number Analyzed 187 participants 83 participants 32 participants
-43.6  (27.35) -42.9  (24.31) -44.0  (21.38)
Week 120 Number Analyzed 178 participants 84 participants 30 participants
-42.7  (22.25) -43.7  (25.88) -43.4  (23.39)
Week 132 Number Analyzed 165 participants 76 participants 29 participants
-43.4  (19.92) -41.4  (27.64) -44.2  (23.86)
Week 144 Number Analyzed 166 participants 70 participants 27 participants
-41.7  (22.60) -43.0  (29.91) -46.0  (25.20)
Week 156 Number Analyzed 163 participants 64 participants 27 participants
-42.8  (21.64) -43.6  (29.88) -48.0  (23.98)
Week 168 Number Analyzed 156 participants 67 participants 29 participants
-43.7  (23.75) -43.2  (28.55) -46.4  (23.28)
Week 180 Number Analyzed 171 participants 65 participants 29 participants
-45.6  (26.65) -45.0  (27.57) -47.2  (24.08)
Week 192 Number Analyzed 161 participants 68 participants 26 participants
-44.7  (30.13) -44.4  (27.94) -48.5  (25.36)
Week 204 Number Analyzed 157 participants 68 participants 28 participants
-44.1  (35.23) -43.5  (28.81) -47.6  (24.55)
Week 216 Number Analyzed 150 participants 62 participants 27 participants
-47.3  (27.43) -44.2  (26.69) -47.4  (23.26)
Week 228 Number Analyzed 143 participants 52 participants 28 participants
-46.0  (27.33) -47.9  (28.86) -48.6  (21.47)
Week 240 Number Analyzed 146 participants 59 participants 28 participants
-46.8  (31.40) -44.2  (29.63) -45.0  (21.97)
Week 252 Number Analyzed 136 participants 55 participants 30 participants
-45.9  (25.86) -45.7  (29.98) -44.3  (23.50)
Week 264 Number Analyzed 121 participants 50 participants 27 participants
-44.9  (24.26) -43.5  (30.06) -44.4  (21.96)
Week 276 Number Analyzed 114 participants 50 participants 24 participants
-46.3  (20.01) -44.2  (26.93) -47.4  (20.53)
Week 288 Number Analyzed 105 participants 44 participants 24 participants
-47.1  (22.36) -48.3  (30.14) -41.6  (17.15)
Week 300 Number Analyzed 98 participants 34 participants 18 participants
-47.4  (20.47) -41.6  (26.38) -42.7  (19.05)
Week 312 Number Analyzed 110 participants 43 participants 25 participants
-45.8  (28.64) -45.8  (28.89) -41.2  (17.55)
14.Secondary Outcome
Title Change From Baseline in Tender Joint Count (TJC68) Over Time
Hide Description Sixty-eight joints were assessed by an evaluator for tenderness or pain. The presence of tenderness was scored as a "1" and absence of tenderness as a "0". The total tender joint count is the sum of the scores, and ranges from 0 to 68 (worst).
Time Frame Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label treated population with available data at each time point
Arm/Group Title Upadacitinib Never Titrated Upadacitinib Titrated Up and Not Down Upadacitinib Titrated Up and Down
Hide Arm/Group Description:
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily (QD) dose of 15 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
Overall Number of Participants Analyzed 306 149 38
Mean (Standard Deviation)
Unit of Measure: joints
Week 6 Number Analyzed 284 participants 146 participants 37 participants
-20.6  (12.81) -21.3  (14.53) -22.1  (12.90)
Week 12 Number Analyzed 280 participants 145 participants 37 participants
-21.3  (12.47) -22.5  (14.65) -20.5  (11.18)
Week 24 Number Analyzed 258 participants 137 participants 36 participants
-22.0  (12.96) -23.9  (14.60) -22.9  (12.17)
Week 36 Number Analyzed 248 participants 133 participants 36 participants
-21.7  (12.58) -24.2  (14.45) -23.4  (13.56)
Week 48 Number Analyzed 234 participants 121 participants 37 participants
-23.1  (13.61) -24.1  (14.43) -24.0  (13.13)
Week 60 Number Analyzed 218 participants 110 participants 36 participants
-23.6  (13.56) -25.0  (14.42) -25.6  (13.54)
Week 72 Number Analyzed 204 participants 104 participants 33 participants
-23.3  (13.06) -24.3  (14.48) -26.1  (13.12)
Week 84 Number Analyzed 209 participants 98 participants 34 participants
-23.2  (12.71) -23.4  (14.23) -27.4  (13.32)
Week 96 Number Analyzed 206 participants 97 participants 34 participants
-23.1  (12.90) -23.9  (14.58) -24.6  (11.94)
Week 108 Number Analyzed 195 participants 92 participants 34 participants
-23.3  (12.62) -23.7  (14.22) -25.2  (12.31)
Week 120 Number Analyzed 189 participants 92 participants 34 participants
-23.1  (13.13) -23.9  (14.17) -26.9  (12.72)
Week 132 Number Analyzed 184 participants 82 participants 31 participants
-23.1  (12.79) -23.7  (13.95) -26.8  (13.74)
Week 144 Number Analyzed 183 participants 75 participants 28 participants
-23.5  (13.28) -23.8  (13.50) -29.3  (13.19)
Week 156 Number Analyzed 181 participants 73 participants 30 participants
-23.7  (13.21) -23.9  (13.00) -28.1  (13.63)
Week 168 Number Analyzed 177 participants 74 participants 30 participants
-24.1  (13.82) -24.4  (13.86) -31.0  (14.12)
Week 180 Number Analyzed 180 participants 70 participants 30 participants
-23.7  (13.60) -24.9  (14.12) -29.5  (12.96)
Week 192 Number Analyzed 169 participants 72 participants 29 participants
-24.0  (13.75) -24.4  (14.15) -31.3  (13.80)
Week 204 Number Analyzed 167 participants 70 participants 30 participants
-24.2  (13.77) -23.6  (14.35) -30.4  (14.53)
Week 216 Number Analyzed 160 participants 64 participants 28 participants
-24.2  (13.82) -24.1  (13.87) -31.6  (13.80)
Week 228 Number Analyzed 154 participants 56 participants 30 participants
-23.9  (13.57) -26.6  (14.65) -30.5  (13.69)
Week 240 Number Analyzed 154 participants 62 participants 29 participants
-24.7  (14.09) -25.6  (14.47) -29.4  (14.28)
Week 252 Number Analyzed 148 participants 58 participants 31 participants
-24.2  (13.78) -25.6  (14.14) -27.5  (13.26)
Week 264 Number Analyzed 135 participants 55 participants 29 participants
-23.7  (13.56) -23.7  (13.28) -27.0  (13.76)
Week 276 Number Analyzed 129 participants 54 participants 28 participants
-23.6  (13.55) -23.9  (13.76) -28.0  (14.41)
Week 288 Number Analyzed 137 participants 51 participants 28 participants
-24.9  (14.42) -25.7  (14.87) -26.6  (14.42)
Week 300 Number Analyzed 127 participants 51 participants 26 participants
-24.3  (14.04) -24.5  (15.18) -28.2  (14.10)
Week 312 Number Analyzed 133 participants 50 participants 27 participants
-24.1  (13.82) -23.2  (14.08) -26.8  (14.48)
15.Secondary Outcome
Title Change From Baseline in Swollen Joint Count (SJC66) Over Time
Hide Description Sixty-six joints were assessed by an evaluator for swelling. The presence of swelling was scored as a "1" and absence of swelling as a "0". The total swollen joint count is the sum of the scores, and ranges from 0 to 66 (worst).
Time Frame Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label treated population with available data at each time point
Arm/Group Title Upadacitinib Never Titrated Upadacitinib Titrated Up and Not Down Upadacitinib Titrated Up and Down
Hide Arm/Group Description:
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily (QD) dose of 15 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
Overall Number of Participants Analyzed 306 149 38
Mean (Standard Deviation)
Unit of Measure: joints
Week 6 Number Analyzed 284 participants 146 participants 37 participants
-12.8  (7.76) -13.5  (10.89) -14.5  (8.70)
Week 12 Number Analyzed 280 participants 145 participants 37 participants
-13.7  (7.95) -13.9  (11.26) -13.5  (6.72)
Week 24 Number Analyzed 258 participants 137 participants 36 participants
-14.2  (8.31) -14.7  (10.87) -15.7  (5.67)
Week 36 Number Analyzed 248 participants 133 participants 36 participants
-14.1  (8.26) -15.1  (10.39) -15.6  (5.94)
Week 48 Number Analyzed 234 participants 121 participants 37 participants
-15.3  (9.47) -15.4  (11.19) -16.0  (6.10)
Week 60 Number Analyzed 218 participants 110 participants 36 participants
-15.6  (9.52) -15.9  (11.83) -17.4  (9.36)
Week 72 Number Analyzed 204 participants 104 participants 33 participants
-15.1  (8.50) -15.5  (10.47) -17.0  (6.31)
Week 84 Number Analyzed 209 participants 98 participants 34 participants
-15.6  (9.18) -14.7  (9.96) -17.0  (6.68)
Week 96 Number Analyzed 206 participants 97 participants 34 participants
-15.3  (9.27) -14.7  (9.48) -16.6  (6.79)
Week 108 Number Analyzed 195 participants 92 participants 34 participants
-15.2  (8.72) -15.2  (10.17) -16.6  (6.96)
Week 120 Number Analyzed 189 participants 89 participants 31 participants
-15.6  (8.77) -14.8  (9.06) -17.5  (7.15)
Week 132 Number Analyzed 184 participants 82 participants 31 participants
-15.7  (9.23) -14.6  (9.79) -17.3  (7.11)
Week 144 Number Analyzed 183 participants 75 participants 28 participants
-15.9  (9.03) -15.3  (9.81) -18.6  (7.17)
Week 156 Number Analyzed 181 participants 73 participants 30 participants
-16.1  (9.74) -15.5  (9.53) -17.5  (7.89)
Week 168 Number Analyzed 177 participants 74 participants 30 participants
-16.9  (11.11) -15.8  (10.51) -20.0  (9.94)
Week 180 Number Analyzed 180 participants 70 participants 30 participants
-16.6  (10.67) -16.2  (10.61) -20.0  (9.91)
Week 192 Number Analyzed 169 participants 72 participants 29 participants
-16.4  (9.87) -15.8  (9.23) -20.7  (10.08)
Week 204 Number Analyzed 167 participants 70 participants 30 participants
-16.7  (10.60) -15.9  (9.53) -19.6  (10.22)
Week 216 Number Analyzed 160 participants 64 participants 28 participants
-16.6  (10.29) -16.1  (8.86) -20.4  (10.12)
Week 228 Number Analyzed 154 participants 56 participants 30 participants
-16.2  (9.51) -17.3  (10.79) -19.8  (10.16)
Week 240 Number Analyzed 154 participants 62 participants 29 participants
-16.8  (10.41) -17.0  (10.43) -18.8  (7.86)
Week 252 Number Analyzed 148 participants 58 participants 31 participants
-16.8  (10.63) -16.9  (9.37) -18.1  (7.78)
Week 264 Number Analyzed 135 participants 55 participants 29 participants
-17.7  (11.38) -16.1  (8.72) -18.3  (7.55)
Week 276 Number Analyzed 129 participants 54 participants 28 participants
-17.8  (11.35) -17.0  (10.60) -18.9  (7.74)
Week 288 Number Analyzed 137 participants 51 participants 28 participants
-17.4  (11.28) -17.8  (11.76) -18.7  (7.67)
Week 300 Number Analyzed 127 participants 51 participants 26 participants
-16.7  (10.21) -17.1  (10.31) -19.3  (7.72)
Week 312 Number Analyzed 133 participants 50 participants 27 participants
-16.7  (9.71) -17.4  (10.41) -18.6  (7.51)
16.Secondary Outcome
Title Change From Baseline in Physician's Global Assessment of Disease Activity Over Time
Hide Description The physician rated the participant's current global RA disease activity (independently from the participant's assessment) on a visual analog scale (VAS) from 0 to 100 mm, where 0 mm indicates no disease activity and 100 mm indicates severe disease activity
Time Frame Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label treated population with available data at Baseline and each time point
Arm/Group Title Upadacitinib Never Titrated Upadacitinib Titrated Up and Not Down Upadacitinib Titrated Up and Down
Hide Arm/Group Description:
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily (QD) dose of 15 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
Overall Number of Participants Analyzed 298 147 38
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 6 Number Analyzed 268 participants 140 participants 37 participants
-46.8  (20.58) -35.5  (21.53) -38.4  (24.08)
Week 12 Number Analyzed 269 participants 140 participants 34 participants
-48.9  (20.45) -39.1  (22.99) -37.5  (21.78)
Week 24 Number Analyzed 248 participants 133 participants 36 participants
-51.2  (18.71) -42.5  (21.24) -40.9  (22.79)
Week 36 Number Analyzed 236 participants 124 participants 35 participants
-51.6  (19.08) -42.7  (20.96) -39.5  (24.20)
Week 48 Number Analyzed 223 participants 116 participants 36 participants
-52.8  (19.12) -45.6  (19.29) -40.6  (20.97)
Week 60 Number Analyzed 211 participants 106 participants 36 participants
-54.2  (16.44) -47.1  (19.64) -44.7  (24.33)
Week 72 Number Analyzed 198 participants 103 participants 34 participants
-53.4  (17.46) -45.9  (18.58) -47.2  (18.47)
Week 84 Number Analyzed 199 participants 96 participants 32 participants
-54.3  (16.44) -43.4  (21.41) -48.5  (17.25)
Week 96 Number Analyzed 192 participants 95 participants 33 participants
-52.3  (17.69) -45.7  (20.42) -46.8  (20.97)
Week 108 Number Analyzed 187 participants 86 participants 33 participants
-55.5  (16.72) -45.9  (18.75) -47.4  (21.09)
Week 120 Number Analyzed 182 participants 86 participants 31 participants
-55.9  (16.38) -48.6  (18.23) -50.1  (21.51)
Week 132 Number Analyzed 177 participants 79 participants 30 participants
-56.1  (16.60) -50.1  (17.19) -52.5  (20.62)
Week 144 Number Analyzed 174 participants 74 participants 29 participants
-56.7  (15.79) -48.2  (18.28) -51.4  (19.66)
Week 156 Number Analyzed 172 participants 70 participants 29 participants
-57.0  (16.90) -48.9  (18.89) -52.4  (19.49)
Week 168 Number Analyzed 168 participants 73 participants 30 participants
-57.0  (15.94) -51.9  (20.24) -55.6  (21.25)
Week 180 Number Analyzed 174 participants 68 participants 30 participants
-57.2  (17.11) -53.0  (18.04) -53.1  (19.34)
Week 192 Number Analyzed 162 participants 68 participants 30 participants
-56.3  (17.25) -52.1  (16.56) -55.1  (20.69)
Week 204 Number Analyzed 158 participants 69 participants 30 participants
-58.0  (16.73) -52.9  (18.09) -54.7  (19.50)
Week 216 Number Analyzed 151 participants 63 participants 31 participants
-58.3  (16.50) -50.8  (18.27) -51.3  (20.42)
Week 228 Number Analyzed 146 participants 55 participants 30 participants
-56.3  (19.63) -53.2  (17.28) -55.0  (19.69)
Week 240 Number Analyzed 148 participants 61 participants 29 participants
-58.1  (17.63) -52.8  (16.04) -49.6  (18.67)
Week 252 Number Analyzed 141 participants 55 participants 31 participants
-57.2  (17.56) -53.9  (17.10) -52.2  (18.12)
Week 264 Number Analyzed 130 participants 52 participants 29 participants
-56.5  (16.68) -50.4  (18.09) -46.4  (18.60)
Week 276 Number Analyzed 123 participants 52 participants 28 participants
-56.9  (16.79) -53.5  (17.07) -50.1  (17.96)
Week 288 Number Analyzed 132 participants 51 participants 29 participants
-57.3  (18.97) -56.3  (17.25) -49.4  (16.31)
Week 300 Number Analyzed 126 participants 50 participants 25 participants
-56.8  (17.93) -52.9  (17.33) -53.6  (17.36)
Week 312 Number Analyzed 125 participants 45 participants 26 participants
-58.7  (16.12) -55.2  (17.19) -49.4  (17.96)
17.Secondary Outcome
Title Change From Baseline in Patient's Global Assessment of Disease Activity Over Time
Hide Description The participant was asked to rate their current RA disease activity over the past 24 hours on a 100 mm VAS, where 0 mm indicates very low disease activity and 100 mm indicates very high disease activity.
Time Frame Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label treated population with available data at Baseline and each time point
Arm/Group Title Upadacitinib Never Titrated Upadacitinib Titrated Up and Not Down Upadacitinib Titrated Up and Down
Hide Arm/Group Description:
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily (QD) dose of 15 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
Overall Number of Participants Analyzed 305 146 37
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 6 Number Analyzed 280 participants 145 participants 36 participants
-35.4  (29.83) -27.2  (27.74) -26.1  (27.46)
Week 12 Number Analyzed 275 participants 143 participants 36 participants
-37.5  (29.00) -29.2  (28.05) -31.3  (23.13)
Week 24 Number Analyzed 257 participants 132 participants 36 participants
-36.9  (28.97) -30.4  (31.16) -32.9  (25.63)
Week 36 Number Analyzed 246 participants 126 participants 35 participants
-37.1  (30.36) -32.6  (28.62) -34.9  (26.00)
Week 48 Number Analyzed 229 participants 116 participants 36 participants
-39.2  (30.36) -30.7  (30.46) -23.6  (26.58)
Week 60 Number Analyzed 219 participants 110 participants 35 participants
-40.8  (28.95) -34.4  (28.36) -38.3  (24.46)
Week 72 Number Analyzed 208 participants 104 participants 33 participants
-40.3  (27.36) -32.1  (30.19) -26.3  (30.70)
Week 84 Number Analyzed 209 participants 99 participants 33 participants
-40.1  (30.37) -32.0  (31.27) -39.4  (21.35)
Week 96 Number Analyzed 205 participants 96 participants 33 participants
-38.1  (30.34) -33.5  (33.51) -33.5  (22.08)
Week 108 Number Analyzed 195 participants 93 participants 33 participants
-40.8  (29.75) -35.0  (29.93) -32.1  (20.65)
Week 120 Number Analyzed 188 participants 87 participants 30 participants
-40.6  (29.76) -32.4  (32.91) -36.6  (28.02)
Week 132 Number Analyzed 184 participants 82 participants 30 participants
-40.1  (29.99) -37.0  (28.43) -38.4  (27.02)
Week 144 Number Analyzed 183 participants 75 participants 28 participants
-37.7  (30.73) -36.8  (28.24) -33.9  (29.68)
Week 156 Number Analyzed 180 participants 74 participants 28 participants
-39.7  (32.65) -36.9  (25.93) -38.6  (21.61)
Week 168 Number Analyzed 177 participants 73 participants 29 participants
-42.7  (29.04) -37.9  (29.10) -39.0  (32.84)
Week 180 Number Analyzed 179 participants 71 participants 29 participants
-40.3  (29.52) -30.7  (33.34) -33.3  (34.03)
Week 192 Number Analyzed 170 participants 72 participants 30 participants
-41.0  (28.73) -33.4  (33.30) -42.1  (23.97)
Week 204 Number Analyzed 166 participants 71 participants 30 participants
-42.0  (29.28) -33.2  (34.00) -43.7  (25.60)
Week 216 Number Analyzed 161 participants 65 participants 30 participants
-39.0  (32.18) -32.5  (30.72) -35.6  (27.03)
Week 228 Number Analyzed 153 participants 59 participants 30 participants
-38.4  (32.29) -28.5  (37.86) -40.1  (24.11)
Week 240 Number Analyzed 155 participants 62 participants 28 participants
-41.9  (30.43) -37.6  (28.56) -33.3  (29.03)
Week 252 Number Analyzed 151 participants 59 participants 30 participants
-40.6  (32.12) -33.8  (31.76) -33.5  (35.96)
Week 264 Number Analyzed 140 participants 55 participants 28 participants
-38.5  (31.53) -31.6  (34.26) -32.7  (34.87)
Week 276 Number Analyzed 130 participants 54 participants 27 participants
-42.4  (27.53) -36.8  (29.40) -26.0  (33.79)
Week 288 Number Analyzed 138 participants 53 participants 28 participants
-43.3  (27.99) -38.5  (32.21) -32.2  (28.16)
Week 300 Number Analyzed 134 participants 52 participants 27 participants
-38.8  (29.04) -33.4  (34.89) -31.6  (25.93)
Week 312 Number Analyzed 137 participants 49 participants 27 participants
-36.5  (32.10) -39.4  (30.60) -37.7  (29.67)
18.Secondary Outcome
Title Change From Baseline in Patient's Assessment of Pain Over Time
Hide Description Participants were asked to indicate the severity of their arthritis pain within the previous week on a visual analog scale from 0 to 100 mm. A score of 0 mm indicates "no pain" and a score of 100 mm indicates "worst possible pain."
Time Frame Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label treated population with available data at Baseline and each time point
Arm/Group Title Upadacitinib Never Titrated Upadacitinib Titrated Up and Not Down Upadacitinib Titrated Up and Down
Hide Arm/Group Description:
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily (QD) dose of 15 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
Overall Number of Participants Analyzed 305 146 37
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 6 Number Analyzed 280 participants 145 participants 36 participants
-38.5  (27.16) -29.9  (24.46) -30.0  (26.37)
Week 12 Number Analyzed 275 participants 143 participants 36 participants
-41.3  (26.07) -29.9  (26.20) -31.9  (20.23)
Week 24 Number Analyzed 257 participants 132 participants 36 participants
-42.2  (25.41) -30.9  (28.77) -36.0  (21.73)
Week 36 Number Analyzed 246 participants 126 participants 35 participants
-40.6  (26.41) -34.6  (26.56) -34.8  (21.83)
Week 48 Number Analyzed 229 participants 116 participants 36 participants
-42.4  (26.50) -31.9  (28.73) -32.6  (23.67)
Week 60 Number Analyzed 219 participants 110 participants 35 participants
-41.9  (27.89) -32.2  (26.50) -38.6  (23.34)
Week 72 Number Analyzed 208 participants 104 participants 33 participants
-42.5  (24.76) -32.0  (25.38) -31.4  (22.95)
Week 84 Number Analyzed 209 participants 99 participants 33 participants
-42.1  (25.87) -33.3  (26.52) -43.0  (20.51)
Week 96 Number Analyzed 205 participants 96 participants 33 participants
-40.5  (28.02) -34.2  (26.14) -37.6  (20.15)
Week 108 Number Analyzed 195 participants 93 participants 33 participants
-43.6  (26.28) -33.9  (27.60) -36.3  (23.12)
Week 120 Number Analyzed 188 participants 87 participants 30 participants
-43.0  (26.67) -36.2  (27.69) -41.9  (21.40)
Week 132 Number Analyzed 184 participants 82 participants 30 participants
-42.2  (26.89) -36.7  (26.71) -34.4  (27.27)
Week 144 Number Analyzed 183 participants 75 participants 28 participants
-41.7  (27.02) -36.7  (27.14) -33.8  (24.60)
Week 156 Number Analyzed 180 participants 74 participants 28 participants
-43.5  (25.72) -37.4  (25.27) -34.6  (24.91)
Week 168 Number Analyzed 177 participants 73 participants 29 participants
-43.6  (27.19) -38.8  (27.67) -41.6  (25.76)
Week 180 Number Analyzed 179 participants 71 participants 29 participants
-42.7  (26.54) -33.6  (30.24) -36.5  (29.20)
Week 192 Number Analyzed 170 participants 72 participants 30 participants
-41.6  (27.90) -33.8  (29.13) -39.9  (25.44)
Week 204 Number Analyzed 166 participants 71 participants 30 participants
-44.4  (25.26) -33.4  (33.05) -41.9  (22.39)
Week 216 Number Analyzed 161 participants 65 participants 30 participants
-42.2  (28.01) -32.5  (32.06) -33.6  (25.98)
Week 228 Number Analyzed 153 participants 59 participants 30 participants
-45.1  (24.96) -29.6  (35.17) -39.8  (24.70)
Week 240 Number Analyzed 155 participants 62 participants 28 participants
-43.4  (27.78) -34.1  (31.98) -36.1  (25.38)
Week 252 Number Analyzed 151 participants 59 participants 30 participants
-44.4  (27.49) -34.3  (28.12) -38.3  (24.92)
Week 264 Number Analyzed 140 participants 55 participants 28 participants
-44.0  (25.43) -35.6  (31.33) -38.2  (24.11)
Week 276 Number Analyzed 130 participants 54 participants 27 participants
-46.3  (24.53) -35.6  (27.39) -34.1  (26.80)
Week 288 Number Analyzed 138 participants 53 participants 28 participants
-46.2  (25.61) -37.6  (28.74) -33.3  (23.30)
Week 300 Number Analyzed 134 participants 52 participants 27 participants
-43.0  (25.18) -34.7  (32.36) -29.9  (30.21)
Week 312 Number Analyzed 137 participants 49 participants 27 participants
-44.1  (25.87) -40.3  (27.37) -33.4  (30.11)
19.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time
Hide Description The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.
Time Frame Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label treated population with available data at Baseline and each time point
Arm/Group Title Upadacitinib Never Titrated Upadacitinib Titrated Up and Not Down Upadacitinib Titrated Up and Down
Hide Arm/Group Description:
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily (QD) dose of 15 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
Overall Number of Participants Analyzed 304 146 37
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 6 Number Analyzed 264 participants 136 participants 35 participants
-0.7  (0.62) -0.6  (0.56) -0.6  (0.47)
Week 12 Number Analyzed 264 participants 138 participants 34 participants
-0.7  (0.64) -0.6  (0.63) -0.7  (0.55)
Week 24 Number Analyzed 236 participants 130 participants 33 participants
-0.8  (0.60) -0.6  (0.61) -0.7  (0.58)
Week 36 Number Analyzed 235 participants 117 participants 32 participants
-0.7  (0.66) -0.6  (0.62) -0.7  (0.66)
Week 48 Number Analyzed 213 participants 111 participants 34 participants
-0.8  (0.63) -0.7  (0.61) -0.7  (0.58)
Week 60 Number Analyzed 206 participants 104 participants 34 participants
-0.8  (0.67) -0.7  (0.66) -0.7  (0.52)
Week 72 Number Analyzed 194 participants 100 participants 33 participants
-0.8  (0.65) -0.7  (0.63) -0.7  (0.54)
Week 84 Number Analyzed 196 participants 90 participants 32 participants
-0.9  (0.62) -0.7  (0.64) -0.7  (0.57)
Week 96 Number Analyzed 192 participants 89 participants 30 participants
-0.8  (0.64) -0.8  (0.69) -0.8  (0.52)
Week 108 Number Analyzed 185 participants 87 participants 33 participants
-0.9  (0.67) -0.7  (0.67) -0.7  (0.58)
Week 120 Number Analyzed 178 participants 84 participants 29 participants
-0.8  (0.64) -0.7  (0.64) -0.8  (0.62)
Week 132 Number Analyzed 176 participants 75 participants 28 participants
-0.9  (0.66) -0.7  (0.64) -0.8  (0.51)
Week 144 Number Analyzed 170 participants 70 participants 27 participants
-0.8  (0.72) -0.8  (0.68) -0.7  (0.61)
Week 156 Number Analyzed 172 participants 72 participants 26 participants
-0.8  (0.69) -0.7  (0.57) -0.8  (0.61)
Week 168 Number Analyzed 168 participants 72 participants 27 participants
-0.8  (0.68) -0.7  (0.67) -0.8  (0.60)
Week 180 Number Analyzed 169 participants 69 participants 28 participants
-0.8  (0.70) -0.7  (0.70) -0.7  (0.64)
Week 192 Number Analyzed 160 participants 66 participants 26 participants
-0.8  (0.68) -0.7  (0.69) -0.8  (0.57)
Week 204 Number Analyzed 160 participants 69 participants 28 participants
-0.9  (0.68) -0.7  (0.79) -0.8  (0.51)
Week 216 Number Analyzed 155 participants 64 participants 30 participants
-0.8  (0.69) -0.7  (0.73) -0.8  (0.61)
Week 228 Number Analyzed 146 participants 57 participants 29 participants
-0.9  (0.72) -0.7  (0.77) -0.7  (0.61)
Week 240 Number Analyzed 146 participants 62 participants 28 participants
-0.8  (0.69) -0.7  (0.77) -0.6  (0.61)
Week 252 Number Analyzed 139 participants 57 participants 27 participants
-0.9  (0.69) -0.7  (0.77) -0.7  (0.59)
Week 264 Number Analyzed 136 participants 50 participants 27 participants
-0.8  (0.68) -0.7  (0.65) -0.7  (0.59)
Week 276 Number Analyzed 127 participants 52 participants 27 participants
-0.8  (0.69) -0.6  (0.66) -0.7  (0.61)
Week 288 Number Analyzed 125 participants 47 participants 26 participants
-0.9  (0.70) -0.7  (0.74) -0.8  (0.61)
Week 300 Number Analyzed 128 participants 51 participants 24 participants
-0.8  (0.76) -0.7  (0.70) -0.7  (0.68)
Week 312 Number Analyzed 129 participants 46 participants 27 participants
-0.8  (0.71) -0.8  (0.74) -0.7  (0.69)
20.Secondary Outcome
Title Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time
Hide Description [Not Specified]
Time Frame Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label treated population with available data at each time point
Arm/Group Title Upadacitinib Never Titrated Upadacitinib Titrated Up and Not Down Upadacitinib Titrated Up and Down
Hide Arm/Group Description:
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily (QD) dose of 15 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
Overall Number of Participants Analyzed 306 149 38
Mean (Standard Deviation)
Unit of Measure: mg/L
Week 6 Number Analyzed 297 participants 149 participants 38 participants
-7.9  (21.74) -10.0  (21.95) -13.0  (29.00)
Week 12 Number Analyzed 282 participants 147 participants 38 participants
-9.0  (18.96) -10.7  (20.94) -12.8  (26.93)
Week 24 Number Analyzed 264 participants 139 participants 38 participants
-9.4  (17.38) -7.2  (36.97) -9.1  (29.38)
Week 36 Number Analyzed 254 participants 133 participants 38 participants
-9.5  (18.62) -11.1  (22.03) -13.5  (28.34)
Week 48 Number Analyzed 239 participants 125 participants 38 participants
-8.8  (17.50) -10.2  (22.28) -13.3  (22.69)
Week 60 Number Analyzed 227 participants 117 participants 37 participants
-9.6  (17.78) -10.3  (22.10) -11.0  (21.62)
Week 72 Number Analyzed 222 participants 111 participants 36 participants
-9.2  (19.42) -9.9  (22.95) -11.2  (20.16)
Week 84 Number Analyzed 217 participants 105 participants 35 participants
-8.3  (24.66) -10.0  (28.56) -10.2  (16.57)
Week 96 Number Analyzed 213 participants 101 participants 35 participants
-10.1  (17.74) -10.3  (22.36) -11.1  (17.61)
Week 108 Number Analyzed 206 participants 96 participants 35 participants
-9.8  (21.56) -10.7  (19.36) -10.8  (17.39)
Week 120 Number Analyzed 198 participants 91 participants 32 participants
-8.4  (18.27) -10.9  (19.63) -9.2  (18.62)
Week 132 Number Analyzed 181 participants 83 participants 33 participants
-8.9  (15.19) -9.0  (21.32) -9.3  (17.53)
Week 144 Number Analyzed 180 participants 76 participants 32 participants
-7.3  (17.15) -9.9  (23.45) -5.9  (26.82)
Week 156 Number Analyzed 176 participants 72 participants 32 participants
-8.6  (16.60) -6.0  (52.17) -10.9  (18.20)
Week 168 Number Analyzed 171 participants 74 participants 32 participants
-7.7  (18.37) -7.5  (28.96) -8.8  (17.88)
Week 180 Number Analyzed 185 participants 72 participants 32 participants
-10.0  (19.41) -10.3  (21.44) -9.2  (19.16)
Week 192 Number Analyzed 177 participants 73 participants 30 participants
-9.4  (23.81) -9.9  (21.04) -9.3  (20.07)
Week 204 Number Analyzed 174 participants 72 participants 32 participants
-8.4  (28.90) -9.6  (21.29) -9.0  (19.07)
Week 216 Number Analyzed 166 participants 68 participants 32 participants
-11.5  (20.22) -10.0  (22.42) -8.4  (19.70)
Week 228 Number Analyzed 165 participants 61 participants 31 participants
-11.0  (20.71) -12.2  (20.89) -10.0  (17.46)
Week 240 Number Analyzed 163 participants 63 participants 32 participants
-10.6  (24.45) -9.1  (22.38) -9.2  (17.55)
Week 252 Number Analyzed 151 participants 61 participants 31 participants
-10.4  (19.33) -9.4  (24.28) -9.9  (18.83)
Week 264 Number Analyzed 141 participants 57 participants 28 participants
-11.2  (21.02) -9.9  (23.99) -11.1  (18.19)
Week 276 Number Analyzed 135 participants 56 participants 27 participants
-10.5  (18.04) -11.2  (20.20) -10.9  (17.95)
Week 288 Number Analyzed 115 participants 51 participants 26 participants
-10.6  (16.09) -12.9  (21.85) -7.5  (14.48)
Week 300 Number Analyzed 113 participants 40 participants 22 participants
-11.1  (14.63) -11.4  (21.67) -11.0  (19.69)
Week 312 Number Analyzed 124 participants 49 participants 29 participants
-10.3  (22.22) -12.0  (21.14) -8.7  (15.19)
21.Secondary Outcome
Title Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time
Hide Description The FACIT Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better quality of life. A positive change from Baseline indicates improvement.
Time Frame Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label treated population with available data at Baseline and each time point
Arm/Group Title Upadacitinib Never Titrated Upadacitinib Titrated Up and Not Down Upadacitinib Titrated Up and Down
Hide Arm/Group Description:
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily (QD) dose of 15 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
Overall Number of Participants Analyzed 304 146 37
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 6 Number Analyzed 278 participants 145 participants 36 participants
9.5  (10.50) 9.0  (9.69) 8.8  (9.26)
Week 12 Number Analyzed 275 participants 142 participants 36 participants
9.9  (10.49) 8.7  (10.87) 8.6  (10.43)
Week 24 Number Analyzed 256 participants 133 participants 36 participants
10.7  (10.04) 10.6  (11.60) 8.3  (9.65)
Week 36 Number Analyzed 244 participants 126 participants 35 participants
10.1  (10.59) 10.0  (11.58) 8.0  (11.50)
Week 48 Number Analyzed 228 participants 116 participants 36 participants
10.4  (10.58) 10.8  (10.44) 8.4  (10.83)
Week 72 Number Analyzed 208 participants 107 participants 33 participants
10.8  (9.55) 10.9  (10.64) 9.2  (11.44)
Week 96 Number Analyzed 204 participants 96 participants 32 participants
10.3  (10.45) 11.7  (12.72) 9.5  (11.27)
Week 108 Number Analyzed 194 participants 93 participants 33 participants
10.5  (10.49) 11.9  (12.08) 7.9  (10.62)
Week 120 Number Analyzed 187 participants 87 participants 30 participants
11.0  (10.76) 11.6  (11.95) 10.7  (11.30)
Week 132 Number Analyzed 182 participants 82 participants 30 participants
11.4  (10.13) 10.7  (11.47) 10.7  (10.36)
Week 144 Number Analyzed 182 participants 75 participants 28 participants
9.9  (11.36) 11.2  (12.09) 9.8  (11.67)
Week 156 Number Analyzed 179 participants 74 participants 28 participants
10.6  (10.94) 11.2  (11.48) 8.6  (12.32)
Week 168 Number Analyzed 176 participants 73 participants 29 participants
10.8  (12.27) 10.6  (12.46) 11.4  (13.18)
Week 180 Number Analyzed 178 participants 71 participants 29 participants
11.0  (11.59) 9.6  (13.56) 11.4  (12.45)
Week 192 Number Analyzed 169 participants 72 participants 30 participants
10.8  (10.50) 10.9  (11.82) 11.5  (13.27)
Week 204 Number Analyzed 164 participants 71 participants 30 participants
11.3  (10.56) 10.2  (13.01) 11.2  (12.70)
Week 216 Number Analyzed 160 participants 65 participants 30 participants
11.4  (11.93) 10.4  (13.92) 10.1  (12.87)
Week 228 Number Analyzed 152 participants 59 participants 30 participants
11.0  (11.25) 10.8  (14.00) 11.1  (13.18)
Week 240 Number Analyzed 154 participants 62 participants 28 participants
11.9  (10.93) 11.4  (13.08) 9.2  (13.81)
Week 252 Number Analyzed 150 participants 59 participants 30 participants
11.5  (10.83) 10.2  (13.68) 8.4  (13.48)
Week 264 Number Analyzed 139 participants 55 participants 28 participants
11.6  (10.95) 10.7  (12.52) 7.8  (13.94)
Week 276 Number Analyzed 129 participants 54 participants 27 participants
12.1  (10.98) 9.2  (13.02) 7.3  (13.02)
Week 288 Number Analyzed 137 participants 53 participants 28 participants
11.6  (10.88) 12.3  (11.83) 9.0  (13.94)
Week 300 Number Analyzed 133 participants 52 participants 27 participants
11.1  (11.14) 9.7  (13.12) 7.0  (13.46)
Week 312 Number Analyzed 136 participants 49 participants 27 participants
10.7  (11.24) 11.6  (12.67) 8.6  (14.35)
22.Secondary Outcome
Title Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time
Hide Description

RA-WIS is a tool to evaluate work instability (the consequence of a mismatch between an individual's functional ability and their work tasks). RA-WIS consists of 23 questions relating to the participant's functioning in their work environment, each answered as Yes or No. The total score is the number of questions answered Yes, and ranges from 0 to 23.

A score < 10 means low risk, scores between 10 and 17 indicate medium risk, and scores > 17 indicate high risk of work instability.

A negative change from Baseline indicates improvement in work instability.
Time Frame Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label treated population who were currently working at Baseline and at each visit visit and with available data at each time point
Arm/Group Title Upadacitinib Never Titrated Upadacitinib Titrated Up and Not Down Upadacitinib Titrated Up and Down
Hide Arm/Group Description:
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily (QD) dose of 15 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
Overall Number of Participants Analyzed 87 53 13
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 6 Number Analyzed 75 participants 45 participants 12 participants
-6.2  (5.55) -3.3  (5.51) -4.1  (3.00)
Week 12 Number Analyzed 70 participants 43 participants 12 participants
-6.6  (6.16) -4.0  (6.32) -4.2  (3.35)
Week 24 Number Analyzed 67 participants 41 participants 12 participants
-7.0  (6.51) -4.6  (6.63) -3.6  (3.53)
Week 36 Number Analyzed 61 participants 42 participants 11 participants
-6.8  (6.29) -4.6  (6.21) -3.3  (6.18)
Week 48 Number Analyzed 55 participants 40 participants 12 participants
-6.8  (5.94) -5.0  (6.47) -3.5  (4.98)
Week 72 Number Analyzed 51 participants 39 participants 12 participants
-7.5  (6.83) -4.8  (6.27) -4.3  (4.10)
Week 96 Number Analyzed 54 participants 37 participants 12 participants
-6.5  (6.72) -6.3  (7.55) -4.0  (4.18)
Week 108 Number Analyzed 52 participants 32 participants 11 participants
-6.8  (6.80) -6.5  (6.71) -3.5  (4.80)
Week 120 Number Analyzed 47 participants 31 participants 9 participants
-7.6  (6.66) -5.1  (7.38) -5.7  (4.44)
Week 132 Number Analyzed 47 participants 29 participants 10 participants
-7.2  (6.04) -5.6  (6.99) -4.7  (3.47)
Week 144 Number Analyzed 46 participants 26 participants 8 participants
-5.9  (6.51) -5.6  (7.65) -4.3  (3.41)
Week 156 Number Analyzed 47 participants 25 participants 8 participants
-6.2  (7.13) -4.3  (7.62) -4.9  (3.72)
Week 168 Number Analyzed 43 participants 24 participants 8 participants
-5.8  (6.01) -4.3  (6.96) -5.1  (6.69)
Week 180 Number Analyzed 43 participants 24 participants 6 participants
-5.3  (6.61) -3.5  (7.03) -4.2  (3.19)
Week 192 Number Analyzed 40 participants 24 participants 7 participants
-5.5  (6.42) -3.5  (7.36) -4.3  (2.93)
Week 204 Number Analyzed 36 participants 23 participants 8 participants
-6.4  (7.06) -3.7  (7.52) -5.0  (3.78)
Week 216 Number Analyzed 38 participants 23 participants 9 participants
-6.0  (7.55) -3.4  (7.11) -5.0  (2.92)
Week 228 Number Analyzed 38 participants 18 participants 7 participants
-6.5  (7.16) -1.9  (7.55) -4.6  (4.24)
Week 240 Number Analyzed 34 participants 21 participants 6 participants
-5.9  (7.05) -3.1  (7.61) -4.5  (4.09)
Week 252 Number Analyzed 33 participants 18 participants 8 participants
-5.8  (6.43) -2.0  (8.05) -5.0  (3.70)
Week 264 Number Analyzed 33 participants 20 participants 8 participants
-5.0  (6.53) -3.4  (8.00) -4.5  (3.89)
Week 276 Number Analyzed 30 participants 18 participants 7 participants
-5.0  (6.74) -2.7  (8.27) -5.0  (2.52)
Week 288 Number Analyzed 29 participants 17 participants 8 participants
-5.0  (7.05) -4.8  (7.38) -4.8  (3.45)
Week 300 Number Analyzed 30 participants 15 participants 8 participants
-4.6  (7.23) -4.3  (8.51) -4.6  (4.07)
Week 312 Number Analyzed 31 participants 15 participants 8 participants
-4.2  (7.00) -3.9  (8.37) -2.9  (4.45)
23.Secondary Outcome
Title Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time
Hide Description

The EQ-5D-5L is a generic measure of health status consisting of two parts. The first part (the descriptive system) assesses health in five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which is rated on 5 levels of severity (1: no problem, 2: slight problems, 3: moderate problems, 4: severe problems, 5: extreme problems).

A health state index score was calculated from individual health profiles using a UK scoring algorithm. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The higher the score the better the health status. A positive change from baseline indicates improvement in health status.
Time Frame Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label treated population with available data at Baseline and each time point
Arm/Group Title Upadacitinib Never Titrated Upadacitinib Titrated Up and Not Down Upadacitinib Titrated Up and Down
Hide Arm/Group Description:
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily (QD) dose of 15 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
Overall Number of Participants Analyzed 304 146 37
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 6 Number Analyzed 278 participants 145 participants 36 participants
0.2  (0.24) 0.2  (0.27) 0.2  (0.18)
Week 12 Number Analyzed 275 participants 142 participants 36 participants
0.2  (0.23) 0.2  (0.29) 0.2  (0.14)
Week 24 Number Analyzed 256 participants 133 participants 36 participants
0.2  (0.23) 0.2  (0.28) 0.2  (0.16)
Week 36 Number Analyzed 244 participants 126 participants 35 participants
0.2  (0.24) 0.2  (0.27) 0.2  (0.16)
Week 48 Number Analyzed 228 participants 116 participants 36 participants
0.2  (0.25) 0.2  (0.31) 0.1  (0.20)
Week 72 Number Analyzed 209 participants 107 participants 33 participants
0.2  (0.24) 0.2  (0.28) 0.2  (0.16)
Week 96 Number Analyzed 204 participants 97 participants 32 participants
0.2  (0.25) 0.2  (0.28) 0.2  (0.15)
Week 108 Number Analyzed 194 participants 93 participants 33 participants
0.2  (0.26) 0.2  (0.28) 0.1  (0.16)
Week 120 Number Analyzed 187 participants 87 participants 30 participants
0.2  (0.26) 0.2  (0.27) 0.2  (0.16)
Week 132 Number Analyzed 182 participants 82 participants 30 participants
0.2  (0.25) 0.2  (0.26) 0.2  (0.15)
Week 144 Number Analyzed 182 participants 75 participants 28 participants
0.2  (0.28) 0.2  (0.27) 0.2  (0.17)
Week 156 Number Analyzed 179 participants 74 participants 28 participants
0.2  (0.27) 0.2  (0.26) 0.1  (0.18)
Week 168 Number Analyzed 176 participants 73 participants 29 participants
0.2  (0.29) 0.2  (0.28) 0.2  (0.20)
Week 180 Number Analyzed 178 participants 71 participants 29 participants
0.2  (0.27) 0.2  (0.33) 0.2  (0.20)
Week 192 Number Analyzed 169 participants 72 participants 30 participants
0.2  (0.27) 0.2  (0.27) 0.2  (0.20)
Week 204 Number Analyzed 164 participants 71 participants 30 participants