A Phase 3 interventional study of Tofacitinib and Placebo in Psoriatic Arthritis, sponsored by Pfizer. Completed at 38 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-08.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
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Among 10 studies testing tofacitinib in Arthritis, Psoriatic — 2 open to participants now, 2 under way, 1 of them phase 3. tofacitinib · Arthritis, Psoriatic.
Among the 10 studies testing tofacitinib in Arthritis, Psoriatic, this one is the 6th largest by enrollment, is the only one that started in 2018, is one of 7 in phase 3, and was the 5th registered.
600 studies on the registry are indexed under Arthritis, Psoriatic; 128 are open to participants now.
Browse Arthritis, Psoriatic studies →2 of the 10 studies testing tofacitinib in Arthritis, Psoriatic are open now, in 2 countries. Recruiting first, the newest first:
NYU Langone Health · Sites in United States
Ages 18+
University of Erlangen-Nürnberg Medical School · Sites in Germany
Ages 18–75
By country, each count listing its studies:
tofacitinib: first FDA approval 2012 (XELJANZ), first EMA approval 2017. What it is approved for, and how studies give it, is on its page →
Of the 88 Arthritis, Psoriatic studies recruiting now, 53 (60%) set no upper age limit and 26 (30%) stop at 75 or younger; 12 take children under 18; 12 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 204 is above the median of 145 across 336 interventional studies indexed under Arthritis, Psoriatic.
Median enrollment 237 across the 10 interventional studies. Of the 7 that completed or were terminated, 5 (71%) have results posted.
This tab as a report to print or save as PDF → With an account.
5 of 10 have an industry lead sponsor. The 6 most frequent:
Pfizer is the lead sponsor of 3,337 studies on the registry; 150 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 392 (65%) have results posted.
29 studies in Arthritis, Psoriatic by Pfizer: 1 open now, 1 under way, none of them phase 3. Of 28 finished, 22 (79%) have results posted.
Among the 29 studies in Arthritis, Psoriatic by Pfizer, this one is the 7th largest by enrollment of the 10 interventional ones that give a count, is the only one that started in 2018, is one of 6 in phase 3, and was the 23rd registered.
Pfizer’s Arthritis, Psoriatic studies by the year they started, since 2003.
None of the studies under way reaches primary completion within a year.
Among the 10 studies testing tofacitinib in Arthritis, Psoriatic, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Pfizer’s 29 in Arthritis, Psoriatic:
Nothing recorded among them since 2026-09-25.
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This is a 6 month study investigating the effectiveness and safety of tofacitinib in treating signs and symptoms and improving physical function in Chinese patients with active psoriatic arthritis and had inadequate response to a conventional synthetic disease modifying anti-rheumatic drug. This is a China alone study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tofacitinib 5 mg BID for 6 months
Drug: Tofacitinib
Placebo for 3 months then tofacitinib 5 mg BID for 3 months
Other: Placebo · Drug: Tofacitinib
tablets, 5 mg BID x 6 months
tablets, to match tofacitinib 5 mg BID x 3 months
tablets, 5 mg BID x 3 months
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 3
ACR50 response: greater than or equal to (≥) 50% improvement in tender (TJC) and swollen joint counts (SJC) and ≥50% improvement in 3 of the 5 remaining ACR-core set measures: patient (PtGA) and physician global assessments (PhyGA), pain, disability (Health Assessment Questionnaire - Disability Index \[HAQ-DI\], scored from 0 to 3), and an acute-phase reactant (C-reactive protein \[CRP\]). TJC was based on 68 joints and SJC was based on 66 joints. PtGA, PhyGA and Pain were VAS on a scale of 0-100 millimeter (mm).
Time frame: Month 3
Percentage of Participants Achieving ACR20 Response at Week 2, Month 1, 2, 3, 4, and 6
ACR20 response:≥20% improvement in TJC and SJC and ≥20% improvement in 3 of the 5 remaining ACR-core set measures: PtGA and PhyGA, pain, disability (HAQ-DI, scored from 0 to 3), and a CRP. TJC was based on 68 joints and SJC was based on 66 joints. PtGA, PhyGA and Pain were VAS on a scale of 0-100 mm.
Time frame: Week 2, Month 1, 2, 3, 4, and 6
Percentage of Participants Achieving ACR70 Response at Week 2, Month 1, 2, 3, 4, and 6
ACR70 response:≥70% improvement in TJC and SJC and ≥70% improvement in 3 of the 5 remaining ACR-core set measures: PtGA and PhyGA, pain, disability (HAQ-DI, scored from 0 to 3), and a CRP. TJC was based on 68 joints and SJC was based on 66 joints. PtGA, PhyGA and Pain were VAS on a scale of 0-100 mm.
Time frame: Week 2, Month 1, 2, 3, 4, and 6
Percentage of Participants Achieving ACR50 Response at Week 2, Month 1, 2, 4, and 6
ACR50 response:≥50% improvement in TJC and SJC and ≥50% improvement in 3 of the 5 remaining ACR-core set measures: PtGA and PhyGA, pain, disability (HAQ-DI, scored from 0 to 3), and a CRP. TJC was based on 68 joints and SJC was based on 66 joints. PtGA, PhyGA and Pain were VAS on a scale of 0-100 mm.
Time frame: Week 2, Month 1, 2, 4, and 6
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 2, Month 1, 2, 3, 4, and 6
The HAQ-DI assessed the degree of difficulty a participant had experienced during 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 consisted of 2-3 items. For each question in the questionnaire, the level of difficulty was scored from 0 to 3 with 0 representing "no difficulty," 1 as "some difficulty," 2 as "much difficulty," and 3 as "unable to do". The HAQ-DI score was the average of the non-missing domain scores. If \>2 domain scores were missing, HAQ-DI score was considered missing. A higher score represented a more limited physical functional status/ability.
Time frame: Baseline, Week 2, Month 1, 2, 3, 4, and 6
HAQ-DI Response (Decrease From Baseline ≥0.30) Rate for Participants With Baseline HAQ-DI ≥0.30 at Week 2, Month 1, 2, 3, 4, and 6
Rate was measured in terms of percentage of participants with HAQ-DI response. The HAQ-DI assessed the degree of difficulty a participant had experienced during 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 consisted of 2-3 items. For each question in the questionnaire, the level of difficulty was scored from 0 to 3 with 0 representing "no difficulty," 1 as "some difficulty," 2 as "much difficulty," and 3 as "unable to do". The HAQ-DI score was the average of the non-missing domain scores. If \>2 domain scores were missing, HAQ-DI score was considered missing. A higher score represented a more limited physical functional status/ability.
Time frame: Week 2, Month 1, 2, 3, 4, and 6
HAQ-DI Response (Decrease From Baseline ≥0.35) Rate for Participants With Baseline HAQ-DI ≥0.35 at Week 2, Month 1, 2, 3, 4, and 6
Rate was measured in terms of percentage of participants with HAQ-DI response. The HAQ-DI assessed the degree of difficulty a participant had experienced during 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 consisted of 2-3 items. For each question in the questionnaire, the level of difficulty was scored from 0 to 3 with 0 representing "no difficulty," 1 as "some difficulty," 2 as "much difficulty," and 3 as "unable to do". The HAQ-DI score was the average of the non-missing domain scores. If \>2 domain scores were missing, HAQ-DI score was considered missing. A higher score represented a more limited physical functional status/ability.
Time frame: Week 2, Month 1, 2, 3, 4, and 6
Change From Baseline in Swollen Joint Count at Week 2, Month 1, 2, 3, 4, and 6
Swollen joint count was an assessment on 66 joints (temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeals, thumb interphalangeal, proximal interphalangeals, distal interphalangeals, knee, ankle, tarsus, metatarsophalangeals, great toe interphalangeal, proximal and distal interphalangeals combined). Artificial joints were not assessed. Each joint was assessed for swelling as: Present/Absent/Not Done/Not Applicable (used for artificial or missing joints).
Time frame: Baseline, Week 2, Month 1, 2, 3, 4, and 6
Change From Baseline in Tender/Painful Joint Count at Week 2, Month 1, 2, 3, 4, and 6
Tender/painful joint count was an assessment on 68 joints (temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeals, thumb interphalangeal, proximal interphalangeals, distal interphalangeals, hip, knee, ankle, tarsus, metatarsophalangeals, great toe interphalangeal, proximal and distal interphalangeals combined). Artificial joints were not assessed. Each joint was assessed for tenderness/pain as: Present/Absent/Not Done/Not Applicable (used for artificial or missing joints).
Time frame: Baseline, Week 2, Month 1, 2, 3, 4, and 6
Change From Baseline in Patient's Assessment of Arthritis Pain Visual Analog Scale (VAS) at Week 2, Month 1, 2, 3, 4, and 6
Participants were assessed the severity of their arthritis pain using a 100 mm VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain).
Time frame: Baseline, Week 2, Month 1, 2, 3, 4, and 6
Change From Baseline in Patient's Global Assessment of Arthritis (VAS) at Week 2, Month 1, 2, 3, 4, and 6
Participants 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).
Time frame: Baseline, Week 2, Month 1, 2, 3, 4, and 6
Change From Baseline in Physician's Global Assessment of Arthritis (VAS) at Week 2, Month 1, 2, 3, 4, and 6
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 should be 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).
Time frame: Baseline, Week 2, Month 1, 2, 3, 4, and 6
Change From Baseline in CRP at Week 2, Month 1, 2, 3, 4, and 6
Blood samples were collected at each visit (except follow-up) for analysis of CRP using an assay by the central laboratory. The test for CRP was a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicated reduction in inflammation and therefore improvement.
Time frame: Baseline, Week 2, Month 1, 2, 3, 4, and 6
Physician's Global Assessment of Psoriasis (PGA-PsO) Response Rates for Participants With Baseline PGA-PsO ≥2 at Month 1, 3 and 6
PGA-PsO response : PGA-PsO = 0 or 1 and decrease from baseline in PGA-PsO ≥2. Rate was measured in terms of percentage of participants with PGA-PsO response. The PGA-PsO was 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 were scored 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 scores were summed and averaged after which the total average was rounded to the nearest whole number score to determine the PGA-PsO score.
Time frame: Month 1, 3 and 6
Change From Baseline in PGA-PsO for Participants With Baseline PGA-PsO>0 at Month 1, 3 and 6
The PGA-PsO was 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 were scored 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 scores were summed and averaged after which the total average was rounded to the nearest whole number score to determine the PGA-PsO score.
Time frame: Baseline, Month 1, 3 and 6
Psoriasis Area and Severity Index (PASI) 75 Response Rates at Month 1, 3 and 6 in Participants With Baseline Psoriatic Body Surface Area (BSA) ≥3% and Baseline PASI >0
PASI75 response: ≥75% improvement from baseline in PASI. Rate was measured in terms of percentage of participants with PASI75 response. PASI quantified the severity of a participant's psoriasis based on both lesion severity and the percent of BSA affected. PASI score ranged from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI was only performed if ≥3% of participant's BSA was affected at baseline.
Time frame: Month 1, 3 and 6
Percent Change From Baseline in PASI Score at Month 1, 3 and 6 for Participants With Baseline BSA ≥3% and Baseline PASI >0
PASI quantified the severity of a participant's psoriasis based on both lesion severity and the percentage of BSA affected. PASI was a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. PASI score ranged from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI was only performed if ≥3% of participant's BSA was affected at baseline.
Time frame: Baseline, Month 1, 3 and 6
Percent Change From Baseline in PASI Clinical Component Scores at Month 1, 3 and 6 for Participants With Baseline BSA ≥3% and Baseline PASI >0
PASI quantified the severity of a participant's psoriasis based on both lesion severity and the percentage of BSA affected. PASI was a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. PASI was only performed if ≥3% of participant's BSA was affected at baseline. The PASI clinical component scores (erythema, induration and scaling) range from 0.0 to 24.0, with higher scores representing increasing severity of psoriasis.
Time frame: Baseline, Month 1, 3 and 6
Percent Change From Baseline in BSA at Month 1, 3 and 6 for Participants With Baseline BSA >0%
Assessment of BSA with psoriasis was performed separately for four body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The BSA with psoriasis (%) was the sum of the numbers of the handpoints across the 4 body regions.
Time frame: Baseline, Month 1, 3 and 6
Change From Baseline in Physician's Global Assessment of Psoriatic Arthritis (PGA-PsA) (VAS) at Month 1, 3 and 6
The blinded investigator or qualified assessor assessed how the participant's overall PsA appeared at the time of the visit. The investigator's response was recorded using a 100 mm VAS (Not active at all to Extremely active).
Time frame: Baseline, Month 1, 3 and 6
Resolution Rate of Dactylitis at Month 1, 3 and 6 for Participants With Baseline Dactylitis Severity Score (DSS) >0
Dactylitis was characterized by swelling of the entire finger or toe. The DSS was a function of finger circumference and tenderness, assessed and summed across all dactylitis digits. Resolution rate of dactylitis was defined as achieving DSS =0. Rate was measured in terms of percentage of participants with resolution of dactylitis. Dactylitis severity was scored based upon digit tenderness using a scale of 0-3, where 0 = no tenderness and 3 = extreme tenderness, in each digit of the hands and feet. DSS was the sum of the severity of the 20 evaluated digits. The range of total dactylitis scores for a participant would be 0-60 (with a higher score indicating more severe dactylitis).
Time frame: Month 1, 3 and 6
Change From Baseline in DSS for Participant With Baseline DSS >0 at Month 1, 3 and 6
Dactylitis was characterized by swelling of the entire finger or toe. The DSS was a function of finger circumference and tenderness, assessed and summed across all dactylitis digits. Dactylitis severity was scored based upon digit tenderness using a scale of 0-3, where 0 = no tenderness and 3 = extreme tenderness, in each digit of the hands and feet. DSS was the sum of the severity of the 20 evaluated digits. The range of total dactylitis scores for a participant would be 0-60 (with a higher score indicating more severe dactylitis).
Time frame: Baseline, Month 1, 3 and 6
Resolution Rate of Enthesitis at Month 1, 3 and 6 for Participants With Baseline Leeds Enthesitis Index (LEI) >0
Resolution rate of enthesitis was defined as percentage of participants achieving enthesitis score (using LEI) =0. Rate was measured in terms of percentage of participants with resolution of enthesitis. Enthesitis score based upon presence/absence of enthesitis at 6 sites using LEI. Six sites, including (right and left): lateral epicondyle humerus, medial femoral condyle and Achilles tendon insertion, were assessed for enthesitis. LEI was the number of sites with presence of enthesitis.
Time frame: Month 1, 3 and 6
Change From Baseline in LEI for Participant With Baseline LEI >0 at Month 1, 3 and 6
Enthesitis score based upon presence/absence of enthesitis at 6 sites using LEI. Six sites, including (right and left): lateral epicondyle humerus, medial femoral condyle and Achilles tendon insertion, were assessed for enthesitis. LEI was the number of sites with presence of enthesitis.
Time frame: Baseline, Month 1, 3 and 6
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Month 1, 3 and 6 for Participants With Baseline NAPSI >0
A target finger nail was evaluated using NAPSI scale. Each quadrant of the target nail was graded for nail matrix psoriasis and nail bed psoriasis, giving that 1 target nail a score of 0-8. At the baseline visit, the worst case fingernail was chosen and the same nail evaluated consistently through the entire study.
Time frame: Baseline, Month 1, 3 and 6
Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) at Week 2, Month 1, 2, 3, 4, and 6
The PsARC consisted of 4 measurements: Tender Joint Count (68), Swollen Joint Count (66), Physician's Global Assessment of Arthritis (VAS) (0-100 mm), Patient's Global Assessment of Arthritis (VAS) (0-100 mm). In order to be a 'PsARC responder', participant must achieve improvement in 2 of 4 measures, one of which must be joint pain or swelling, without worsening in any measure.
Time frame: Week 2, Month 1, 2, 3, 4, and 6
Change From Baseline in Disease Activity Score (DAS)28-3 (CRP) at Week 2, Month 1, 2, 3, 4, and 6
The DAS was a derived measurement with differential weighting given to each component. The components of the DAS 28-3 arthritis assessment were: Tender/Painful Joint Count (28), Swollen Joint Count (28), CRP (refer to above OMs for more details of these components). DAS28 scores range from 0 to 9.4. A DAS28-3 (CRP) score higher than 5.1 indicates high disease activity, a DAS28-3 (CRP) score less than 3.2 indicates low disease activity, and a DAS28-3 (CRP) score less than 2.6 indicates clinical remission. A higher score represented a more severe disease activity, and a negative change from baseline indicates improvement. DAS28-3(CRP)=\[0.56\*sqrt(TJC28)+0.28\*sqrt(SJC28)+0.36\*ln(CRP+1)\]\*1.10+1.15, where sqrt() refers to the square root, and ln() refers to the natural logarithm.
Time frame: Baseline, Week 2, Month 1, 2, 3, 4, and 6
Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6
The SF 36 v.2 (Acute) was a 36 item generic health status measure. It measured 8 general health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. These domains were summarized as physical and mental component summary scores. The score range for the physical and mental health scores was 0-100 (100=highest level of functioning).
Time frame: Baseline, Month 1, 3 and 6
Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Domain Scores at Month 1, 3 and 6
On the EQ-5D (participant version, 3 categories of response per question), 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) were assessed. The status of each dimension had three possible responses with the corresponding scores of 1 (no problem), 2 (some problems) and 3 (severe problems).
Time frame: Baseline, Month 1, 3 and 6
Change From Baseline in EuroQol Visual Analogue Scale (EQ-VAS) Score at Month 1, 3 and 6
The EQ-VAS recorded the patient's self-rated health on a vertical visual analogue scale where the endpoint was labelled 'Best imaginable health state' and 'Worst imaginable health state'. Based on the patient's mark on the VAS form a score ranging from 0 to 100 mm was recorded.
Time frame: Baseline, Month 1, 3 and 6
Change From Baseline in Work Productivity and Activity Impairment-Psoriatic Arthritis (WPAI-PsA) at Month 3 and 6: Work Time Missed, Impairment While Working, Overall Work Impairment
The WPAI-PsA was a 6-item questionnaire that measured absenteeism (work time missed), presenteesism (impairment at work/reduced on -the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism) and activity impairment. WPAI-PsA outcomes were expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Time frame: Baseline, Month 3 and 6
Change From Baseline in WPAI-PsA at Month 3 and 6: Activity Impairment
The WPAI-PsA was a 6-item questionnaire that measured absenteeism (work time missed), presenteesism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism) and activity impairment. WPAI-PsA outcomes were expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Time frame: Baseline, Month 3 and 6
| Milestone | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Started | 136 | 68 |
| Completed | 129 | 63 |
| Not completed | 7 | 5 |
| Withdrew: Adverse event | 2 | 5 |
| Withdrew: Lack of efficacy | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Failure to meet randomization criteria | 2 | 0 |
| Withdrew: Other | 1 | 0 |
| Milestone | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Started | 129 | 63 |
| Completed | 126 | 61 |
| Not completed | 3 | 2 |
| Withdrew: Adverse event | 2 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Pregnancy | 0 | 1 |
| Withdrew: Other | 1 | 0 |
ACR50 response: greater than or equal to (≥) 50% improvement in tender (TJC) and swollen joint counts (SJC) and ≥50% improvement in 3 of the 5 remaining ACR-core set measures: patient (PtGA) and physician global assessments (PhyGA), pain, disability (Health Assessment Questionnaire - Disability Index \[HAQ-DI\], scored from 0 to 3), and an acute-phase reactant (C-reactive protein \[CRP\]). TJC was based on 68 joints and SJC was based on 66 joints. PtGA, PhyGA and Pain were VAS on a scale of 0-100 millimeter (mm).
| Percentage of participants | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 3 | 38.24 | 5.88 |
ACR20 response:≥20% improvement in TJC and SJC and ≥20% improvement in 3 of the 5 remaining ACR-core set measures: PtGA and PhyGA, pain, disability (HAQ-DI, scored from 0 to 3), and a CRP. TJC was based on 68 joints and SJC was based on 66 joints. PtGA, PhyGA and Pain were VAS on a scale of 0-100 mm.
| Percentage of participants | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Week 2 | 22.79 | 7.35 |
| Month 1 | 38.97 | 8.82 |
| Month 2 | 61.76 | 10.29 |
| Month 3 | 64.71 | 27.94 |
| Month 4 | 69.85 | 45.59 |
| Month 6 | 72.79 | 58.82 |
ACR70 response:≥70% improvement in TJC and SJC and ≥70% improvement in 3 of the 5 remaining ACR-core set measures: PtGA and PhyGA, pain, disability (HAQ-DI, scored from 0 to 3), and a CRP. TJC was based on 68 joints and SJC was based on 66 joints. PtGA, PhyGA and Pain were VAS on a scale of 0-100 mm.
| Percentage of participants | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Week 2 | 1.47 | 0 |
| Month 1 | 2.21 | 0 |
| Month 2 | 8.82 | 1.47 |
| Month 3 | 14.71 | 1.47 |
| Month 4 | 20.59 | 7.35 |
| Month 6 | 36.76 | 23.53 |
ACR50 response:≥50% improvement in TJC and SJC and ≥50% improvement in 3 of the 5 remaining ACR-core set measures: PtGA and PhyGA, pain, disability (HAQ-DI, scored from 0 to 3), and a CRP. TJC was based on 68 joints and SJC was based on 66 joints. PtGA, PhyGA and Pain were VAS on a scale of 0-100 mm.
| Percentage of participants | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Week 2 | 4.41 | 1.47 |
| Month 1 | 9.56 | 1.47 |
| Month 2 | 30.15 | 2.94 |
| Month 4 | 41.18 | 19.12 |
| Month 6 | 55.15 | 36.76 |
The HAQ-DI assessed the degree of difficulty a participant had experienced during 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 consisted of 2-3 items. For each question in the questionnaire, the level of difficulty was scored from 0 to 3 with 0 representing "no difficulty," 1 as "some difficulty," 2 as "much difficulty," and 3 as "unable to do". The HAQ-DI score was the average of the non-missing domain scores. If \>2 domain scores were missing, HAQ-DI score was considered missing. A higher score represented a more limited physical functional status/ability.
| unit on a scale | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Week 2 | -0.14 ± 0.025 | -0.03 ± 0.036 |
| Month 1 | -0.18 ± 0.026 | -0.05 ± 0.037 |
| Month 2 | -0.28 ± 0.028 | -0.07 ± 0.039 |
| Month 3 | -0.30 ± 0.031 | -0.08 ± 0.044 |
| Month 4 | -0.32 ± 0.026 | -0.23 ± 0.038 |
| Month 6 | -0.38 ± 0.025 | -0.31 ± 0.036 |
Rate was measured in terms of percentage of participants with HAQ-DI response. The HAQ-DI assessed the degree of difficulty a participant had experienced during 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 consisted of 2-3 items. For each question in the questionnaire, the level of difficulty was scored from 0 to 3 with 0 representing "no difficulty," 1 as "some difficulty," 2 as "much difficulty," and 3 as "unable to do". The HAQ-DI score was the average of the non-missing domain scores. If \>2 domain scores were missing, HAQ-DI score was considered missing. A higher score represented a more limited physical functional status/ability.
| Percentage of participants | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Week 2 | 36.14 | 23.08 |
| Month 1 | 37.35 | 33.33 |
| Month 2 | 60.24 | 38.46 |
| Month 3 | 65.06 | 41.03 |
| Month 4 | 63.86 | 51.28 |
| Month 6 | 73.49 | 66.67 |
Rate was measured in terms of percentage of participants with HAQ-DI response. The HAQ-DI assessed the degree of difficulty a participant had experienced during 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 consisted of 2-3 items. For each question in the questionnaire, the level of difficulty was scored from 0 to 3 with 0 representing "no difficulty," 1 as "some difficulty," 2 as "much difficulty," and 3 as "unable to do". The HAQ-DI score was the average of the non-missing domain scores. If \>2 domain scores were missing, HAQ-DI score was considered missing. A higher score represented a more limited physical functional status/ability.
| Percentage of participants | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Week 2 | 36.14 | 23.08 |
| Month 1 | 37.35 | 33.33 |
| Month 2 | 60.24 | 38.46 |
| Month 3 | 65.06 | 41.03 |
| Month 4 | 63.86 | 51.28 |
| Month 6 | 73.49 | 66.67 |
Swollen joint count was an assessment on 66 joints (temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeals, thumb interphalangeal, proximal interphalangeals, distal interphalangeals, knee, ankle, tarsus, metatarsophalangeals, great toe interphalangeal, proximal and distal interphalangeals combined). Artificial joints were not assessed. Each joint was assessed for swelling as: Present/Absent/Not Done/Not Applicable (used for artificial or missing joints).
| Joint count | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Week 2 | -3.04 ± 0.367 | -0.34 ± 0.516 |
| Month 1 | -4.06 ± 0.409 | -0.27 ± 0.582 |
| Month 2 | -5.55 ± 0.437 | -0.66 ± 0.622 |
| Month 3 | -6.42 ± 0.489 | -0.57 ± 0.697 |
| Month 4 | -7.28 ± 0.336 | -4.08 ± 0.476 |
| Month 6 | -8.07 ± 0.386 | -5.48 ± 0.545 |
Tender/painful joint count was an assessment on 68 joints (temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeals, thumb interphalangeal, proximal interphalangeals, distal interphalangeals, hip, knee, ankle, tarsus, metatarsophalangeals, great toe interphalangeal, proximal and distal interphalangeals combined). Artificial joints were not assessed. Each joint was assessed for tenderness/pain as: Present/Absent/Not Done/Not Applicable (used for artificial or missing joints).
| Joint count | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Week 2 | -3.19 ± 0.585 | 0.21 ± 0.825 |
| Month 1 | -5.38 ± 0.589 | -0.35 ± 0.838 |
| Month 2 | -7.44 ± 0.588 | -1.76 ± 0.837 |
| Month 3 | -8.90 ± 0.637 | -1.89 ± 0.910 |
| Month 4 | -10.15 ± 0.617 | -6.19 ± 0.878 |
| Month 6 | -11.91 ± 0.638 | -9.51 ± 0.906 |
Participants were assessed the severity of their arthritis pain using a 100 mm VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain).
| mm | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Week 2 | -9.7 ± 1.429 | -3.13 ± 2.025 |
| Month 1 | -14.07 ± 1.421 | -2.37 ± 2.038 |
| Month 2 | -18.80 ± 1.606 | -2.66 ± 2.286 |
| Month 3 | -23.07 ± 1.735 | -1.20 ± 2.478 |
| Month 4 | -24.79 ± 1.641 | -17.84 ± 2.346 |
| Month 6 | -29.37 ± 1.692 | -26.27 ± 2.435 |
Participants 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).
| mm | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Week 2 | -13.67 ± 1.521 | -7.52 ± 2.157 |
| Month 1 | -17.89 ± 1.593 | -4.80 ± 2.283 |
| Month 2 | -22.49 ± 1.679 | -9.33 ± 2.392 |
| Month 3 | -26.02 ± 1.825 | -7.25 ± 2.606 |
| Month 4 | -28.68 ± 1.613 | -21.67 ± 2.316 |
| Month 6 | -33.49 ± 1.669 | -28.35 ± 2.404 |
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 should be 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).
| mm | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Week 2 | -11.94 ± 1.126 | -2.30 ± 1.579 |
| Month 1 | -17.10 ± 1.324 | -7.58 ± 1.887 |
| Month 2 | -25.16 ± 1.419 | -8.19 ± 2.024 |
| Month 3 | -29.45 ± 1.436 | -11.03 ± 2.053 |
| Month 4 | -33.33 ± 1.413 | -26.11 ± 2.004 |
| Month 6 | -38.79 ± 1.307 | -31.13 ± 1.851 |
Blood samples were collected at each visit (except follow-up) for analysis of CRP using an assay by the central laboratory. The test for CRP was a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicated reduction in inflammation and therefore improvement.
| mg/L | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Week 2 | -8.63 ± 0.641 | -1.42 ± 0.904 |
| Month 1 | -9.37 ± 0.673 | -1.50 ± 0.958 |
| Month 2 | -9.24 ± 0.679 | -1.83 ± 0.967 |
| Month 3 | -9.78 ± 0.700 | -1.98 ± 1.001 |
| Month 4 | -10.28 ± 0.354 | -10.58 ± 0.503 |
| Month 6 | -10.24 ± 0.445 | -8.95 ± 0.638 |
PGA-PsO response : PGA-PsO = 0 or 1 and decrease from baseline in PGA-PsO ≥2. Rate was measured in terms of percentage of participants with PGA-PsO response. The PGA-PsO was 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 were scored 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 scores were summed and averaged after which the total average was rounded to the nearest whole number score to determine the PGA-PsO score.
| Percentage of participants | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Month 1 | 0.94 | 0.00 |
| Month 3 | 9.43 | 1.96 |
| Month 6 | 10.38 | 21.57 |
The PGA-PsO was 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 were scored 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 scores were summed and averaged after which the total average was rounded to the nearest whole number score to determine the PGA-PsO score.
| Unit on a scale | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Month 1 | -0.66 ± 0.064 | -0.31 ± 0.091 |
| Month 3 | -1.12 ± 0.080 | -0.52 ± 0.114 |
| Month 6 | -1.25 ± 0.089 | -1.26 ± 0.128 |
PASI75 response: ≥75% improvement from baseline in PASI. Rate was measured in terms of percentage of participants with PASI75 response. PASI quantified the severity of a participant's psoriasis based on both lesion severity and the percent of BSA affected. PASI score ranged from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI was only performed if ≥3% of participant's BSA was affected at baseline.
| Percentage of participants | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Month 1 | 18.67 | 3.70 |
| Month 3 | 36.00 | 11.11 |
| Month 6 | 41.33 | 59.26 |
PASI quantified the severity of a participant's psoriasis based on both lesion severity and the percentage of BSA affected. PASI was a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. PASI score ranged from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI was only performed if ≥3% of participant's BSA was affected at baseline.
| Percentage | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Month 1 | -42.23 ± 4.021 | -16.34 ± 6.750 |
| Month 3 | -60.86 ± 4.660 | -25.95 ± 7.637 |
| Month 6 | -62.72 ± 5.617 | -68.03 ± 9.065 |
PASI quantified the severity of a participant's psoriasis based on both lesion severity and the percentage of BSA affected. PASI was a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. PASI was only performed if ≥3% of participant's BSA was affected at baseline. The PASI clinical component scores (erythema, induration and scaling) range from 0.0 to 24.0, with higher scores representing increasing severity of psoriasis.
| Percentage | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Month 1: Erythema | -44.53 ± 5.553 | -4.89 ± 9.335 |
| Month 1: Induration | -39.91 ± 4.329 | -14.73 ± 7.261 |
| Month 1: Scaling | -37.25 ± 5.331 | -15.94 ± 8.954 |
| Month 3: Erythema | -63.49 ± 5.471 | -14.38 ± 8.993 |
| Month 3: Induration | -58.71 ± 4.935 | -29.01 ± 8.082 |
| Month 3: Scaling | -56.91 ± 5.575 | -20.13 ± 9.153 |
| Month 6: Erythema | -61.40 ± 5.543 | -68.43 ± 8.911 |
| Month 6: Induration | -60.47 ± 6.468 | -69.63 ± 10.430 |
| Month 6: Scaling | -63.20 ± 6.088 | -63.89 ± 9.803 |
Assessment of BSA with psoriasis was performed separately for four body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The BSA with psoriasis (%) was the sum of the numbers of the handpoints across the 4 body regions.
| Percentage | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Month 1 | -34.82 ± 4.781 | -6.13 ± 6.878 |
| Month 3 | -51.91 ± 6.142 | -5.44 ± 8.671 |
| Month 6 | -67.68 ± 6.225 | -40.91 ± 8.792 |
The blinded investigator or qualified assessor assessed how the participant's overall PsA appeared at the time of the visit. The investigator's response was recorded using a 100 mm VAS (Not active at all to Extremely active).
| mm | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Month 1 | -17.94 ± 1.376 | -7.19 ± 1.965 |
| Month 3 | -30.29 ± 1.479 | -10.84 ± 2.108 |
| Month 6 | -38.75 ± 1.315 | -32.05 ± 1.873 |
Dactylitis was characterized by swelling of the entire finger or toe. The DSS was a function of finger circumference and tenderness, assessed and summed across all dactylitis digits. Resolution rate of dactylitis was defined as achieving DSS =0. Rate was measured in terms of percentage of participants with resolution of dactylitis. Dactylitis severity was scored based upon digit tenderness using a scale of 0-3, where 0 = no tenderness and 3 = extreme tenderness, in each digit of the hands and feet. DSS was the sum of the severity of the 20 evaluated digits. The range of total dactylitis scores for a participant would be 0-60 (with a higher score indicating more severe dactylitis).
| Percentage of participants | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Month 1 | 21.51 | 7.32 |
| Month 3 | 45.16 | 19.51 |
| Month 6 | 64.52 | 41.46 |
Dactylitis was characterized by swelling of the entire finger or toe. The DSS was a function of finger circumference and tenderness, assessed and summed across all dactylitis digits. Dactylitis severity was scored based upon digit tenderness using a scale of 0-3, where 0 = no tenderness and 3 = extreme tenderness, in each digit of the hands and feet. DSS was the sum of the severity of the 20 evaluated digits. The range of total dactylitis scores for a participant would be 0-60 (with a higher score indicating more severe dactylitis).
| Unit on a scale | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Month 1 | -4.26 ± 0.691 | -1.17 ± 1.052 |
| Month 3 | -6.55 ± 0.543 | -2.49 ± 0.826 |
| Month 6 | -7.80 ± 0.190 | -6.83 ± 0.289 |
Resolution rate of enthesitis was defined as percentage of participants achieving enthesitis score (using LEI) =0. Rate was measured in terms of percentage of participants with resolution of enthesitis. Enthesitis score based upon presence/absence of enthesitis at 6 sites using LEI. Six sites, including (right and left): lateral epicondyle humerus, medial femoral condyle and Achilles tendon insertion, were assessed for enthesitis. LEI was the number of sites with presence of enthesitis.
| Percentage of participants | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Month 1 | 38.03 | 25.00 |
| Month 3 | 49.30 | 25.00 |
| Month 6 | 64.79 | 60.71 |
Enthesitis score based upon presence/absence of enthesitis at 6 sites using LEI. Six sites, including (right and left): lateral epicondyle humerus, medial femoral condyle and Achilles tendon insertion, were assessed for enthesitis. LEI was the number of sites with presence of enthesitis.
| Unit on a scale | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Month 1 | -1.04 ± 0.142 | -0.74 ± 0.231 |
| Month 3 | -1.36 ± 0.155 | -0.99 ± 0.251 |
| Month 6 | -1.87 ± 0.127 | -1.61 ± 0.203 |
A target finger nail was evaluated using NAPSI scale. Each quadrant of the target nail was graded for nail matrix psoriasis and nail bed psoriasis, giving that 1 target nail a score of 0-8. At the baseline visit, the worst case fingernail was chosen and the same nail evaluated consistently through the entire study.
| Unit on a scale | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Month 1 | -0.26 ± 0.108 | -0.25 ± 0.146 |
| Month 3 | -1.03 ± 0.175 | -0.80 ± 0.235 |
| Month 6 | -2.43 ± 0.189 | -2.10 ± 0.251 |
The PsARC consisted of 4 measurements: Tender Joint Count (68), Swollen Joint Count (66), Physician's Global Assessment of Arthritis (VAS) (0-100 mm), Patient's Global Assessment of Arthritis (VAS) (0-100 mm). In order to be a 'PsARC responder', participant must achieve improvement in 2 of 4 measures, one of which must be joint pain or swelling, without worsening in any measure.
| Percentage of participants | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Week 2 | 33.09 | 11.76 |
| Month 1 | 56.62 | 20.59 |
| Month 2 | 65.44 | 13.24 |
| Month 3 | 69.12 | 29.41 |
| Month 4 | 69.85 | 51.47 |
| Month 6 | 79.41 | 63.24 |
The DAS was a derived measurement with differential weighting given to each component. The components of the DAS 28-3 arthritis assessment were: Tender/Painful Joint Count (28), Swollen Joint Count (28), CRP (refer to above OMs for more details of these components). DAS28 scores range from 0 to 9.4. A DAS28-3 (CRP) score higher than 5.1 indicates high disease activity, a DAS28-3 (CRP) score less than 3.2 indicates low disease activity, and a DAS28-3 (CRP) score less than 2.6 indicates clinical remission. A higher score represented a more severe disease activity, and a negative change from baseline indicates improvement. DAS28-3(CRP)=\[0.56\*sqrt(TJC28)+0.28\*sqrt(SJC28)+0.36\*ln(CRP+1)\]\*1.10+1.15, where sqrt() refers to the square root, and ln() refers to the natural logarithm.
| Unit on a scale | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Week 2 | -0.68 ± 0.046 | -0.05 ± 0.065 |
| Month 1 | -0.92 ± 0.054 | -0.12 ± 0.077 |
| Month 2 | -1.13 ± 0.060 | -0.26 ± 0.086 |
| Month 3 | -1.34 ± 0.070 | -0.30 ± 0.100 |
| Month 4 | -1.59 ± 0.074 | -1.16 ± 0.105 |
| Month 6 | -1.85 ± 0.083 | -1.63 ± 0.119 |
The SF 36 v.2 (Acute) was a 36 item generic health status measure. It measured 8 general health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. These domains were summarized as physical and mental component summary scores. The score range for the physical and mental health scores was 0-100 (100=highest level of functioning).
| Unit on a scale | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Month 1: Physical Functioning Domain | 3.53 ± 0.570 | -0.19 ± 0.819 |
| Month 1: Role-Physical Domain | 3.93 ± 0.630 | 0.75 ± 0.903 |
| Month 1: Bodily Pain Domain | 5.58 ± 0.492 | 2.47 ± 0.706 |
| Month 1: General Health Domain | 3.33 ± 0.537 | -0.21 ± 0.770 |
| Month 1: Vitality Domain | 3.12 ± 0.687 | 0.08 ± 0.987 |
| Month 1: Social Function Domain | 2.65 ± 0.637 | 0.07 ± 0.915 |
| Month 1: Role-Emotional Domain | 3.19 ± 0.763 | 1.15 ± 1.095 |
| Month 1: Mental Health Domain | 1.77 ± 0.669 | -0.14 ± 0.960 |
| Month 1: Physical Component Summary | 4.52 ± 0.437 | 0.76 ± 0.626 |
| Month 1: Mental Component Summary | 1.85 ± 0.671 | 0.07 ± 0.964 |
| Month 3: Physical Functioning Domain | 4.33 ± 0.705 | 1.80 ± 1.001 |
| Month 3: Role-Physical Domain | 5.94 ± 0.705 | 1.52 ± 1.004 |
| Month 3: Bodily Pain Domain | 7.60 ± 0.614 | 2.30 ± 0.874 |
| Month 3: General Health Domain | 5.11 ± 0.725 | -0.16 ± 1.032 |
| Month 3: Vitality Domain | 3.81 ± 0.784 | 1.71 ± 1.116 |
| Month 3: Social Function Domain | 4.75 ± 0.681 | 0.42 ± 0.969 |
| Month 3: Role-Emotional Domain | 5.30 ± 0.795 | 1.86 ± 1.132 |
| Month 3: Mental Health Domain | 2.90 ± 0.728 | -0.58 ± 1.036 |
| Month 3: Physical Component Summary | 6.02 ± 0.567 | 1.85 ± 0.806 |
| Month 3: Mental Component Summary | 3.38 ± 0.715 | 0.11 ± 1.019 |
| Month 6: Physical Functioning Domain | 6.35 ± 0.600 | 5.96 ± 0.860 |
| Month 6: Role-Physical Domain | 6.88 ± 0.705 | 5.84 ± 1.011 |
| Month 6: Bodily Pain Domain | 10.68 ± 0.678 | 10.31 ± 0.973 |
| Month 6: General Health Domain | 5.54 ± 0.762 | 4.32 ± 1.091 |
| Month 6: Vitality Domain | 5.60 ± 0.868 | 3.61 ± 1.246 |
| Month 6: Social Function Domain | 5.58 ± 0.691 | 5.30 ± 0.991 |
| Month 6: Role-Emotional Domain | 6.35 ± 0.782 | 4.12 ± 1.121 |
| Month 6: Mental Health Domain | 3.68 ± 0.795 | 2.97 ± 1.141 |
| Month 6: Physical Component Summary | 7.94 ± 0.580 | 7.55 ± 0.831 |
| Month 6: Mental Component Summary | 3.99 ± 0.812 | 2.20 ± 1.166 |
On the EQ-5D (participant version, 3 categories of response per question), 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) were assessed. The status of each dimension had three possible responses with the corresponding scores of 1 (no problem), 2 (some problems) and 3 (severe problems).
| Unit on a scale | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Month 1: Mobility | -0.14 ± 0.038 | -0.02 ± 0.055 |
| Month 1: Self-Care | -0.15 ± 0.031 | 0.01 ± 0.045 |
| Month 1: Usual Activities | -0.19 ± 0.039 | -0.05 ± 0.056 |
| Month 1: Pain/Discomfort | -0.28 ± 0.037 | -0.15 ± 0.054 |
| Month 1: Anxiety/Depression | -0.19 ± 0.036 | -0.11 ± 0.051 |
| Month 3: Mobility | -0.24 ± 0.037 | 0.01 ± 0.053 |
| Month 3: Self-Care | -0.16 ± 0.033 | 0.02 ± 0.047 |
| Month 3: Usual Activities | -0.32 ± 0.040 | 0.01 ± 0.057 |
| Month 3: Pain/Discomfort | -0.38 ± 0.042 | -0.10 ± 0.059 |
| Month 3: Anxiety/Depression | -0.23 ± 0.036 | -0.12 ± 0.052 |
| Month 6: Mobility | -0.32 ± 0.032 | -0.22 ± 0.046 |
| Month 6: Self-Care | -0.22 ± 0.028 | -0.19 ± 0.040 |
| Month 6: Usual Activities | -0.36 ± 0.037 | -0.25 ± 0.053 |
| Month 6: Pain/Discomfort | -0.56 ± 0.046 | -0.56 ± 0.065 |
| Month 6: Anxiety/Depression | -0.22 ± 0.038 | -0.28 ± 0.055 |
The EQ-VAS recorded the patient's self-rated health on a vertical visual analogue scale where the endpoint was labelled 'Best imaginable health state' and 'Worst imaginable health state'. Based on the patient's mark on the VAS form a score ranging from 0 to 100 mm was recorded.
| mm | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Month 1 | 9.88 ± 1.191 | 3.87 ± 1.710 |
| Month 3 | 12.48 ± 1.484 | 1.68 ± 2.108 |
| Month 6 | 18.52 ± 1.398 | 17.60 ± 2.002 |
The WPAI-PsA was a 6-item questionnaire that measured absenteeism (work time missed), presenteesism (impairment at work/reduced on -the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism) and activity impairment. WPAI-PsA outcomes were expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
| Percentage | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Month 3: Work Time Missed | -1.01 ± 1.422 | -1.86 ± 1.933 |
| Month 3: Impairment While Working | -16.11 ± 2.703 | -9.77 ± 3.673 |
| Month 3: Overall Work Impairment | -16.67 ± 2.789 | -10.45 ± 3.790 |
| Month 6: Work Time Missed | -1.09 ± 1.451 | -0.01 ± 2.132 |
| Month 6: Impairment While Working | -21.11 ± 2.819 | -18.73 ± 4.014 |
| Month 6: Overall Work Impairment | -20.91 ± 3.031 | -18.28 ± 4.389 |
The WPAI-PsA was a 6-item questionnaire that measured absenteeism (work time missed), presenteesism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism) and activity impairment. WPAI-PsA outcomes were expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
| Percentage | Tofacitinib | Placebo Then Tofacitinib |
|---|---|---|
| Month 3: Activity Impairment | -17.20 ± 1.778 | -4.39 ± 2.525 |
| Month 6: Activity Impairment | -21.91 ± 1.805 | -22.97 ± 2.589 |
Collected over For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tofacitinib: Up to Month 3 | 0/136 (0%) | 0/136 (0%) | 60/136 (44.1%) |
| Placebo: Up to Month 3 | 1/68 (1.5%) | 3/68 (4.4%) | 16/68 (23.5%) |
| Tofacitinib: Up to Month 6 | 0/136 (0%) | 2/136 (1.5%) | 94/136 (69.1%) |
| Placebo Then Tofacitinib: Up to Month 6 | 1/68 (1.5%) | 5/68 (7.4%) | 37/68 (54.4%) |
| Event | Tofacitinib: Up to Month 3 | Placebo: Up to Month 3 | Tofacitinib: Up to Month 6 | Placebo Then Tofacitinib: Up to Month 6 |
|---|---|---|---|---|
| Atrial tachycardiaCardiac disorders | 0/136 | 1/68 | 0/136 | 1/68 |
| Supraventricular extrasystolesCardiac disorders | 0/136 | 1/68 | 0/136 | 1/68 |
| AccidentInjury, poisoning and procedural complications | 0/136 | 1/68 | 0/136 | 1/68 |
| Psoriatic arthropathyMusculoskeletal and connective tissue disorders | 0/136 | 1/68 | 0/136 | 1/68 |
| Foetal deathPregnancy, puerperium and perinatal conditions | 0/136 | 1/68 | 0/136 | 1/68 |
| UrticariaSkin and subcutaneous tissue disorders | 0/136 | 1/68 | 0/136 | 1/68 |
| PneumoniaInfections and infestations | 0/136 | 0/68 | 0/136 | 1/68 |
| NephrolithiasisRenal and urinary disorders | 0/136 | 0/68 | 0/136 | 1/68 |
| Limb injuryInjury, poisoning and procedural complications | 0/136 | 0/68 | 1/136 | 0/68 |
| Tendon injuryInjury, poisoning and procedural complications | 0/136 | 0/68 | 1/136 | 0/68 |
| Event | Tofacitinib: Up to Month 3 | Placebo: Up to Month 3 | Tofacitinib: Up to Month 6 | Placebo Then Tofacitinib: Up to Month 6 |
|---|---|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 25/136 | 7/68 | 36/136 | 7/68 |
| Blood creatine phosphokinase increasedInvestigations | 9/136 | 1/68 | 20/136 | 2/68 |
| HyperlipidaemiaMetabolism and nutrition disorders | 9/136 | 2/68 | 14/136 | 6/68 |
| DiarrhoeaGastrointestinal disorders | 9/136 | 2/68 | 12/136 | 2/68 |
| Hepatic function abnormalHepatobiliary disorders | 0/136 | 0/68 | 12/136 | 3/68 |
| Alanine aminotransferase increasedInvestigations | 7/136 | 4/68 | 11/136 | 5/68 |
| Aspartate aminotransferase increasedInvestigations | 0/136 | 0/68 | 11/136 | 4/68 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/136 | 0/68 | 11/136 | 0/68 |
| Urinary tract infectionInfections and infestations | 0/136 | 0/68 | 4/136 | 5/68 |
| Abdominal discomfortGastrointestinal disorders | 9/136 | 1/68 | 9/136 | 2/68 |
Safety analysis set: included all participants who received at least one dose of the study drug (tofacitinib or placebo)
| Age, Continuous(Years) | Tofacitinib | Placebo Then Tofacitinib | Total |
|---|---|---|---|
| Mean | 45.3 ± 11.59 | 43.9 ± 10.40 | 44.8 ± 11.20 |
| Sex: Female, Male(Participants) | Tofacitinib | Placebo Then Tofacitinib | Total |
|---|---|---|---|
| Female | 57 | 26 | 83 |
| Male | 79 | 42 | 121 |
| Ethnicity (NIH/OMB)(Participants) | Tofacitinib | Placebo Then Tofacitinib | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 136 | 68 | 204 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Tofacitinib | Placebo Then Tofacitinib | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 136 | 68 | 204 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Data sharing details ↗ · www.pfizer.com
Ran from Aug 2018 to primary completion in Apr 2021, 32 months.
Results were first posted in Feb 2024, 2 years 9 months after primary completion.
Of 68 industry-sponsored phase 3 interventional studies under Arthritis, Psoriatic, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 39. This study's 32 months is above that.
Counting every sponsor, half of 74 studies reached it within 28 months; a quarter within 19 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tofacitinib