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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000358-13 | EudraCT Number | ||
| ORAL STRATEGY | Other Identifier | Alias Study Number |
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To assess the efficacy of tofacitinib monotherapy or tofacitinib with methotrexate as compared to adalimumab with methotrexate. To compare the efficacy of tofacitinib monotherapy compared to tofacitinib combined with methotrexate. To compare effects on all health outcomes measures in the study. To evaluate the safety and tolerability of tofacitinib and adalimumab. To evaluate the safety of the zoster vaccine given prior to the initiation of tofacitinb or adalimumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tofacitinib 5 mg twice daily with methotrexate | Experimental |
| |
| Tofacitinib 5 mg twice daily monotherapy | Experimental |
| |
| Adalimumab with methotrexate | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tofacitinib with methotrexate | Drug | Tofacitinib 5 mg twice daily, oral for 12 months Methotrexate (previous stable dose 15-25 mg) every week, oral for 12 months Placebo for adalimumab every other week, subcutaneous for 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology Criteria 50% Improvement (ACR50) Response at Month 6 | ACR50 is a greater than or equal to (≥) 50 percent (%) improvement in tender joint count (TJC) or swollen joint count (SJC) and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment (PGA) of disease activity, 2) participant's assessment (PtGA) of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein (CRP) at each visit. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Simplified Disease Activity Index (SDAI) Value at Month 6 | SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 centimeter (cm) visual analogue scale (VAS) (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI less than or equal to (≤) 3.3 indicates disease remission, >3.4 to 11 indicates low disease activity, >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheumatology Associates of North Alabama, PC | Huntsville | Alabama | 35801 | United States | ||
| Arthrocare, Arthritis Care & Research, PC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41565911 | Derived | Takeuchi T, Tanaka Y, Yamanaka H, Yamaoka K, Sugiyama N, Iikuni N, Toyoizumi S, Kwok K, Tsai WC, Mysler E, Moots RJ, Smolen JS, Fleischmann R. Efficacy and Safety of Tofacitinib and Adalimumab in Rheumatoid Arthritis by Body Mass Index-Normalized Methotrexate Dose: A Post Hoc Analysis. Rheumatol Ther. 2026 Apr;13(2):423-434. doi: 10.1007/s40744-025-00823-0. Epub 2026 Jan 22. | |
| 39192350 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Although a total of 1,152 participants were randomized, only 1,146 participants received treatment and are included in the full analysis set summarized below.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tofacitinib 5 mg BID | One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months. |
| FG001 | Tofacitinib 5 mg BID + MTX |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Tofacitinib without methotrexate | Drug | Tofacitinib 5 mg twice daily, oral for 12 months Placebo for methotrexate (previous stable dose) every week, oral for 12 months Placebo for adalimumab every other week, subcutaneous for 12 months |
|
| Adalimumab with methotrexate | Biological | Placebo for tofacitinib twice daily, oral for 12 months Methotrexate (previous stable dose 15-25 mg) every week, oral for 12 months Adalimumab 40 mg every other week, subcutaneous for 12 months |
|
| Month 6 |
| Change From Baseline in Clinical Disease Activity Index (CDAI) Value at Month 6 | CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity. | Month 6 |
| Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including CRP at Month 6 | DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA (millimeters [mm]) + 0.96. Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-4 (CRP) ≤3.2 indicates low disease activity, >3.2 to 5.1 indicates moderate to high disease activity, and less than (<) 2.6 indicates remission. | Month 6 |
| Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including Erythrocyte Sedimentation Rate (ESR) at Month 6 | DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-3 (ESR) ≤3.2 indicates low disease activity, >3.2 to 5.1 indicates moderate to high disease activity, and <2.6 indicates remission. | Month 6 |
| Percentage of Participants Achieving Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria at Month 6 | To meet the ACR-EULAR Boolean remission criteria, a participant must satisfy all of the following: TJC ≤1 and SJC ≤1 (both based on a 28-joint assessment), CRP ≤1 mg/dL, and PtGA ≤1 on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). | Month 6 |
| Percentage of Participants Achieving SDAI ≤3.3 at Month 6 | SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI ≤3.3 indicates disease remission. | Month 6 |
| Percentage of Participants Achieving CDAI ≤2.8 at Month 6 | CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission. | Month 6 |
| Percentage of Participants Achieving DAS28-4 (ESR) <2.6 at Month 6 | DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (ESR) <2.6 indicates disease remission. | Month 6 |
| Percentage of Participants Achieving DAS28-4 (CRP) <2.6 at Month 6 | DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA (mm) + 0.96. Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (CRP) <2.6 indicates remission. | Month 6 |
| Percentage of Participants Achieving SDAI ≤11 at Month 6 | SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI ≤3.3 indicates disease remission, >3.4 to 11 indicates low disease activity. | Month 6 |
| Percentage of Participants Achieving CDAI ≤10 at Month 6 | CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission, >2.8 to 10 indicates low disease activity. | Month 6 |
| Percentage of Participants Achieving DAS28-4 (ESR) ≤3.2 at Month 6 | DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (ESR) ≤3.2 indicates low disease activity. | Month 6 |
| Percentage of Participants Achieving DAS28-4 (CRP) ≤3.2 at Month 6 | DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA + 0.96. Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-4 (CRP) ≤3.2 indicates low disease activity. | Month 6 |
| Percentage of Participants Achieving American College of Rheumatology Criteria 20% Improvement (ACR20) Response at Month 6 | ACR20 response is a ≥20% improvement in TJC or SJC and 20% improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit. | Month 6 |
| Percentage of Participants Achieving American College of Rheumatology Criteria 70% Improvement (ACR70) Response at Month 6 | ACR70 response is a ≥70% improvement in TJC or SJC and 70% improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit. | Month 6 |
| Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Month 6 | The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dressing and grooming, arising, eating, walking, reach, grip, hygiene and other activities over the past week. Each activity category consists of 2 to 3 items. Each item is scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity requiring assistance from another individual or the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. | Month 6 |
| Percentage of Participants Achieving an HAQ-DI Decrease of at Least 0.22 at Month 6 | The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dressing and grooming, arising, eating, walking, reach, grip, hygiene and other activities over the past week. Each activity category consists of 2 to 3 items. Each item is scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity requiring assistance from another individual or the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. A decrease of 0.22 or more is considered a positive response. | Month 6 |
| Change From Baseline in the Short-Form-36 (SF-36) Health Survey, Physical Component Score at Month 6 | The SF-36 health survey is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based scores for both the SF-36 version 2 (v2) and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher PCS score represents better physical health status. | Month 6 |
| Change From Baseline in the SF-36 Health Survey, Mental Component Score at Month 6 | The SF-36 health survey is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The health domains are aggregated into two summary scores known as the PCS score and the MCS score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher MCS score represents better physical health status. | Month 6 |
| Change From Baseline in the SF-36 Health Survey, Physical Functioning Domain Score at Month 6 | SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 10 items of the physical functioning scale represent levels and kinds of limitations between extremes of physical activities, including lifting and carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture the presence and extent of physical limitations using a 3-level response continuum. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher physical functioning domain score represents better physical functioning. | Month 6 |
| Change From Baseline in the SF-36 Health Survey, Role Physical Domain Score at Month 6 | SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 4-item role physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; and d) accomplishing less. Items in the role physical scale are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher role physical domain score represents better role physical functioning. | Month 6 |
| Change From Baseline in the SF-36 Health Survey, Bodily Pain Domain Score at Month 6 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher bodily pain domain score represents less bodily pain. | Month 6 |
| Change From Baseline in the SF-36 Health Survey, General Health Domain Score at Month 6 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The general health scale consists of 5 items including a rating of health and 4 items addressing the respondent's view and expectations of his or her health. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher general health domain score represents better general health perceptions. | Month 6 |
| Change From Baseline in the SF-36 Health Survey, Vitality Domain Score at Month 6 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher vitality domain score represents better vitality. | Month 6 |
| Change From Baseline in the SF-36 Health Survey, Social Functioning Domain Score at Month 6 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 2-item social functioning scale assesses health-related effects on quantity and quality of social activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher social functioning domain score represents better social functioning. | Month 6 |
| Change From Baseline in the SF-36 Health Survey, Role Emotional Domain Score at Month 6 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 3-item role emotional scale assesses mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. All 3 items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher role emotional domain score represents better role emotional functioning. | Month 6 |
| Change From Baseline in the SF-36 Health Survey, Mental Health Domain Score at Month 6 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. All items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher mental health domain score represents better mental health functioning. | Month 6 |
| Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 | The WPAI: Rheumatoid Arthritis is a 6 item questionnaire that is specific for rheumatoid arthritis and yields four types of scores: absenteeism, presenteesism (impairment at work/reduced job effectiveness), work productivity loss and activity impairment. WPAI outcomes are expressed as impairment percentages ranging from 0 to 100, with higher numbers indicating greater impairment and less productivity. | Month 6 |
| Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 | The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). This profile of scores across the 5-dimensions (e.g. 11231, 33212, etc.) is transformed into a single health utility score using a formula developed by the EuroQol Group that applies country specific preference weights. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rated the current health state on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicating a better health state. | Month 6 |
| Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Total Score at Month 6 | FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant's response (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). | Month 6 |
| Gilbert |
| Arizona |
| 85234 |
| United States |
| Medvin Clinical Research | Covina | California | 91722 | United States |
| St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare | Fullerton | California | 92835 | United States |
| HealthCare Partners Medical Group | Huntington Beach | California | 92646 | United States |
| Keck Medicine of USC - Division of Rheumatology | Los Angeles | California | 90033 | United States |
| University of Southern California (USC) Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
| Ronald Reagan UCLA Medical Center - Drug Information Center | Los Angeles | California | 90095 | United States |
| UCLA David Geffen School of Medicine, Division of Rheumatology | Los Angeles | California | 90095 | United States |
| Medvin Clinical Research | Placentia | California | 92870 | United States |
| San Diego Arthritis Medical Clinic | San Diego | California | 92108 | United States |
| Inland Rheumatology Clinical Trials, Inc. | Upland | California | 91786 | United States |
| Medvin Clinical Research | Van Nuys | California | 91405 | United States |
| Medvin Clinical Research | Whittier | California | 90602 | United States |
| Joao M. A. Nascimento | Bridgeport | Connecticut | 06606 | United States |
| AARDS Research, Inc. | Aventura | Florida | 33180 | United States |
| Arthritis and Rheumatic Disease Specialties | Aventura | Florida | 33180 | United States |
| Riverside Clinical Research | Edgewater | Florida | 32132 | United States |
| Centre for Rheumatology, Immunology and Arthritis | Fort Lauderdale | Florida | 33309 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Omega Research Consultants, LLC | Orlando | Florida | 32804 | United States |
| Arthritis Center, Inc. | Palm Harbor | Florida | 34684 | United States |
| Gulf Region Clinical Research Institute Llc | Pensacola | Florida | 32514 | United States |
| West Broward Rheumatology Associates, Inc. | Tamarac | Florida | 33321 | United States |
| BayCare Medical Group Inc | Tampa | Florida | 33614 | United States |
| The Center for Arthritis and Rheumatism | Vero Beach | Florida | 32960 | United States |
| The Office of Alastair C. Kennedy, MD | Vero Beach | Florida | 32960 | United States |
| Advanced Clinical Research of Orlando, Inc. | Winter Garden | Florida | 34787 | United States |
| Coeur D'Alene Arthritis Clinic | Coeur d'Alene | Idaho | 83814 | United States |
| Institute of Arthritis Research | Idaho Falls | Idaho | 83404 | United States |
| Deerbrook Medical Associates | Vernon Hills | Illinois | 60061 | United States |
| Diagnostic Rheumatology and Research PC | Indianapolis | Indiana | 46227 | United States |
| Ochsner Clinic Baton Rouge | Baton Rouge | Louisiana | 70809 | United States |
| Arthritis and Diabetes Clinic, Inc | Monroe | Louisiana | 71203 | United States |
| Arthritis Treatment Center | Frederick | Maryland | 21702 | United States |
| Jasper Clinic | Kalamazoo | Michigan | 49007 | United States |
| Arthritis and Osteoporosis Treatment and Research Center | Flowood | Mississippi | 39232 | United States |
| Clinvest/ A Division of Banyan Group, Inc. | Springfield | Missouri | 65807 | United States |
| St. Louis Center For Clinical Research Barbara Caciolo, MD | St Louis | Missouri | 63128 | United States |
| Dr. Prem C. Chatpar M.D.,LLC | Plainview | New York | 11803 | United States |
| PMG Research of Salisbury, LLC | Salisbury | North Carolina | 28144 | United States |
| Rowan Diagnostic Clinic | Salisbury | North Carolina | 28144 | United States |
| PMG Research of Wilmington | Wilmington | North Carolina | 28401 | United States |
| Trinity Health Center - Medical Arts | Minot | North Dakota | 58701 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Altoona Center For Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Arthritis Group | Philadelphia | Pennsylvania | 19152-3303 | United States |
| Low Country Rheumatology, PA | Charleston | South Carolina | 29406 | United States |
| West Tennessee Research Institute | Jackson | Tennessee | 38305 | United States |
| Accurate Clinical Management, LLC | Baytown | Texas | 77521 | United States |
| Arthritis Care And Diagnostic Center, P.A. | Dallas | Texas | 75231 | United States |
| Metroplex Clinical Research Center | Dallas | Texas | 75231 | United States |
| Accurate Clinical Management, LLC | Houston | Texas | 77004 | United States |
| Rheumatology Clinic of Houston, PA | Houston | Texas | 77065 | United States |
| Houston Institute For Clinical Research | Houston | Texas | 77074 | United States |
| Arthritis & Osteoporosis Associates, LLP | Lubbock | Texas | 79424 | United States |
| Southwest Rheumatology Research, LLC. | Mesquite | Texas | 75150 | United States |
| Accurate Clinical Research, Inc. | San Antonio | Texas | 78229 | United States |
| Arthritis & Osteoporosis Center of South Texas | San Antonio | Texas | 78232 | United States |
| Arthritis Northwest, PLLC | Spokane | Washington | 99204 | United States |
| Atencion Integral en Reumatologia (AIR) | CABA | Buenos Aires | C1426AAL | Argentina |
| Centro Medico Privado de Reumatologia | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Centro Radiologico Luis Mendez Collado SRL | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Organizacion Medica de Investigacion S.A - OMI | Buenos Aires | 1015 | Argentina |
| CER San Juan, Centro Polivalente de Asistencia e Investigacion Clinica | San Juan | 5400 | Argentina |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia |
| Pacific Private Clinic | Southport | Queensland | 4215 | Australia |
| QML Pathology | Southport | Queensland | 4215 | Australia |
| The Queen Elizabeth Hospital | Woodville South | South Australia | 5011 | Australia |
| Emeritus Research | Malvern East | Victoria | 3145 | Australia |
| RK Will Pty Ltd | Victoria Park | Western Australia | 6100 | Australia |
| University Hospital Clinical Center Banja Luka | Banja Luka | Republika Srpska | 78000 | Bosnia and Herzegovina |
| University Clinical Center Tuzla | Tuzla | 75000 | Bosnia and Herzegovina |
| UMHAT "Dr. Georgi Stranski" EAD | Pleven | 5800 | Bulgaria |
| MHAT "Kaspela" EOOD | Plovdiv | 4002 | Bulgaria |
| MHAT EUROHOSPITAL Plovdiv | Plovdiv | 4004 | Bulgaria |
| MHAT Akta Medika OOD | Rousse | 5400 | Bulgaria |
| MHAT Ruse AD | Rousse | 7002 | Bulgaria |
| MHAT Shumen AD | Shumen | 9700 | Bulgaria |
| NMTH Tsar Boris Clinic of Internal Diseases | Sofia | 1233 | Bulgaria |
| MHAT Lyulin EAD | Sofia | 1336 | Bulgaria |
| MHAT "Targovishte" AD | Targovisthe | 7700 | Bulgaria |
| Kw Musculoskeletal Research Inc | Kitchener | Ontario | N2M 5N6 | Canada |
| Centre de Recherche Musculo-Squelettique | Trois-Rivières | Quebec | G8Z 1Y2 | Canada |
| Quantum Research Ltda | Puerto Varas | Los Lagos Region | 5550170 | Chile |
| Quantum Research | Puerto Varas | Los Lagos Region | 5550170 | Chile |
| Prosalud | Santiago | Santiago Metropolitan | 7510047 | Chile |
| Estudios Clinicos Quinta Region Ltda. | Viña del Mar | Valparaiso | 2520997 | Chile |
| Revmacentrum MUDr. Mostera, s.r.o. | Brno-Židenice | Czech Republic | 615 00 | Czechia |
| Revmatologie s.r.o. | Brno | 63800 | Czechia |
| Revmatologicka ambulance | Česká Lípa | 470 01 | Czechia |
| Vesalion, s.r.o. | Ostrava- Moravska Ostrava | 702 00 | Czechia |
| Revmatologie | Prague | 140 00 | Czechia |
| Foundation Parnu Hospital | Pärnu | 80010 | Estonia |
| East-Tallinn Central Hospital Ltd | Tallinn | 11312 | Estonia |
| North Estonia Medical Centre Foundation | Tallinn | 13419 | Estonia |
| Bnai Zion Medical Center | Haifa | 31048 | Israel |
| Rambam Health Care Campus | Haifa | 3109601 | Israel |
| Hadassah Medical Center | Jerusalem | 91120 | Israel |
| The Chaim Sheba Medical Center | Tel Litwinsky | 5262000 | Israel |
| Health Center 4 | Riga | LV-1012 | Latvia |
| ORTO clinic Ltd | Riga | LV1005 | Latvia |
| Alytaus District S. Kudirkos Hospital | Alytus | LT-62114 | Lithuania |
| VAKK "Clinic of Dr. Kilda" | Kaunas | LT-50128 | Lithuania |
| PI Republican Siauliai Hospital | Šiauliai | LT-76231 | Lithuania |
| Unidad de Enfermedades Reumaticas y Cronico Degenerativas S. C. | Torreón | Coahuila | 27000 | Mexico |
| Centro Integral en Reumatologia, SA de CV | Guadalajara | Jalisco | 44160 | Mexico |
| CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C. Consultorio Medico de Reumatologia | Mexico City | Mexico City | 11850 | Mexico |
| Centro de Investigacion de Tratamientos Innovadores de Sinaloa S.C. | Culiacán | Sinaloa | 80000 | Mexico |
| Centro de Investigacion en Tratamientos Innovadores de Sinaloa S.C. | Culiacán | Sinaloa | 80000 | Mexico |
| Centro Multidisciplinario para el Desarrollo Especializado de la Invetigacion Clinica en Yucatan | Mérida | Yucatán | 97133 | Mexico |
| Departamento de Imagen de Hospital Star Medica Merida | Mérida | Yucatán | 97133 | Mexico |
| Laboratorio clínico del Hospital Star Medica Merida | Mérida | Yucatán | 97133 | Mexico |
| Storage for lab kits and study materials | Mérida | Yucatán | 97133 | Mexico |
| Investigacion y Biomedica de Chihuahua, SC | Chihuahua City | 31000 | Mexico |
| Centro de Integral en Reumatologia SA de CV | Jalisco | 44160 | Mexico |
| Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C. | San Luis Potosí City | 78213 | Mexico |
| Unidad de Investigaciones Reumatologicas A.C. | San Luis Potosí City | 78290 | Mexico |
| Unidad de Investigacion en Medicina Interna y Enfermedades criticas-Hogar Clinica San Juan de Dios | Arequipa | 04020 | Peru |
| ABK REUMAR S.R.L. de Medicentro Biociencias_ BIO CIENCIAS PERU S.R.L. | Lima | 21 | Peru |
| Instituto Peruano del Hueso y la Articulacion | Lima | 27 | Peru |
| Investigaciones Clinicas S.A.C. | Lima | 33 | Peru |
| Mary Mediatrix Medical Center | Lipa City | Batangas | 4217 | Philippines |
| Brokenshire Integrated Health Ministries, Inc. | Davao City | Davao DEL SUR | 8000 | Philippines |
| Iloilo Doctors' Hospital, Inc | Iloilo City | Iloilo | 5000 | Philippines |
| University of the Philippines Manila-Philippine General Hospital | Manila | National Capital Region | 1000 | Philippines |
| Jose R. Reyes Memorial Medical Center-Rayuma Klinik | Manila | National Capital Region | 1003 | Philippines |
| St. Luke's Medical Center | Quezon City | National Capital Region | 1102 | Philippines |
| Far Eastern University - NRMF Medical Center | Quezon City | National Capital Region | 1118 | Philippines |
| Perpetual Succour Hospital | Cebu City | 6000 | Philippines |
| Davao Doctors Hospital | Davao City | 8000 | Philippines |
| St. Paul's Hospital of Iloilo, Inc. | Iloilo City | 5000 | Philippines |
| Medica Pro Familia Sp. z o.o. S.K.A. Oddzial Krakow | Krakow | Malopolska | 30-002 | Poland |
| Centrum Medyczne Amed | Warsaw | WOJ Mazowieckie | 01-518 | Poland |
| Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy, | Bydgoszcz | 85-168 | Poland |
| Centrum Medyczne SILESIANA Sp. z o.o. | Bytom | 41-902 | Poland |
| Nzoz Bif-Med | Bytom | 41-902 | Poland |
| Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka | Elblag | 82-300 | Poland |
| Synexus Polska Sp. z o.o. Oddzial w Gdyni | Gdynia | 81-384 | Poland |
| Synexus Polska Sp. z o.o. Oddzial w Katowicach | Katowice | 40-040 | Poland |
| Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna | Lodz | 90-242 | Poland |
| Lecznica MAK-MED, NZOZ | Nadarzyn | 05-830 | Poland |
| Prywatna Praktyka Lekarska | Poznan | 61-397 | Poland |
| Synexus Polska Sp. z o.o. Oddzial w Warszawie | Warsaw | 01192 | Poland |
| MTZ Clinical Research Sp. z o.o. | Warsaw | 02-106 | Poland |
| Synexus Polska Sp. z o.o. Oddzial we Wroclawiu | Wroclaw | 50-088 | Poland |
| Spitalul Clinic Judetean de Urgenta Cluj Napoca Reumatologie | Cluj-Napoca | Cluj | 400006 | Romania |
| Covamed Serv SRL | Sfantu Gheorghe | Covasna | 520052 | Romania |
| Spitalul Judetean de Urgenta "Dr. Constantin Opris" | Baia Mare | Maramureş | 430031 | Romania |
| S.C. Clinica Somesan S.R.L. | Baia Mare | Maramureş | 430352 | Romania |
| Ianuli Med Consult SRL, Reumatologie | Bucharest | 010976 | Romania |
| Spitalul Clinic Sf. Maria, Medicina interna - Reumatologie | Bucharest | 011172 | Romania |
| Spitalul Clinic Sf. Maria | Bucharest | 011172 | Romania |
| Spitalul Clinic "Dr. I. Cantacuzino" | Bucharest | 020475 | Romania |
| Centrul Clinic de Boli Reumatismale "Dr. Ion Stoia" | Bucharest | 020983 | Romania |
| Spitalul Clinic Judetean de Urgenta - "Sf.Apostol Andrei" Galati | Galati | 800578 | Romania |
| Spitalul Clinic de Recuperare Iasi | Iași | 700661 | Romania |
| Republic Hospital n.a. V.A. Baranov | Petrozavodsk | Karelia Republic | 185019 | Russia |
| State Budgetary Healthcare Institution of Karelia Republic "Republic Hospital n.a. V.A. Baranov" | Petrozavodsk | Karelia Republic | 185019 | Russia |
| SAHI of KR "Kemerovo Regional Clinical Hospital" | Kemerovo | 650066 | Russia |
| SBEI HPE First Moscow State Medical University n.a.I.M.Sechenov of MoH of RF based on UCH#1 | Moscow | 119991 | Russia |
| CJSC "European Medical Center" | Moscow | 129090 | Russia |
| SBEI HPE Novosibirsk State Medical University of MoH of RF | Novosibirsk | 630102 | Russia |
| State Budgetary Healthcare Institution "Orenburg Regional Clinical Hospital" | Orenburg | 460018 | Russia |
| State Budgetary Institution of Ryazan Region "Regional Clinical Cardiology Dispensary" | Ryazan | 390026 | Russia |
| Limited Liability Company AVA-PETER | Saint Petersburg | 191014 | Russia |
| State Budgetary Institution of Healthcare "Samara Regional Clinical Hospital n.a. V.D. Seredavin" | Samara | 443095 | Russia |
| State Institution of Healthcare "Regional Clinical Hospital" | Saratov | 410053 | Russia |
| Non-state Healthcare Institution "Regional Hospital at Smolensk Station of OJSC "Russian Railways" | Smolensk | 214025 | Russia |
| State Autonomous Healthcare lnstitution of Yarostavl Region | Yaroslavl | 150003 | Russia |
| State Budgetary Healthcare Institution of Yaroslavl Region "Clinical Hospital #3" | Yaroslavl | 150007 | Russia |
| Iatros International | Bloemfontein | Free State | 9301 | South Africa |
| LCS Clinical Research Unit | Johannesburg | Gauteng | 2021 | South Africa |
| WCR: Wits Clinical Research Charlotte Maxeke Johannesburg Academic Hospital | Johannesburg | Gauteng | 2193 | South Africa |
| WCR: Wits Clinical Research | Johannesburg | Gauteng | 2193 | South Africa |
| Charlotte Maxeke Johannesburg Academic Hospital | Parktown, Johannesburg | Gauteng | 2193 | South Africa |
| Clinical Research Unit, University of Pretoria | Pretoria | Gauteng | 0002 | South Africa |
| Netcare Jakaranda Hospital | Pretoria | Gauteng | 0002 | South Africa |
| University of Pretoria | Pretoria | Gauteng | 0002 | South Africa |
| Netcare St Augustine's Hospital | Durban | KwaZulu-Natal | 4001 | South Africa |
| Arthritis Clinical Research Trials | Cape Town | Western Cape | 7405 | South Africa |
| Panorama Medical Centre | Cape Town | Western Cape | 7500 | South Africa |
| Wineland Medical Research Centre | Stellenbosch | Western Cape | 7600 | South Africa |
| Inha University Hospital | Jung-Gu | Incheon | 22332 | South Korea |
| Kyungpook National University Hospital | Daegu | 41944 | South Korea |
| Daegu Catholic University Medical Center | Daegu | 42472 | South Korea |
| Chonnam National University Hospital | Gwangju | 61469 | South Korea |
| Hanyang University Seoul Hospital | Seoul | 04763 | South Korea |
| Konkuk University Medical Center | Seoul | 05030 | South Korea |
| Complejo Hospitalario Universitario de Santiago de Compostela, Hospital Clinico Universitario | Santiago de Compostela | A Coruna | 15706 | Spain |
| Complexo Hospitalario Universitario A Coruna | A Coruña | 15006 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Hospital Regional Universitario de Malaga | Málaga | 29009 | Spain |
| Hospital Infanta Luisa | Seville | 41010 | Spain |
| Chung Shan Medical University Hospital | Taichung | Taiwan ROC | 402 | Taiwan |
| Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation | Hualien City | 97002 | Taiwan |
| Kaohsiung Medical University Chung-Ho Memorial Hospital - New | Kaohsiung City | 807 | Taiwan |
| Kaohsiung Veterans General Hospital | Kaohsiung City | 81362 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Chang Gung Medical Foundation - Linkou Branch | Taoyuan County | 33305 | Taiwan |
| Phramongkutklao Hospital | Bangkok | Rajthevi | 10400 | Thailand |
| Cardiology Unit,Department of Medicine, Faculty of Medicine, Ramathibodi Hospital,Mahidol University | Bangkok | 10400 | Thailand |
| Div. of Allergy Immunology and Rheumatology, Dept. of Medicine, | Bangkok | 10400 | Thailand |
| Siriraj Hospital Mahidol University | Bangkok | 10700 | Thailand |
| Songklanagarind Hospital - Prince of Songkhla University | Songkhla | 90110 | Thailand |
| Ankara Universitesi Tip Fakultesi Ibn-i Sina Hastanesi | Ankara | 06100 | Turkey (Türkiye) |
| Ondokuz Mayis Universitesi Tip Fakultesi Saglik Uyg. ve Eg. | Samsun | 55139 | Turkey (Türkiye) |
| Ondokuz Mayis Universitesi Tip Fakultesi Saglik Uygulama ve Egitim Merkezi | Samsun | 55139 | Turkey (Türkiye) |
| Cumhuriyet Universitesi Tip Fakultesi Hastanesi | Sivas | 58140 | Turkey (Türkiye) |
| The Dudley Group NHS Foundation Trust | Dudley | WEST Midlands | DY1 2HQ | United Kingdom |
| The Royal Wolverhamptons NHS Trust | Cannock | WS11 5XY | United Kingdom |
| The Leeds Teaching Hospitals NHS Trust | Leeds | LS7 4SA | United Kingdom |
| Aintree University Hospital NHS Foundation Trust | Liverpool | L9 7AL | United Kingdom |
| Royal Free London NHS Foundation Trust | London | NW3 2QG | United Kingdom |
| Derived |
| Hetland ML, Strangfeld A, Bonfanti G, Soudis D, Deuring JJ, Edwards RA. Machine learning prediction and explanatory models of serious infections in patients with rheumatoid arthritis treated with tofacitinib. Arthritis Res Ther. 2024 Aug 27;26(1):153. doi: 10.1186/s13075-024-03376-9. |
| 38958913 | Derived | Wright GC, Mysler E, Kwok K, Cadatal MJ, Germino R, Yndestad A, Kinch CD, Ogdie A. Impact of Race on the Efficacy and Safety of Tofacitinib in Rheumatoid Arthritis: Post Hoc Analysis of Pooled Clinical Trials. Rheumatol Ther. 2024 Oct;11(5):1135-1164. doi: 10.1007/s40744-024-00677-y. Epub 2024 Jul 3. |
| 38883150 | Derived | Pope J, Finckh A, Silva-Fernandez L, Mandl P, Fan H, Rivas JL, Valderrama M, Montoro M. Tofacitinib Monotherapy in Rheumatoid Arthritis: Clinical Trials and Real-World Data Contextualization of Patients, Efficacy, and Treatment Retention. Open Access Rheumatol. 2024 Jun 11;16:115-126. doi: 10.2147/OARRR.S446431. eCollection 2024. |
| 37925660 | Derived | Citera G, Jain R, Irazoque F, Madariaga H, Gruben D, Wang L, Stockert L, Santana K, Ebrahim A, Ponce de Leon D. Tofacitinib Efficacy in Patients with Rheumatoid Arthritis and Probable Depression/Anxiety: Post Hoc Analysis of Phase 3 and 3b/4 Randomized Controlled Trials. Rheumatol Ther. 2024 Feb;11(1):35-50. doi: 10.1007/s40744-023-00612-7. Epub 2023 Nov 5. |
| 36931693 | Derived | Kristensen LE, Danese S, Yndestad A, Wang C, Nagy E, Modesto I, Rivas J, Benda B. Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance. Ann Rheum Dis. 2023 Jul;82(7):901-910. doi: 10.1136/ard-2022-223715. Epub 2023 Mar 17. |
| 36814062 | Derived | Dougados M, Taylor PC, Bingham CO 3rd, Fallon L, Brault Y, Roychoudhury S, Wang L, Kessouri M. The effect of tofacitinib on residual pain in patients with rheumatoid arthritis and psoriatic arthritis. RMD Open. 2022 Sep;8(2):e002478. doi: 10.1136/rmdopen-2022-002478. |
| 36601090 | Derived | Hansen KE, Mortezavi M, Nagy E, Wang C, Connell CA, Radi Z, Litman HJ, Adami G, Rossini M. Fracture in clinical studies of tofacitinib in rheumatoid arthritis. Ther Adv Musculoskelet Dis. 2022 Dec 27;14:1759720X221142346. doi: 10.1177/1759720X221142346. eCollection 2022. |
| 36600185 | Derived | Curtis JR, Yamaoka K, Chen YH, Bhatt DL, Gunay LM, Sugiyama N, Connell CA, Wang C, Wu J, Menon S, Vranic I, Gomez-Reino JJ. Malignancy risk with tofacitinib versus TNF inhibitors in rheumatoid arthritis: results from the open-label, randomised controlled ORAL Surveillance trial. Ann Rheum Dis. 2023 Mar;82(3):331-343. doi: 10.1136/ard-2022-222543. Epub 2022 Dec 5. |
| 36526796 | Derived | Winthrop KL, Yndestad A, Henrohn D, Danese S, Marsal S, Galindo M, Woolcott JC, Jo H, Kwok K, Shapiro AB, Jones TV, Diehl A, Su C, Panes J, Cohen SB. Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs. Rheumatol Ther. 2023 Apr;10(2):357-373. doi: 10.1007/s40744-022-00507-z. Epub 2022 Dec 17. |
| 35232809 | Derived | Bessette L, Mysler E, Kinch CD, Kwok K, Lukic T, On PV, van Vollenhoven RF. Impact of Tofacitinib on Components of the ACR Response Criteria: Post Hoc Analysis of Phase III and Phase IIIb/IV Trials. J Rheumatol. 2022 Jun;49(6):566-576. doi: 10.3899/jrheum.210707. Epub 2022 Mar 1. |
| 34921355 | Derived | Dikranian A, Gold D, Bessette L, Nash P, Azevedo VF, Wang L, Woolcott J, Shapiro AB, Szumski A, Fleishaker D, Wollenhaupt J. Frequency and Duration of Early Non-serious Adverse Events in Patients with Rheumatoid Arthritis and Psoriatic Arthritis Treated with Tofacitinib. Rheumatol Ther. 2022 Apr;9(2):411-433. doi: 10.1007/s40744-021-00405-w. Epub 2021 Dec 17. |
| 34870800 | Derived | Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6. |
| 34429160 | Derived | Takeuchi T, Fleischmann R, Iikuni N, Shi H, Soma K, Paulissen J, Hirose T, Smolen JS. Differences and similarities in clinical and functional responses among patients receiving tofacitinib monotherapy, tofacitinib plus methotrexate, and adalimumab plus methotrexate: a post hoc analysis of data from ORAL Strategy. Arthritis Res Ther. 2021 Aug 24;23(1):220. doi: 10.1186/s13075-021-02591-y. |
| 33127856 | Derived | Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395. |
| 32816215 | Derived | Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. |
| 31673419 | Derived | Strand V, Mysler E, Moots RJ, Wallenstein GV, DeMasi R, Gruben D, Soma K, Iikuni N, Smolen JS, Fleischmann R. Patient-reported outcomes for tofacitinib with and without methotrexate, or adalimumab with methotrexate, in rheumatoid arthritis: a phase IIIB/IV trial. RMD Open. 2019 Oct 1;5(2):e001040. doi: 10.1136/rmdopen-2019-001040. eCollection 2019. |
| 31207152 | Derived | Calabrese LH, Abud-Mendoza C, Lindsey SM, Lee SH, Tatulych S, Takiya L, Iikuni N, Soma K, Luo Z, Fleischmann R. Live Zoster Vaccine in Patients With Rheumatoid Arthritis Treated With Tofacitinib With or Without Methotrexate, or Adalimumab With Methotrexate: A Post Hoc Analysis of Data From a Phase IIIb/IV Randomized Study. Arthritis Care Res (Hoboken). 2020 Mar;72(3):353-359. doi: 10.1002/acr.24010. |
| 28629665 | Derived | Fleischmann R, Mysler E, Hall S, Kivitz AJ, Moots RJ, Luo Z, DeMasi R, Soma K, Zhang R, Takiya L, Tatulych S, Mojcik C, Krishnaswami S, Menon S, Smolen JS; ORAL Strategy investigators. Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL Strategy): a phase 3b/4, double-blind, head-to-head, randomised controlled trial. Lancet. 2017 Jul 29;390(10093):457-468. doi: 10.1016/S0140-6736(17)31618-5. Epub 2017 Jun 16. |
One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months. |
| FG002 | Adalimumab 40 mg + MTX | One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tofacitinib 5 mg BID | One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months. |
| BG001 | Tofacitinib 5 mg BID + MTX | One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months. |
| BG002 | Adalimumab 40 mg + MTX | One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving American College of Rheumatology Criteria 50% Improvement (ACR50) Response at Month 6 | ACR50 is a greater than or equal to (≥) 50 percent (%) improvement in tender joint count (TJC) or swollen joint count (SJC) and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment (PGA) of disease activity, 2) participant's assessment (PtGA) of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein (CRP) at each visit. | Full analysis set (FAS) included all participants who were randomized and received at least one dose of the randomized investigational drug (tofacitinib or adalimumab). | Posted | Number | Percentage of participants | Month 6 |
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| Secondary | Change From Baseline in Simplified Disease Activity Index (SDAI) Value at Month 6 | SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 centimeter (cm) visual analogue scale (VAS) (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI less than or equal to (≤) 3.3 indicates disease remission, >3.4 to 11 indicates low disease activity, >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity. | FAS | Posted | Least Squares Mean | Standard Error | Score on a scale | Month 6 |
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| Secondary | Change From Baseline in Clinical Disease Activity Index (CDAI) Value at Month 6 | CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity. | FAS | Posted | Least Squares Mean | Standard Error | Score on a scale | Month 6 |
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| Secondary | Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including CRP at Month 6 | DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA (millimeters [mm]) + 0.96. Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-4 (CRP) ≤3.2 indicates low disease activity, >3.2 to 5.1 indicates moderate to high disease activity, and less than (<) 2.6 indicates remission. | FAS | Posted | Least Squares Mean | Standard Error | Score on a scale | Month 6 |
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| Secondary | Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including Erythrocyte Sedimentation Rate (ESR) at Month 6 | DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-3 (ESR) ≤3.2 indicates low disease activity, >3.2 to 5.1 indicates moderate to high disease activity, and <2.6 indicates remission. | FAS | Posted | Least Squares Mean | Standard Error | Score on a scale | Month 6 |
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| Secondary | Percentage of Participants Achieving Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria at Month 6 | To meet the ACR-EULAR Boolean remission criteria, a participant must satisfy all of the following: TJC ≤1 and SJC ≤1 (both based on a 28-joint assessment), CRP ≤1 mg/dL, and PtGA ≤1 on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). | FAS | Posted | Number | Percentage of participants | Month 6 |
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| Secondary | Percentage of Participants Achieving SDAI ≤3.3 at Month 6 | SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI ≤3.3 indicates disease remission. | FAS | Posted | Number | Percentage of participants | Month 6 |
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| Secondary | Percentage of Participants Achieving CDAI ≤2.8 at Month 6 | CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission. | FAS | Posted | Number | Percentage of participants | Month 6 |
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| Secondary | Percentage of Participants Achieving DAS28-4 (ESR) <2.6 at Month 6 | DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (ESR) <2.6 indicates disease remission. | FAS | Posted | Number | Percentage of participants | Month 6 |
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| Secondary | Percentage of Participants Achieving DAS28-4 (CRP) <2.6 at Month 6 | DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA (mm) + 0.96. Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (CRP) <2.6 indicates remission. | FAS | Posted | Number | Percentage of participants | Month 6 |
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| Secondary | Percentage of Participants Achieving SDAI ≤11 at Month 6 | SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI ≤3.3 indicates disease remission, >3.4 to 11 indicates low disease activity. | FAS | Posted | Number | Percentage of participants | Month 6 |
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| Secondary | Percentage of Participants Achieving CDAI ≤10 at Month 6 | CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission, >2.8 to 10 indicates low disease activity. | FAS | Posted | Number | Percentage of participants | Month 6 |
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| Secondary | Percentage of Participants Achieving DAS28-4 (ESR) ≤3.2 at Month 6 | DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (ESR) ≤3.2 indicates low disease activity. | FAS | Posted | Number | Percentage of participants | Month 6 |
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| Secondary | Percentage of Participants Achieving DAS28-4 (CRP) ≤3.2 at Month 6 | DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA + 0.96. Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-4 (CRP) ≤3.2 indicates low disease activity. | FAS | Posted | Number | Percentage of participants | Month 6 |
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| Secondary | Percentage of Participants Achieving American College of Rheumatology Criteria 20% Improvement (ACR20) Response at Month 6 | ACR20 response is a ≥20% improvement in TJC or SJC and 20% improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit. | FAS | Posted | Number | Percentage of participants | Month 6 |
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| Secondary | Percentage of Participants Achieving American College of Rheumatology Criteria 70% Improvement (ACR70) Response at Month 6 | ACR70 response is a ≥70% improvement in TJC or SJC and 70% improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit. | FAS | Posted | Number | Percentage of participants | Month 6 |
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| Secondary | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Month 6 | The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dressing and grooming, arising, eating, walking, reach, grip, hygiene and other activities over the past week. Each activity category consists of 2 to 3 items. Each item is scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity requiring assistance from another individual or the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. | FAS | Posted | Least Squares Mean | Standard Error | Units on a scale | Month 6 |
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| Secondary | Percentage of Participants Achieving an HAQ-DI Decrease of at Least 0.22 at Month 6 | The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dressing and grooming, arising, eating, walking, reach, grip, hygiene and other activities over the past week. Each activity category consists of 2 to 3 items. Each item is scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity requiring assistance from another individual or the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. A decrease of 0.22 or more is considered a positive response. | FAS | Posted | Number | Percentage of participants | Month 6 |
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| Secondary | Change From Baseline in the Short-Form-36 (SF-36) Health Survey, Physical Component Score at Month 6 | The SF-36 health survey is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based scores for both the SF-36 version 2 (v2) and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher PCS score represents better physical health status. | FAS | Posted | Least Squares Mean | Standard Error | Score on a scale | Month 6 |
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| Secondary | Change From Baseline in the SF-36 Health Survey, Mental Component Score at Month 6 | The SF-36 health survey is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The health domains are aggregated into two summary scores known as the PCS score and the MCS score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher MCS score represents better physical health status. | FAS | Posted | Least Squares Mean | Standard Error | Score on a scale | Month 6 |
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| Secondary | Change From Baseline in the SF-36 Health Survey, Physical Functioning Domain Score at Month 6 | SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 10 items of the physical functioning scale represent levels and kinds of limitations between extremes of physical activities, including lifting and carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture the presence and extent of physical limitations using a 3-level response continuum. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher physical functioning domain score represents better physical functioning. | FAS | Posted | Least Squares Mean | Standard Error | Score on a scale | Month 6 |
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| Secondary | Change From Baseline in the SF-36 Health Survey, Role Physical Domain Score at Month 6 | SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 4-item role physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; and d) accomplishing less. Items in the role physical scale are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher role physical domain score represents better role physical functioning. | FAS | Posted | Least Squares Mean | Standard Error | Score on a scale | Month 6 |
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| Secondary | Change From Baseline in the SF-36 Health Survey, Bodily Pain Domain Score at Month 6 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher bodily pain domain score represents less bodily pain. | FAS | Posted | Least Squares Mean | Standard Error | Score on a scale | Month 6 |
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| Secondary | Change From Baseline in the SF-36 Health Survey, General Health Domain Score at Month 6 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The general health scale consists of 5 items including a rating of health and 4 items addressing the respondent's view and expectations of his or her health. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher general health domain score represents better general health perceptions. | FAS | Posted | Least Squares Mean | Standard Error | Score on a scale | Month 6 |
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| Secondary | Change From Baseline in the SF-36 Health Survey, Vitality Domain Score at Month 6 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher vitality domain score represents better vitality. | FAS | Posted | Least Squares Mean | Standard Error | Score on a scale | Month 6 |
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| Secondary | Change From Baseline in the SF-36 Health Survey, Social Functioning Domain Score at Month 6 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 2-item social functioning scale assesses health-related effects on quantity and quality of social activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher social functioning domain score represents better social functioning. | FAS | Posted | Least Squares Mean | Standard Error | Score on a scale | Month 6 |
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| Secondary | Change From Baseline in the SF-36 Health Survey, Role Emotional Domain Score at Month 6 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 3-item role emotional scale assesses mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. All 3 items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher role emotional domain score represents better role emotional functioning. | FAS | Posted | Least Squares Mean | Standard Error | Score on a scale | Month 6 |
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| Secondary | Change From Baseline in the SF-36 Health Survey, Mental Health Domain Score at Month 6 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. All items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher mental health domain score represents better mental health functioning. | FAS | Posted | Least Squares Mean | Standard Error | Score on a scale | Month 6 |
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| Secondary | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 | The WPAI: Rheumatoid Arthritis is a 6 item questionnaire that is specific for rheumatoid arthritis and yields four types of scores: absenteeism, presenteesism (impairment at work/reduced job effectiveness), work productivity loss and activity impairment. WPAI outcomes are expressed as impairment percentages ranging from 0 to 100, with higher numbers indicating greater impairment and less productivity. | FAS | Posted | Least Squares Mean | Standard Error | Percentage of impairment | Month 6 |
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| Secondary | Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 | The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). This profile of scores across the 5-dimensions (e.g. 11231, 33212, etc.) is transformed into a single health utility score using a formula developed by the EuroQol Group that applies country specific preference weights. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rated the current health state on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicating a better health state. | FAS | Posted | Least Squares Mean | Standard Error | Units on a scale | Month 6 |
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| Secondary | Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Total Score at Month 6 | FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant's response (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). | FAS | Posted | Least Squares Mean | Standard Error | Units on a scale | Month 6 |
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SAEs were assessed from informed consent up to at least 28 calendar days after last dose of investigational product. AEs were recorded from the time the subject has taken at least one dose of study treatment through last subject visit.
An event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tofacitinib 5 mg BID | One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months. | 35 | 384 | 51 | 384 | ||
| EG001 | Tofacitinib 5 mg BID + MTX | One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months. | 27 | 376 | 72 | 376 | ||
| EG002 | Adalimumab 40 mg + MTX | One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months. | 24 | 386 | 69 | 386 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA, version 19.1 | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA, version 19.1 | Non-systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA, version 19.1 | Non-systematic Assessment |
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| Cor pulmonale | Cardiac disorders | MedDRA, version 19.1 | Non-systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA, version 19.1 | Non-systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA, version 19.1 | Non-systematic Assessment |
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| Pericarditis | Cardiac disorders | MedDRA, version 19.1 | Non-systematic Assessment |
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| Wolff-Parkinson-White syndrome | Cardiac disorders | MedDRA, version 19.1 | Non-systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA, version 19.1 | Non-systematic Assessment |
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| Corneal thinning | Eye disorders | MedDRA, version 19.1 | Non-systematic Assessment |
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| Necrotising retinitis | Eye disorders | MedDRA, version 19.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA, version 19.1 | Non-systematic Assessment |
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| Diverticulum intestinal | Gastrointestinal disorders | MedDRA, version 19.1 | Non-systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA, version 19.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA, version 19.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA, version 19.1 | Non-systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA, version 19.1 | Non-systematic Assessment |
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| Cholecystitis chronic | Hepatobiliary disorders | MedDRA, version 19.1 | Non-systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Clostridial sepsis | Infections and infestations | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| H1N1 influenza | Infections and infestations | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Meningitis bacterial | Infections and infestations | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Meningitis tuberculous | Infections and infestations | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Salpingo-oophoritis | Infections and infestations | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA, version 19.1 | Non-systematic Assessment |
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| Tracheobronchitis | Infections and infestations | MedDRA, version 19.1 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA, version 19.1 | Non-systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA, version 19.1 | Non-systematic Assessment |
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| Varicella zoster virus infection | Infections and infestations | MedDRA, version 19.1 | Non-systematic Assessment |
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| Exposure via father | Injury, poisoning and procedural complications | MedDRA, version 19.1 | Non-systematic Assessment |
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| Fibula fracture | Injury, poisoning and procedural complications | MedDRA, version 19.1 | Non-systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | MedDRA, version 19.1 | Non-systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | MedDRA, version 19.1 | Non-systematic Assessment |
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| Meniscus injury | Injury, poisoning and procedural complications | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA, version 19.1 | Non-systematic Assessment |
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| Thermal burn | Injury, poisoning and procedural complications | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA, version 19.1 | Non-systematic Assessment |
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| Tibia fracture | Injury, poisoning and procedural complications | MedDRA, version 19.1 | Non-systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Bone disorder | Musculoskeletal and connective tissue disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA, version 19.1 | Non-systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA, version 19.1 | Non-systematic Assessment |
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| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Anogenital warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Enteropathy-associated T-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Lobular breast carcinoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Hypertonia | Nervous system disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Radicular syndrome | Nervous system disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Unintended pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Diabetic nephropathy | Renal and urinary disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Rheumatoid lung | Respiratory, thoracic and mediastinal disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Cellulitis with abscess | Infections and infestations | MedDRA, version 19.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA, version 19.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA, version 19.1 | Non-systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. Investigators will, on request, remove any previously undisclosed Confidential Information (other than the Study results themselves) before disclosure.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| C479163 | tofacitinib |
| D008727 | Methotrexate |
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Normal approximation to proportions |
Multiplicity-adjusted |
| 0.0512 |
| Difference in response rate |
| -5.50 |
| 2-Sided |
| 98.34 |
| -13.98 |
| 2.98 |
| Non-Inferiority or Equivalence |
Non-inferiority was a treatment difference larger than -13% at the population level |
| Normal approximation to proportions | Multiplicity adjusted | <0.0001 | Difference in response rate | 2.23 | 2-Sided | 98.34 | -6.40 | 10.86 | Non-Inferiority or Equivalence | Non-inferiority was a treatment difference larger than -13% at the population level |
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One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
|
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|
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
|
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| Units | Counts |
|---|---|
| Participants |
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| Participants |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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|
| OG002 |
| Adalimumab 40 mg + MTX |
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months. |
|
|
|
| OG002 | Adalimumab 40 mg + MTX | One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months. |
|
|
|
| OG002 |
| Adalimumab 40 mg + MTX |
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months. |
|
|
|
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months. |
|
|
|
| OG002 | Adalimumab 40 mg + MTX | One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months. |
|
|
|
| OG002 | Adalimumab 40 mg + MTX | One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months. |
|
|
|
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months. |
|
|
|
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months. |
|
|
|
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months. |
|
|
|
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months. |
|
|
|
| OG002 | Adalimumab 40 mg + MTX | One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months. |
|
|
|
| Adalimumab 40 mg + MTX |
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months. |
|
|
|
|
|
|
| OG002 | Adalimumab 40 mg + MTX | One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months. |
|
|
|
|
|
|