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Trial record 10 of 649 for:    Russian Federation | Chile

Long-Term Effectiveness And Safety Of CP-690,550 For The Treatment Of Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00413699
Recruitment Status : Completed
First Posted : December 20, 2006
Results First Posted : March 27, 2018
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Arthritis, Rheumatoid
Intervention Drug: CP-690,550
Enrollment 4488
Recruitment Details Initial period (IP): conducted at multiple sites, participants were assigned to Tofacitinib 5 mg and 10 mg BID. Extension period (EP): participants who took part initially in IP, completed 2 years of lymphocyte assessment in IP, given consent, were enrolled in EP and assigned to “Extension Period: Tofacitinib 5 mg”. EP was conducted in 2 countries.
Pre-assignment Details Participants had previously participated in qualifying studies (A3921019, A3921025, A3921032, A3921035, A3921044, A3921045, A3921046, A3921064, A3921068, A3921069, A3921073, A3921109, A3921129, A3921130, A3921152, A3921237) prior to enrollment in initial period.
Arm/Group Title Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) Initial Period: Tofacitinib 10 mg BID Extension Period: Tofacitinib 5 mg
Hide Arm/Group Description Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID. Participants with average total daily dose across study >=15 were assigned to 10 mg BID. Participants who completed 2 years of lymphocyte assessment in Initial period and enrolled for Extension period received Tofacitinib (CP-690,550) 5 mg orally, twice daily up to 12 months.
Period Title: Initial Period
Started 1123 3358 0
Completed 484 1653 0
Not Completed 639 1705 0
Reason Not Completed
Death             25             30             0
Lack of Efficacy             59             115             0
Lost to Follow-up             31             101             0
Protocol Violation             38             89             0
Pregnancy             10             8             0
Did not meet entrance criteria             2             2             0
Medication error without adverse event             0             1             0
Study terminated by Sponsor             0             1             0
Not specified             67             211             0
Adverse event related to study drug             178             527             0
Adverse event not related to study drug             113             248             0
Missing end of study page             0             4             0
No longer willing to participate             116             368             0
Period Title: Extension Period
Started 0 0 48
Completed 0 0 43
Not Completed 0 0 5
Reason Not Completed
No Longer Willing to Participate             0             0             2
Protocol Violation             0             0             1
Adverse Event             0             0             2
Arm/Group Title Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) Initial Period: Tofacitinib 10 mg BID Total
Hide Arm/Group Description Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID. Participants with average total daily dose across study >=15 were assigned to 10 mg BID. Total of all reporting groups
Overall Number of Baseline Participants 1123 3358 4481
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1123 participants 3358 participants 4481 participants
<18 years
0
   0.0%
0
   0.0%
0
   0.0%
18 to 64 years
916
  81.6%
2838
  84.5%
3754
  83.8%
>=65 years
207
  18.4%
520
  15.5%
727
  16.2%
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1123 participants 3358 participants 4481 participants
Female
927
  82.5%
2744
  81.7%
3671
  81.9%
Male
196
  17.5%
614
  18.3%
810
  18.1%
1.Primary Outcome
Title Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports
Hide Description

Treatment-emergent non serious AEs by System Organ Class (SOC) (all causalities) and Laboratory Test Abnormalities (without regard to baseline) The stated number of participants analyzed was the total number of participants in each group (AEs). The actual number of participants analyzed for each laboratory parameter varied, and is provided for each.

Abs=absolute; ALT=alanine aminotransferase; AST=aspartate aminotransferase; ESR=erythrocyte sedimentation rate; GGT=gamma glutamyl transferase; hgb=hemoglobin; HDL=high density lipids; LDL=low density lipids; LLN=lower limit of normal; qual=qualitative; Tot=total; ULN=upper limit of normal; WBC=white blood cell

Time Frame Includes laboratory test abnormality data for all visits and adverse event data up to 999 days after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
For abnormal laboratory results, those listed include both mandatory and optional laboratory tests. The number of participants analyzed is the number with at least one evaluable observation of the given laboratory test. Fasting lipids were only collected from participants who enrolled more than 14 days after last visit of their qualifying study.
Arm/Group Title Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) Initial Period: Tofacitinib 10 mg BID Initial Period: All Tofacitinib
Hide Arm/Group Description:
Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID.
Participants with average total daily dose across study >=15 were assigned to 10 mg BID.
All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.
Overall Number of Participants Analyzed 1123 3358 4481
Measure Type: Number
Unit of Measure: Number of participants
Participants with non-serious AEs Number Analyzed 1123 participants 3358 participants 4481 participants
991 2963 3954
Blood and lymphatic system disorders Number Analyzed 1123 participants 3358 participants 4481 participants
159 395 554
Cardiac disorders Number Analyzed 1123 participants 3358 participants 4481 participants
93 185 278
Congenital, familial and genetic disorders Number Analyzed 1123 participants 3358 participants 4481 participants
6 16 22
Ear and labyrinth disorders Number Analyzed 1123 participants 3358 participants 4481 participants
67 138 205
Endocrine disorders Number Analyzed 1123 participants 3358 participants 4481 participants
29 94 123
Eye disorders Number Analyzed 1123 participants 3358 participants 4481 participants
117 259 376
Gastrointestinal disorders Number Analyzed 1123 participants 3358 participants 4481 participants
393 1011 1404
General disorders and admin site conditions Number Analyzed 1123 participants 3358 participants 4481 participants
169 477 646
Hepatobiliary disorders Number Analyzed 1123 participants 3358 participants 4481 participants
60 176 236
Immune system disorders Number Analyzed 1123 participants 3358 participants 4481 participants
18 87 105
Infections and infestations Number Analyzed 1123 participants 3358 participants 4481 participants
704 2200 2904
Injury, poisoning and procedural complications Number Analyzed 1123 participants 3358 participants 4481 participants
244 721 965
Investigations Number Analyzed 1123 participants 3358 participants 4481 participants
402 995 1397
Metabolism and nutrition disorders Number Analyzed 1123 participants 3358 participants 4481 participants
184 562 746
Musculoskeletal and connective tissue disorders Number Analyzed 1123 participants 3358 participants 4481 participants
425 1314 1739
Neoplasms benign, malignant and unspecified Number Analyzed 1123 participants 3358 participants 4481 participants
80 219 299
Nervous system disorders Number Analyzed 1123 participants 3358 participants 4481 participants
222 639 861
Pregnancy, puerperium and perinatal conditions Number Analyzed 1123 participants 3358 participants 4481 participants
1 0 1
Product issues Number Analyzed 1123 participants 3358 participants 4481 participants
2 8 10
Psychiatric disorders Number Analyzed 1123 participants 3358 participants 4481 participants
97 280 377
Renal and urinary disorders Number Analyzed 1123 participants 3358 participants 4481 participants
123 265 388
Reproductive system and breast disorders Number Analyzed 1123 participants 3358 participants 4481 participants
89 206 295
Respiratory, thoracic and mediastinal disorders Number Analyzed 1123 participants 3358 participants 4481 participants
208 634 842
Skin and subcutaneous tissue disorders Number Analyzed 1123 participants 3358 participants 4481 participants
201 682 883
Social circumstances Number Analyzed 1123 participants 3358 participants 4481 participants
1 5 6
Surgical and medical procedures Number Analyzed 1123 participants 3358 participants 4481 participants
2 4 6
Vascular disorders Number Analyzed 1123 participants 3358 participants 4481 participants
207 468 675
Participants evaluable for lab abnormalities Number Analyzed 1123 participants 3358 participants 4481 participants
1118 3346 4464
Participants with laboratory abnormalities Number Analyzed 1123 participants 3358 participants 4481 participants
1095 3208 4303
Hemoglobin <0.8x LLN Number Analyzed 1117 participants 3343 participants 4460 participants
57 148 205
Hematocrit <0.8x LLN Number Analyzed 1117 participants 3343 participants 4460 participants
29 67 96
Red blood cell count <0.8x LLN Number Analyzed 1049 participants 3343 participants 4392 participants
32 142 174
Reticulocytes (Abs) <0.5x LLN Number Analyzed 570 participants 75 participants 645 participants
44 5 49
Reticulocytes (Abs) >1.5x ULN Number Analyzed 570 participants 75 participants 645 participants
49 9 58
Platelets <0.5x LLN Number Analyzed 1116 participants 3343 participants 4459 participants
5 2 7
Platelets >1.75x ULN Number Analyzed 1116 participants 3343 participants 4459 participants
5 25 30
Reticulocyte count (%) <0.5x LLN Number Analyzed 46 participants 34 participants 80 participants
1 1 2
Reticulocyte count (%) >1.5x ULN Number Analyzed 46 participants 34 participants 80 participants
24 17 41
WBC count <0.6x LLN Number Analyzed 1117 participants 3343 participants 4460 participants
21 33 54
WBC count >1.5x ULN Number Analyzed 1117 participants 3343 participants 4460 participants
29 71 100
Lymphocytes (Abs) <0.8x LLN Number Analyzed 1117 participants 3343 participants 4460 participants
254 789 1043
Lymphocytes (Abs) >1.2x ULN Number Analyzed 1117 participants 3343 participants 4460 participants
23 94 117
Lymphocytes (%) <0.8x LLN Number Analyzed 1043 participants 3343 participants 4386 participants
401 1267 1668
Lymphocytes (%) >1.2x ULN Number Analyzed 1043 participants 3343 participants 4386 participants
23 75 98
Tot neutrophils (Abs) <0.8x LLN Number Analyzed 1117 participants 3343 participants 4460 participants
105 305 410
Tot neutrophils (Abs) >1.2x ULN Number Analyzed 1117 participants 3343 participants 4460 participants
239 617 856
Neutrophils (%) <0.8x LLN Number Analyzed 1042 participants 3343 participants 4385 participants
23 75 98
Neutrophils (%) >1.2x ULN Number Analyzed 1042 participants 3343 participants 4385 participants
29 93 122
Basophils (Abs) >1.2x ULN Number Analyzed 1117 participants 3343 participants 4460 participants
19 10 29
Basophils (%) >1.2x ULN Number Analyzed 1043 participants 3343 participants 4386 participants
76 221 297
Eosinophils (Abs) >1.2x ULN Number Analyzed 1117 participants 3343 participants 4460 participants
24 58 82
Eosinophils (%) >1.2x ULN Number Analyzed 1043 participants 3343 participants 4386 participants
36 118 154
Monocytes (Abs) >1.2x ULN Number Analyzed 1117 participants 3343 participants 4460 participants
65 107 172
Monocytes (%) >1.2x ULN Number Analyzed 1043 participants 3343 participants 4386 participants
128 405 533
ESR >1.5x ULN Number Analyzed 1113 participants 3343 participants 4456 participants
872 2411 3283
Total bilirubin >1.5x ULN Number Analyzed 1117 participants 3345 participants 4462 participants
18 38 56
Direct bilirubin >1.5x ULN Number Analyzed 1088 participants 3344 participants 4432 participants
5 14 19
Indirect bilirubin >1.5x ULN Number Analyzed 1041 participants 3344 participants 4385 participants
4 18 22
AST >3.0x ULN Number Analyzed 1117 participants 3344 participants 4461 participants
52 111 163
ALT >3.0x ULN Number Analyzed 1117 participants 3345 participants 4462 participants
87 189 276
GGT >3.0x ULN Number Analyzed 1118 participants 3345 participants 4463 participants
82 239 321
Alkaline phosphatase >3.0x ULN Number Analyzed 1118 participants 3345 participants 4463 participants
3 10 13
Total protein <0.8x LLN Number Analyzed 1118 participants 3345 participants 4463 participants
1 0 1
Total protein >1.2x ULN Number Analyzed 1118 participants 3345 participants 4463 participants
2 4 6
Albumin <0.8x LLN Number Analyzed 1118 participants 3345 participants 4463 participants
11 28 39
Albumin >1.2x ULN Number Analyzed 1118 participants 3345 participants 4463 participants
0 0 0
Blood urea nitrogen >1.3x ULN Number Analyzed 1118 participants 3345 participants 4463 participants
87 126 213
Creatinine >1.3x ULN Number Analyzed 1118 participants 3345 participants 4463 participants
52 95 147
Cholesterol >1.3x ULN Number Analyzed 1104 participants 3345 participants 4449 participants
42 130 172
HDL Cholesterol <0.8x LLN Number Analyzed 1097 participants 3301 participants 4398 participants
32 59 91
LDL Cholesterol >1.2x ULN Number Analyzed 1094 participants 3293 participants 4387 participants
69 145 214
Triglycerides >1.3x ULN Number Analyzed 1096 participants 3300 participants 4396 participants
196 373 569
Sodium <0.95x LLN Number Analyzed 1118 participants 3345 participants 4463 participants
6 19 25
Sodium >1.05x ULN Number Analyzed 1118 participants 3345 participants 4463 participants
11 18 29
Potassium <0.9x LLN Number Analyzed 1118 participants 3345 participants 4463 participants
28 62 90
Potassium >1.1x ULN Number Analyzed 1118 participants 3345 participants 4463 participants
11 25 36
Chloride <0.9x LLN Number Analyzed 1118 participants 3345 participants 4463 participants
3 5 8
Chloride >1.1x ULN Number Analyzed 1118 participants 3345 participants 4463 participants
0 1 1
Calcium <0.9x LLN Number Analyzed 1041 participants 3345 participants 4386 participants
2 8 10
Calcium >1.1x ULN Number Analyzed 1041 participants 3345 participants 4386 participants
6 9 15
Bicarbonate (venous) <0.9x LLN Number Analyzed 1117 participants 3345 participants 4462 participants
106 277 383
Bicarbonate (venous) >1.1x ULN Number Analyzed 1117 participants 3345 participants 4462 participants
1 5 6
Glucose <0.6x LLN Number Analyzed 1118 participants 3345 participants 4463 participants
3 4 7
Glucose >1.5x ULN Number Analyzed 1118 participants 3345 participants 4463 participants
125 345 470
Creatine Kinase >2.0x ULN Number Analyzed 1041 participants 3345 participants 4386 participants
203 908 1111
C-reactive protein >1.25x ULN Number Analyzed 697 participants 242 participants 939 participants
365 106 471
Urine specific gravity <1.003 Number Analyzed 1098 participants 3319 participants 4417 participants
2 7 9
Urine specific gravity >1.030 Number Analyzed 1098 participants 3319 participants 4417 participants
203 303 506
Urine pH <4.5 Number Analyzed 1098 participants 3319 participants 4417 participants
0 0 0
Urine pH >8 Number Analyzed 1098 participants 3319 participants 4417 participants
20 17 37
Urine glucose (qual) ≥1 Number Analyzed 1095 participants 3319 participants 4414 participants
60 148 208
Urine ketones (qual) ≥1 Number Analyzed 686 participants 103 participants 789 participants
2 1 3
Urine protein (qual) ≥1 Number Analyzed 1097 participants 3319 participants 4416 participants
65 222 287
Urine blood/hgb (qual) ≥1 Number Analyzed 1098 participants 3319 participants 4417 participants
444 1260 1704
Urine leukocyte esterase ≥1 Number Analyzed 687 participants 132 participants 819 participants
158 23 181
Urine red blood cells ≥20 Number Analyzed 678 participants 1498 participants 2176 participants
198 491 689
Urine WBC ≥20 Number Analyzed 689 participants 1603 participants 2292 participants
219 507 726
Urine epithelial cells ≥6 Number Analyzed 422 participants 38 participants 460 participants
205 20 225
Urine casts >1 Number Analyzed 420 participants 38 participants 458 participants
0 0 0
Urine granular casts >1 Number Analyzed 0 participants 2 participants 2 participants
0 0
Urine hyaline casts >1 Number Analyzed 14 participants 60 participants 74 participants
0 0 0
Urine bacteria >20 Number Analyzed 384 participants 35 participants 419 participants
0 0 0
2.Primary Outcome
Title Extension Period: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.
Time Frame Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period.
Arm/Group Title Extension Period: Tofacitinib 5 mg
Hide Arm/Group Description:
Participants who completed 2 years of lymphocyte assessment in Initial period and enrolled for Extension period received Tofacitinib (CP-690,550) 5 mg orally, twice daily up to 12 months.
Overall Number of Participants Analyzed 48
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with AEs
16
  33.3%
Participants with SAEs
5
  10.4%
3.Primary Outcome
Title Extension Period: Number of Participants With Laboratory Test Abnormalities
Hide Description Criteria for laboratory abnormalities: hemoglobin (Hg), hematocrit, red blood cell (RBC), high density lipoprotein (HDL) cholesterol:<0.8*lower limit of normal (LLN), platelet<0.5*LLN/>1.75*upper limit of normal (ULN), white blood cell (WBC)<0.6*LLN/>1.5*ULN, lymphocyte, neutrophil, protein, albumin <0.8*LLN/>1.2*ULN, basophil, eosinophil, monocyte, low density lipoprotein (LDL) cholesterol: >1.2*ULN; bilirubin>1.5*ULN, aspartate amino transferase(AT), alanine AT, gammaglutamyl transferase, alkaline phosphatase:>3.0*ULN; blood urea nitrogen, creatinine, cholesterol, triglyceride:>1.3*ULN; sodium <0.95*LLN/>1.05*ULN, potassium, chloride, calcium, bicarbonate: <0.9*LLN/>1.1*ULN; glucose<0.6*LLN/>1.5*ULN; Urine (specific gravity<1.003/>1.030, pH<4.5/>8, glucose, ketone, protein, blood/Hg(>=1; RBC, WBC>=20; creatinine kinase>2*ULN).
Time Frame Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period.
Arm/Group Title Extension Period: Tofacitinib 5 mg
Hide Arm/Group Description:
Participants who completed 2 years of lymphocyte assessment in Initial period and enrolled for Extension period received Tofacitinib (CP-690,550) 5 mg orally, twice daily up to 12 months.
Overall Number of Participants Analyzed 48
Measure Type: Count of Participants
Unit of Measure: Participants
30
  62.5%
4.Primary Outcome
Title Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis
Hide Description Treatment-emergent AEs by SOC (all causalities) - all participants, by time. Data presented for Post Month 96 includes data up to and including Month 114.
Time Frame Includes AEs for every visit and up to 999 days after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
The stated number of participants analyzed is the total number of participants enrolled in each group. The number of evaluable participants is the number remaining in the study in the given time period.
Arm/Group Title Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) Initial Period: Tofacitinib 10 mg BID Initial Period: All Tofacitinib
Hide Arm/Group Description:
Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID.
Participants with average total daily dose across study >=15 were assigned to 10 mg BID.
All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.
Overall Number of Participants Analyzed 1123 3358 4481
Measure Type: Number
Unit of Measure: Number of participants
Evaluable for AEs at Months 0 to 6 1123 3358 4481
Percent with AEs at Months 0 to 6 59.4 61.8 61.2
Percent discontinued due to AEs at Months 0 to 6 4.2 4.0 4.0
Evaluable for AEs at Months 6 to 12 1033 3121 4154
Percent with AEs at Months 6 to 12 45.1 47.7 47.1
Percent discontinued due to AEs at Months 6 to 12 2.1 3.7 3.3
Evaluable for AEs at Months 12 to 18 969 2865 3834
Percent with AEs at Months 12 to 18 41.2 46.8 45.4
Percent discontinued due to AEs at Months 12 to 18 3.2 3.4 3.3
Evaluable at Months 18 to 24 896 2660 3556
Percent with AEs at Months 18 to 24 38.1 43.2 41.9
Percent discontinued due to AEs at Months 18 to 24 2.8 2.9 2.9
Evaluable for AEs at Months 24 to 30 820 2461 3281
Percent with AEs at Months 24 to 30 40.7 44.5 43.5
Percent discontinued due to AEs at Months 24 to 30 3.2 2.8 2.9
Evaluable for AEs at Months 30 to 36 774 2288 3062
Percent with AEs at Months 30 to 36 39.0 40.7 40.3
Percent discontinued due to AEs at Months 30 to 36 2.6 2.5 2.5
Evaluable for AEs at Months 36 to 42 729 2162 2891
Percent with AEs at Months 36 to 42 38.1 37.5 37.6
Percent discontinued due to AEs at Months 36 to 42 2.5 2.5 2.5
Evaluable for AEs at Months 42 to 48 652 1843 2495
Percent with AEs at Months 42 to 48 37.9 34.3 35.3
Percent discontinued due to AEs at Months 42 to 48 2.8 2.9 2.9
Evaluable for AEs at Months 48 to 54 558 1471 2029
Percent with AEs at Months 48 to 54 36.0 36.4 36.3
Percent discontinued due to AEs at Months 48 to 54 2.0 2.5 2.4
Evaluable for AEs at Months 54 to 60 466 1172 1638
Percent with AEs at Months 54 to 60 37.1 35.4 35.9
Percent discontinued due to AEs at Months 54 to 60 3.6 2.7 3.0
Evaluable for AEs at Months 60 to 66 414 918 1332
Percent with AEs at Months 60 to 66 33.8 31.4 32.1
Percent discontinued due to AEs at Months 60 to 66 2.4 1.9 2.0
Evaluable for AEs at Months 66 to 72 379 670 1049
Percent with AEs at Months 66 to 72 33.5 21.6 25.9
Percent discontinued due to AEs at Months 66 to 72 3.2 0.7 1.6
Evaluable for AEs at Months 72 to 78 336 262 598
Percent with AEs at Months 72 to 78 33.6 22.5 28.8
Percent discontinued due to AEs at Months 72 to 78 0.9 0.4 0.7
Evaluable for AEs at Months 78 to 84 302 86 388
Percent with AEs at Months 78 to 84 36.8 26.7 34.5
Percent discontinued due to AEs at Months 78 to 84 3.3 1.2 2.8
Evaluable for AEs at Months 84 to 90 273 42 315
Percent with AEs at Months 84 to 90 30.8 35.7 31.4
Percent discontinued due to AEs at Months 84 to 90 1.8 0 1.6
Evaluable for AEs at Months 90 to 96 234 34 268
Percent with AEs at Months 90 to 96 21.8 29.4 22.8
Percent discontinued due to AEs at Months 90 to 96 0.9 0 0.7
Evaluable for AEs post Month 96 130 15 145
Percent with AEs post Month 96 20.8 46.7 23.4
Percent discontinued due to AEs post Month 96 1.5 0 1.4
5.Primary Outcome
Title Extension Period: Percentage of Participants With Adverse Events and Who Discontinued Treatment Due to Adverse Events to Assess Long-term Safety and Tolerability of Tofacitinib
Hide Description Long term safety and tolerability of Tofacitinib was measured as following: percentage (%) of participants with AEs, percentage of participants who discontinued due to AEs. An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship.
Time Frame Baseline (Day 1 at Entry of Extension Period) up to Month 6 of Extension Period; Month 6 of Extension Period to Month 12 of Extension Period
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. Here, “Number Analyzed” signifies number of participants evaluable for specified categories.
Arm/Group Title Extension Period: Tofacitinib 5 mg
Hide Arm/Group Description:
Participants who completed 2 years of lymphocyte assessment in Initial period and enrolled for Extension period received Tofacitinib (CP-690,550) 5 mg orally, twice daily up to 12 months.
Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: Percentage of participants
Baseline to Month 6: % of Participants with AEs Number Analyzed 48 participants
31.3
Baseline to Month6:% of Participants Discontinued Number Analyzed 48 participants
4.2
Month 6 to 12: % of Participants with AEs Number Analyzed 17 participants
17.6
Month 6 to 12: % of Participants Discontinued Number Analyzed 17 participants
0
6.Secondary Outcome
Title Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses
Hide Description The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented. ACR20 is defined as a 20% improvement from baseline in tender/painful joint count and swollen joint count, and at least 3 of the following 5 variables: Subject's Global Assessment of Arthritis, Physician's Global Assessment of Arthritis, Subject's Assessment of Arthritis Pain, Health Assessment Questionnaire - Disability Index, C-Reactive Protein (CRP). ACR50 is a 50% improvement and ACR70 a 70% improvement in these variables.
Time Frame Every visit until study completion
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.
Arm/Group Title Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) Initial Period: Tofacitinib 10 mg BID Initial Period: All Tofacitinib
Hide Arm/Group Description:
Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID.
Participants with average total daily dose across study >=15 were assigned to 10 mg BID.
All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.
Overall Number of Participants Analyzed 1123 3358 4481
Measure Type: Number
Unit of Measure: Percent of participants
ACR20 at Month 1 Number Analyzed 1114 participants 3307 participants 4421 participants
70.65 73.60 72.86
ACR20 at Month 2 Number Analyzed 1080 participants 3254 participants 4334 participants
74.81 76.06 75.75
ACR20 at Month 3 Number Analyzed 1069 participants 3228 participants 4297 participants
75.68 78.00 77.43
ACR20 at Month 6 Number Analyzed 1040 participants 3132 participants 4172 participants
75.58 77.36 76.92
ACR20 at Month 9 Number Analyzed 1003 participants 3022 participants 4025 participants
76.57 77.53 77.29
ACR20 at Month 12 Number Analyzed 972 participants 2891 participants 3863 participants
77.88 78.24 78.15
ACR20 at Month 15 Number Analyzed 938 participants 2775 participants 3713 participants
76.76 78.67 78.18
ACR20 at Month 18 Number Analyzed 910 participants 2665 participants 3575 participants
77.91 78.46 78.32
ACR20 at Month 21 Number Analyzed 860 participants 2565 participants 3425 participants
77.91 79.42 79.04
ACR20 at Month 24 Number Analyzed 824 participants 2464 participants 3288 participants
79.61 78.37 78.68
ACR20 at Month 27 Number Analyzed 796 participants 2361 participants 3157 participants
79.15 79.16 79.16
ACR20 at Month 30 Number Analyzed 770 participants 2288 participants 3058 participants
80.00 79.90 79.92
ACR20 at Month 33 Number Analyzed 749 participants 2219 participants 2968 participants
80.51 79.81 79.99
ACR20 at Month 36 Number Analyzed 730 participants 2157 participants 2887 participants
81.78 79.37 79.98
ACR20 at Month 39 Number Analyzed 690 participants 2073 participants 2763 participants
78.55 81.23 80.56
ACR20 at Month 42 Number Analyzed 657 participants 1907 participants 2564 participants
78.69 80.49 80.03
ACR20 at Month 45 Number Analyzed 616 participants 1658 participants 2274 participants
82.14 79.55 80.26
ACR20 at Month 48 Number Analyzed 581 participants 1486 participants 2067 participants
78.31 80.69 80.02
ACR20 at Month 51 Number Analyzed 490 participants 1355 participants 1845 participants
83.47 80.30 81.14
ACR20 at Month 54 Number Analyzed 471 participants 1208 participants 1679 participants
79.19 78.97 79.04
ACR20 at Month 57 Number Analyzed 441 participants 1021 participants 1462 participants
80.73 82.37 81.87
ACR20 at Month 60 Number Analyzed 411 participants 920 participants 1331 participants
81.75 82.39 82.19
ACR20 at Month 63 Number Analyzed 396 participants 692 participants 1230 participants
80.30 82.97 82.11
ACR20 at Month 66 Number Analyzed 382 participants 705 participants 1087 participants
79.84 81.42 80.86
ACR20 at Month 69 Number Analyzed 358 participants 486 participants 844 participants
82.68 83.54 83.18
ACR20 at Month 72 Number Analyzed 339 participants 287 participants 626 participants
82.01 82.58 82.27
ACR20 at Month 75 Number Analyzed 309 participants 171 participants 480 participants
82.20 78.95 81.04
ACR20 at Month 78 Number Analyzed 295 participants 91 participants 386 participants
81.69 80.22 81.35
ACR20 at Month 81 Number Analyzed 286 participants 54 participants 340 participants
82.52 79.63 82.06
ACR20 at Month 84 Number Analyzed 271 participants 44 participants 315 participants
82.66 81.82 82.54
ACR20 at Month 87 Number Analyzed 264 participants 41 participants 305 participants
84.47 70.73 82.62
ACR20 at Month 90 Number Analyzed 241 participants 39 participants 280 participants
82.57 74.36 81.43
ACR20 at Month 93 Number Analyzed 196 participants 28 participants 224 participants
82.14 78.57 81.70
ACR20 at Month 96 Number Analyzed 144 participants 16 participants 160 participants
78.47 81.25 78.75
ACR20 at Month 99 Number Analyzed 65 participants 11 participants 76 participants
83.08 90.91 84.21
ACR20 at Month 102 Number Analyzed 22 participants 4 participants 26 participants
77.27 50.00 73.08
ACR20 at Month 105 Number Analyzed 15 participants 3 participants 18 participants
73.33 66.67 72.22
ACR20 at Month 108 Number Analyzed 8 participants 1 participants 9 participants
62.50 100.00 66.67
ACR20 at Month 111 Number Analyzed 3 participants 1 participants 4 participants
100.00 100.00 100.00
ACR20 at Month 114 Number Analyzed 1 participants 0 participants 1 participants
100.00 100.00
ACR50 at Month 1 Number Analyzed 1114 participants 3307 participants 4421 participants
47.67 49.56 49.08
ACR50 at Month 2 Number Analyzed 1080 participants 3254 participants 4334 participants
50.19 53.29 52.51
ACR50 at Month 3 Number Analyzed 1069 participants 3228 participants 4297 participants
51.45 54.52 53.76
ACR50 at Month 6 Number Analyzed 1040 participants 3132 participants 4172 participants
52.79 55.75 55.01
ACR50 at Month 9 Number Analyzed 1003 participants 3022 participants 4025 participants
53.24 55.96 55.28
ACR50 at Month 12 Number Analyzed 972 participants 2891 participants 3863 participants
52.98 56.73 55.79
ACR50 at Month 15 Number Analyzed 938 participants 2775 participants 3713 participants
55.76 56.61 56.40
ACR50 at Month 18 Number Analyzed 910 participants 2665 participants 3575 participants
55.16 57.30 56.76
ACR50 at Month 21 Number Analyzed 860 participants 2565 participants 3425 participants
54.77 59.10 58.01
ACR50 at Month 24 Number Analyzed 824 participants 2464 participants 3288 participants
57.77 57.67 57.69
ACR50 at Month 27 Number Analyzed 796 participants 2361 participants 3157 participants
56.91 58.58 58.16
ACR50 at Month 30 Number Analyzed 770 participants 2288 participants 3058 participants
58.83 58.65 58.70
ACR50 at Month 33 Number Analyzed 749 participants 2219 participants 2968 participants
57.68 59.31 58.89
ACR50 at Month 36 Number Analyzed 730 participants 2157 participants 2887 participants
58.49 58.51 58.50
ACR50 at Month 39 Number Analyzed 690 participants 2073 participants 2763 participants
59.28 59.29 59.28
ACR50 at Month 42 Number Analyzed 657 participants 1907 participants 2564 participants
58.60 59.99 59.63
ACR50 at Month 45 Number Analyzed 616 participants 1658 participants 2274 participants
59.42 60.07 59.89
ACR50 at Month 48 Number Analyzed 581 participants 1486 participants 2067 participants
58.00 57.60 57.72
ACR50 at Month 51 Number Analyzed 490 participants 1355 participants 1845 participants
62.45 59.19 60.05
ACR50 at Month 54 Number Analyzed 471 participants 1208 participants 1679 participants
58.60 59.44 59.20
ACR50 at Month 57 Number Analyzed 441 participants 1021 participants 1462 participants
61.45 61.12 61.22
ACR50 at Month 60 Number Analyzed 411 participants 920 participants 1331 participants
62.53 60.65 61.23
ACR50 at Month 63 Number Analyzed 396 participants 834 participants 1230 participants
64.39 61.99 62.76
ACR50 at Month 66 Number Analyzed 382 participants 705 participants 1087 participants
60.73 60.85 60.81
ACR50 at Month 69 Number Analyzed 358 participants 486 participants 844 participants
58.10 61.11 59.83
ACR50 at Month 72 Number Analyzed 339 participants 287 participants 626 participants
62.54 59.93 61.34
ACR50 at Month 75 Number Analyzed 309 participants 171 participants 480 participants
61.49 56.14 59.58
ACR50 at Month 78 Number Analyzed 295 participants 91 participants 386 participants
60.00 58.24 59.59
ACR50 at Month 81 Number Analyzed 286 participants 54 participants 340 participants
63.99 51.85 62.06
ACR50 at Month 84 Number Analyzed 271 participants 44 participants 315 participants
63.10 54.55 61.90
ACR50 at Month 87 Number Analyzed 264 participants 41 participants 305 participants
67.05 43.90 63.93
ACR50 at Month 90 Number Analyzed 241 participants 39 participants 280 participants
61.00 46.15 58.93
ACR50 at Month 93 Number Analyzed 196 participants 28 participants 224 participants
61.22 57.14 60.71
ACR50 at Month 96 Number Analyzed 144 participants 16 participants 160 participants
61.11 56.25 60.63
ACR50 at Month 99 Number Analyzed 65 participants 11 participants 76 participants
53.85 54.55 53.95
ACR50 at Month 102 Number Analyzed 22 participants 4 participants 26 participants
54.55 25.00 50.00
ACR50 at Month 105 Number Analyzed 15 participants 3 participants 18 participants
66.67 33.33 61.11
ACR50 at Month 108 Number Analyzed 8 participants 1 participants 9 participants
50.00 0.00 44.44
ACR50 at Month 111 Number Analyzed 3 participants 1 participants 4 participants
100.00 0.00 75.00
ACR50 at Month 114 Number Analyzed 1 participants 0 participants 1 participants
100.00 100.00
ACR70 at Month 1 Number Analyzed 1114 participants 3307 participants 4421 participants
26.66 28.82 28.27
ACR70 at Month 2 Number Analyzed 1080 participants 3254 participants 4334 participants
27.78 31.53 30.60
ACR70 at Month 3 Number Analyzed 1069 participants 3228 participants 4297 participants
29.37 33.09 32.16
ACR70 at Month 6 Number Analyzed 1040 participants 3132 participants 4172 participants
31.06 33.75 33.08
ACR70 at Month 9 Number Analyzed 1003 participants 3022 participants 4025 participants
31.80 34.91 34.14
ACR70 at Month 12 Number Analyzed 972 participants 2891 participants 3863 participants
31.38 35.84 34.71
ACR70 at Month 15 Number Analyzed 938 participants 2775 participants 3713 participants
32.94 36.54 35.63
ACR70 at Month 18 Number Analyzed 910 participants 2665 participants 3575 participants
35.82 36.40 36.25
ACR70 at Month 21 Number Analyzed 860 participants 2565 participants 3425 participants
33.49 37.66 36.61
ACR70 at Month 24 Number Analyzed 824 participants 2464 participants 3288 participants
35.44 38.15 37.47
ACR70 at Month 27 Number Analyzed 796 participants 2361 participants 3157 participants
36.06 38.33 37.76
ACR70 at Month 30 Number Analyzed 770 participants 2288 participants 3058 participants
37.27 38.99 38.55
ACR70 at Month 33 Number Analyzed 749 participants 2219 participants 2968 participants
33.64 38.26 37.10
ACR70 at Month 36 Number Analyzed 730 participants 2157 participants 2887 participants
36.71 37.41 37.24
ACR70 at Month 39 Number Analyzed 690 participants 2073 participants 2763 participants
38.41 38.88 38.76
ACR70 at Month 42 Number Analyzed 657 participants 1907 participants 2564 participants
35.77 38.91 38.10
ACR70 at Month 45 Number Analyzed 616 participants 1658 participants 2274 participants
36.69 38.18 37.77
ACR70 at Month 48 Number Analyzed 581 participants 1486 participants 2067 participants
35.97 37.01 36.72
ACR70 at Month 51 Number Analyzed 490 participants 1355 participants 1845 participants
39.59 37.34 37.94
ACR70 at Month 54 Number Analyzed 471 participants 1208 participants 1679 participants
36.73 39.32 38.59
ACR70 at Month 57 Number Analyzed 441 participants 1021 participants 1462 participants
38.78 39.47 39.26
ACR70 at Month 60 Number Analyzed 411 participants 920 participants 1331 participants
37.96 38.91 38.62
ACR70 at Month 63 Number Analyzed 396 participants 834 participants 1230 participants
38.64 39.33 39.11
ACR70 at Month 66 Number Analyzed 382 participants 705 participants 1087 participants
38.22 40.14 39.47
ACR70 at Month 69 Number Analyzed 358 participants 486 participants 844 participants
38.55 41.56 40.28
ACR70 at Month 72 Number Analyzed 339 participants 287 participants 626 participants
40.12 36.59 38.50
ACR70 at Month 75 Number Analyzed 309 participants 171 participants 480 participants
40.13 36.84 38.96
ACR70 at Month 78 Number Analyzed 295 participants 91 participants 386 participants
42.37 32.97 40.16
ACR70 at Month 81 Number Analyzed 286 participants 54 participants 340 participants
41.26 35.19 40.29
ACR70 at Month 84 Number Analyzed 271 participants 44 participants 315 participants
42.07 31.82 40.63
ACR70 at Month 87 Number Analyzed 264 participants 41 participants 305 participants
42.80 21.95 40.00
ACR70 at Month 90 Number Analyzed 241 participants 39 participants 280 participants
38.17 25.64 36.43
ACR70 at Month 93 Number Analyzed 196 participants 28 participants 224 participants
41.84 39.29 41.52
ACR70 at Month 96 Number Analyzed 144 participants 16 participants 160 participants
43.75 31.25 42.50
ACR70 at Month 99 Number Analyzed 65 participants 11 participants 76 participants
40.00 18.18 36.84
ACR70 at Month 102 Number Analyzed 22 participants 4 participants 26 participants
40.91 25.00 38.46
ACR70 at Month 105 Number Analyzed 15 participants 3 participants 18 participants
46.67 33.33 44.44
ACR70 at Month 108 Number Analyzed 8 participants 1 participants 9 participants
25.00 0.00 22.22
ACR70 at Month 111 Number Analyzed 3 participants 1 participants 4 participants
100.00 0.00 75.00
ACR70 at Month 114 Number Analyzed 1 participants 0 participants 1 participants
100.00 100.00
7.Secondary Outcome
Title Extension Period: Percentage of Participants With American College of Rheumatology (ACR) 20, 50, and 70 Responses
Hide Description ACR20=20 percent (%) improvement from baseline (Month 0 at entry of Initial Period) in tender/painful joint count and swollen joint count, and in at least 3 of 5 variables: participant’s global assessment of arthritis (PtGA), physician's global assessment of arthritis (PGA), participant’s assessment of arthritis pain (PtA), HAQ-DI, C-reactive protein. ACR50 is a 50% improvement and ACR70 is a 70% improvement in these variables. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant’s overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PtA: participant assessed arthritis pain by 100 millimeter (mm) visual analogue scale, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability.
Time Frame Month 3, 6, 9 and 12 of Extension Period
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. Here, "Number Analyzed" signifies number of participants who were evaluable for specified categories.
Arm/Group Title Extension Period: Tofacitinib 5 mg
Hide Arm/Group Description:
Participants who completed 2 years of lymphocyte assessment in Initial period and enrolled for Extension period received Tofacitinib (CP-690,550) 5 mg orally, twice daily up to 12 months.
Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: Percentage of participants
ACR20 at Month 3 Number Analyzed 47 participants
70.21
ACR20 at Month 6 Number Analyzed 36 participants
66.67
ACR20 at Month 9 Number Analyzed 15 participants
86.67
ACR20 at Month 12 Number Analyzed 2 participants
50.00
ACR50 at Month 3 Number Analyzed 47 participants
48.94
ACR50 at Month 6 Number Analyzed 36 participants
55.56
ACR50 at Month 9 Number Analyzed 15 participants
60.00
ACR50 at Month 12 Number Analyzed 2 participants
50.00
ACR70 at Month 3 Number Analyzed 47 participants
23.40
ACR70 at Month 6 Number Analyzed 36 participants
36.11
ACR70 at Month 9 Number Analyzed 15 participants
40.00
ACR70 at Month 12 Number Analyzed 2 participants
50.00
8.Secondary Outcome
Title Initial Period: Area Under American College of Rheumatology (ACR) n Curve
Hide Description No data were collected for this endpoint because it was removed from the protocol in a previous amendment.
Time Frame Not applicable as no data were collected for this endpoint.
Hide Outcome Measure Data
Hide Analysis Population Description
No data were collected for this endpoint as it was removed from the protocol in a protocol amendment.
Arm/Group Title Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) Initial Period: Tofacitinib 10 mg BID Initial Period: All Tofacitinib
Hide Arm/Group Description:
Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID.
Participants with average total daily dose across study >=15 were assigned to 10 mg BID.
All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR])
Hide Description

Descriptive statistics for DAS28-3 (CRP) and DAS28-4 (ESR). The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.

DAS28 is a composite score, calculated using a mathematical formula, and is derived from the number of tender/painful joints (out of 28), number of swollen joints (out of 28), and a blood marker of inflammation (ESR or CRP). DAS28-4 also includes a score of general health in the formula.

The score range is from 0 to 9.4, with a higher score indicating more disease activity. A score of >5.1 indicates active disease, a score of ≤3.2 indicates low disease activity, and a score of <2.6 indicates disease remission.

Time Frame Every visit until study completion
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.
Arm/Group Title Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) Initial Period: Tofacitinib 10 mg BID Initial Period: All Tofacitinib
Hide Arm/Group Description:
Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID.
Participants with average total daily dose across study >=15 were assigned to 10 mg BID.
All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.
Overall Number of Participants Analyzed 1123 3358 4481
Mean (Standard Deviation)
Unit of Measure: Score calculated from formula
DAS28-4 (ESR) Baseline Number Analyzed 1002 participants 3296 participants 4298 participants
6.27  (1.02) 6.39  (1.04) 6.36  (1.04)
DAS28-4 (ESR) Month 1 Number Analyzed 1036 participants 3254 participants 4290 participants
3.81  (1.32) 3.78  (1.36) 3.79  (1.35)
DAS28-4 (ESR) Month 2 Number Analyzed 1026 participants 3222 participants 4248 participants
3.72  (1.27) 3.66  (1.32) 3.68  (1.31)
DAS28-4 (ESR) Month 3 Number Analyzed 1033 participants 3203 participants 4236 participants
3.75  (1.32) 3.61  (1.30) 3.65  (1.31)
DAS28-4 (ESR) Month 6 Number Analyzed 1015 participants 3110 participants 4125 participants
3.67  (1.33) 3.61  (1.30) 3.62  (1.31)
DAS28-4 (ESR) Month 9 Number Analyzed 992 participants 3003 participants 3995 participants
3.60  (1.31) 3.58  (1.32) 3.59  (1.31)
DAS28-4 (ESR) Month 12 Number Analyzed 967 participants 2862 participants 3829 participants
3.61  (1.26) 3.56  (1.30) 3.57  (1.29)
DAS28-4 (ESR) Month 15 Number Analyzed 922 participants 2759 participants 3681 participants
3.54  (1.26) 3.53  (1.30) 3.53  (1.29)
DAS28-4 (ESR) Month 18 Number Analyzed 899 participants 2655 participants 3554 participants
3.57  (1.26) 3.50  (1.28) 3.52  (1.28)
DAS28-4 (ESR) Month 21 Number Analyzed 850 participants 2547 participants 3397 participants
3.58  (1.25) 3.45  (1.27) 3.48  (1.26)
DAS28-4 (ESR) Month 24 Number Analyzed 818 participants 2441 participants 3259 participants
3.54  (1.21) 3.46  (1.26) 3.48  (1.25)
DAS28-4 (ESR) Month 27 Number Analyzed 787 participants 2343 participants 3130 participants
3.52  (1.20) 3.44  (1.25) 3.46  (1.24)
DAS28-4 (ESR) Month 30 Number Analyzed 764 participants 2257 participants 3021 participants
3.54  (1.23) 3.43  (1.25) 3.46  (1.24)
DAS28-4 (ESR) Month 33 Number Analyzed 746 participants 2199 participants 2945 participants
3.51  (1.22) 3.42  (1.27) 3.45  (1.26)
DAS28-4 (ESR) Month 36 Number Analyzed 720 participants 2141 participants 2861 participants
3.51  (1.23) 3.42  (1.27) 3.44  (1.26)
DAS28-4 (ESR) Month 39 Number Analyzed 679 participants 2056 participants 2735 participants
3.56  (1.27) 3.39  (1.24) 3.43  (1.25)
DAS28-4 (ESR) Month 42 Number Analyzed 642 participants 1890 participants 2532 participants
3.53  (1.26) 3.40  (1.26) 3.43  (1.26)
DAS28-4 (ESR) Month 45 Number Analyzed 609 participants 1641 participants 2250 participants
3.45  (1.20) 3.37  (1.21) 3.39  (1.20)
DAS28-4 (ESR) Month 48 Number Analyzed 570 participants 1471 participants 2041 participants
3.46  (1.16) 3.36  (1.21) 3.39  (1.20)
DAS28-4 (ESR) Month 51 Number Analyzed 481 participants 1344 participants 1825 participants
3.43  (1.20) 3.39  (1.24) 3.40  (1.23)
DAS28-4 (ESR) Month 54 Number Analyzed 467 participants 1194 participants 1661 participants
3.54  (1.23) 3.38  (1.25) 3.42  (1.25)
DAS28-4 (ESR) Month 57 Number Analyzed 438 participants 1006 participants 1444 participants
3.48  (1.19) 3.36  (1.21) 3.40  (1.20)
DAS28-4 (ESR) Month 60 Number Analyzed 408 participants 908 participants 1316 participants
3.51  (1.27) 3.34  (1.20) 3.39  (1.22)
DAS28-4 (ESR) Month 63 Number Analyzed 388 participants 825 participants 1213 participants
3.51  (1.15) 3.30  (1.16) 3.37  (1.16)
DAS28-4 (ESR) Month 66 Number Analyzed 379 participants 700 participants 1079 participants
3.58  (1.12) 3.34  (1.17) 3.42  (1.15)
DAS28-4 (ESR) Month 69 Number Analyzed 355 participants 483 participants 838 participants
3.51  (1.18) 3.35  (1.20) 3.41  (1.19)
DAS28-4 (ESR) Month 72 Number Analyzed 338 participants 284 participants 622 participants
3.45  (1.20) 3.42  (1.19) 3.44  (1.20)
DAS28-4 (ESR) Month 75 Number Analyzed 299 participants 169 participants 468 participants
3.43  (1.11) 3.41  (1.14) 3.43  (1.12)
DAS28-4 (ESR) Month 78 Number Analyzed 291 participants 91 participants 382 participants
3.44  (1.14) 3.32  (1.20) 3.41  (1.16)
DAS28-4 (ESR) Month 81 Number Analyzed 284 participants 54 participants 338 participants
3.40  (1.11) 3.56  (1.24) 3.42  (1.13)
DAS28-4 (ESR) Month 84 Number Analyzed 271 participants 44 participants 315 participants
3.32  (1.13) 3.42  (1.37) 3.34  (1.16)
DAS28-4 (ESR) Month 87 Number Analyzed 263 participants 41 participants 304 participants
3.33  (1.13) 3.19  (1.15) 3.31  (1.13)
DAS28-4 (ESR) Month 90 Number Analyzed 237 participants 39 participants 276 participants
3.34  (1.14) 3.28  (1.10) 3.33  (1.13)
DAS28-4 (ESR) Month 93 Number Analyzed 191 participants 28 participants 219 participants
3.33  (1.14) 3.23  (1.12) 3.32  (1.13)
DAS28-4 (ESR) Month 96 Number Analyzed 142 participants 16 participants 158 participants
3.30  (1.12) 3.48  (1.06) 3.32  (1.11)
DAS28-4 (ESR) Month 99 Number Analyzed 65 participants 11 participants 76 participants
3.26  (1.07) 3.04  (1.24) 3.23  (1.09)
DAS28-4 (ESR) Month 102 Number Analyzed 22 participants 4 participants 26 participants
3.34  (1.47) 3.10  (1.76) 3.30  (1.48)
DAS28-4 (ESR) Month 105 Number Analyzed 14 participants 3 participants 17 participants
3.64  (1.52) 2.65  (0.97) 3.46  (1.46)
DAS28-4 (ESR) Month 108 Number Analyzed 8 participants 1 participants 9 participants
3.36  (1.76) 4.65  (0) 3.51  (1.70)
DAS28-4 (ESR) Month 111 Number Analyzed 3 participants 1 participants 4 participants
2.03  (0.69) 3.59  (0) 2.42  (0.96)
DAS28-4 (ESR) Month 114 Number Analyzed 1 participants 0 participants 1 participants
1.28  (0) 1.28  (0)
DAS28-3 (CRP) Baseline Number Analyzed 1112 participants 3340 participants 4452 participants
5.31  (0.95) 5.34  (0.98) 5.33  (0.97)
DAS28-3 (CRP) Month 1 Number Analyzed 1096 participants 3234 participants 4330 participants
3.10  (1.19) 2.96  (1.22) 2.99  (1.21)
DAS28-3 (CRP) Month 2 Number Analyzed 1070 participants 3180 participants 4250 participants
3.01  (1.15) 2.87  (1.17) 2.90  (1.17)
DAS28-3 (CRP) Month 3 Number Analyzed 1057 participants 3190 participants 4247 participants
2.98  (1.15) 2.81  (1.15) 2.85  (1.15)
DAS28-3 (CRP) Month 6 Number Analyzed 1026 participants 3106 participants 4132 participants
2.89  (1.16) 2.79  (1.15) 2.81  (1.16)
DAS28-3 (CRP) Month 9 Number Analyzed 993 participants 3008 participants 4001 participants
2.82  (1.12) 2.74  (1.16) 2.76  (1.15)
DAS28-3 (CRP) Month 12 Number Analyzed 962 participants 2874 participants 3836 participants
2.81  (1.11) 2.72  (1.13) 2.74  (1.13)
DAS28-3 (CRP) Month 15 Number Analyzed 923 participants 2761 participants 3684 participants
2.73  (1.10) 2.69  (1.13) 2.70  (1.12)
DAS28-3 (CRP) Month 18 Number Analyzed 899 participants 2654 participants 3553 participants
2.72  (1.11) 2.66  (1.11) 2.68  (1.11)
DAS28-3 (CRP) Month 21 Number Analyzed 856 participants 2556 participants 3412 participants
2.75  (1.12) 2.62  (1.09) 2.65  (1.09)
DAS28-3 (CRP) Month 24 Number Analyzed 813 participants 2456 participants 3269 participants
2.96  (1.07) 2.63  (1.11) 2.64  (1.10)
DAS28-3 (CRP) Month 27 Number Analyzed 793 participants 2345 participants 3138 participants
2.66  (1.06) 2.60  (1.09) 2.62  (1.08)
DAS28-3 (CRP) Month 30 Number Analyzed 766 participants 2271 participants 3037 participants
2.65  (1.07) 2.59  (1.09) 2.60  (1.08)
DAS28-3 (CRP) Month 33 Number Analyzed 745 participants 2209 participants 2954 participants
2.64  (1.06) 2.58  (1.10) 2.60  (1.09)
DAS28-3 (CRP) Month 36 Number Analyzed 724 participants 2142 participants 2866 participants
2.64  (1.07) 2.59  (1.08) 2.60  (1.08)
DAS28-3 (CRP) Month 39 Number Analyzed 686 participants 2057 participants 2743 participants
2.65  (1.10) 2.57  (1.07) 2.59  (1.08)
DAS28-3 (CRP) Month 42 Number Analyzed 653 participants 1893 participants 2546 participants
2.63  (1.09) 2.57  (1.09) 2.59  (1.09)
DAS28-3 (CRP) Month 45 Number Analyzed 611 participants 1644 participants 2255 participants
2.57  (1.04) 2.53  (1.03) 2.54  (1.03)
DAS28-3 (CRP) Month 48 Number Analyzed 579 participants 1469 participants 2048 participants
2.59  (1.03) 2.54  (1.05) 2.56  (1.04)
DAS28-3 (CRP) Month 51 Number Analyzed 487 participants 1348 participants 1835 participants
2.59  (0.99) 2.57  (1.07) 2.57  (1.05)
DAS28-3 (CRP) Month 54 Number Analyzed 468 participants 1198 participants 1666 participants
2.68  (1.07) 2.56  (1.05) 2.59  (1.06)
DAS28-3 (CRP) Month 57 Number Analyzed 439 participants 1011 participants 1450 participants
2.63  (1.03) 2.54  (1.04) 2.56  (1.03)
DAS28-3 (CRP) Month 60 Number Analyzed 407 participants 913 participants 1320 participants
2.66  (1.09) 2.53  (1.03) 2.57  (1.05)
DAS28-3 (CRP) Month 63 Number Analyzed 390 participants 824 participants 1214 participants
2.67  (1.01) 2.51  (0.98) 2.56  (0.99)
DAS28-3 (CRP) Month 66 Number Analyzed 376 participants 702 participants 1078 participants
2.70  (1.02) 2.53  (1.01) 2.59  (1.02)
DAS28-3 (CRP) Month 69 Number Analyzed 355 participants 483 participants 838 participants
2.67  (1.06) 2.55  (1.00) 2.60  (1.03)
DAS28-3 (CRP) Month 72 Number Analyzed 337 participants 285 participants 622 participants
2.65  (1.04) 2.64  (1.03) 2.64  (1.04)
DAS28-3 (CRP) Month 75 Number Analyzed 304 participants 170 participants 474 participants
2.63  (1.05) 2.59  (1.02) 2.61  (1.04)
DAS28-3 (CRP) Month 78 Number Analyzed 292 participants 91 participants 383 participants
2.59  (1.02) 2.68  (1.01) 2.61  (1.02)
DAS28-3 (CRP) Month 81 Number Analyzed 285 participants 54 participants 339 participants
2.54  (0.96) 2.82  (1.13) 2.59  (0.99)
DAS28-3 (CRP) Month 84 Number Analyzed 269 participants 44 participants 313 participants
2.49  (0.94) 2.84  (1.20) 2.54  (0.99)
DAS28-3 (CRP) Month 87 Number Analyzed 264 participants 41 participants 305 participants
2.52  (0.97) 2.56  (0.91) 2.52  (0.96)
DAS28-3 (CRP) Month 90 Number Analyzed 240 participants 39 participants 279 participants
2.55  (1.00) 2.58  (0.95) 2.55  (0.99)
DAS28-3 (CRP) Month 93 Number Analyzed 196 participants 28 participants 224 participants
2.59  (1.00) 2.59  (0.85) 2.59  (0.98)
DAS28-3 (CRP) Month 96 Number Analyzed 144 participants 16 participants 160 participants
2.59  (0.93) 2.68  (0.80) 2.60  (0.92)
DAS28-3 (CRP) Month 99 Number Analyzed 64 participants 11 participants 75 participants
2.58  (0.89) 2.49  (1.12) 2.57  (0.92)
DAS28-3 (CRP) Month 102 Number Analyzed 13 participants 3 participants 16 participants
2.66  (0.78) 2.29  (1.01) 2.59  (0.81)
DAS28-3 (CRP) Month 105 Number Analyzed 12 participants 2 participants 14 participants
3.31  (1.23) 1.76  (0.34) 3.09  (1.26)
DAS28-3 (CRP) Month 108 Number Analyzed 7 participants 1 participants 8 participants
3.46  (1.59) 3.70  (0) 3.49  (1.47)
DAS28-3 (CRP) Month 111 Number Analyzed 3 participants 1 participants 4 participants
1.82  (0.50) 2.49  (0) 1.98  (0.53)
DAS28-3 (CRP) Month 114 Number Analyzed 1 participants 0 participants 1 participants
2.67  (0) 2.67  (0)
10.Secondary Outcome
Title Extension Period: Change From Baseline in Disease Activity Score (DAS) 28-3 C-Reactive Protein (CRP)(DAS28-3 CRP) and DAS28-4 Erythrocyte Sedimentation Rate (ESR)(DAS28-4 ESR) at Month 3, 6, 9 and 12
Hide Description DAS28 is composite score, calculated using mathematical formula, derived from: 1) tender/painful joints count, out of 28 joints (TJC28), 2) swollen joints count, out of 28 joints (SJC28), 3) blood marker of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]). DAS28-4 also include score of general health (GH). GH is general health or participants’ global assessment of disease activity on 100 mm visual analog scale (GH score: 0 mm [very well] to 100 mm [extremely bad], higher scores = worse health condition). DAS28-3(CRP) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.36*ln[CRP+1]) *1.10 + 1.15) and DAS28-4(ESR) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.70*ln[ESR] + 0.014*GH), where sqrt = square root, ln = natural logarithm. DAS28-4 ESR and DAS28-3 CRP: score ranges from 0 (none) to 9.4 (extreme disease activity), with a higher score indicating more disease activity. Score of <=3.2 indicate low disease activity and score of <2.6 indicate disease remission.
Time Frame Baseline (Month 0 at the entry of Initial period); Month 3, 6, 9 and 12 of Extension Period
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. Here, "Number Analyzed" signifies number of participants who were evaluable for specified categories.
Arm/Group Title Extension Period: Tofacitinib 5 mg
Hide Arm/Group Description:
Participants who completed 2 years of lymphocyte assessment in Initial period and enrolled for Extension period received Tofacitinib (CP-690,550) 5 mg orally, twice daily up to 12 months.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
DAS28-4 (ESR) Baseline Number Analyzed 47 participants
5.68  (1.26)
DAS28-4 (ESR): Change at Month 3 Number Analyzed 43 participants
-2.82  (1.52)
DAS28-4 (ESR): Change at Month 6 Number Analyzed 34 participants
-3.02  (1.50)
DAS28-4 (ESR): Change at Month 9 Number Analyzed 15 participants
-3.13  (1.66)
DAS28-4 (ESR): Change at Month 12 Number Analyzed 2 participants
-2.55  (3.70)
DAS28-3 (CRP): Baseline Number Analyzed 48 participants
4.67  (1.24)
DAS28-3 (CRP): Change at Month 3 Number Analyzed 42 participants
-2.36  (1.25)
DAS28-3 (CRP): Change at Month 6 Number Analyzed 34 participants
-2.49  (1.30)
DAS28-3 (CRP): Change at Month 9 Number Analyzed 15 participants
-3.04  (1.49)
DAS28-3 (CRP): Change at Month 12 Number Analyzed 1 participants
0.29 [1]   (NA)
[1]
Standard deviation was not estimable as only 1 participant was evaluable.
11.Secondary Outcome
Title Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2
Hide Description

Percent participants with DAS28-4 (ESR) <2.6 and ≤3.2 and percent participants with DAS28-3 (CRP) <2.6 and ≤3.2. The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.

DAS28 is a composite score, calculated using a mathematical formula, and is derived from the number of tender/painful joints (out of 28), number of swollen joints (out of 28), and a blood marker of inflammation (ESR or CRP). DAS28-4 also includes a score of general health in the formula.

The score range is from 0 to 9.4, with a higher score indicating more disease activity. A score of >5.1 indicates active disease, a score of ≤3.2 indicates low disease activity, and a score of <2.6 indicates disease remission.

Time Frame Every visit until study completion
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set - No Imputation. The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.
Arm/Group Title Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) Initial Period: Tofacitinib 10 mg BID Initial Period: All Tofacitinib
Hide Arm/Group Description:
Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID.
Participants with average total daily dose across study >=15 were assigned to 10 mg BID.
All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.
Overall Number of Participants Analyzed 1123 3358 4481
Measure Type: Number
Unit of Measure: Percent of participants
DAS28-4 (ESR) <2.6 Baseline Number Analyzed 1002 participants 3296 participants 4298 participants
0.2 0.3 0.3
DAS28-4 (ESR) <2.6 Month 1 Number Analyzed 1036 participants 3254 participants 4290 participants
19.9 20.4 20.3
DAS28-4 (ESR) <2.6 Month 2 Number Analyzed 1026 participants 3222 participants 4248 participants
20.5 22.5 22.0
DAS28-4 (ESR) <2.6 Month 3 Number Analyzed 1033 participants 3203 participants 4236 participants
20.0 22.9 22.2
DAS28-4 (ESR) <2.6 Month 6 Number Analyzed 1015 participants 3110 participants 4125 participants
22.9 23.4 23.3
DAS28-4 (ESR) <2.6 Month 9 Number Analyzed 992 participants 3003 participants 3995 participants
24.4 25.1 24.9
DAS28-4 (ESR) <2.6 Month 12 Number Analyzed 967 participants 2862 participants 3829 participants
22.3 24.4 23.9
DAS28-4 (ESR) <2.6 Month 15 Number Analyzed 922 participants 2759 participants 3681 participants
23.8 25.7 25.2
DAS28-4 (ESR) <2.6 Month 18 Number Analyzed 899 participants 2655 participants 3554 participants
25.3 26.9 26.4
DAS28-4 (ESR) <2.6 Month 21 Number Analyzed 850 participants 2547 participants 3397 participants
22.2 27.1 25.9
DAS28-4 (ESR) <2.6 Month 24 Number Analyzed 818 participants 2441 participants 3259 participants
22.7 26.8 25.8
DAS28-4 (ESR) <2.6 Month 27 Number Analyzed 787 participants 2343 participants 3130 participants
22.6 27.9 26.5
DAS28-4 (ESR) <2.6 Month 30 Number Analyzed 764 participants 2257 participants 3021 participants
24.6 27.7 26.9
DAS28-4 (ESR) <2.6 Month 33 Number Analyzed 746 participants 2199 participants 2945 participants
23.7 28.3 27.1
DAS28-4 (ESR) <2.6 Month 36 Number Analyzed 720 participants 2141 participants 2861 participants
25.6 28.9 28.1
DAS28-4 (ESR) <2.6 Month 39 Number Analyzed 679 participants 2056 participants 2735 participants
23.9 28.4 27.3
DAS28-4 (ESR) <2.6 Month 42 Number Analyzed 642 participants 1890 participants 2532 participants
24.3 27.9 27.0
DAS28-4 (ESR) <2.6 Month 45 Number Analyzed 609 participants 1641 participants 2250 participants
24.1 27.5 26.6
DAS28-4 (ESR) <2.6 Month 48 Number Analyzed 570 participants 1471 participants 2041 participants
23.5 28.0 26.8
DAS28-4 (ESR) <2.6 Month 51 Number Analyzed 481 participants 1344 participants 1825 participants
28.3 27.3 27.6
DAS28-4 (ESR) <2.6 Month 54 Number Analyzed 467 participants 1194 participants 1661 participants
21.4 28.3 26.4
DAS28-4 (ESR) <2.6 Month 57 Number Analyzed 438 participants 1006 participants 1444 participants
23.1 28.0 26.5
DAS28-4 (ESR) <2.6 Month 60 Number Analyzed 408 participants 908 participants 1316 participants
24.0 28.6 27.2
DAS28-4 (ESR) <2.6 Month 63 Number Analyzed 388 participants 825 participants 1213 participants
22.4 29.5 27.2
DAS28-4 (ESR) <2.6 Month 66 Number Analyzed 379 participants 700 participants 1079 participants
19.5 26.9 24.3
DAS28-4 (ESR) <2.6 Month 69 Number Analyzed 355 participants 483 participants 838 participants
23.9 26.3 25.3
DAS28-4 (ESR) <2.6 Month 72 Number Analyzed 338 participants 284 participants 622 participants
25.7 25.0 25.4
DAS28-4 (ESR) <2.6 Month 75 Number Analyzed 299 participants 169 participants 468 participants
23.7 26.0 24.6
DAS28-4 (ESR) <2.6 Month 78 Number Analyzed 291 participants 91 participants 382 participants
24.7 33.0 26.7
DAS28-4 (ESR) <2.6 Month 81 Number Analyzed 284 participants 54 participants 338 participants
24.6 22.2 24.3
DAS28-4 (ESR) <2.6 Month 84 Number Analyzed 271 participants 44 participants 315 participants
27.3 27.3 27.3
DAS28-4 (ESR) <2.6 Month 87 Number Analyzed 263 participants 41 participants 304 participants
31.2 31.7 31.3
DAS28-4 (ESR) <2.6 Month 90 Number Analyzed 237 participants 39 participants 276 participants
28.7 25.6 28.3
DAS28-4 (ESR) <2.6 Month 93 Number Analyzed 191 participants 28 participants 219 participants
28.3 28.6 28.3
DAS28-4 (ESR) <2.6 Month 96 Number Analyzed 142 participants 16 participants 158 participants
25.4 18.8 24.7
DAS28-4 (ESR) <2.6 Month 99 Number Analyzed 65 participants 11 participants 76 participants
27.7 36.4 28.9
DAS28-4 (ESR) <2.6 Month 102 Number Analyzed 22 participants 4 participants 26 participants
31.8 50.0 34.6
DAS28-4 (ESR) <2.6 Month 105 Number Analyzed 14 participants 3 participants 17 participants
28.6 33.3 29.4
DAS28-4 (ESR) <2.6 Month 108 Number Analyzed 8 participants 1 participants 9 participants
25.0 0 22.2
DAS28-4 (ESR) </=3.2 Baseline Number Analyzed 1002 participants 3296 participants 4298 participants
0.4 0.7 0.6
DAS28-4 (ESR) </=3.2 Month 1 Number Analyzed 1036 participants 3254 participants 4290 participants
34.2 37.6 36.8
DAS28-4 (ESR) </=3.2 Month 2 Number Analyzed 1026 participants 3222 participants 4248 participants
36.7 40.5 39.6
DAS28-4 (ESR) </=3.2 Month 3 Number Analyzed 1033 participants 3203 participants 4236 participants
36.6 41.6 40.4
DAS28-4 (ESR) </=3.2 Month 6 Number Analyzed 1015 participants 3110 participants 4125 participants
39.8 42.5 41.9
DAS28-4 (ESR) </=3.2 Month 9 Number Analyzed 992 participants 3003 participants 3995 participants
41.3 43.8 43.2
DAS28-4 (ESR) </=3.2 Month 12 Number Analyzed 967 participants 2862 participants 3829 participants
42.1 42.5 42.4
DAS28-4 (ESR) </=3.2 Month 18 Number Analyzed 899 participants 2655 participants 3554 participants
42.7 45.0 44.4
DAS28-4 (ESR) </=3.2 Month 21 Number Analyzed 850 participants 2547 participants 3397 participants
41.9 47.2 45.9
DAS28-4 (ESR) </=3.2 Month 24 Number Analyzed 818 participants 2441 participants 3259 participants
42.5 46.5 45.5
DAS28-4 (ESR) </=3.2 Month 27 Number Analyzed 787 participants 2343 participants 3130 participants
44.9 46.9 46.4
DAS28-4 (ESR) </=3.2 Month 30 Number Analyzed 764 participants 2257 participants 3021 participants
42.8 47.4 46.2
DAS28-4 (ESR) </=3.2 Month 33 Number Analyzed 746 participants 2199 participants 2945 participants
42.8 47.5 46.3
DAS28-4 (ESR) </=3.2 Month 36 Number Analyzed 720 participants 2141 participants 2861 participants
44.6 48.4 47.5
DAS28-4 (ESR) </=3.2 Month 39 Number Analyzed 679 participants 2056 participants 2735 participants
42.6 48.3 46.9
DAS28-4 (ESR) </=3.2 Month 42 Number Analyzed 642 participants 1890 participants 2532 participants
45.8 49.2 48.3
DAS28-4 (ESR) </=3.2 Month 45 Number Analyzed 609 participants 1641 participants 2250 participants
45.3 48.4 47.6
DAS28-4 (ESR) </=3.2 Month 48 Number Analyzed 570 participants 1471 participants 2041 participants
46.1 49.4 48.5
DAS28-4 (ESR) </=3.2 Month 51 Number Analyzed 481 participants 1344 participants 1825 participants
44.9 49.0 47.9
DAS28-4 (ESR) </=3.2 Month 54 Number Analyzed 467 participants 1194 participants 1661 participants
43.7 49.4 47.8
DAS28-4 (ESR) </=3.2 Month 57 Number Analyzed 438 participants 1006 participants 1444 participants
45.2 50.3 48.8
DAS28-4 (ESR) </=3.2 Month 60 Number Analyzed 408 participants 908 participants 1316 participants
46.3 49.9 48.8
DAS28-4 (ESR) </=3.2 Month 63 Number Analyzed 388 participants 825 participants 1213 participants
41.0 49.9 47.1
DAS28-4 (ESR) </=3.2 Month 66 Number Analyzed 379 participants 700 participants 1079 participants
38.8 49.7 45.9
DAS28-4 (ESR) </=3.2 Month 69 Number Analyzed 355 participants 483 participants 838 participants
45.6 50.3 48.3
DAS28-4 (ESR) </=3.2 Month 72 Number Analyzed 338 participants 284 participants 622 participants
44.7 48.2 46.3
DAS28-4 (ESR) </=3.2 Month 75 Number Analyzed 299 participants 169 participants 468 participants
43.1 48.5 45.1
DAS28-4 (ESR) </=3.2 Month 78 Number Analyzed 291 participants 91 participants 382 participants
44.7 45.1 44.8
DAS28-4 (ESR) </=3.2 Month 81 Number Analyzed 284 participants 54 participants 338 participants
49.3 48.1 49.1
DAS28-4 (ESR) </=3.2 Month 84 Number Analyzed 271 participants 44 participants 315 participants
47.2 45.5 47.0
DAS28-4 (ESR) </=3.2 Month 87 Number Analyzed 263 participants 41 participants 304 participants
47.9 46.3 47.7
DAS28-4 (ESR) </=3.2 Month 90 Number Analyzed 237 participants 39 participants 276 participants
46.0 46.2 46.0
DAS28-4 (ESR) </=3.2 Month 93 Number Analyzed 191 participants 28 participants 219 participants
48.2 50.0 48.4
DAS28-4 (ESR) </=3.2 Month 96 Number Analyzed 142 participants 16 participants 158 participants
47.2 43.8 46.8
DAS28-4 (ESR) </=3.2 Month 99 Number Analyzed 65 participants 11 participants 76 participants
43.1 54.5 44.7
DAS28-4 (ESR) </=3.2 Month 102 Number Analyzed 22 participants 4 participants 26 participants
45.5 50.0 46.2
DAS28-4 (ESR) </=3.2 Month 105 Number Analyzed 14 participants 3 participants 17 participants
42.9 66.7 47.1
DAS28-4 (ESR) </=3.2 Month 108 Number Analyzed 8 participants 1 participants 9 participants
50.0 0 44.4
DAS28-3 (CRP) <2.6 Baseline Number Analyzed 1112 participants 3340 participants 4452 participants
0.5 0.9 0.8
DAS28-3 (CRP) <2.6 Month 1 Number Analyzed 1096 participants 3234 participants 4330 participants
38.0 43.0 41.7
DAS28-3 (CRP) <2.6 Month 2 Number Analyzed 1070 participants 3180 participants 4250 participants
39.7 47.1 45.2
DAS28-3 (CRP) <2.6 Month 3 Number Analyzed 1057 participants 3190 participants 4247 participants
42.3 47.5 46.2
DAS28-3 (CRP) <2.6 Month 6 Number Analyzed 1026 participants 3106 participants 4132 participants
45.2 49.0 48.1
DAS28-3 (CRP) <2.6 Month 9 Number Analyzed 993 participants 3008 participants 4001 participants
47.1 50.7 49.8
DAS28-3 (CRP) <2.6 Month 12 Number Analyzed 962 participants 2874 participants 3836 participants
47.8 51.8 50.8
DAS28-3 (CRP) <2.6 Month 15 Number Analyzed 923 participants 2761 participants 3684 participants
50.6 52.3 51.9
DAS28-3 (CRP) <2.6 Month 18 Number Analyzed 899 participants 2654 participants 3553 participants
51.3 54.1 53.4
DAS28-3 (CRP) <2.6 Month 21 Number Analyzed 856 participants 2556 participants 3412 participants
51.1 55.5 54.4
DAS28-3 (CRP) <2.6 Month 24 Number Analyzed 813 participants 2456 participants 3269 participants
51.9 55.3 54.4
DAS28-3 (CRP) <2.6 Month 27 Number Analyzed 793 participants 2345 participants 3138 participants
53.2 55.8 55.2
DAS28-3 (CRP) <2.6 Month 30 Number Analyzed 766 participants 2271 participants 3037 participants
53.3 56.8 55.9
DAS28-3 (CRP) <2.6 Month 33 Number Analyzed 745 participants 2209 participants 2954 participants
54.1 56.0 55.6
DAS28-3 (CRP) <2.6 Month 36 Number Analyzed 724 participants 2142 participants 2866 participants
52.9 55.6 54.9
DAS28-3 (CRP) <2.6 Month 39 Number Analyzed 686 participants 2057 participants 2743 participants
54.2 56.9 56.2
DAS28-3 (CRP) <2.6 Month 42 Number Analyzed 653 participants 1893 participants 2546 participants
54.2 56.8 56.2
DAS28-3 (CRP) <2.6 Month 45 Number Analyzed 611 participants 1644 participants 2255 participants
56.3 58.6 58.0
DAS28-3 (CRP) <2.6 Month 48 Number Analyzed 579 participants 1469 participants 2048 participants
55.4 59.3 58.2
DAS28-3 (CRP) <2.6 Month 51 Number Analyzed 487 participants 1348 participants 1835 participants
56.1 57.3 56.9
DAS28-3 (CRP) <2.6 Month 54 Number Analyzed 468 participants 1198 participants 1666 participants
52.6 57.8 56.3
DAS28-3 (CRP) <2.6 Month 57 Number Analyzed 439 participants 1011 participants 1450 participants
55.6 57.7 57.0
DAS28-3 (CRP) <2.6 Month 60 Number Analyzed 407 participants 913 participants 1320 participants
55.0 57.9 57.0
DAS28-3 (CRP) <2.6 Month 63 Number Analyzed 390 participants 824 participants 1214 participants
51.0 58.1 55.8
DAS28-3 (CRP) <2.6 Month 66 Number Analyzed 376 participants 702 participants 1078 participants
51.9 59.3 56.7
DAS28-3 (CRP) <2.6 Month 69 Number Analyzed 355 participants 483 participants 838 participants
53.5 57.8 56.0
DAS28-3 (CRP) <2.6 Month 72 Number Analyzed 337 participants 285 participants 622 participants
52.2 55.4 53.7
DAS28-3 (CRP) <2.6 Month 75 Number Analyzed 304 participants 170 participants 474 participants
53.9 53.5 53.8
DAS28-3 (CRP) <2.6 Month 78 Number Analyzed 292 participants 91 participants 383 participants
58.2 51.6 56.7
DAS28-3 (CRP) <2.6 Month 81 Number Analyzed 285 participants 54 participants 339 participants
58.6 51.9 57.5
DAS28-3 (CRP) <2.6 Month 84 Number Analyzed 269 participants 44 participants 313 participants
61.7 43.2 59.1
DAS28-3 (CRP) <2.6 Month 87 Number Analyzed 264 participants 41 participants 305 participants
60.2 48.8 58.7
DAS28-3 (CRP) <2.6 Month 90 Number Analyzed 240 participants 39 participants 279 participants
60.8 46.2 58.8
DAS28-3 (CRP) <2.6 Month 93 Number Analyzed 196 participants 28 participants 224 participants
56.1 53.6 55.8
DAS28-3 (CRP) <2.6 Month 96 Number Analyzed 144 participants 16 participants 160 participants
56.3 37.5 54.4
DAS28-3 (CRP) <2.6 Month 99 Number Analyzed 64 participants 11 participants 75 participants
50.0 63.6 52.0
DAS28-3 (CRP) <2.6 Month 102 Number Analyzed 13 participants 3 participants 16 participants
46.2 66.7 50.0
DAS28-3 (CRP) <2.6 Month 105 Number Analyzed 12 participants 2 participants 14 participants
33.3 100 42.9
DAS28-3 (CRP) <2.6 Month 108 Number Analyzed 7 participants 1 participants 8 participants
42.9 0 37.5
DAS28-3 (CRP) <2.6 Month 111 Number Analyzed 3 participants 1 participants 4 participants
100 100 100
DAS28-3 (CRP) </=3.2 Month 1 Number Analyzed 1096 participants 3234 participants 4330 participants
55.3 61.9 60.2
DAS28-3 (CRP) </=3.2 Month 2 Number Analyzed 1070 participants 3180 participants 4250 participants
60.7 64.5 63.6
DAS28-3 (CRP) </=3.2 Month 3 Number Analyzed 1057 participants 3190 participants 4247 participants
60.6 66.3 64.9
DAS28-3 (CRP) </=3.2 Month 6 Number Analyzed 1026 participants 3106 participants 4132 participants
64.4 67.1 66.4
DAS28-3 (CRP) </=3.2 Month 9 Number Analyzed 993 participants 3008 participants 4001 participants
66.4 68.3 67.8
DAS28-3 (CRP) </=3.2 Month 12 Number Analyzed 962 participants 2874 participants 3836 participants
66.1 70.0 69.0
DAS28-3 (CRP) </=3.2 Month 15 Number Analyzed 923 participants 2761 participants 3684 participants
70.0 70.0 70.0
DAS28-3 (CRP) </=3.2 Month 18 Number Analyzed 899 participants 2654 participants 3553 participants
69.2 71.7 71.1
DAS28-3 (CRP) </=3.2 Month 21 Number Analyzed 856 participants 2556 participants 3412 participants
69.5 72.5 71.8
DAS28-3 (CRP) </=3.2 Month 24 Number Analyzed 813 participants 2456 participants 3269 participants
71.7 72.5 72.3
DAS28-3 (CRP) </=3.2 Month 27 Number Analyzed 793 participants 2345 participants 3138 participants
72.6 73.0 72.9
DAS28-3 (CRP) </=3.2 Month 30 Number Analyzed 766 participants 2271 participants 3037 participants
73.0 73.8 73.6
DAS28-3 (CRP) </=3.2 Month 33 Number Analyzed 745 participants 2209 participants 2954 participants
72.2 74.5 73.9
DAS28-3 (CRP) </=3.2 Month 36 Number Analyzed 724 participants 2142 participants 2866 participants
73.8 73.4 73.5
DAS28-3 (CRP) </=3.2 Month 39 Number Analyzed 686 participants 2057 participants 2743 participants
73.2 74.6 74.2
DAS28-3 (CRP) </=3.2 Month 42 Number Analyzed 653 participants 1893 participants 2546 participants
73.8 74.7 74.5
DAS28-3 (CRP) </=3.2 Month 45 Number Analyzed 611 participants 1644 participants 2255 participants
74.6 75.2 75.1
DAS28-3 (CRP) </=3.2 Month 48 Number Analyzed 579 participants 1469 participants 2048 participants
74.6 75.0 74.9
DAS28-3 (CRP) </=3.2 Month 51 Number Analyzed 487 participants 1348 participants 1835 participants
74.3 75.1 74.9
DAS28-3 (CRP) </=3.2 Month 54 Number Analyzed 468 participants 1198 participants 1666 participants
71.4 76.4 75.0
DAS28-3 (CRP) </=3.2 Month 57 Number Analyzed 439 participants 1011 participants 1450 participants
73.6 75.2 74.7
DAS28-3 (CRP) </=3.2 Month 60 Number Analyzed 407 participants 913 participants 1320 participants
72.5 77.0 75.6
DAS28-3 (CRP) </=3.2 Month 63 Number Analyzed 390 participants 824 participants 1214 participants
72.8 76.5 75.3
DAS28-3 (CRP) </=3.2 Month 66 Number Analyzed 376 participants 702 participants 1078 participants
71.5 78.1 75.8
DAS28-3 (CRP) </=3.2 Month 69 Number Analyzed 355 participants 483 participants 838 participants
69.9 77.0 74.0
DAS28-3 (CRP) </=3.2 Month 72 Number Analyzed 337 participants 285 participants 622 participants
74.8 73.3 74.1
DAS28-3 (CRP) </=3.2 Month 75 Number Analyzed 304 participants 170 participants 474 participants
77.0 72.9 75.5
DAS28-3 (CRP) </=3.2 Month 78 Number Analyzed 292 participants 91 participants 383 participants
74.3 70.3 73.4
DAS28-3 (CRP) </=3.2 Month 81 Number Analyzed 285 participants 54 participants 339 participants
75.8 68.5 74.6
DAS28-3 (CRP) </=3.2 Month 84 Number Analyzed 269 participants 44 participants 313 participants
79.2 68.2 77.6
DAS28-4 (CRP) </=3.2 Month 87 Number Analyzed 264 participants 41 participants 305 participants
81.1 70.7 79.7
DAS28-3 (CRP) </=3.2 Month 90 Number Analyzed 240 participants 39 participants 279 participants
77.1 74.4 76.7
DAS28-3 (CRP) </=3.2 Month 93 Number Analyzed 196 participants 28 participants 224 participants
75.0 67.9 74.1
DAS28-3 (CRP) </=3.2 Month 96 Number Analyzed 144 participants 16 participants 160 participants
77.1 87.5 78.1
DAS28-3 (CRP) </=3.2 Month 99 Number Analyzed 64 participants 11 participants 75 participants
76.6 81.8 77.3
DAS28-3 (CRP) </=3.2 Month 102 Number Analyzed 13 participants 3 participants 16 participants
84.6 66.7 81.3
DAS28-3 (CRP) </=3.2 Month 105 Number Analyzed 12 participants 2 participants 14 participants
50.0 100 57.1
DAS28-3 (CRP) </=3.2 Month 108 Number Analyzed 7 participants 1 participants 8 participants
42.9 0 37.5
12.Secondary Outcome
Title Extension Period: Percentage of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) Less Than (<) 2.6 and Less Than or (<=) 3.2
Hide Description DAS28 is composite score, calculated using mathematical formula, derived from: 1) tender/painful joints count, out of 28 joints (TJC28), 2) swollen joints count, out of 28 joints (SJC28), 3) blood marker of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]). DAS28-4 also include score of GH. GH is general health or participants’ global assessment of disease activity on 100 mm visual analog scale (GH score: 0 mm [very well] to 100 mm [extremely bad], higher scores = worse health condition). DAS28-3(CRP) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.36*ln[CRP+1]) *1.10 + 1.15) and DAS28-4(ESR) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.70*ln[ESR] + 0.014*GH), where sqrt = square root, ln = natural logarithm. DAS28-4 ESR and DAS28-3 CRP: score range is from 0 (none) to 9.4 (extreme disease activity), with a higher score indicating more disease activity. Score of <=3.2 indicate low disease activity and score of <2.6 indicate disease remission.
Time Frame Baseline (Day 1 at the entry of Extension period); Month 3, 6, 9 and 12 of Extension Period
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. Here, "Number Analyzed" signifies number of participants who were evaluable for specified categories.
Arm/Group Title Extension Period: Tofacitinib 5 mg
Hide Arm/Group Description:
Participants who completed 2 years of lymphocyte assessment in Initial period and enrolled for Extension period received Tofacitinib (CP-690,550) 5 mg orally, twice daily up to 12 months.
Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: Percentage of participants
DAS28-4 (ESR) <2.6: Baseline Number Analyzed 48 participants
12.5
DAS28-4 (ESR) <2.6: Month 3 Number Analyzed 44 participants
40.9
DAS28-4 (ESR) <2.6: Month 6 Number Analyzed 35 participants
45.7
DAS28-4 (ESR) <2.6: Month 9 Number Analyzed 15 participants
46.7
DAS28-4 (ESR) <2.6: Month 12 Number Analyzed 2 participants
50.0
DAS28-4 (ESR) <=3.2: Baseline Number Analyzed 48 participants
29.2
DAS28-4 (ESR) <=3.2: Month 3 Number Analyzed 44 participants
68.2
DAS28-4 (ESR) <=3.2: Month 6 Number Analyzed 35 participants
68.6
DAS28-4 (ESR) <=3.2: Month 9 Number Analyzed 15 participants
66.7
DAS28-4 (ESR) <=3.2: Month 12 Number Analyzed 2 participants
50.0
DAS28-3 (CRP) <2.6: Baseline Number Analyzed 47 participants
27.7
DAS28-3 (CRP) <2.6: Month 3 Number Analyzed 42 participants
61.9
DAS28-3 (CRP) <2.6: Month 6 Number Analyzed 34 participants
67.6
DAS28-3 (CRP) <2.6: Month 9 Number Analyzed 15 participants
80.0
DAS28-3 (CRP) <2.6: Month 12 Number Analyzed 1 participants
0
DAS28-3 (CRP) <=3.2: Baseline Number Analyzed 47 participants
53.2
DAS28-3 (CRP) <=3.2: Month 3 Number Analyzed 42 participants
85.7
DAS28-3 (CRP) <=3.2: Month 6 Number Analyzed 34 participants
85.3
DAS28-3 (CRP) <=3.2: Month 9 Number Analyzed 15 participants
80.0
DAS28-3 (CRP) <=3.2: Month 12 Number Analyzed 1 participants
0
13.Secondary Outcome
Title Initial Period: Health Assessment Questionnaire – Disability Index (HAQ-DI) Score
Hide Description Change from baseline by visit. HAQ-DI scores range from 0 to 3, where lower score implies less disease. A reduction from baseline in score indicates an improvement in condition. A clinically meaningful decrease from baseline is defined as a decrease of at least 0.22 units. The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.
Time Frame Every visit until study completion
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.
Arm/Group Title Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) Initial Period: Tofacitinib 10 mg BID Initial Period: All Tofacitinib
Hide Arm/Group Description:
Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID.
Participants with average total daily dose across study >=15 were assigned to 10 mg BID.
All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.
Overall Number of Participants Analyzed 1123 3358 4481
Mean (Standard Deviation)
Unit of Measure: Units on scale
Month 1 Number Analyzed 1098 participants 3264 participants 4362 participants
-0.57  (0.62) -0.61  (0.63) -0.60  (0.63)
Month 2 Number Analyzed 1067 participants 3213 participants 4280 participants
-0.58  (0.62) -0.65  (0.65) -0.63  (0.65)
Month 3 Number Analyzed 1057 participants 3196 participants 4253 participants
-0.58  (0.63) -0.66  (0.65) -0.64  (0.65)
Month 6 Number Analyzed 1029 participants 3105 participants 4134 participants
-0.58  (0.65) -0.65  (0.66) -0.64  (0.66)
Month 9 Number Analyzed 990 participants 2992 participants 3982 participants
-0.58  (0.64) -0.66  (0.66) -0.64  (0.66)
Month 12 Number Analyzed 960 participants 2866 participants 3826 participants
-0.58  (0.65) -0.66  (0.67) -0.64  (0.67)
Month 15 Number Analyzed 926 participants 2756 participants 3682 participants
-0.61  (0.65) -0.68  (0.68) -0.66  (0.67)
Month 18 Number Analyzed 898 participants 2646 participants 3544 participants
-0.60  (0.65) -0.68  (0.67) -0.66  (0.67)
Month 21 Number Analyzed 849 participants 2542 participants 3391 participants
-0.60  (0.67) -0.69  (0.68) -0.67  (0.68)
Month 24 Number Analyzed 815 participants 2443 participants 3258 participants
-0.60  (0.65) -0.69  (0.68) -0.67  (0.67)
Month 27 Number Analyzed 789 participants 2341 participants 3130 participants
-0.62  (0.65) -0.69  (0.68) -0.67  (0.67)
Month 30 Number Analyzed 757 participants 2258 participants 3015 participants
-0.58  (0.66) -0.68  (0.69) -0.66  (0.68)
Month 33 Number Analyzed 741 participants 2194 participants 2935 participants
-0.60  (0.66) -0.67  (0.69) -0.66  (0.68)
Month 36 Number Analyzed 720 participants 2136 participants 2856 participants
-0.63  (0.66) -0.67  (0.68) -0.66  (0.67)
Month 39 Number Analyzed 683 participants 2053 participants 2736 participants
-0.59  (0.67) -0.68  (0.69) -0.66  (0.69)
Month 42 Number Analyzed 649 participants 1884 participants 2533 participants
-0.59  (0.67) -0.66  (0.68) -0.65  (0.68)
Month 45 Number Analyzed 609 participants 1636 participants 2245 participants
-0.59  (0.69) -0.64  (0.69) -0.63  (0.69)
Month 48 Number Analyzed 575 participants 1468 participants 2043 participants
-0.58  (0.69) -0.64  (0.69) -0.62  (0.68)
Month 51 Number Analyzed 482 participants 1332 participants 1814 participants
-0.59  (0.69) -0.63  (0.66) -0.62  (0.67)
Month 54 Number Analyzed 463 participants 1191 participants 1654 participants
-0.57  (0.68) -0.65  (0.67) -0.63  (0.67)
Month 57 Number Analyzed 434 participants 1011 participants 1445 participants
-0.57  (0.69) -0.66  (0.68) -0.63  (0.68)
Month 60 Number Analyzed 405 participants 916 participants 1321 participants
-0.59  (0.68) -0.66  (0.69) -0.64  (0.69)
Month 63 Number Analyzed 392 participants 828 participants 1220 participants
-0.57  (0.68) -0.68  (0.70) -0.64  (0.69)
Month 66 Number Analyzed 375 participants 702 participants 1077 participants
-0.54  (0.70) -0.67  (0.69) -0.63  (0.70)
Month 69 Number Analyzed 353 participants 484 participants 837 participants
-0.55  (0.70) -0.66  (0.71) -0.61  (0.71)
Month 72 Number Analyzed 335 participants 286 participants 621 participants
-0.57  (0.71) -0.62  (0.73) -0.59  (0.72)
Month 75 Number Analyzed 303 participants 171 participants 474 participants
-0.57  (0.72) -0.58  (0.73) -0.57  (0.72)
Month 78 Number Analyzed 289 participants 91 participants 380 participants
-0.54  (0.73) -0.61  (0.78) -0.56  (0.74)
Month 81 Number Analyzed 282 participants 54 participants 336 participants
-0.55  (0.73) -0.64  (0.68) -0.56  (0.72)
Month 84 Number Analyzed 269 participants 44 participants 313 participants
-0.53  (0.73) -0.56  (0.68) -0.53  (0.72)
Month 87 Number Analyzed 262 participants 41 participants 303 participants
-0.53  (0.70) -0.53  (0.60) -0.53  (0.69)
Month 90 Number Analyzed 240 participants 39 participants 279 participants
-0.52  (0.72) -0.54  (0.61) -0.52  (0.70)
Month 93 Number Analyzed 194 participants 28 participants 222 participants
-0.52  (0.75) -0.50  (0.60) -0.52  (0.73)
Month 96 Number Analyzed 143 participants 16 participants 159 participants
-0.54  (0.77) -0.48  (0.58) -0.53  (0.75)
Month 99 Number Analyzed 64 participants 11 participants 75 participants
-0.53  (0.80) -0.44  (0.51) -0.52  (0.76)
Month 102 Number Analyzed 22 participants 3 participants 25 participants
-0.61  (0.82) -0.29  (0.85) -0.58  (0.81)
Month 105 Number Analyzed 15 participants 3 participants 18 participants
-0.65  (0.91) -0.50  (0.99) -0.63  (0.90)
Month 108 Number Analyzed 8 participants 1 participants 9 participants
-0.89  (0.97) 0.13  (0) -0.78  (0.97)
Month 111 Number Analyzed 3 participants 1 participants 4 participants
-1.29  (1.34) 0.25  (0) -0.91  (1.34)
Month 114 Number Analyzed 1 participants 0 participants 1 participants
-0.13  (0) -0.13  (0)
14.Secondary Outcome
Title Extension Period: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 3, 6, 9 and 12
Hide Description HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 categories of daily living activities: dressing/grooming; arising; eating; walking; reach; grip; hygiene; and other activities. Each activity category consisted of 2-3 questionnaire. Each questionnaire was scored on a 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity that required assistance from another individual or required the use of an assistive device was adjusted to a score of 2 to represent a more limited functional status. Overall score was computed as the sum of total scores divided by the number of questionnaire answered. Total possible HAQ-DI score range: 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.
Time Frame Baseline (Month 0 at the entry of Initial Period); Month 3, 6, 9, and 12 of Extension Period
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. Here, "Number Analyzed" signifies number of participants who were evaluable for specified categories.
Arm/Group Title Extension Period: Tofacitinib 5 mg
Hide Arm/Group Description:
Participants who completed 2 years of lymphocyte assessment in Initial period and enrolled for Extension period received Tofacitinib (CP-690,550) 5 mg orally, twice daily up to 12 months.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline Number Analyzed 48 participants
1.35  (0.63)
Change at Month 3 Number Analyzed 46 participants
-0.48  (0.58)
Change at Month 6 Number Analyzed 35 participants
-0.55  (0.65)
Change at Month 9 Number Analyzed 15 participants
-0.58  (0.70)
Change at Month 12 Number Analyzed 2 participants
-1.50  (1.94)
15.Secondary Outcome
Title Initial Period: Short-Form-36 Health Survey (SF-36) Score
Hide Description Change from Baseline for Physical Component and Mental Component Scores by visit. SF-36 is a health status measure of 8 general health domains, each scored on a 0 to 100 scale: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These domains can be summarized as physical and mental component scores. The domain scores were "normed" and the resulting component scores treated as Z-scores with a scale of negative to positive infinity. A higher score implies less disease. The greater the change from baseline, the greater the improvement. The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.
Time Frame Every visit until study completion
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.
Arm/Group Title Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) Initial Period: Tofacitinib 10 mg BID Initial Period: All Tofacitinib
Hide Arm/Group Description:
Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID.
Participants with average total daily dose across study >=15 were assigned to 10 mg BID.
All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.
Overall Number of Participants Analyzed 1123 3358 4481
Mean (Standard Deviation)
Unit of Measure: Scores on scale
Physical Component Month 3 Number Analyzed 983 participants 2693 participants 3676 participants
7.90  (8.70) 8.85  (8.92) 8.60  (8.87)
Physical Component Month 6 Number Analyzed 961 participants 2629 participants 3590 participants
8.10  (8.94) 9.02  (9.11) 8.77  (9.07)
Physical Component Month 9 Number Analyzed 534 participants 2499 participants 3033 participants
8.60  (9.07) 8.80  (9.20) 8.77  (9.18)
Physical Component Month 12 Number Analyzed 903 participants 2449 participants 3352 participants
8.44  (8.53) 8.78  (9.26) 8.69  (9.07)
Physical Component Month 15 Number Analyzed 733 participants 2324 participants 3057 participants
8.43  (8.88) 8.98  (9.05) 8.85  (9.01)
Physical Component Month 18 Number Analyzed 855 participants 2188 participants 3043 participants
8.14  (8.89) 8.99  (9.18) 8.75  (9.11)
Physical Component Month 21 Number Analyzed 767 participants 2005 participants 2772 participants
8.00  (8.70) 8.85  (8.96) 8.62  (8.90)
Physical Component Month 24 Number Analyzed 797 participants 2102 participants 2899 participants
8.28  (8.73) 9.00  (9.30) 8.80  (9.15)
Physical Component Month 27 Number Analyzed 739 participants 1663 participants 2402 participants
8.41  (8.84) 8.64  (9.16) 8.57  (9.06)
Physical Component Month 30 Number Analyzed 708 participants 1566 participants 2274 participants
7.78  (8.81) 8.56  (9.06) 8.32  (8.99)
Physical Component Month 33 Number Analyzed 682 participants 1444 participants 2126 participants
8.17  (8.87) 8.39  (9.31) 8.32  (9.17)
Physical Component Month 36 Number Analyzed 676 participants 1530 participants 2206 participants
8.31  (8.97) 8.43  (9.22) 8.40  (9.14)
Physical Component Month 39 Number Analyzed 609 participants 1176 participants 1785 participants
8.05  (9.26) 8.13  (9.14) 8.10  (9.18)
Physical Component Month 42 Number Analyzed 573 participants 923 participants 1496 participants
7.81  (9.32) 8.07  (9.13) 7.97  (9.21)
Physical Component Month 45 Number Analyzed 540 participants 652 participants 1192 participants
8.40  (9.87) 8.33  (9.40) 8.36  (9.61)
Physical Component Month 48 Number Analyzed 537 participants 1044 participants 1581 participants
8.12  (9.56) 8.27  (9.23) 8.22  (9.34)
Physical Component Month 51 Number Analyzed 417 participants 304 participants 721 participants
7.88  (9.69) 8.55  (9.70) 8.16  (9.69)
Physical Component Month 54 Number Analyzed 396 participants 175 participants 571 participants
7.72  (9.41) 8.82  (9.47) 8.06  (9.43)
Physical Component Month 57 Number Analyzed 372 participants 105 participants 477 participants
7.57  (9.72) 8.12  (9.69) 7.69  (9.71)
Physical Component Month 60 Number Analyzed 371 participants 259 participants 630 participants
7.94  (9.74) 9.29  (9.43) 8.49  (9.63)
Physical Component Month 63 Number Analyzed 345 participants 68 participants 413 participants
7.73  (9.76) 7.90  (8.98) 7.76  (9.63)
Physical Component Month 66 Number Analyzed 327 participants 56 participants 383 participants
7.92  (9.41) 7.58  (7.88) 7.87  (9.20)
Physical Component Month 69 Number Analyzed 267 participants 40 participants 307 participants
7.68  (9.32) 9.12  (7.06) 7.87  (9.06)
Physical Component Month 72 Number Analyzed 316 participants 54 participants 370 participants
7.90  (9.93) 8.70  (10.24) 8.02  (9.97)
Physical Component Month 75 Number Analyzed 84 participants 12 participants 96 participants
9.03  (10.96) 5.75  (9.05) 8.62  (10.75)
Physical Component Month 78 Number Analyzed 55 participants 7 participants 62 participants
10.22  (11.10) 7.39  (7.09) 9.90  (10.72)
Physical Component Month 81 Number Analyzed 49 participants 4 participants 53 participants
10.51  (10.17) 7.90  (13.05) 10.31  (10.28)
Physical Component Month 84 Number Analyzed 93 participants 11 participants 104 participants
8.93  (11.56) 7.14  (8.01) 8.74  (11.22)
Physical Component Month 87 Number Analyzed 26 participants 2 participants 28 participants
11.92  (10.49) 15.23  (3.64) 12.16  (10.15)
Physical Component Month 90 Number Analyzed 12 participants 1 participants 13 participants
13.50  (10.98) 16.50  (0) 13.73  (10.55)
Physical Component Month 93 Number Analyzed 1 participants 0 participants 1 participants
26.71  (0) 26.71  (0)
Physical Component Month 96 Number Analyzed 5 participants 0 participants 5 participants
4.61  (9.75) 4.61  (9.75)
Physical Component Month 99 Number Analyzed 1 participants 0 participants 1 participants
-8.26  (0) -8.26  (0)
Mental Component Month 3 Number Analyzed 983 participants 2693 participants 3676 participants
4.37  (10.88) 4.91  (11.18) 4.77  (11.10)
Mental Component Month 6 Number Analyzed 961 participants 2629 participants 3590 participants
3.94  (10.85) 4.81  (11.12) 4.58  (11.06)
Mental Component Month 9 Number Analyzed 534 participants 2499 participants 3033 participants
4.65  (10.78) 5.04  (11.17) 4.97  (11.10)
Mental Component Month 12 Number Analyzed 903 participants 2449 participants 3352 participants
3.77  (11.03) 4.81  (11.43) 4.53  (11.33)
Mental Component Month 15 Number Analyzed 733 participants 2324 participants 3057 participants
4.14  (11.21) 4.79  (11.52) 4.63  (11.45)
Mental Component Month 18 Number Analyzed 855 participants 2188 participants 3043 participants
4.12  (11.11) 4.87  (11.41) 4.66  (11.33)
Mental Component Month 21 Number Analyzed 767 participants 2005 participants 2772 participants
4.21  (11.08) 4.87  (11.22) 4.68  (11.18)
Mental Component Month 24 Number Analyzed 797 participants 2102 participants 2899 participants
4.12  (11.06) 5.08  (11.32) 4.82  (11.26)
Mental Component Month 27 Number Analyzed 739 participants 1663 participants 2402 participants
3.67  (10.53) 4.91  (11.28) 4.53  (11.07)
Mental Component Month 30 Number Analyzed 708 participants 1566 participants 2274 participants
3.58  (11.14) 4.68  (11.71) 4.34  (11.54)
Mental Component Month 33 Number Analyzed 682 participants 1444 participants 2126 participants
3.91  (10.65) 4.82  (11.74) 4.53  (11.40)
Mental Component Month 36 Number Analyzed 676 participants 1530 participants 2206 participants
3.83  (10.94) 4.81  (11.60) 4.51  (11.40)
Mental Component Month 39 Number Analyzed 609 participants 1176 participants 1785 participants
3.60  (11.02) 4.59  (11.75) 4.25  (11.51)
Mental Component Month 42 Number Analyzed 573 participants 923 participants 1496 participants
3.23  (11.40) 4.55  (11.63) 4.04  (11.56)
Mental Component Month 45 Number Analyzed 540 participants 652 participants 1192 participants
3.16  (11.63) 4.40  (11.64) 3.83  (11.56)
Mental Component Month 48 Number Analyzed 537 participants 1044 participants 1581 participants
3.48  (11.71) 4.73  (11.83) 4.31  (11.80)
Mental Component Month 51 Number Analyzed 417 participants 304 participants 721 participants
3.61  (12.12) 4.83  (11.82) 4.13  (12.00)
Mental Component Month 54 Number Analyzed 396 participants 175 participants 571 participants
3.44  (11.77) 6.49  (12.67) 4.38  (12.12)
Mental Component Month 57 Number Analyzed 372 participants 105 participants 477 participants
3.24  (12.24) 5.10  (11.74) 3.65  (12.15)
Mental Component Month 60 Number Analyzed 371 participants 259 participants 630 participants
3.05  (12.06) 5.18  (12.22) 3.93  (12.16)
Mental Component Month 63 Number Analyzed 345 participants 68 participants 413 participants
3.04  (11.61) 4.22  (10.32) 3.23  (11.40)
Mental Component Month 66 Number Analyzed 327 participants 56 participants 383 participants
2.96  (11.32) 3.47  (8.33) 3.04  (10.93)
Mental Component Month 69 Number Analyzed 267 participants 40 participants 307 participants
3.90  (12.35) 4.90  (9.84) 4.03  (12.04)
Mental Component Month 72 Number Analyzed 316 participants 54 participants 370 participants
3.78  (11.48) 5.32  (12.80) 4.00  (11.68)
Mental Component Month 75 Number Analyzed 84 participants 12 participants 96 participants
5.04  (12.22) 1.52  (11.38) 4.60  (12.12)
Mental Component Month 78 Number Analyzed 55 participants 7 participants 62 participants
4.12  (13.37) 1.05  (13.28) 3.77  (13.29)
Mental Component Month 81 Number Analyzed 49 participants 4 participants 53 participants
6.09  (10.40) 2.60  (14.75) 5.83  (10.64)
Mental Component Month 84 Number Analyzed 93 participants 11 participants 104 participants
5.73  (13.07) -2.36  (11.63) 4.87  (13.11)
Mental Component Month 87 Number Analyzed 26 participants 2 participants 28 participants
7.52  (13.03) 16.93  (2.66) 8.19  (12.79)
Mental Component Month 90 Number Analyzed 12 participants 1 participants 13 participants
4.61  (11.75) 18.75  (0) 5.65  (11.86)
Mental Component Month 93 Number Analyzed 1 participants 0 participants 1 participants
14.03  (0) 14.03  (0)
Mental Component Month 96 Number Analyzed 5 participants 0 participants 5 participants
7.58  (9.73) 7.58  (9.73)
Mental Component Month 99 Number Analyzed 1 participants 0 participants 1 participants
22.28  (0) 22.28  (0)
16.Secondary Outcome
Title Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU)
Hide Description

Change from Baseline Scores for each: FACIT Fatigue Scale (score range 0 to 52, higher score indicates higher quality of life and an increase from baseline score indicates improvement), EuroQol EQ 5D (index values derived from a measure of central tendency and a measure of dispersion, an increase from baseline indicates improvement, score range 0 to 1), Work Limitations (WL) Physical Demands (covers ability to perform job tasks that involve bodily strength, a decrease from baseline indicates improvement, score range 0 to 100, higher scores indicating greater limitation), and RA Healthcare Resource Utilization Work Performance in Past 3 Months on Days Bothered by RA (assesses healthcare use over previous 3 months, a decrease from baseline indicates improvement, score range 0 to 10).

The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.

Time Frame Every visit until study completion
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.
Arm/Group Title Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) Initial Period: Tofacitinib 10 mg BID Initial Period: All Tofacitinib
Hide Arm/Group Description:
Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID.
Participants with average total daily dose across study >=15 were assigned to 10 mg BID.
All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.
Overall Number of Participants Analyzed 1123 3358 4481
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
FACIT Month 6 Number Analyzed 370 participants 2544 participants 2914 participants
6.29  (8.98) 7.33  (10.57) 7.19  (10.39)
FACIT Month 12 Number Analyzed 582 participants 2396 participants 2978 participants
5.98  (9.74) 7.33  (10.56) 7.06  (10.41)
FACIT Month 18 Number Analyzed 729 participants 2168 participants 2897 participants
6.14  (10.06) 7.40  (10.65) 7.09  (10.51)
FACIT Month 24 Number Analyzed 704 participants 2053 participants 2757 participants
5.90  (9.76) 7.42  (10.56) 7.03  (10.38)
FACIT Month 30 Number Analyzed 618 participants 1525 participants 2143 participants
5.36  (10.08) 7.00  (10.91) 6.52  (10.70)
FACIT Month 36 Number Analyzed 589 participants 1497 participants 2086 participants
5.95  (9.87) 6.87  (10.94) 6.61  (10.66)
FACIT Month 42 Number Analyzed 491 participants 898 participants 1389 participants
5.35  (10.36) 6.83  (10.86) 6.31  (10.71)
FACIT Month 48 Number Analyzed 464 participants 1025 participants 1489 participants
6.01  (10.33) 6.88  (10.95) 6.61  (10.77)
FACIT Month 54 Number Analyzed 330 participants 169 participants 499 participants
6.16  (10.49) 8.51  (11.58) 6.96  (10.92)
FACIT Month 60 Number Analyzed 318 participants 256 participants 574 participants
5.96  (10.69) 8.88  (11.65) 7.27  (11.21)
FACIT Month 66 Number Analyzed 277 participants 55 participants 332 participants
5.64  (10.93) 6.67  (10.58) 5.81  (10.86)
FACIT Month 72 Number Analyzed 272 participants 51 participants 323 participants
5.73  (11.10) 8.63  (10.71) 6.18  (11.07)
FACIT Month 78 Number Analyzed 32 participants 7 participants 39 participants
12.06  (11.15) 0.71  (14.84) 10.03  (12.48)
FACIT Month 84 Number Analyzed 74 participants 11 participants 85 participants
9.13  (12.88) 2.91  (12.36) 8.32  (12.91)
FACIT Month 90 Number Analyzed 6 participants 1 participants 7 participants
18.67  (9.14) 10.00  (0) 17.43  (8.96)
FACIT Month 96 Number Analyzed 3 participants 0 participants 3 participants
6.00  (2.65) 6.00  (2.65)
EuroQol Month 6 Number Analyzed 323 participants 2021 participants 2344 participants
0.20  (0.31) 0.22  (0.32) 0.22  (0.32)
EuroQol Month 12 Number Analyzed 538 participants 1897 participants 2435 participants
0.22  (0.30) 0.22  (0.33) 0.22  (0.32)
EuroQol Month 18 Number Analyzed 684 participants 1748 participants 2432 participants
0.20  (0.32) 0.23  (0.33) 0.22  (0.33)
EuroQol Month 24 Number Analyzed 664 participants 1619 participants 2283 participants
0.20  (0.31) 0.23  (0.33) 0.22  (0.32)
EuroQol Month 30 Number Analyzed 616 participants 1456 participants 2072 participants
0.19  (0.31) 0.22  (0.33) 0.21  (0.32)
EuroQol Month 36 Number Analyzed 582 participants 1397 participants 1979 participants
0.21  (0.30) 0.23  (0.33) 0.22  (0.32)
EuroQol Month 42 Number Analyzed 483 participants 874 participants 1357 participants
0.18  (0.31) 0.24  (0.33) 0.22  (0.32)
EuroQol Month 48 Number Analyzed 464 participants 1010 participants 1474 participants
0.19  (0.31) 0.23  (0.33) 0.22  (0.32)
EuroQol Month 54 Number Analyzed 330 participants 167 participants 497 participants
0.22  (0.32) 0.32  (0.36) 0.22  (0.32)
EuroQol Month 60 Number Analyzed 317 participants 255 participants 572 participants
0.20  (0.33) 0.27  (0.35) 0.23  (0.34)
EuroQol Month 66 Number Analyzed 276 participants 53 participants 329 participants
0.21  (0.33) 0.24  (0.34) 0.21  (0.33)
EuroQol Month 72 Number Analyzed 273 participants 50 participants 323 participants
0.22  (0.32) 0.28  (0.35) 0.23  (0.32)
EuroQol Month 78 Number Analyzed 32 participants 7 participants 39 participants
0.36  (0.37) 0.10  (0.51) 0.31  (0.40)
EuroQol Month 84 Number Analyzed 75 participants 11 participants 86 participants
0.27  (0.35) 0.21  (0.43) 0.27  (0.36)
EuroQol Month 90 Number Analyzed 6 participants 1 participants 7 participants
0.47  (0.32) 0.84  (0) 0.52  (0.32)
EuroQol Month 96 Number Analyzed 3 participants 0 participants 3 participants
0.09  (0.04) 0.09  (0.04)
WL: Physical Demands Month 6 Number Analyzed 109 participants 900 participants 1009 participants
-5.34  (39.81) -3.67  (38.17) -3.85  (38.33)
WL: Physical Demands Month 12 Number Analyzed 96 participants 808 participants 904 participants
-5.31  (37.81) -4.02  (39.25) -4.16  (39.08)
WL: Physical Demands Month 18 Number Analyzed 83 participants 706 participants 789 participants
-7.97  (35.46) -2.29  (37.48) -2.89  (37.29)
WL: Physical Demands Month 24 Number Analyzed 63 participants 544 participants 607 participants
-2.62  (36.05) -4.46  (37.54) -4.27  (37.36)
WL: Physical Demands Month 30 Number Analyzed 51 participants 444 participants 495 participants
-10.12  (37.17) -3.75  (37.67) -4.41  (37.63)
WL: Physical Demands Month 36 Number Analyzed 35 participants 350 participants 385 participants
-7.31  (34.69) -3.95  (39.58) -4.25  (39.14)
WL: Physical Demands Month 42 Number Analyzed 24 participants 246 participants 270 participants
-13.51  (33.91) -4.81  (38.98) -5.58  (38.58)
WL: Physical Demands Month 48 Number Analyzed 19 participants 126 participants 145 participants
-25.86  (34.47) 0.73  (38.68) -2.76  (39.09)
WL: Physical Demands Month 54 Number Analyzed 2 participants 20 participants 22 participants
-39.17  (62.46) -13.27  (45.69) -15.63  (46.18)
WL: Physical Demands Month 60 Number Analyzed 0 participants 3 participants 3 participants
-27.78  (34.94) -27.78  (34.94)
WL: Physical Demands Month 66 Number Analyzed 0 participants 1 participants 1 participants
8.33  (0) 8.33  (0)
RA-HCRU Month 6 Number Analyzed 189 participants 1419 participants 1608 participants
-2.01  (6.20) -2.08  (4.15) -2.07  (4.44)
RA-HCRU Month 12 Number Analyzed 180 participants 1329 participants 1509 participants
-2.41  (6.43) -2.26  (3.76) -2.28  (4.17)
RA-HCRU Month 18 Number Analyzed 161 participants 1162 participants 1323 participants
-1.88  (2.93) -2.24  (3.90) -2.19  (3.80)
RA-HCRU Month 24 Number Analyzed 162 participants 1101 participants 1263 participants
-2.03  (3.18) -2.22  (3.26) -2.19  (3.25)
RA-HCRU Month 30 Number Analyzed 126 participants 785 participants 911 participants
-1.67  (3.02) -2.16  (4.17) -2.10  (4.04)
RA-HCRU Month 36 Number Analyzed 106 participants 759 participants 865 participants
-2.38  (2.91) -2.32  (4.14) -2.33  (4.01)
RA-HCRU Month 42 Number Analyzed 68 participants 455 participants 523 participants
-1.68  (2.84) -2.18  (4.70) -2.11  (4.51)
RA-HCRU Month 48 Number Analyzed 66 participants 527 participants 593 participants
-1.88  (3.24) -2.15  (4.67) -2.12  (4.53)
RA-HCRU Month 54 Number Analyzed 3 participants 39 participants 42 participants
-2.00  (1.00) -2.59  (3.42) -2.55  (3.30)
RA-HCRU Month 60 Number Analyzed 4 participants 94 participants 98 participants
-2.00  (3.56) -2.88  (2.85) -2.85  (2.87)
RA-HCRU Month 66 Number Analyzed 0 participants 0 participants 0 participants
RA-HCRU Month 72 Number Analyzed 0 participants 4 participants 4 participants
-1.25  (6.70) -1.25  (6.70)
RA-HCRU Month 78 Number Analyzed 0 participants 0 participants 0 participants
RA-HCRU Month 84 Number Analyzed 0 participants 0 participants 0 participants
RA-HCRU Month 90 Number Analyzed 0 participants 0 participants 0 participants
RA-HCRU Month 96 Number Analyzed 0 participants 0 participants 0 participants
17.Secondary Outcome
Title Initial Period: Preservation of Joint Structure in Participants Who Had Baseline Radiographs Obtained in Their Qualifying Index Study
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Modified Total Sharp Score per visit. Baseline score was the last available assessment from the index study. The Modified Total Sharp Score measures disease progression; increased scores indicate disease progression. Score range 0 (normal) to 448 (worst possible total score). The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.

TSS=Total Sharp Score

Time Frame Every 6 months until study completion
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Hide Analysis Population Description
The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.
Arm/Group Title Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) Initial Period: Tofacitinib 10 mg BID Initial Period: All Tofacitinib
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Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID.
Participants with average total daily dose across study >=15 were assigned to 10 mg BID.
All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.
Overall Number of Participants Analyzed 1123 3358 4481
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Modified TSS Baseline Number Analyzed 95 participants 1061 participants 1156 participants
20.55  (33.37) 24.13  (43.57) 23.84  (42.83)
Modified TSS Month 6 Number Analyzed 82 participants 937 participants 1019 participants
22.58  (35.10) 25.12  (44.42) 24.91  (43.74)
Modified TSS Month 12 Number Analyzed 85 participants 918 participants 1003 participants
21.26  (33.75) 24.73  (44.08) 24.44  (43.30)
Modified TSS Month 24 Number Analyzed 77 participants 801 participants 878 participants
22.07  (35.85) 24.85  (43.21) 24.61  (42.61)
Modified TSS Month 36 Number Analyzed 35 participants 379 participants 414 participants
25.88  (37.74) 28.22  (44.95) 28.02  (44.35)
18.Secondary Outcome
Title Vaccine Sub-study. Percent Achieving a Satisfactory Humoral Response to the Pneumococcal Vaccine as Defined by ≥ 2-fold Increase in Antibody Concentrations
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Number (%) of participants achieving a satisfactory humoral response to the pneumococcal vaccine as defined by ≥2-fold increase in antibody concentration from vaccine sub-study visit 2 (vaccination baseline) in ≥6 of 12 anti-pneumococcal antigens (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.

95% CI is based on Clopper-Pearson exact method for response rate.

Time Frame From vaccine sub-study visit 2 (baseline) to sub-study visit 4
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Hide Analysis Population Description
Evaluable Immunogenicity Population
Arm/Group Title Tofacitinib 10 mg BID Continuous Visit 3 Tofacitinib 10 mg BID Interrupted Visit 3 Tofacitinib 10 mg BID Continuous Visit 4 Tofacitinib 10 mg BID Interrupted Visit 4