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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003668-55 | EudraCT Number |
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This is a 12-month study investigating the effectiveness and safety of tofactinib in treating the signs and symptoms of active psoriatic arthritis and improving physical function and preserving bone structure in patients with an inadequate response to a traditional, nonbiologic disease-modifying antirheumatic drug. Adalimumab is used as a comparator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tofacitinib 5 mgBID x 12 months | Experimental |
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| Tofacitinib 10 mg BID x 12 months | Experimental |
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| Adalimumab 40 mg q2 weeks x 12 months | Active Comparator |
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| Placebo x3 months, then tofacitinib 5 mg BIDx 9 months | Placebo Comparator |
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| Placebo x 3 months, then tofacitinib 10 mg BID x 9 months | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tofacitinib 5 mg BID | Drug | Tofacitinib orally (po) 1 tablet of 5 mg and placebo po 1 tablet BID x 12 months Placebo injections subcu every 2 weeks x 12 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20): Month 3 | ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, health assessment questionnaire - disability index (HAQ-DI), and C-reactive protein (CRP). | At end of Month 3 |
| Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | The HAQ-DI assesses the difficulty a participant has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability. | From Baseline to Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Van Der Heijdel Modified Total Sharp Score (mTSS) for Psoriatic Arthritis | Assessment of joint damage includes a joint erosion score (range 0-320) and a joint space narrowing (JSN) score (range 0-208). The mTSS is the sum of the erosion and JSN scores (range 0-528). A higher score indicates more severe disease status. If a component score is missing, the mTSS will be missing. |
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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, PC | Birmingham | Alabama | 35205 | United States | ||
| Rheumatology Associates of North Alabama, PC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41148555 | Derived | Gossec L, Sellas A, Gruben DC, Valderrama M, Gomez S, Kinch C, Citera G. Response to Tofacitinib in Patients with Psoriatic Arthritis and Probable Anxiety/Depressive Disorder: A Post Hoc Analysis of Phase 3 Trials. Rheumatol Ther. 2025 Dec;12(6):1175-1186. doi: 10.1007/s40744-025-00800-7. Epub 2025 Oct 28. | |
| 40461265 | Derived |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Information relating to our policy on data sharing and the process for requesting data can be found at the following link:
http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests
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Of 611 participants screened for entry into the study, 422 received treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tofacitinib, 5 mg, Twice Daily | Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks. |
| FG001 | Tofacitinib, 10 mg, Twice Daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Tofacitinib 10 mg BID | Drug | Tofacitinib po 2 tablets of 5 mg BID x 12 months Placebo injections subcu every 2 weeks x 12 months |
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| Adalimumab | Drug | Placebo po 2 tablets BIDx 12 months Adalimumab 40 mg subcu injections every 2 weeks x 12 months |
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| Placebo | Drug | Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 1 tablet of 5 mg and placebo po 1 tablet BID x 9 months Placebo injections every 2 weeks x 12 months |
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| Placebo | Drug | Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 2 tablets (5 mg) BID x 9 months Placebo injections every 2 weeks x 12 months |
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| From Baseline to Month 12 |
| Percentage of Participants With Progressed Modified Total Sharp Score (mTSS) at Month 12 | Assessment of joint damage includes a joint erosion score (range 0-320) and a JSN score (range 0-208). The mTSS is the sum of the erosion and JSN scores (range 0-528). A higher score indicates more severe disease status. If a component score is missing, the mTSS will be missing. Progressor is defined as an increase in mTSS >0.5 from baseline. | At Month 12 |
| Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | ACR50 was calculated as a ≥50% improvement from baseline in tender/painful and swollen joint counts and ≥50% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP. | At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 |
| Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | ACR70 was calculated as a ≥70% improvement from baseline in tender/painful and swollen joint counts and ≥70% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP. . | At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 |
| Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP. | At Week 2 and Months 1, 2, 4, 6, 9, and 12 |
| Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | The HAQ-DI assesses the difficulty a participant has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability. | From Baseline to Week 2 and Months 1, 2, 4, 6, 9, and 12 |
| Change From Baseline in American College of Rheumatology Response Criteria Components: C-reactive Protein Levels | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. | From Baseline to end of Month 3 |
| Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Assessment of Arthritis Pain | Participants assessed the severity of their arthritis pain using a 100-mm visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain. | From Baseline to end of Month 3 |
| Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Global Assessment of Arthritis | Participant answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The participant's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very well) and 100 (very poorly). | From Baseline to end of Month 3 |
| Change From Baseline in American College of Rheumatology Response Criteria Components Score: Physician's Global Assessment of Arthritis | The blinded investigator or qualified assessor assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor). | From Baseline to end of Month 3 |
| Change From Baseline in American College of Rheumatology Response Criteria Components Score: Swollen Joint Count | Swollen joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty six (66) joints were assessed by a blinded assessor to determine the number of joints that were considered swelling. | From Baseline to end of Month 3 |
| Change From Baseline in American College of Rheumatology Response Criteria Components Score: Tender/Painful Joint Count | Tender/painful joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty eight (68) joints were assessed by a blinded assessor to determine the number of joints that were considered tender or painful. | From Baseline to end of Month 3 |
| Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | The PsARC covers 4 measures: Tender/painful joint count, swollen joint count, the Physician's Global Assessment of Arthritis, and the Patient's Global Assessment of Arthritis. The PsARC response is defined as improvement in 2 of 4 items, 1 of which must be joint pain or swelling, without worsening in any measure. Improvement criteria: ≥20% improvement in Physician's Global Assessment of Arthritis; ≥20% improvement in Patient's Global Assessment of Arthritis; ≥30% improvement in tender joint count; and ≥30% improvement in swollen joint count. | At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 |
| Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response | The PGA-PsO is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are rated separately over the whole body according to a 5-point severity scale, scored as 0=none; 1, 2, 3, or 4=most severe. The severity rating scores are summed and the average taken; the total average is rounded to the nearest whole number score to determine a PGA-PsO score on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe). | From Baseline to Months 1, 3, 6, 9, and 12 |
| Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 | PASI determines psoriasis severity based on lesion severity & percentage body surface area (BSA) affected. Lesion severity is assessed for erythema, induration, & scaling, evaluated separately for head & neck, upper limbs, trunk, & lower limbs & rated for each body area according to a 5 point scale: 0=no involvement; 1=slight; 2=moderate; 3=marked; 4=very marked. BSA involvement is the extent (%) of body area affected by psoriasis & is assigned a score: 0=no involvement; 1=0-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. In each area, sum of severity rating scores is multiplied by the score representing the percentage of area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The sum of numbers obtained for the 4 body areas is the PASI score & can vary in increments of 0.1 & range from 0.0 to 72.0, higher scores represent greater severity of psoriasis. PASI75 is defined as a 75% reduction from baseline in PASI. | At Months 1, 3, 6, 9, and 12 |
| Change From Baseline in Dactylitis Severity Score (DSS) | Dactylitis is characterized by swelling of the entire finger or toe. The DSS is a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis is scored on a scale of 0-3, where 0=no tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a patient is 0-60. Higher score indicates greater degree of tenderness. | From Baseline to Months 1, 3, 6, 9, and 12 |
| Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | The SPARCC Enthesitis Index identifies the presence or absence of tenderness at 16 enthesial sites, including the bilateral Achilles tendons, plantar fascia insertion at the calcaneus, patellar tendon insertion at the base of the patella, quadriceps insertion into the superior border of the patella, supraspinatus insertion into the greater tuberosity of the humerus, and medial and lateral epicondyles. On examination, tenderness is recorded as present (1) or absent (0) for each of the 16 sites, with an overall total score ranging from 0 to 16. Higher score indicates a greater number of sites that are affected by enthesitis. | From Baseline to Months 1, 3, 6, 9, and 12 |
| Change From Baseline in the Leeds Enthesitis Index (LEI) | Enthesitis is inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assesses enthesitis in 6 sites. Tenderness is recorded as either present (1) or absent (0) for each of the 6 sites, for an total score of 0-6. Higher score indicates a greater number of sites that are affected by enthesitis. | From Baseline to Months 1, 3, 6, 9, and 12 |
| Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score | 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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a standard deviation (SD) of 10 points, and ranges from minus infinity to plus infinity. A higher PCS score represents better physical health status. | From Baseline to Months 1, 3, 6, 9, and 12 |
| Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score | 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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher MCS score represents better mental health status. | From Baseline to Months 1, 3, 6, 9, and 12 |
| Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain | 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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher physical functioning domain score represents better physical functioning. | From Baseline to Months 1, 3, 6, 9, and 12 |
| Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain | 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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-physical domain score represents better role-physical functioning. | From Baseline to Months 1, 3, 6, 9, and 12 |
| Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain | 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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher bodily pain domain score represents less bodily pain. | From Baseline to Months 1, 3, 6, 9, and 12 |
| Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain | 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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher general health domain score represents better general health perceptions. | From Baseline to Months 1, 3, 6, 9, and 12 |
| Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain | 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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher vitality domain score represents better vitality. | From Baseline to Months 1, 3, 6, 9, and 12 |
| Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain | 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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher social functioning domain score represents better social functioning. | From Baseline to Months 1, 3, 6, 9, and 12 |
| Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain | 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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-emotional domain score represents better role-emotional functioning. | From Baseline to Months 1, 3, 6, 9, and 12 |
| Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain | 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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher mental health domain score represents better mental health functioning. | From Baseline to Months 1, 3, 6, 9, and 12 |
| Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility | The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status. | From Baseline to Months 1, 3, 6, 9, and 12 |
| Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care | The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status. | From Baseline to Months 1, 3, 6, 9, and 12 |
| Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities | The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status. | From Baseline to Months 1, 3, 6, 9, and 12 |
| Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort | The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status. | From Baseline to Months 1, 3, 6, 9, and 12 |
| Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression | The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status. | From Baseline to Months 1, 3, 6, 9, and 12 |
| Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today | The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 (worst imaginable health state) to 100 mm (best imaginable health state) visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state; higher scores indicate a better health state, with a higher value representing better health status. | From Baseline to Months 1, 3, 6, 9, and 12 |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score | FACIT-F is a 13-item questionnaire, with each item scored on a 5-point scale ranging from 0 (not at all) to 4 (very much). Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0 to 52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless ("washed out"), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better fatigue status. | From Baseline to Months 1, 3, 6, 9, and 12 |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score | FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless ("washed out"), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue experience. | From Baseline to Months 1, 3, 6, 9, and 12 |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score | FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless ("washed out"), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue impact on daily functioning. | From Baseline to Months 1, 3, 6, 9, and 12 |
| Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) | BASDAI is a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a visual analog scale of 0-100mm (0=none and 100=very severe) participants answer 6 questions measuring discomfort, pain, and fatigue. The final BASDAI score averages the individual assessments for a final score ranging 0-10cm, with higher scores representing more severe ankylosing spondylitis disease activity. | From Baseline to Months 1, 3, 6, 9, and 12 |
| Huntsville |
| Alabama |
| 35801 |
| United States |
| Arizona Arthritis & Rheumatology Associates, P.C. | Glendale | Arizona | 85306 | United States |
| Medvin Clinical Research | Covina | California | 91723 | United States |
| Desert Medical Advances | Palm Desert | California | 92260 | United States |
| Advances In Medicine (X-Rays) | Rancho Mirage | California | 92270 | United States |
| San Diego Arthritis Medical Clinic | San Diego | California | 92108 | United States |
| Millennium Research | Ormond Beach | Florida | 32174 | United States |
| Arthritis Center, Inc. | Palm Harbor | Florida | 34684 | United States |
| Klein & Associates, M.D., P.A. | Hagerstown | Maryland | 21740 | United States |
| Clinical Pharmacology Study Group | Worcester | Massachusetts | 01605 | United States |
| St. Paul Rheumatology, PA | Eagan | Minnesota | 55121 | United States |
| Physician Research Collaboration, LLC | Lincoln | Nebraska | 68516 | United States |
| Dartmouth-Hitchcock Medical Center (DHMC) | Lebanon | New Hampshire | 03756 | United States |
| Paramount Medical Research & Consulting, LLC | Middleburg Heights | Ohio | 44130 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Low Country Rheumatology, PA | Charleston | South Carolina | 29406 | United States |
| Pioneer Research Solutions, Inc. | Houston | Texas | 77008 | United States |
| Drug Shipment/Storage: Huntsman Cancer Hospital at the University of Utah | Salt Lake City | Utah | 84112 | United States |
| University of Utah Hospital & Clinics | Salt Lake City | Utah | 84132 | United States |
| Dynacare Laboratories (Specimen processing for shipment) | Seattle | Washington | 98122 | United States |
| Investigational Drug Service Pharmacy, Swedish Medical Center. | Seattle | Washington | 98122 | United States |
| Seattle Rheumatology Associates | Seattle | Washington | 98122 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| Rheumatology Research Unit | Maroochydore | Queensland | 4558 | Australia |
| Pacific Private Clinic | Southport | Queensland | 4215 | Australia |
| Monash Health, Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
| Pharmacy Clinical Trials | Clayton | Victoria | 3168 | Australia |
| St. Vincent's Hospital (Melbourne) | Fitzroy | Victoria | 3065 | Australia |
| Emeritus Research Pty Ltd | Malvern East | Victoria | 3145 | Australia |
| Hopital Erasme - Clinique Universitaire de Bruxelles | Brussels | 1070 | Belgium |
| University Hospital Leuven, Department of Rheumatology | Leuven | 3000 | Belgium |
| UMHAT "Dr. G. Stranski" EAD | Pleven | 5800 | Bulgaria |
| MHAT"Plovdiv" AD | Plovdiv | 4000 | Bulgaria |
| MHAT "Kaspela" EOOD | Plovdiv | 4002 | Bulgaria |
| UMHAT "Sv. Ivan Rilski" EAD | Sofia | 1612 | Bulgaria |
| MC "New rehabilitation center" EOOD, Rheumatology Cabinet | Stara Zagora | 6003 | Bulgaria |
| Rheumatology Research Associates | Edmonton | Alberta | T5M 0H4 | Canada |
| K. Papp Clinical Research | Waterloo | Ontario | N2J 1C4 | Canada |
| West Island Rheumatology Research Associates | Pointe-Claire | Quebec | H9R 3J1 | Canada |
| Revmacentrum MUDr. Mostera, s.r.o. | Brno | Czech Republic | 615 00 | Czechia |
| Revmatologicky Ustav - Lekarna (pharmacy only) | Prague | Czech Republic | 128 50 | Czechia |
| Revmatologicka ambulance | Prague | Czech Republic | 140 00 | Czechia |
| MEDIGAP, s.r.o. (radiology only) | Praha 1 - Nove Mesto | Czech Republic | 110 00 | Czechia |
| Lekarna Na Lidicke (Pharmacy only) | Brno | 602 00 | Czechia |
| X-MEDICA s.r.o (radiology only) | Brno | 61300 | Czechia |
| Revmatologie s.r.o. | Brno | 638 00 | Czechia |
| Stavovska s.r.o. (pharmacy only) | Brno | 63800 | Czechia |
| Vesalion s.r.o. | Ostrava | 70200 | Czechia |
| Revmatologicky ustav - Lekarna | Prague | 128 50 | Czechia |
| Revmatologicky ustav | Prague | 128 50 | Czechia |
| MEDIGAP, s.r.o | Praha 1- Nove Mesto | 110 00 | Czechia |
| Medical Plus s.r.o. Lekarna Hradebni s. r.o | Uherské Hradiště | 68601 | Czechia |
| Centre Hospitalier Sud-Francilien - Secretariat de Rhumatologie | Corbeil-Essonnes | 91106 | France |
| Charite Universitaetsmedizin Berlin | Berlin | 10117 | Germany |
| Klinische Forschung Berlin-Mitte GmbH | Berlin | 10117 | Germany |
| Rheumapraxis Steglitz | Berlin | 12161 | Germany |
| University Hospital of Cologne | Cologne | 50937 | Germany |
| Klinische Forschung Schwerin GmbH | Schwerin | 19055 | Germany |
| Revita Reumatologiai Rendelo | Budapest | 1027 | Hungary |
| Qualiclinic Kft. | Budapest | 1036 | Hungary |
| Magyar Honvedseg Egeszsegugyi Kozpont,Reumatologiai osztaly | Budapest | 1062 | Hungary |
| Csolnoky Ferenc Korhaz, Radiologiai Osztaly X-Ray Only | Veszprém | 8200 | Hungary |
| Csolnoky Ferenc Korhaz, Reumatologiai Osztaly | Veszprém | 8200 | Hungary |
| Centro Integral en Reumatologia SA de CV | Guadalajara | Jalisco | 44160 | Mexico |
| Centro de Investigacion de Tratamientos Innovadores de Sinaloa, S.C. | Culiacán | Sinaloa | 80000 | Mexico |
| Laboratorios de Analisis Clinicos CEMSI | Culiacán | Sinaloa | 80000 | Mexico |
| Sanatorio CEMSI Chapultepec (For Emergencies Only) | Culiacán | Sinaloa | 80040 | Mexico |
| Hospital General de Culiacán Dr. Bernardo J. Gastélum | Culiacán | Sinaloa | 80230 | Mexico |
| Instituto Medico Panamericano, S.A. de C.V. (For Emergencies Only) | Mérida | Yucatán | 97000 | Mexico |
| Unidad Reumatologica Las Americas, S.C.P. | Mérida | Yucatán | 97000 | Mexico |
| Centro de Investigacion Clinica Pensiones | Mérida | Yucatán | 97070 | Mexico |
| Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan | Mérida | Yucatán | 97130 | Mexico |
| Hospital Star Medica Merida (For Emergencies Only) | Mérida | Yucatán | 97133 | Mexico |
| HOSPITAL STAR MEDICA S.A DE C.V- (emergencies only) | Mérida | Yucatán | 97133 | Mexico |
| Investigacion y Biomedicina de Chihuahua SC | Chihuahua City | 31000 | Mexico |
| Cliditer, S. A. de C. V | Mexico City | 06700 | Mexico |
| Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Chirurgiczna dla Dzieci "PriamaMed" Sp.P.," | Bialystok | 15-002 | Poland |
| ZDROWIE OSTEO-MEDIC s.c. L. i A. Racewicz, A. i J. Supronik | Bialystok | 15-351 | Poland |
| ClinicMed Badurski i wspolnicy Spolka Jawna | Bialystok | 15-879 | Poland |
| Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy, | Bydgoszcz | 85-168 | Poland |
| Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka Partnerska | Elblag | 82-300 | Poland |
| Centrum Radiologii for X-Ray only | Elblag | 82-300 | Poland |
| NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska Lek. Med. Barbara Bazela | Elblag | 82-300 | Poland |
| Przychodnia Specjalistyczna Lekarskiej Spoldzielni Pracy "Medica" | Grodzisk Mazowiecki | 05-825 | Poland |
| Zespol Poradni Specjalistycznych Reumed Filia Onyksowa | Lublin | 20-582 | Poland |
| NZOZ Lecznica MAK-MED S.C. | Nadarzyn | 05-830 | Poland |
| Prywatna Praktyka Lekarska Prof. UM dr hab. Pawel Hrycaj | Poznan | 61-397 | Poland |
| NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna w Toruniu | Torun | 87-100 | Poland |
| Medica Pro Familia Sp. z o.o. S.K.A. | Warsaw | 01-868 | Poland |
| Rheuma Medicus Zaklad Opieki Zdrowotnej | Warsaw | 02-118 | Poland |
| Reumatika Centrum Reumatologii | Warsaw | 02-691 | Poland |
| Klinika Ambroziak Estederm Sp. z o.o. ,S.K.A | Warsaw | 02-758 | Poland |
| Synexus Polska Sp. z o.o. Oddz. we Wroclawiu | Wroclaw | 50-088 | Poland |
| Regional State Budgetary Healthcare Institution of Karelia Republic | Petrozavodsk | Karelia Republic | 185019 | Russia |
| State Budgetary Institution of Healthcare of Moscow City Clinical Hospital | Moscow | 119049 | Russia |
| OOO City Neurological Centre "Sibneiromed" | Novosibirsk | 630091 | Russia |
| Limited Liability Company Consultative Diagnostic Rheumatology Center "Healthy Joints" | Novosibirsk | 630099 | Russia |
| State Institution of Healthcare "Regional Clinical Hospital" | Saratov | 410053 | Russia |
| State Budget Educational Institution of Highest Professional Education | Tomsk | 634050 | Russia |
| State Healthcare Institution of Yaroslavl Region Clinical Emergency Hospital n.a. N.V. Solovyev | Yaroslavl | 150003 | Russia |
| State Institution of Healthcare of Yaroslavl Region | Yaroslavl | 150003 | Russia |
| ROMJAN s.r.o., Reumatologicka ambulancia | Bratislava | Slovak Republic | 832 63 | Slovakia |
| MEDMAN s.r.o. - reumatologicka ambulancia | Martin | Slovak Republic | 036 01 | Slovakia |
| Nestatna reumatologicka ambulancia | Bratislava | 841 04 | Slovakia |
| Reumex s.r.o | Rimavská Sobota | 979 01 | Slovakia |
| Hospital Clinico de Santiago | Santiago de Compostela | A Coruna | 15706 | Spain |
| Corporació Sanitaria Parc Tauli | Sabadell | Barcelona | 08208 | Spain |
| Hospital Universitario Marques de Valdecilla | Santander | Cantabria | 39008 | Spain |
| Complexo Hospitalario Universitario A Coruna | A Coruña | 15006 | Spain |
| Hospital Infanta Luisa | Seville | 41010 | Spain |
| Hospital Universitario y Politecnico La Fe | Valencia | 46026 | Spain |
| Taipei Veterans General Hospital | Taipei | Taiwan Roc | 11217 | Taiwan |
| Buddhist Dalin Tzu Chi General Hospital | Chiayi City | 62247 | Taiwan |
| Chang Gung Medical Foundation-Kaohsiung Branch | Kaohsiung City | 83301 | Taiwan |
| Chung Shan Medical University Hospital | Taichung | 40201 | Taiwan |
| Barking Havering and Redbridge University Hospital NHS Trust-King George Hospital | Goodmayes | Essex | IG3 8YB | United Kingdom |
| Barking, Havering and Redbridge University Hospitals NHS Trust | Romford | Essex | RM7 0AG | United Kingdom |
| The Dudley Group NHS Foundation Trust | Dudley | West Midlands | DY1 2HQ | United Kingdom |
| Bradford Teaching Hospitals NHS Foundation Trust | Bradford | West Yorkshire | BD5 0NA | United Kingdom |
| Bradford Royal Infirmary, BTHFT | Bradford | West Yorkshire | BD9 6RJ | United Kingdom |
| Wirral University Teaching Hospital NHS Foundation Trust | Upton | Wirral | CH49 5PE | United Kingdom |
| York Teaching Hospital NHS Foundation Trust | York | YO31 8HE | United Kingdom |
| Gladman D, Tillett W, Gruben D, Coates LC, Hahne S, Volkov M. Identification of distinct disease activity trajectories in patients with psoriatic arthritis receiving tofacitinib: a post hoc analysis of two phase 3 studies. RMD Open. 2025 Jun 3;11(2):e005250. doi: 10.1136/rmdopen-2024-005250. |
| 40241921 | Derived | Gladman DD, Dougados M, Marzo-Ortega H, Cadatal MJ, Agarwal E, Kinch CD, Nash P. Long-term tofacitinib efficacy and safety in psoriatic arthritis with or without prior biologic DMARD exposure: a post hoc analysis. Rheumatol Adv Pract. 2025 Jan 21;9(2):rkaf008. doi: 10.1093/rap/rkaf008. eCollection 2025. |
| 39702318 | Derived | Gladman DD, Nash P, Mease PJ, FitzGerald O, Duench S, Cadatal MJ, Masri KR. Efficacy and safety of tofacitinib in an open-label, long-term extension study in patients with psoriatic arthritis who received adalimumab or tofacitinib in a Phase 3 randomized controlled study: a post hoc analysis. Arthritis Res Ther. 2024 Dec 19;26(1):218. doi: 10.1186/s13075-024-03442-2. |
| 39453735 | Derived | Menon S, Shoji S, Tsuchiwata S, Fallon L, Kanik K. Exposure-Response Analysis of Tofacitinib in Active Psoriatic Arthritis: Results from Two Phase 3 Studies. J Clin Pharmacol. 2025 Mar;65(3):369-377. doi: 10.1002/jcph.6147. Epub 2024 Oct 25. |
| 37608391 | Derived | Mease PJ, Orbai AM, FitzGerald O, Bedaiwi M, Dona L Fleishaker, Mundayat R, Young P, Helliwell PS. Efficacy of tofacitinib on enthesitis in patients with active psoriatic arthritis: analysis of pooled data from two phase 3 studies. Arthritis Res Ther. 2023 Aug 22;25(1):153. doi: 10.1186/s13075-023-03108-5. |
| 36958766 | Derived | Eder L, Gladman DD, Mease P, Pollock RA, Luna R, Aydin SZ, Ogdie A, Polachek A, Gruben D, Cadatal MJ, Kinch C, Strand V. Sex differences in the efficacy, safety and persistence of patients with psoriatic arthritis treated with tofacitinib: a post-hoc analysis of phase 3 trials and long-term extension. RMD Open. 2023 Mar;9(1):e002718. doi: 10.1136/rmdopen-2022-002718. |
| 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. |
| 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. |
| 36476498 | Derived | Schneeberger EE, Citera G, Nash P, Smolen JS, Mease PJ, Soriano ER, Helling C, Szumski AE, Mundayat R, de Leon DP. Comparison of disease activity index for psoriatic arthritis (DAPSA) and minimal disease activity (MDA) targets for patients with psoriatic arthritis: A post hoc analysis of data from phase 3 tofacitinib studies. Semin Arthritis Rheum. 2023 Feb;58:152134. doi: 10.1016/j.semarthrit.2022.152134. Epub 2022 Nov 13. |
| 36076054 | Derived | de Vlam K, Mease PJ, Bushmakin AG, Fleischmann R, Ogdie A, Azevedo VF, Merola JF, Woolcott J, Cappelleri JC, Fallon L, Taylor PC. Identifying and Quantifying the Role of Inflammation in Pain Reduction for Patients With Psoriatic Arthritis Treated With Tofacitinib: A Mediation Analysis. Rheumatol Ther. 2022 Oct;9(5):1451-1464. doi: 10.1007/s40744-022-00482-5. Epub 2022 Sep 8. |
| 36045453 | Derived | Orbai AM, Mease PJ, Helliwell PS, FitzGerald O, Fleishaker DL, Mundayat R, Young P. Effect of tofacitinib on dactylitis and patient-reported outcomes in patients with active psoriatic arthritis: post-hoc analysis of phase III studies. BMC Rheumatol. 2022 Sep 1;6(1):68. doi: 10.1186/s41927-022-00298-4. |
| 35385361 | Derived | Taylor PC, Bushmakin AG, Cappelleri JC, Young P, Germino R, Merola JF, Yosipovitch G. Relationships of dermatologic symptoms and quality of life in patients with psoriatic arthritis: analysis of two tofacitinib phase III studies. J Dermatolog Treat. 2022 Aug;33(5):2614-2620. doi: 10.1080/09546634.2022.2060924. Epub 2022 Apr 11. |
| 35139908 | Derived | Gladman DD, Coates LC, Wu J, Fallon L, Bacci ED, Cappelleri JC, Bushmakin AG, Helliwell PS. Time to response for clinical and patient-reported outcomes in patients with psoriatic arthritis treated with tofacitinib, adalimumab, or placebo. Arthritis Res Ther. 2022 Feb 9;24(1):40. doi: 10.1186/s13075-022-02721-0. |
| 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. |
| 34510295 | Derived | Kivitz AJ, FitzGerald O, Nash P, Pang S, Azevedo VF, Wang C, Takiya L. Efficacy and safety of tofacitinib by background methotrexate dose in psoriatic arthritis: post hoc exploratory analysis from two phase III trials. Clin Rheumatol. 2022 Feb;41(2):499-511. doi: 10.1007/s10067-021-05894-2. Epub 2021 Sep 12. |
| 34226183 | Derived | de Vlam K, Ogdie A, Bushmakin AG, Cappelleri JC, Fleischmann R, Taylor PC, Azevedo V, Fallon L, Woolcott J, Mease PJ. Median time to pain improvement and the impact of baseline pain severity on pain response in patients with psoriatic arthritis treated with tofacitinib. RMD Open. 2021 Jul;7(2):e001609. doi: 10.1136/rmdopen-2021-001609. |
| 33766074 | Derived | Coates LC, Bushmakin AG, FitzGerald O, Gladman DD, Fallon L, Cappelleri JC, Hsu MA, Helliwell PS. Relationships between psoriatic arthritis composite measures of disease activity with patient-reported outcomes in phase 3 studies of tofacitinib. Arthritis Res Ther. 2021 Mar 26;23(1):94. doi: 10.1186/s13075-021-02474-2. |
| 32910531 | Derived | Ritchlin CT, Giles JT, Ogdie A, Gomez-Reino JJ, Helliwell P, Young P, Wang C, Wu J, Romero AB, Woolcott J, Stockert L. Tofacitinib in Patients With Psoriatic Arthritis and Metabolic Syndrome: A Post hoc Analysis of Phase 3 Studies. ACR Open Rheumatol. 2020 Oct;2(10):543-554. doi: 10.1002/acr2.11166. Epub 2020 Sep 10. |
| 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. |
| 32006348 | Derived | Burmester GR, Curtis JR, Yun H, FitzGerald O, Winthrop KL, Azevedo VF, Rigby WFC, Kanik KS, Wang C, Biswas P, Jones T, Palmetto N, Hendrikx T, Menon S, Rojo R. An Integrated Analysis of the Safety of Tofacitinib in Psoriatic Arthritis across Phase III and Long-Term Extension Studies with Comparison to Real-World Observational Data. Drug Saf. 2020 Apr;43(4):379-392. doi: 10.1007/s40264-020-00904-9. |
| 31112005 | Derived | Gladman DD, Charles-Schoeman C, McInnes IB, Veale DJ, Thiers B, Nurmohamed M, Graham D, Wang C, Jones T, Wolk R, DeMasi R. Changes in Lipid Levels and Incidence of Cardiovascular Events Following Tofacitinib Treatment in Patients With Psoriatic Arthritis: A Pooled Analysis Across Phase III and Long-Term Extension Studies. Arthritis Care Res (Hoboken). 2019 Oct;71(10):1387-1395. doi: 10.1002/acr.23930. |
| 31111255 | Derived | Cella D, Wilson H, Shalhoub H, Revicki DA, Cappelleri JC, Bushmakin AG, Kudlacz E, Hsu MA. Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis. J Patient Rep Outcomes. 2019 May 20;3(1):30. doi: 10.1186/s41687-019-0115-4. |
| 30824647 | Derived | van der Heijde D, Gladman DD, FitzGerald O, Kavanaugh A, Graham D, Wang C, Fallon L. Radiographic Progression According to Baseline C-reactive Protein Levels and Other Risk Factors in Psoriatic Arthritis Treated with Tofacitinib or Adalimumab. J Rheumatol. 2019 Sep;46(9):1089-1096. doi: 10.3899/jrheum.180971. Epub 2019 Mar 1. |
| 30713721 | Derived | Strand V, de Vlam K, Covarrubias-Cobos JA, Mease PJ, Gladman DD, Graham D, Wang C, Cappelleri JC, Hendrikx T, Hsu MA. Tofacitinib or adalimumab versus placebo: patient-reported outcomes from OPAL Broaden-a phase III study of active psoriatic arthritis in patients with an inadequate response to conventional synthetic disease-modifying antirheumatic drugs. RMD Open. 2019 Jan 11;5(1):e000806. doi: 10.1136/rmdopen-2018-000806. eCollection 2019. |
| 30680661 | Derived | Cella D, Wilson H, Shalhoub H, Revicki DA, Cappelleri JC, Bushmakin AG, Kudlacz E, Hsu MA. Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis. J Patient Rep Outcomes. 2019 Jan 24;3(1):5. doi: 10.1186/s41687-019-0094-5. |
|
| 30414064 | Derived | Nash P, Coates LC, Fleischmann R, Papp KA, Gomez-Reino JJ, Kanik KS, Wang C, Wu J, Menon S, Hendrikx T, Ports WC. Efficacy of Tofacitinib for the Treatment of Psoriatic Arthritis: Pooled Analysis of Two Phase 3 Studies. Rheumatol Ther. 2018 Dec;5(2):567-582. doi: 10.1007/s40744-018-0131-5. Epub 2018 Nov 9. |
| 30373651 | Derived | Helliwell P, Coates LC, FitzGerald O, Nash P, Soriano ER, Elaine Husni M, Hsu MA, Kanik KS, Hendrikx T, Wu J, Kudlacz E. Disease-specific composite measures for psoriatic arthritis are highly responsive to a Janus kinase inhibitor treatment that targets multiple domains of disease. Arthritis Res Ther. 2018 Oct 29;20(1):242. doi: 10.1186/s13075-018-1739-0. |
| 29045212 | Derived | Mease P, Hall S, FitzGerald O, van der Heijde D, Merola JF, Avila-Zapata F, Cieslak D, Graham D, Wang C, Menon S, Hendrikx T, Kanik KS. Tofacitinib or Adalimumab versus Placebo for Psoriatic Arthritis. N Engl J Med. 2017 Oct 19;377(16):1537-1550. doi: 10.1056/NEJMoa1615975. |
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
| FG002 | Adalimumab, 40 mg, Every 2 Weeks | Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks. |
| FG003 | Placebo/Tofacitinib, 5 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. |
| FG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tofacitinib, 5 mg, Twice Daily | Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks. |
| BG001 | Tofacitinib, 10 mg, Twice Daily | Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks. |
| BG002 | Adalimumab, 40 mg, Every 2 Weeks | Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks. |
| BG003 | Placebo/Tofacitinib, 5 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. |
| BG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks. |
| BG005 | 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 Meeting American College of Rheumatology Response Criteria ≥20% (ACR20): Month 3 | ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, health assessment questionnaire - disability index (HAQ-DI), and C-reactive protein (CRP). | All participants who were randomized and received at least 1 dose of study drug. | Posted | Number | Percentage or participants | At end of Month 3 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | The HAQ-DI assesses the difficulty a participant has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability. | All participants who were randomized, received at least 1 dose of study drug and were evaluable. | Posted | Least Squares Mean | Standard Error | Units on a scale | From Baseline to Month 3 |
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| Secondary | Change From Baseline in the Van Der Heijdel Modified Total Sharp Score (mTSS) for Psoriatic Arthritis | Assessment of joint damage includes a joint erosion score (range 0-320) and a joint space narrowing (JSN) score (range 0-208). The mTSS is the sum of the erosion and JSN scores (range 0-528). A higher score indicates more severe disease status. If a component score is missing, the mTSS will be missing. | All participants who were randomized, received at least 1 dose of study drug and were evaluable. | Posted | Least Squares Mean | Standard Error | Units on a scale | From Baseline to Month 12 |
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| Secondary | Percentage of Participants With Progressed Modified Total Sharp Score (mTSS) at Month 12 | Assessment of joint damage includes a joint erosion score (range 0-320) and a JSN score (range 0-208). The mTSS is the sum of the erosion and JSN scores (range 0-528). A higher score indicates more severe disease status. If a component score is missing, the mTSS will be missing. Progressor is defined as an increase in mTSS >0.5 from baseline. | All participants who were randomized, received at least 1 dose of study drug and were evaluable. | Posted | Number | Percentage of participants | At Month 12 |
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| Secondary | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | ACR50 was calculated as a ≥50% improvement from baseline in tender/painful and swollen joint counts and ≥50% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP. | All participants who were randomized and received at least 1 dose of study drug. n=number of responders. | Posted | Number | Percentage of participants | At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 |
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| Secondary | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | ACR70 was calculated as a ≥70% improvement from baseline in tender/painful and swollen joint counts and ≥70% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP. . | All participants who were randomized and received at least 1 dose of study drug. n=number of responders. | Posted | Number | Percentage of participants | At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 |
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| Secondary | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP. | All participants who were randomized and received at least 1 dose of study drug. n=number of responders. | Posted | Number | Percentage of participants | At Week 2 and Months 1, 2, 4, 6, 9, and 12 |
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| Secondary | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | The HAQ-DI assesses the difficulty a participant has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability. | All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit. | Posted | Least Squares Mean | Standard Error | Units on a scale | From Baseline to Week 2 and Months 1, 2, 4, 6, 9, and 12 |
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| Secondary | Change From Baseline in American College of Rheumatology Response Criteria Components: C-reactive Protein Levels | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. | All participants who were randomized, received at least 1 dose of study drug and were evaluable. | Posted | Least Squares Mean | Standard Error | mg/L | From Baseline to end of Month 3 |
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| Secondary | Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Assessment of Arthritis Pain | Participants assessed the severity of their arthritis pain using a 100-mm visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain. | All participants who were randomized, received at least 1 dose of study drug and were evaluable. | Posted | Least Squares Mean | Standard Error | mm | From Baseline to end of Month 3 |
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| Secondary | Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Global Assessment of Arthritis | Participant answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The participant's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very well) and 100 (very poorly). | All participants who were randomized, received at least 1 dose of study drug and were evaluable. | Posted | Least Squares Mean | Standard Error | mm | From Baseline to end of Month 3 |
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| Secondary | Change From Baseline in American College of Rheumatology Response Criteria Components Score: Physician's Global Assessment of Arthritis | The blinded investigator or qualified assessor assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor). | All participants who were randomized, received at least 1 dose of study drug and were evaluable. | Posted | Least Squares Mean | Standard Error | mm | From Baseline to end of Month 3 |
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| Secondary | Change From Baseline in American College of Rheumatology Response Criteria Components Score: Swollen Joint Count | Swollen joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty six (66) joints were assessed by a blinded assessor to determine the number of joints that were considered swelling. | All participants who were randomized, received at least 1 dose of study drug and were evaluable. | Posted | Least Squares Mean | Standard Error | Joints | From Baseline to end of Month 3 |
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| Secondary | Change From Baseline in American College of Rheumatology Response Criteria Components Score: Tender/Painful Joint Count | Tender/painful joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty eight (68) joints were assessed by a blinded assessor to determine the number of joints that were considered tender or painful. | All participants who were randomized, received at least 1 dose of study drug and were evaluable. | Posted | Least Squares Mean | Standard Error | Joints | From Baseline to end of Month 3 |
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| Secondary | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | The PsARC covers 4 measures: Tender/painful joint count, swollen joint count, the Physician's Global Assessment of Arthritis, and the Patient's Global Assessment of Arthritis. The PsARC response is defined as improvement in 2 of 4 items, 1 of which must be joint pain or swelling, without worsening in any measure. Improvement criteria: ≥20% improvement in Physician's Global Assessment of Arthritis; ≥20% improvement in Patient's Global Assessment of Arthritis; ≥30% improvement in tender joint count; and ≥30% improvement in swollen joint count. | All participants who were randomized and received at least 1 dose of study drug. n=number of responders. | Posted | Number | Percentage of participants | At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 |
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| Secondary | Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response | The PGA-PsO is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are rated separately over the whole body according to a 5-point severity scale, scored as 0=none; 1, 2, 3, or 4=most severe. The severity rating scores are summed and the average taken; the total average is rounded to the nearest whole number score to determine a PGA-PsO score on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe). | All participants who were randomized, received at least 1 dose of study drug with baseline PGA-PsO>0 and were evaluable. n=number of participants evaluable at each visit. | Posted | Least Squares Mean | Standard Error | Units on a scale | From Baseline to Months 1, 3, 6, 9, and 12 |
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| Secondary | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 | PASI determines psoriasis severity based on lesion severity & percentage body surface area (BSA) affected. Lesion severity is assessed for erythema, induration, & scaling, evaluated separately for head & neck, upper limbs, trunk, & lower limbs & rated for each body area according to a 5 point scale: 0=no involvement; 1=slight; 2=moderate; 3=marked; 4=very marked. BSA involvement is the extent (%) of body area affected by psoriasis & is assigned a score: 0=no involvement; 1=0-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. In each area, sum of severity rating scores is multiplied by the score representing the percentage of area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The sum of numbers obtained for the 4 body areas is the PASI score & can vary in increments of 0.1 & range from 0.0 to 72.0, higher scores represent greater severity of psoriasis. PASI75 is defined as a 75% reduction from baseline in PASI. | All participants who were randomized and received at least 1 dose of study drug with PASI>0 and BSA ≥3% at baseline. n=number of responders. | Posted | Number | Percentage of participants | At Months 1, 3, 6, 9, and 12 |
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| Secondary | Change From Baseline in Dactylitis Severity Score (DSS) | Dactylitis is characterized by swelling of the entire finger or toe. The DSS is a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis is scored on a scale of 0-3, where 0=no tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a patient is 0-60. Higher score indicates greater degree of tenderness. | All participants who were randomized, received at least 1 dose of study drug with baseline DSS>0 and were evaluable. n=number of participants evaluable at each visit. | Posted | Least Squares Mean | Standard Error | Units on a scale | From Baseline to Months 1, 3, 6, 9, and 12 |
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| Secondary | Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | The SPARCC Enthesitis Index identifies the presence or absence of tenderness at 16 enthesial sites, including the bilateral Achilles tendons, plantar fascia insertion at the calcaneus, patellar tendon insertion at the base of the patella, quadriceps insertion into the superior border of the patella, supraspinatus insertion into the greater tuberosity of the humerus, and medial and lateral epicondyles. On examination, tenderness is recorded as present (1) or absent (0) for each of the 16 sites, with an overall total score ranging from 0 to 16. Higher score indicates a greater number of sites that are affected by enthesitis. | All participants who were randomized, received at least 1 dose of study drug with baseline SPARCC Enthesitis Score>0 and were evaluable. n=number of participants evaluable at each visit. | Posted | Least Squares Mean | Standard Error | Units on a scale | From Baseline to Months 1, 3, 6, 9, and 12 |
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| Secondary | Change From Baseline in the Leeds Enthesitis Index (LEI) | Enthesitis is inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assesses enthesitis in 6 sites. Tenderness is recorded as either present (1) or absent (0) for each of the 6 sites, for an total score of 0-6. Higher score indicates a greater number of sites that are affected by enthesitis. | All participants who were randomized, received at least 1 dose of study drug with baseline LEI>0 and were evaluable. n=number of participants evaluable at each visit. | Posted | Least Squares Mean | Standard Error | Units on a scale | From Baseline to Months 1, 3, 6, 9, and 12 |
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| Secondary | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score | 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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a standard deviation (SD) of 10 points, and ranges from minus infinity to plus infinity. A higher PCS score represents better physical health status. | All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit. | Posted | Least Squares Mean | Standard Error | Units on a scale | From Baseline to Months 1, 3, 6, 9, and 12 |
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| Secondary | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score | 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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher MCS score represents better mental health status. | All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit. | Posted | Least Squares Mean | Standard Error | Units on a scale | From Baseline to Months 1, 3, 6, 9, and 12 |
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| Secondary | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain | 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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher physical functioning domain score represents better physical functioning. | All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit. | Posted | Least Squares Mean | Standard Error | Units on a scale | From Baseline to Months 1, 3, 6, 9, and 12 |
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| Secondary | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain | 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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-physical domain score represents better role-physical functioning. | All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit. | Posted | Least Squares Mean | Standard Error | Units on a scale | From Baseline to Months 1, 3, 6, 9, and 12 |
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| Secondary | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain | 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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher bodily pain domain score represents less bodily pain. | All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit. | Posted | Least Squares Mean | Standard Error | Units on a scale | From Baseline to Months 1, 3, 6, 9, and 12 |
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| Secondary | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain | 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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher general health domain score represents better general health perceptions. | All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit. | Posted | Least Squares Mean | Standard Error | Units on a scale | From Baseline to Months 1, 3, 6, 9, and 12 |
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| Secondary | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain | 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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher vitality domain score represents better vitality. | All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit. | Posted | Least Squares Mean | Standard Error | Units on a scale | From Baseline to Months 1, 3, 6, 9, and 12 |
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| Secondary | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain | 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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher social functioning domain score represents better social functioning. | All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number pf participants evaluable at each visit. | Posted | Least Squares Mean | Standard Error | Units on a scale | From Baseline to Months 1, 3, 6, 9, and 12 |
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| Secondary | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain | 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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-emotional domain score represents better role-emotional functioning. | All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit. | Posted | Least Squares Mean | Standard Error | Units on a scale | From Baseline to Months 1, 3, 6, 9, and 12 |
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| Secondary | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain | 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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher mental health domain score represents better mental health functioning. | All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit. | Posted | Least Squares Mean | Standard Error | Units on a scale | From Baseline to Months 1, 3, 6, 9, and 12 |
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| Secondary | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility | The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status. | All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit. | Posted | Least Squares Mean | Standard Error | Units on a scale | From Baseline to Months 1, 3, 6, 9, and 12 |
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| Secondary | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care | The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status. | All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit. | Posted | Least Squares Mean | Standard Error | Units on a scale | From Baseline to Months 1, 3, 6, 9, and 12 |
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| Secondary | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities | The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status. | All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit. | Posted | Least Squares Mean | Standard Error | Units on a scale | From Baseline to Months 1, 3, 6, 9, and 12 |
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| Secondary | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort | The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status. | All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit | Posted | Least Squares Mean | Standard Error | Units on a scale | From Baseline to Months 1, 3, 6, 9, and 12 |
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| Secondary | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression | The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status. | All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit. | Posted | Least Squares Mean | Standard Error | Units on a scale | From Baseline to Months 1, 3, 6, 9, and 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today | The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 (worst imaginable health state) to 100 mm (best imaginable health state) visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state; higher scores indicate a better health state, with a higher value representing better health status. | All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit. | Posted | Least Squares Mean | Standard Error | mm | From Baseline to Months 1, 3, 6, 9, and 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score | FACIT-F is a 13-item questionnaire, with each item scored on a 5-point scale ranging from 0 (not at all) to 4 (very much). Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0 to 52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless ("washed out"), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better fatigue status. | All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit. | Posted | Least Squares Mean | Standard Error | Units on a scale | From Baseline to Months 1, 3, 6, 9, and 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score | FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless ("washed out"), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue experience. | All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit. | Posted | Least Squares Mean | Standard Error | Units on a scale | From Baseline to Months 1, 3, 6, 9, and 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score | FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless ("washed out"), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue impact on daily functioning. | All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit. | Posted | Least Squares Mean | Standard Error | Units on a scale | From Baseline to Months 1, 3, 6, 9, and 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) | BASDAI is a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a visual analog scale of 0-100mm (0=none and 100=very severe) participants answer 6 questions measuring discomfort, pain, and fatigue. The final BASDAI score averages the individual assessments for a final score ranging 0-10cm, with higher scores representing more severe ankylosing spondylitis disease activity. | All participants who were randomized, received at least 1 dose of study drug with presence of spondylitis at screening and baseline BASDAI score>0 cm and were evaluable. n=number of participants evaluable at each visit. | Posted | Least Squares Mean | Standard Error | cm | From Baseline to Months 1, 3, 6, 9, and 12 |
|
Not provided
Not provided
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, Twice Daily | Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks. | 8 | 107 | 31 | 107 | ||
| EG001 | Tofacitinib, 10 mg, Twice Daily | Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks. | 4 | 104 | 43 | 104 | ||
| EG002 | Adalimumab, 40 mg, Every 2 Weeks | Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks. | 9 | 106 | 43 | 106 | ||
| EG003 | Placebo/Tofacitinib, 5 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. | 3 | 52 | 15 | 52 | ||
| EG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks | 4 | 53 | 22 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Pyoderma streptococcal | Infections and infestations | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Infected neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of the vulva | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Nephropathy | Renal and urinary disorders | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Postmenopausal haemorrhage | Reproductive system and breast disorders | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Rectocele | Reproductive system and breast disorders | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA, Version 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA, Version 18.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA, Version 18.1 | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C479163 | tofacitinib |
| C494814 | BID protein, human |
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| 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 |
|
MR=NR |
| <0.0001 |
| Risk Difference (RD) |
| 27.24 |
| Standard Error of the Mean |
| 6.64 |
| 2-Sided |
| 95 |
| 14.22 |
| 40.26 |
| Superiority or Other |
| Large sample approximation | MR=NR | 0.0055 | Risk Difference (RD) | 18.55 | Standard Error of the Mean | 6.69 | 2-Sided | 95 | 5.45 | 31.66 | Superiority or Other |
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
| OG003 | Placebo | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
|
| OG003 |
| Placebo/Tofacitinib, 5 mg, Twice Daily |
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks. |
| OG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks |
|
|
| Placebo/Tofacitinib, 5 mg, Twice Daily |
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. |
| OG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks. |
|
|
| OG003 | Placebo/Tofacitinib, 5 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. |
| OG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks. |
| OG005 | Placebo | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
| OG003 | Placebo/Tofacitinib, 5 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. |
| OG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks |
| OG005 | Placebo | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
| OG003 | Placebo/Tofacitinib, 5 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. |
| OG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks |
| OG005 | Placebo | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks. |
| OG003 | Placebo/Tofacitinib, 5 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. |
| OG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks. |
| OG005 | Placebo | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
| Placebo |
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
| Placebo |
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
| OG003 | Placebo | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
| Placebo |
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
| OG003 |
| Placebo |
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks. |
| OG003 | Placebo/Tofacitinib, 5 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. |
| OG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks. |
| OG005 | Placebo | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks. |
| OG003 | Placebo/Tofacitinib, 5 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. |
| OG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks |
| OG005 | Placebo | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks. |
| OG002 | Adalimumab, 40 mg, Every 2 Weeks | Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks. |
| OG003 | Placebo/Tofacitinib, 5 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. |
| OG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks |
| OG005 | Placebo | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
| OG003 | Placebo/Tofacitinib, 5 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. |
| OG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks |
| OG005 | Placebo | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
| OG002 |
| Adalimumab, 40 mg, Every 2 Weeks |
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks. |
| OG003 | Placebo/Tofacitinib, 5 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. |
| OG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks |
| OG005 | Placebo | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
| OG003 | Placebo/Tofacitinib, 5 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. |
| OG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks |
| OG005 | Placebo | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
| OG002 |
| Adalimumab, 40 mg, Every 2 Weeks |
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks. |
| OG003 | Placebo/Tofacitinib, 5 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. |
| OG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks |
| OG005 | Placebo | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
| Adalimumab, 40 mg, Every 2 Weeks |
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks. |
| OG003 | Placebo/Tofacitinib, 5 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. |
| OG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks |
| OG005 | Placebo | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
| Adalimumab, 40 mg, Every 2 Weeks |
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks. |
| OG003 | Placebo/Tofacitinib, 5 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. |
| OG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks |
| OG005 | Placebo | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
| Adalimumab, 40 mg, Every 2 Weeks |
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks. |
| OG003 | Placebo/Tofacitinib, 5 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. |
| OG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks |
| OG005 | Placebo | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
| Adalimumab, 40 mg, Every 2 Weeks |
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks. |
| OG003 | Placebo/Tofacitinib, 5 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. |
| OG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks |
| OG005 | Placebo | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
| Adalimumab, 40 mg, Every 2 Weeks |
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks. |
| OG003 | Placebo/Tofacitinib, 5 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. |
| OG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks |
| OG005 | Placebo | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
| Adalimumab, 40 mg, Every 2 Weeks |
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks. |
| OG003 | Placebo/Tofacitinib, 5 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. |
| OG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks |
| OG005 | Placebo | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
| Adalimumab, 40 mg, Every 2 Weeks |
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks. |
| OG003 | Placebo/Tofacitinib, 5 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. |
| OG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks |
| OG005 | Placebo | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
| Adalimumab, 40 mg, Every 2 Weeks |
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks. |
| OG003 | Placebo/Tofacitinib, 5 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. |
| OG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks |
| OG005 | Placebo | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
| Adalimumab, 40 mg, Every 2 Weeks |
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks. |
| OG003 | Placebo/Tofacitinib, 5 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. |
| OG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks |
| OG005 | Placebo | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
| OG002 | Adalimumab, 40 mg, Every 2 Weeks | Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks. |
| OG003 | Placebo/Tofacitinib, 5 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. |
| OG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks |
| OG005 | Placebo | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
| OG002 | Adalimumab, 40 mg, Every 2 Weeks | Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks. |
| OG003 | Placebo/Tofacitinib, 5 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. |
| OG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks |
| OG005 | Placebo | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
| OG002 | Adalimumab, 40 mg, Every 2 Weeks | Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks. |
| OG003 | Placebo/Tofacitinib, 5 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. |
| OG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks |
| OG005 | Placebo | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
| OG002 | Adalimumab, 40 mg, Every 2 Weeks | Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks. |
| OG003 | Placebo/Tofacitinib, 5 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. |
| OG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks |
| OG005 | Placebo | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
| OG002 | Adalimumab, 40 mg, Every 2 Weeks | Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks. |
| OG003 | Placebo/Tofacitinib, 5 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. |
| OG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks |
| OG005 | Placebo | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
| OG002 | Adalimumab, 40 mg, Every 2 Weeks | Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks. |
| OG003 | Placebo/Tofacitinib, 5 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. |
| OG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks |
| OG005 | Placebo | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
| OG002 | Adalimumab, 40 mg, Every 2 Weeks | Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks. |
| OG003 | Placebo/Tofacitinib, 5 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. |
| OG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks |
| OG005 | Placebo | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
| OG002 | Adalimumab, 40 mg, Every 2 Weeks | Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks. |
| OG003 | Placebo/Tofacitinib, 5 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. |
| OG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks |
| OG005 | Placebo | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
| OG002 | Adalimumab, 40 mg, Every 2 Weeks | Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks. |
| OG003 | Placebo/Tofacitinib, 5 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. |
| OG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks |
| OG005 | Placebo | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
|
|
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks. |
| OG003 | Placebo/Tofacitinib, 5 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. |
| OG004 | Placebo/Tofacitinib, 10 mg, Twice Daily | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks |
| OG005 | Placebo | Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. |
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