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Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)

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ClinicalTrials.gov Identifier: NCT03502616
Recruitment Status : Completed
First Posted : April 18, 2018
Results First Posted : January 11, 2021
Last Update Posted : September 17, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Ankylosing Spondylitis
Intervention Drug: Tofacitinib
Enrollment 270
Recruitment Details  
Pre-assignment Details Safety data was planned to be collected and reported for both: Week 0 to Week 16 and from Week 0 to Week 48.
Arm/Group Title Tofacitinib Placebo Then Tofacitinib
Hide Arm/Group Description Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks. Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Period Title: Up to Week 16
Started 134 136
Treated 133 136
Completed 132 133
Not Completed 2 3
Reason Not Completed
Withdrawal by Subject             1             2
Lost to Follow-up             0             1
Randomized, but not treated             1             0
Period Title: Week 16 to Week 48
Started 132 133
Treated 132 133
Completed 125 127
Not Completed 7 6
Reason Not Completed
Withdrawal by Subject             6             6
Lost to Follow-up             1             0
Arm/Group Title Tofacitinib Placebo Then Tofacitinib Total
Hide Arm/Group Description Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks. Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48). Total of all reporting groups
Overall Number of Baseline Participants 133 136 269
Hide Baseline Analysis Population Description
Safety analysis set: included all participants who were randomized and received at least one dose of the investigational product (that is [i.e.], tofacitinib or placebo).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 133 participants 136 participants 269 participants
42.2  (11.85) 40.0  (11.06) 41.1  (11.49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 136 participants 269 participants
Female
17
  12.8%
28
  20.6%
45
  16.7%
Male
116
  87.2%
108
  79.4%
224
  83.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 136 participants 269 participants
White
107
  80.5%
106
  77.9%
213
  79.2%
Asian
25
  18.8%
30
  22.1%
55
  20.4%
Not reported
1
   0.8%
0
   0.0%
1
   0.4%
1.Primary Outcome
Title Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS)20 Response at Week 16
Hide Description ASAS20 assess 4 domains: Patient Global Assessment of Disease (PGA) (assess disease activity on a scale of 0 [not active] to 10 [very active], high score=more disease activity), total back pain (scale of 0 [no pain] to 10 [most severe pain], high score=more severity), Function (Bath Ankylosing Spondylitis Functional Index [BASFI]; participant's level of ability on scale of 0 [easy] to 10 [impossible], low score= better functional health) and Inflammation (morning stiffness, Mean of Question [Q]5 and Q6 of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] defined as 6-item questionnaire measure disease activity on a scale of 0 [none] to 10 [severe], high score=more disease activity). ASAS20 response: greater than or equal to (>=) 20 percent (%) improvement from baseline in disease activity and absolute change of >=1 unit in >=3 domains and no worsening of >=20% and an absolute change of >=1 unit in remaining domain.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response (MR) was considered to be Non-response (NR) (MR=NR).
Arm/Group Title Tofacitinib Placebo Then Tofacitinib
Hide Arm/Group Description:
Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.
Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Overall Number of Participants Analyzed 133 136
Measure Type: Number
Unit of Measure: Percentage of participants
56.39 29.41
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via Cochran-Mantel-Haenszel (CMH) approach.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 27.08
Confidence Interval (2-Sided) 95%
15.89 to 38.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.71
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Achieving Ankylosing Spondylitis (ASAS)40 Response at Week 16
Hide Description ASAS40 assessed 4 domains: the "PGA" (assess disease activity on a scale of 0 [not active] to 10 [very active], higher score=more disease activity), total back pain (on a scale of 0 [no pain] to 10 [most severe pain], higher score=more severity), Function (from BASFI: assess participant's level of ability on a scale of 0 [easy] to 10 [impossible], lower scores= better functional health) and Inflammation (morning stiffness, Mean of Q5 and Q6 of BASDAI defined as 6 item questionnaire: measures disease activity on a scale of 0 [none] to 10 [severe], higher score=more disease activity). ASAS40 response: >=40% and >=2 units improvement in >=3 domains and no worsening at all in the remaining domain.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response (MR) was considered to be Non-response (NR) (MR=NR).
Arm/Group Title Tofacitinib Placebo Then Tofacitinib
Hide Arm/Group Description:
Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.
Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Overall Number of Participants Analyzed 133 136
Measure Type: Number
Unit of Measure: Percentage of participants
40.60 12.50
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 28.17
Confidence Interval (2-Sided) 95%
18.26 to 38.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.06
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (AEs)
Hide Description An AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03, severity was graded as Grade 1: asymptomatic/mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily living (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Treatment-emergent were events between first dose of study drug and up to 48 weeks that were absent before treatment or that worsened relative to pretreatment state.
Time Frame Baseline up to Week 16 and Baseline up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Arm/Group Title Tofacitinib Placebo Then Tofacitinib
Hide Arm/Group Description:
Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.
Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Overall Number of Participants Analyzed 133 136
Measure Type: Count of Participants
Unit of Measure: Participants
Up to Week 16
73
  54.9%
70
  51.5%
Up to Week 48
103
  77.4%
93
  68.4%
4.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity
Hide Description AE: any untoward medical occurrence in subject who receive study drug without regard to possibility of causal relationship. Treatment-emergent AEs were events that occurred between first dose of study drug and up to 48 weeks that were absent before treatment or that worsened relative to pretreatment state. The severity grades (mild, moderate and severe) were defined as - mild: did not interfere with participant's usual function, moderate: Interfered to some extent with participant's usual function and severe: Interfered significantly with participant's usual function.
Time Frame Baseline up to Week 16 and Baseline up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Arm/Group Title Tofacitinib Placebo Then Tofacitinib
Hide Arm/Group Description:
Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.
Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Overall Number of Participants Analyzed 133 136
Measure Type: Count of Participants
Unit of Measure: Participants
Up to Week 16: Mild
53
  39.8%
52
  38.2%
Up to Week 16: Moderate
18
  13.5%
18
  13.2%
Up to Week 16: Severe
2
   1.5%
0
   0.0%
Up to Week 48: Mild
57
  42.9%
57
  41.9%
Up to Week 48: Moderate
40
  30.1%
36
  26.5%
Up to Week 48: Severe
6
   4.5%
0
   0.0%
5.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Hide Description Hematology (Hemoglobin, Hematocrit, Erythrocyte, Lymphocyte/Leukocyte, Neutrophil/Leukocyte <0.8*Lower limit of normal (LLN), Reticulocyte >1.5*Upper limit of normal (ULN), Erythrocyte Mean Corpuscular Volume, Erythrocyte Mean Corpuscular Hemoglobin, Erythrocyte Mean Corpuscular HGB Concentration <0.9*LLN, >1.1*ULN, Reticulocyte/Erythrocyte, Leukocyte >1.5*ULN, Lymphocyte, Neutrophil <0.8*LLN and >1.2*ULN, Basophil, Basophil/Leukocyte, Eosinophil, Eosinophil/Leukocyte, Monocyte, Monocyte/Leukocyte >1.2*ULN); Clinical Chemistry (Bilirubin, Glucose >1.5*ULN, AST, ALT, Gamma Glutamyl Transferase >3.0*ULN, Urea, Creatinine, Triglyceride, Cholesterol >1.3*ULN, LDL Cholesterol>1.2*ULN, Potassium, C Reactive Protein >1.1*ULN, Bicarbonate <0.9*LLN, Creatine Kinase >2.0*ULN, HDL Cholesterol <0.8*LLN), Urinalysis (Specific Gravity >1.035, pH >8, Glucose, Ketones, Protein, Hemoglobin >=1, Erythrocyte, Leukocyte >=20, Granular Cast, Hyaline Cast>1.
Time Frame Baseline up to Week 16 and Baseline up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo). Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Tofacitinib Placebo Then Tofacitinib
Hide Arm/Group Description:
Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.
Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Overall Number of Participants Analyzed 132 136
Measure Type: Count of Participants
Unit of Measure: Participants
Up to Week 16
106
  80.3%
129
  94.9%
Up to Week 48
126
  95.5%
131
  96.3%
6.Secondary Outcome
Title Number of Participants With Vital Signs Abnormalities
Hide Description Criteria for abnormalities in vital signs: Pulse rate <40 beats per minute (bpm) to >120 bpm, Sitting Diastolic blood pressure < 50 millimeter of mercury (mmHg), increase and decrease in change from baseline of >= 20mmHg, sitting systolic blood pressure < 90 mmHg, increase and decrease in change from baseline of >= 30mmHg.
Time Frame Baseline up to Week 16 and Baseline up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo). Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Tofacitinib Placebo Then Tofacitinib
Hide Arm/Group Description:
Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.
Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Overall Number of Participants Analyzed 132 136
Measure Type: Count of Participants
Unit of Measure: Participants
Up to Week 16, Pulse rate: <40 bpm
0
   0.0%
0
   0.0%
Up to Week 16, Pulse rate: >120 bpm
0
   0.0%
0
   0.0%
Up to Week 16, Sitting diastolic blood pressure: <50 mmHg
0
   0.0%
0
   0.0%
Up to Week 16, Sitting diastolic blood pressure: Change >= 20mmHg increase
2
   1.5%
4
   2.9%
Up to Week 16, Sitting diastolic blood pressure: Change >= 20mmHg decrease
6
   4.5%
4
   2.9%
Up to Week 16, Sitting systolic blood pressure: <90mmHg
1
   0.8%
0
   0.0%
Up to Week 16, Sitting systolic blood pressure: Change >= 30mmHg increase
2
   1.5%
4
   2.9%
Up to Week 16, Sitting systolic blood pressure: Change >= 30mmHg decrease
2
   1.5%
5
   3.7%
Up to Week 48, Pulse rate: <40 bpm
0
   0.0%
0
   0.0%
Up to Week 48, Pulse rate: >120 bpm
0
   0.0%
1
   0.7%
Up to Week 48, Sitting diastolic blood pressure: <50 mmHg
0
   0.0%
0
   0.0%
Up to Week 48, Sitting diastolic blood pressure: Change >= 20mmHg increase
5
   3.8%
8
   5.9%
Up to Week 48, Sitting diastolic blood pressure: Change >= 20mmHg decrease
11
   8.3%
8
   5.9%
Up to Week 48, Sitting systolic blood pressure: <90mmHg
1
   0.8%
0
   0.0%
Up to Week 48, Sitting systolic blood pressure: Change >= 30mmHg increase
5
   3.8%
5
   3.7%
Up to Week 48, Sitting systolic blood pressure: Change >= 30mmHg decrease
5
   3.8%
7
   5.1%
7.Secondary Outcome
Title Number of Participants With Abnormalities in Physical Examination
Hide Description Complete physical examination: included general appearance, skin (presence of rash), heent (head, eyes, ears, nose and throat), lungs (auscultation), heart (auscultation for presence of murmurs, gallops, rubs), lower extremities (presence of peripheral edema), abdominal (palpation and auscultation), neurologic (mental status, station, gait, reflexes, motor and sensory function, coordination) and lymph nodes. Abnormalities in physical examination was based on investigator's discretion/clinical judgement.
Time Frame Screening, Week 16, and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo). Here, "number analyzed" signifies participants evaluable for this outcome measure for specified rows.
Arm/Group Title Tofacitinib Placebo Then Tofacitinib
Hide Arm/Group Description:
Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.
Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Overall Number of Participants Analyzed 133 136
Measure Type: Count of Participants
Unit of Measure: Participants
Abdomen: Screening Number Analyzed 133 participants 135 participants
2
   1.5%
1
   0.7%
Abdomen: Week 16 Number Analyzed 132 participants 132 participants
1
   0.8%
2
   1.5%
Abdomen: Week 48 Number Analyzed 119 participants 119 participants
1
   0.8%
1
   0.8%
Extremities: Screening Number Analyzed 133 participants 136 participants
17
  12.8%
15
  11.0%
Extremities: Week 16 Number Analyzed 132 participants 132 participants
8
   6.1%
14
  10.6%
Extremities: Week 48 Number Analyzed 119 participants 119 participants
4
   3.4%
7
   5.9%
General appearance: Screening Number Analyzed 133 participants 135 participants
10
   7.5%
11
   8.1%
General appearance: Week 16 Number Analyzed 132 participants 132 participants
9
   6.8%
9
   6.8%
General appearance: Week 48 Number Analyzed 119 participants 119 participants
7
   5.9%
6
   5.0%
Head, eyes, ears, nose, throat: Screening Number Analyzed 133 participants 135 participants
5
   3.8%
7
   5.2%
Head, eyes, ears, nose, throat: Week 16 Number Analyzed 132 participants 132 participants
4
   3.0%
7
   5.3%
Head, eyes, ears, nose, throat: Week 48 Number Analyzed 119 participants 119 participants
3
   2.5%
7
   5.9%
Heart: Screening Number Analyzed 133 participants 136 participants
2
   1.5%
2
   1.5%
Heart: Week 16 Number Analyzed 132 participants 132 participants
0
   0.0%
2
   1.5%
Heart: Week 48 Number Analyzed 119 participants 119 participants
0
   0.0%
2
   1.7%
Lungs: Screening Number Analyzed 133 participants 136 participants
1
   0.8%
0
   0.0%
Lungs: Week 16 Number Analyzed 132 participants 132 participants
0
   0.0%
0
   0.0%
Lungs: Week 48 Number Analyzed 119 participants 119 participants
0
   0.0%
0
   0.0%
Lymph nodes: Screening Number Analyzed 133 participants 136 participants
2
   1.5%
3
   2.2%
Lymph nodes: Week 16 Number Analyzed 132 participants 131 participants
1
   0.8%
2
   1.5%
Lymph nodes: Week 48 Number Analyzed 119 participants 119 participants
1
   0.8%
2
   1.7%
Neurological: Screening Number Analyzed 133 participants 135 participants
4
   3.0%
0
   0.0%
Neurological: Week 16 Number Analyzed 132 participants 131 participants
1
   0.8%
0
   0.0%
Neurological: Week 48 Number Analyzed 119 participants 119 participants
2
   1.7%
0
   0.0%
Skin: Screening Number Analyzed 133 participants 135 participants
18
  13.5%
18
  13.3%
Skin: Week 16 Number Analyzed 132 participants 132 participants
14
  10.6%
13
   9.8%
Skin: Week 48 Number Analyzed 119 participants 119 participants
12
  10.1%
12
  10.1%
8.Secondary Outcome
Title Number of Participants With Electrocardiogram (ECG) Abnormalities
Hide Description Twelve-lead electrocardiograms (ECGs) were obtained for all participants. Criteria for ECG abnormality: PR interval >=300 and a percent change from baseline of >=25 or 50%; QRS duration >=140 and a percent change from baseline of >=50%; QT interval >=500; QTCB, QTCF interval <480 or >=450, <500 or >=480, >=500, change from baseline of <60 and >=30, and change from baseline of >=60.
Time Frame Baseline up to Week 16, Baseline up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo). Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for this outcome measure for specified rows.
Arm/Group Title Tofacitinib Placebo Then Tofacitinib
Hide Arm/Group Description:
Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.
Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Overall Number of Participants Analyzed 131 133
Measure Type: Count of Participants
Unit of Measure: Participants
Up to Week 16, PR interval: >=300 Number Analyzed 131 participants 131 participants
0
   0.0%
0
   0.0%
Up to Week 16, PR interval: %Change>=25/50% Number Analyzed 131 participants 131 participants
0
   0.0%
1
   0.8%
Up to Week 16, QRS duration: >=140 Number Analyzed 131 participants 131 participants
1
   0.8%
1
   0.8%
Up to Week 16, QRS duration: %Change>=50% Number Analyzed 131 participants 131 participants
0
   0.0%
0
   0.0%
Up to Week 16, QT interval: >=500 Number Analyzed 131 participants 131 participants
0
   0.0%
0
   0.0%
Up to Week 16, QTCB interval: >=450 and <480 Number Analyzed 131 participants 131 participants
3
   2.3%
7
   5.3%
Up to Week 16, QTCB interval: >=480 and <500 Number Analyzed 131 participants 131 participants
0
   0.0%
1
   0.8%
Up to Week 16, QTCB interval: >=500 Number Analyzed 131 participants 131 participants
0
   0.0%
0
   0.0%
Up to Week 16, QTCB interval: change >=30 and <60 Number Analyzed 131 participants 131 participants
9
   6.9%
7
   5.3%
Up to Week 16, QTCB interval: change >=60 Number Analyzed 131 participants 131 participants
0
   0.0%
0
   0.0%
Up to Week 16, QTCF interval: >=450 and <480 Number Analyzed 131 participants 131 participants
3
   2.3%
4
   3.1%
Up to Week 16, QTCF interval: >=480 and <500 Number Analyzed 131 participants 131 participants
0
   0.0%
0
   0.0%
Up to Week 16, QTCF interval: >=500 Number Analyzed 131 participants 131 participants
0
   0.0%
0
   0.0%
Up to Week 16, QTCF interval: change >=30 and <60 Number Analyzed 131 participants 131 participants
5
   3.8%
3
   2.3%
Up to Week 16, QTCF interval: change >=60 Number Analyzed 131 participants 131 participants
0
   0.0%
0
   0.0%
Up to Week 48, PR interval: >=300 Number Analyzed 131 participants 133 participants
0
   0.0%
0
   0.0%
Up to Week 48, PR interval: %Change>=25/50% Number Analyzed 131 participants 133 participants
0
   0.0%
1
   0.8%
Up to Week 48, QRS duration: >=140 Number Analyzed 131 participants 133 participants
3
   2.3%
1
   0.8%
Up to Week 48, QRS duration: %Change>=50% Number Analyzed 131 participants 133 participants
0
   0.0%
0
   0.0%
Up to Week 48, QT interval: >=500 Number Analyzed 131 participants 133 participants
0
   0.0%
1
   0.8%
Up to Week 48, QTCB interval: >=450 and <480 Number Analyzed 131 participants 133 participants
10
   7.6%
10
   7.5%
Up to Week 48, QTCB interval: >=480 and <500 Number Analyzed 131 participants 133 participants
1
   0.8%
1
   0.8%
Up to Week 48, QTCB interval: >=500 Number Analyzed 131 participants 133 participants
0
   0.0%
0
   0.0%
Up to Week 48, QTCB interval: change >=30 and <60 Number Analyzed 131 participants 133 participants
14
  10.7%
11
   8.3%
Up to Week 48, QTCB interval: change >=60 Number Analyzed 131 participants 133 participants
1
   0.8%
0
   0.0%
Up to Week 48, QTCF interval: >=450 and <480 Number Analyzed 131 participants 133 participants
5
   3.8%
5
   3.8%
Up to Week 48, QTCF interval: >=480 and <500 Number Analyzed 131 participants 133 participants
1
   0.8%
0
   0.0%
Up to Week 48, QTCF interval: >=500 Number Analyzed 131 participants 133 participants
0
   0.0%
0
   0.0%
Up to Week 48, QTCF interval: change >=30 and <60 Number Analyzed 131 participants 133 participants
9
   6.9%
7
   5.3%
Up to Week 48, QTCF interval: change >=60 Number Analyzed 131 participants 133 participants
1
   0.8%
0
   0.0%
9.Secondary Outcome
Title Percentage of Participants Achieving ASAS20 Response at Weeks 2, 4, 8, 12, 24, 32, 40 and 48
Hide Description ASAS20 assess 4 domains: PGA of Disease (assess disease activity on a scale of 0 [not active] to 10 [very active], high score=more disease activity), total back pain (scale of 0 [no pain] to 10 [most severe pain], high score=more severity), Function (BASFI; participant's level of ability on scale of 0 [easy] to 10 [impossible], low score= better functional health) and Inflammation (morning stiffness, Mean of Q5 and Q6 of BASDAI defined as 6-item questionnaire measure disease activity on a scale of 0 [none] to 10 [severe], high score=more disease activity). ASAS20 response: >= 20% improvement from baseline in disease activity and absolute change of >=1 unit in >=3 domains and no worsening of >=20% and an absolute change of >=1 unit in remaining domain.
Time Frame Weeks 2, 4, 8, 12, 24, 32, 40 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response (MR) was considered to be Non-response (NR) (MR=NR).
Arm/Group Title Tofacitinib Placebo Then Tofacitinib
Hide Arm/Group Description:
Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.
Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Overall Number of Participants Analyzed 133 136
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 28.57 10.29
Week 4 51.13 19.85
Week 8 57.14 25.00
Week 12 63.91 29.41
Week 24 63.16 59.56
Week 32 68.42 64.71
Week 40 68.42 66.91
Week 48 65.41 60.29
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 18.28
Confidence Interval (2-Sided) 95%
9.06 to 27.50
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.70
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 31.35
Confidence Interval (2-Sided) 95%
20.64 to 42.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.47
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 32.24
Confidence Interval (2-Sided) 95%
21.32 to 43.17
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.57
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 34.61
Confidence Interval (2-Sided) 95%
23.63 to 45.58
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.60
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5360
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 3.65
Confidence Interval (2-Sided) 95%
-7.92 to 15.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.90
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4971
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 3.83
Confidence Interval (2-Sided) 95%
-7.22 to 14.87
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7792
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 1.58
Confidence Interval (2-Sided) 95%
-9.49 to 12.66
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.65
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3685
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 5.22
Confidence Interval (2-Sided) 95%
-6.15 to 16.58
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.80
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants Achieving ASAS40 Response at Weeks 2, 4, 8, 12, 24, 32, 40 and 48
Hide Description ASAS40 assessed 4 domains: the "PGA" (assess disease activity on a scale of 0 [not active] to 10 [very active], higher score=more disease activity), total back pain (on a scale of 0 [no pain] to 10 [most severe pain], higher score=more severity), Function (from BASFI: assess participant's level of ability on a scale of 0 [easy] to 10 [impossible], lower scores= better functional health) and Inflammation (morning stiffness, Mean of Q5 and Q6 of BASDAI defined as 6 item questionnaire: measures disease activity on a scale of 0 [none] to 10 [severe], higher score=more disease activity). ASAS40 response: >=40% and >=2 units improvement in >=3 domains and no worsening at all in the remaining domain.
Time Frame Weeks 2, 4, 8, 12, 24, 32, 40 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response (MR) was considered to be Non-response (NR) (MR=NR).
Arm/Group Title Tofacitinib Placebo Then Tofacitinib
Hide Arm/Group Description:
Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.
Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Overall Number of Participants Analyzed 133 136
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 10.53 4.41
Week 4 27.07 3.68
Week 8 34.59 5.88
Week 12 42.86 11.76
Week 24 48.12 41.91
Week 32 50.38 44.12
Week 40 50.38 42.65
Week 48 50.38 44.85
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0548
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 6.12
Confidence Interval (2-Sided) 95%
-0.13 to 12.37
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 23.43
Confidence Interval (2-Sided) 95%
15.30 to 31.56
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 28.56
Confidence Interval (2-Sided) 95%
19.66 to 37.47
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.54
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 31.18
Confidence Interval (2-Sided) 95%
21.34 to 41.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2926
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 6.29
Confidence Interval (2-Sided) 95%
-5.43 to 18.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.98
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2856
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 6.37
Confidence Interval (2-Sided) 95%
-5.32 to 18.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.97
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1894
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 7.83
Confidence Interval (2-Sided) 95%
-3.87 to 19.54
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.97
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3544
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 5.59
Confidence Interval (2-Sided) 95%
-6.24 to 17.43
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.04
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Hide Description ASDAS(CRP) was derived using BASDAI (6-item questionnaire measures disease activity on a scale of 0 [none] to 10 [severe], higher score=more disease activity) and PGA (measure disease activity on a scale of 0 [not active] to 10 [very active], high score=more disease activity) and calculated by using the following formula, 0.121 x Back Pain (Q2 of BASDAI) + 0.058 x Duration of Morning Stiffness (Q6 of BASDAI) + 0.110 x PGA + 0.073 x Peripheral Pain/Swelling (Q3 of BASDAI) + 0.579 x Ln(high sensitivity [hs] CRP mg/Liter [L] + 1). If hsCRP values were smaller than 2 mg/L, they were set to 2 mg/L in the formula. The range of score was >= 0.636 to no defined upper limit. A negative change from baseline value indicates decrease in disease activity; a positive change from baseline value indicates increase in disease activity.
Time Frame Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Tofacitinib Placebo Then Tofacitinib
Hide Arm/Group Description:
Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.
Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Overall Number of Participants Analyzed 132 136
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 2 -0.88  (0.056) -0.17  (0.056)
Week 4 -1.14  (0.065) -0.24  (0.065)
Week 8 -1.30  (0.074) -0.24  (0.074)
Week 12 -1.38  (0.075) -0.28  (0.075)
Week 16 -1.36  (0.073) -0.39  (0.073)
Week 24 -1.51  (0.082) -1.32  (0.081)
Week 32 -1.56  (0.084) -1.37  (0.084)
Week 40 -1.65  (0.086) -1.40  (0.086)
week 48 -1.70  (0.087) -1.50  (0.086)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 2: Analysis performed using Mixed model for repeated measures (MMRM) which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.71
Confidence Interval (2-Sided) 95%
-0.85 to -0.57
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.072
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.90
Confidence Interval (2-Sided) 95%
-1.07 to -0.74
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.083
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.06
Confidence Interval (2-Sided) 95%
-1.25 to -0.87
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.095
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.09
Confidence Interval (2-Sided) 95%
-1.28 to -0.90
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.096
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.98
Confidence Interval (2-Sided) 95%
-1.16 to -0.79
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.093
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 24: Analysis performed using Mixed model for repeated measures (MMRM) which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0623
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.40 to 0.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.103
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 32: Analysis performed using Mixed model for repeated measures (MMRM) which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0836
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.18
Confidence Interval (2-Sided) 95%
-0.39 to 0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.106
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 40: Analysis performed using Mixed model for repeated measures (MMRM) which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0205
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.25
Confidence Interval (2-Sided) 95%
-0.47 to -0.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.108
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 48: Analysis performed using Mixed model for repeated measures (MMRM) which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0614
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.20
Confidence Interval (2-Sided) 95%
-0.42 to 0.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.108
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Hide Description Blood samples were collected for analysis of hsCRP using an assay analyzed by central laboratory. hsCRP is an acute phase reactant, which was indicative of inflammation and of its severity.
Time Frame Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Tofacitinib Placebo Then Tofacitinib
Hide Arm/Group Description:
Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.
Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Overall Number of Participants Analyzed 132 136
Least Squares Mean (Standard Error)
Unit of Measure: Milligrams per deciliter (mg/dL)
Week 2 -1.07  (0.089) -0.14  (0.088)
Week 4 -1.06  (0.094) -0.14  (0.094)
Week 8 -1.05  (0.153) -0.03  (0.152)
Week 12 -1.11  (0.089) -0.15  (0.090)
Week 16 -1.05  (0.096) -0.09  (0.096)
Week 24 -1.21  (0.058) -1.16  (0.058)
Week 32 -1.16  (0.076) -1.08  (0.075)
Week 40 -1.22  (0.089) -1.09  (0.089)
Week 48 -1.17  (0.081) -1.11  (0.080)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.93
Confidence Interval (2-Sided) 95%
-1.15 to -0.70
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.113
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.92
Confidence Interval (2-Sided) 95%
-1.16 to -0.68
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.121
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.02
Confidence Interval (2-Sided) 95%
-1.40 to -0.63
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.196
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.96
Confidence Interval (2-Sided) 95%
-1.19 to -0.74
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.115
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.96
Confidence Interval (2-Sided) 95%
-1.20 to -0.72
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.122
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4731
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.05
Confidence Interval (2-Sided) 95%
-0.20 to 0.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.073
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4055
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-0.26 to 0.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.094
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2648
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.12
Confidence Interval (2-Sided) 95%
-0.34 to 0.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.111
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5558
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.06
Confidence Interval (2-Sided) 95%
-0.25 to 0.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.099
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score at Weeks 16 and 48
Hide Description The ASQoL was an 18-item questionnaire assessed the amount of restriction participant experienced in daily activities, level of pain and fatigue, and the impact on the participant's emotional state. Each item was scored as 0 (no impact) or 1 (yes - impact). A total score was calculated by summing the items. The total score ranged from 0 (no impact) to 18 (yes-impact), with higher values indicated more impaired health-related quality of life.
Time Frame Baseline, Weeks 16 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. Here, "number analyzed" signifies participants evaluable for this outcome measure for specified time point.
Arm/Group Title Tofacitinib Placebo Then Tofacitinib
Hide Arm/Group Description:
Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.
Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Overall Number of Participants Analyzed 129 131
Least Squares Mean (Standard Error)
Unit of Measure: Units on scale
Week 16 Number Analyzed 129 participants 130 participants
-4.03  (0.404) -2.01  (0.405)
Week 48 Number Analyzed 129 participants 131 participants
-5.97  (0.454) -4.70  (0.451)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 16: Analysis performed using Analysis of covariance (ANCOVA) model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -2.02
Confidence Interval (2-Sided) 95%
-3.03 to -1.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.513
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0270
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.26
Confidence Interval (2-Sided) 95%
-2.38 to -0.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.567
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in Short-Form-36 Health Survey-Version 2 Acute (SF-36v2) Score at Weeks 16 and 48
Hide Description SF-36 v.2 (Acute): 36-item generic health status measure. It measured 8 general health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, mental health. These domains were aggregated into 2 summary scores - physical component summary (PCS), mental component summary (MCS). Four domains comprised PCS score (physical functioning, role-physical, bodily pain, general health) and remaining 4 domains comprised MCS score (vitality, social functioning, role-emotional, mental health). Normalized domain scores, PCS, MCS scores are used in analyses. Component and domain scores were scored by using United States 1998 general population norm. Resulting norm-based T-scores for both the SF36 version 2 and SF36 health domain scale and component summary measures had means of 50 and standard deviations of 10. Higher PCS/MCS/domain score represent better health status.
Time Frame Baseline, Weeks 16 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Tofacitinib Placebo Then Tofacitinib
Hide Arm/Group Description:
Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.
Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Overall Number of Participants Analyzed 129 130
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 16: Physical Functioning 5.52  (0.665) 3.29  (0.665)
Week 16: Role-Physical 6.13  (0.744) 3.13  (0.745)
Week 16: Bodily Pain 7.93  (0.710) 3.47  (0.713)
Week 16: General Health 5.00  (0.617) 1.76  (0.618)
Week 16: Vitality 5.34  (0.864) 3.56  (0.869)
Week 16: Social Functioning 5.45  (0.835) 2.49  (0.837)
Week 16: Role-Emotional 4.13  (1.020) 2.05  (1.017)
Week 16: Mental Health 3.57  (0.886) 2.49  (0.888)
Week 16: Physical Component Summary 6.69  (0.588) 3.14  (0.590)
Week 16: Mental Component Summary 3.45  (0.914) 2.13  (0.915)
Week 48: Physical Functioning 7.80  (0.775) 6.94  (0.766)
Week 48: Role-Physical 8.66  (0.870) 7.29  (0.862)
Week 48: Bodily Pain 11.67  (0.920) 9.55  (0.912)
Week 48: General Health 6.31  (0.777) 5.10  (0.770)
Week 48: Vitality 9.83  (0.997) 9.28  (0.992)
Week 48: Social Functioning 8.16  (0.923) 6.77  (0.915)
Week 48: Role-Emotional 7.17  (1.004) 6.32  (0.989)
Week 48: Mental Health 7.10  (0.960) 6.45  (0.954)
Week 48: Physical Component Summary 8.81  (0.720) 7.39  (0.714)
Week 48: Mental Component Summary 7.07  (0.926) 6.35  (0.920)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 16, Physical Functioning: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0088
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.22
Confidence Interval (2-Sided) 95%
0.56 to 3.88
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.841
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 16, Role-Physical: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0016
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 3.00
Confidence Interval (2-Sided) 95%
1.15 to 4.85
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.939
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 16, Bodily Pain: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 4.46
Confidence Interval (2-Sided) 95%
2.69 to 6.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.900
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 16, General Health: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 3.24
Confidence Interval (2-Sided) 95%
1.70 to 4.78
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.781
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 16, Vitality: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1065
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.78
Confidence Interval (2-Sided) 95%
-0.38 to 3.94
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.098
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 16, Social Functioning: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0055
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.96
Confidence Interval (2-Sided) 95%
0.88 to 5.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.059
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 16, Role-Emotional: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1084
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.08
Confidence Interval (2-Sided) 95%
-0.46 to 4.61
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.289
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 16, Mental Health: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3379
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
-1.13 to 3.29
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.124
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 16, Physical Component Summary: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 3.55
Confidence Interval (2-Sided) 95%
2.09 to 5.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.744
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 16, Mental Component Summary: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2529
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.33
Confidence Interval (2-Sided) 95%
-0.95 to 3.61
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.158
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 48, Physical Functioning: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3744
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
-1.04 to 2.76
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.964
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 48, Role-Physical: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2091
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.36
Confidence Interval (2-Sided) 95%
-0.77 to 3.50
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.083
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 48, Bodily Pain: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0654
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.12
Confidence Interval (2-Sided) 95%
-0.14 to 4.38
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.146
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 48, General Health: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2100
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.22
Confidence Interval (2-Sided) 95%
-0.69 to 3.12
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.968
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 48, Vitality: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6568
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.56
Confidence Interval (2-Sided) 95%
-1.90 to 3.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.248
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 48, Social Functioning: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2288
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.39
Confidence Interval (2-Sided) 95%
-0.88 to 3.66
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.152
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 48, Role-Emotional: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4955
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
-1.61 to 3.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.250
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 48, Mental Health: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5888
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.65
Confidence Interval (2-Sided) 95%
-1.71 to 3.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.200
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 48, Physical Component Summary: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1150
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.42
Confidence Interval (2-Sided) 95%
-0.35 to 3.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.896
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 48, Mental Component Summary: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5347
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.72
Confidence Interval (2-Sided) 95%
-1.56 to 3.00
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.158
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Cervical Rotation Angle at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Hide Description BASMI assess axial status and spinal mobility. It composed of 5 clinical measures: lateral spinal flexion, tragus-to-wall distance, lumbar flexion (modified Schober), maximal intermalleolar distance, cervical rotation. BASMI - Linear Method score was average of 5 individual component score mapped between 0 and 10, high score=more impairment of axial status, spinal mobility. For cervical rotation angle, participant sit straight on chair with chin level and hands on knees. Blinded assessor place goniometer at top of head in line with nose and ask participant to rotate neck maximally to left, follows with goniometer and record angle between sagittal plane and new plane after rotation. A second reading obtained and both readings recorded. Procedure repeated for right side. Better of two for each side was selected for scoring. Scoring done by calculating mean of left and right measurement and recorded in degrees (range: 0 to 90), higher cervical rotation value=better health status.
Time Frame Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Tofacitinib Placebo Then Tofacitinib
Hide Arm/Group Description:
Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.
Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Overall Number of Participants Analyzed 132 136
Least Squares Mean (Standard Error)
Unit of Measure: Degrees
Week 2 2.25  (0.701) 0.95  (0.698)
Week 4 3.63  (0.797) 2.07  (0.792)
Week 8 6.26  (0.825) 2.44  (0.824)
Week 12 6.24  (1.002) 2.92  (1.004)
Week 16 7.74  (1.009) 3.00  (1.008)
Week 24 7.68  (1.139) 7.49  (1.131)
Week 32 7.25  (1.087) 8.23  (1.080)
Week 40 7.62  (1.215) 8.34  (1.207)
Week 48 7.63  (1.201) 8.23  (1.188)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1513
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.29
Confidence Interval (2-Sided) 95%
-0.48 to 3.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.898
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1279
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.56
Confidence Interval (2-Sided) 95%
-0.45 to 3.56
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.020
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 3.83
Confidence Interval (2-Sided) 95%
1.75 to 5.90
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.056
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0102
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 3.32
Confidence Interval (2-Sided) 95%
0.79 to 5.84
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.282
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 4.73
Confidence Interval (2-Sided) 95%
2.20 to 7.26
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.285
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8950
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.19
Confidence Interval (2-Sided) 95%
-2.64 to 3.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.439
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4732
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.98
Confidence Interval (2-Sided) 95%
-3.67 to 1.71
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.365
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6359
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.72
Confidence Interval (2-Sided) 95%
-3.72 to 2.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.523
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6894
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.60
Confidence Interval (2-Sided) 95%
-3.54 to 2.35
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.495
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Intermalleolar Distance at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Hide Description BASMI assessed axial status and spinal mobility, using linear function. It composed of 5 clinical measures: lateral spinal flexion, tragus-to-wall distance, lumbar flexion (modified Schober), maximal intermalleolar distance, cervical rotation. BASMI - Linear Method score was average of 5 individual component scores mapped between 0 and 10, with higher scores indicating more impairment of axial status and spinal mobility. For the assessment of intermalleolar distances, participant should lie supine with the knees straight and feet/toes pointing straight up and asked to separate the legs as far as possible and the distance between the medial malleoli was measured (in Centimeters [cm] to the nearest 0.1 cm). Distance (in cm) was greater than or equal to 0, with no maximum defined range: higher intermalleolar distance value indicates better health status.
Time Frame Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Tofacitinib Placebo Then Tofacitinib
Hide Arm/Group Description:
Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.
Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Overall Number of Participants Analyzed 132 136
Least Squares Mean (Standard Error)
Unit of Measure: Centimeters
Week 2 2.29  (0.733) 0.90  (0.730)
Week 4 3.62  (0.861) 0.84  (0.856)
Week 8 4.68  (0.979) 1.36  (0.976)
Week 12 5.33  (1.106) 1.97  (1.108)
Week 16 6.84  (1.084) 2.64  (1.082)
Week 24 7.79  (1.177) 4.39  (1.174)
Week 32 8.98  (1.221) 5.32  (1.215)
Week 40 8.60  (1.229) 4.75  (1.222)
Week 48 7.83  (1.233) 4.34  (1.222)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1410
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.39
Confidence Interval (2-Sided) 95%
-0.46 to 3.24
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.940
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0122
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.78
Confidence Interval (2-Sided) 95%
0.61 to 4.95
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.102
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0085
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 3.32
Confidence Interval (2-Sided) 95%
0.86 to 5.79
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.252
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0184
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 3.36
Confidence Interval (2-Sided) 95%
0.57 to 6.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.416
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0026
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 4.19
Confidence Interval (2-Sided) 95%
1.47 to 6.91
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.380
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0236
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 3.40
Confidence Interval (2-Sided) 95%
0.46 to 6.35
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.495
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0182
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 3.66
Confidence Interval (2-Sided) 95%
0.63 to 6.70
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.541
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0133
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 3.85
Confidence Interval (2-Sided) 95%
0.81 to 6.90
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.545
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0245
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 3.49
Confidence Interval (2-Sided) 95%
0.45 to 6.52
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.541
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Lateral Spinal Flexion at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Hide Description BASMI assess axial status, spinal mobility, using linear function. It composed of 5 clinical measures. BASMI - Linear Method score-average of 5 component scores mapped between 0 and 10, with high scores =more impairment of axial status, spinal mobility. For assessment of lateral spinal flexion: participant stand upright with head and back rest against wall as close as possible with shoulders level and feet 30 cm apart and feet parallel. At tip of middle finger, place a mark on thigh. This neutral position recorded. Participant bend sideways without bending knees or lifting heels while attempting to keep shoulders in same position (flexion position). Second mark placed, lateral flexion recorded (left or right as appropriate) using cm tape measure. Two tries for left, two tries for right measured. Result of two tries recorded for left and right separately in cm to nearest 0.1 cm. Distance (in cm) should be >=0, with no maximum defined range: high value indicates better health status.
Time Frame Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Tofacitinib Placebo Then Tofacitinib
Hide Arm/Group Description:
Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.
Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Overall Number of Participants Analyzed 132 136
Least Squares Mean (Standard Error)
Unit of Measure: Centimeters
Week 2 0.60  (0.200) -0.21  (0.199)
Week 4 0.96  (0.235) -0.10  (0.233)
Week 8 1.34  (0.238) 0.15  (0.237)
Week 12 1.42  (0.214) -0.21  (0.214)
Week 16 1.79  (0.269) -0.08  (0.269)
Week 24 1.70  (0.278) 0.75  (0.276)
Week 32 1.90  (0.319) 1.31  (0.316)
Week 40 2.15  (0.332) 1.37  (0.329)
Week 48 1.64  (0.345) 1.34  (0.340)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0018
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.30 to 1.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.257
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.47 to 1.65
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.301
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
0.59 to 1.79
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.305
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.63
Confidence Interval (2-Sided) 95%
1.09 to 2.17
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.274
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.87
Confidence Interval (2-Sided) 95%
1.20 to 2.55
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.344
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0075
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.26 to 1.65
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.353
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1489
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.58
Confidence Interval (2-Sided) 95%
-0.21 to 1.38
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.403
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0609
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.78
Confidence Interval (2-Sided) 95%
-0.04 to 1.61
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.417
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4822
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.30
Confidence Interval (2-Sided) 95%
-0.54 to 1.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.429
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Lumbar Flexion (Modified Schober) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Hide Description BASMI assessed axial status and spinal mobility. BASMI - Linear Method score was average of 5 individual component scores mapped between 0 and 10, with higher scores indicating more impairment of axial status and spinal mobility. For the assessment of lumbar flexion, With the participant standing erect and outer edges of feet 30 cm apart, a mark was placed in the midpoint of a line that joins the posterior superior iliac spines (baseline mark). A second mark (A) was placed 10 cm above the baseline mark and a third mark (B) 5 cm below the baseline mark. Then have the participant maximally bend forward, keeping the knees fully extended. With the participant's spine in full flexion, the distance between marks A and B (in cm to the nearest 0.1 cm) was re-measured. Distance (in cm) was greater than or equal to 0, with no maximum defined range. Higher value indicates better health status.
Time Frame Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Tofacitinib Placebo Then Tofacitinib
Hide Arm/Group Description:
Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.
Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Overall Number of Participants Analyzed 132 136
Least Squares Mean (Standard Error)
Unit of Measure: Centimeters
Week 2 0.30  (0.102) -0.07  (0.102)
Week 4 0.41  (0.102) -0.11  (0.102)
Week 8 0.32  (0.116) -0.17  (0.115)
Week 12 0.26  (0.111) -0.22  (0.111)
Week 16 0.46  (0.115) -0.06  (0.115)
Week 24 0.51  (0.149) 0.20  (0.148)
Week 32 0.64  (0.143) 0.39  (0.142)
Week 40 0.58  (0.156) 0.50  (0.155)
Week 48 0.45  (0.146) 0.35  (0.144)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0047
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.37
Confidence Interval (2-Sided) 95%
0.12 to 0.63
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.131
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.52
Confidence Interval (2-Sided) 95%
0.26 to 0.77
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.131
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib, Placebo Then Tofacitinib
Comments Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0012
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]