Trial · NCT01976364
Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis
NCT01976364, Phase 3, Completed, Pfizer; results first posted 2020-05-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis. Trials, record NCT01976364. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01976364
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis
- NCT number
- NCT01976364
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 686 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Arthritis, Psoriatic
- Interventions
- Tofacitinib, Tofacitinib, Methotrexate, Placebo Methotrexate
- First posted
- 2013-11-05
- Last updated
- 2020-05-21
- Other registries' IDs
- eudract:2011-002169-39
- Results first posted
- 2020-05-21
Source ClinicalTrials.gov
Registered outcomes75
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 48 months that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs. |
| Primary | Number of Adverse Events (AEs) by Severity | Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study) | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified into 3 categories according to their severity as mild AEs (did not interfere with participant's usual function), moderate AEs (interfered to some extent with participant's usual function) and severe AEs (interfered significantly with participant's usual function). |
| Primary | Number of Participants With Abnormal Clinical Laboratory Values | Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study) | Laboratory tests: hematology (Hb, hematocrit, RBC count, platelets, reticulocytes, WBC count, count and absolute lymphocytes,neutrophils, basophils, eosinophils, monocytes. Liver function (bilirubin \[total, direct, indirect\], AST, ALT, alkaline phosphatase, gamma-glutamyl transferase, albumin, total protein), renal function (blood urea nitrogen, creatinine), Lipids (cholesterol, HDL, LDL, triglyceride, apolipoprotein \[A-1, B\]), electrolytes (sodium, potassium, chloride, calcium, biocarbonate), chemistry (glucose, HbA1c, creatinine kinapse), urinalysis dipstick(urine pH, glucose, ketones, protein, blood, leukocyte, esterase), urinalysis microscopy (urine- RBC, WBC, bacteria, epithelial cells),C-reactive protein. Laboratory abnormality: determined by investigator per pre-defined criteria. |
| Primary | Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values | Date of first dose of study medication (Baseline) up to 48 months (36 months of main study and 12 months of sub-study) | Laboratory tests: hematology (Hb, hematocrit, RBC count, platelets, reticulocytes, WBC count, count and absolute lymphocytes, neutrophils, basophils, eosinophils, monocytes. Liver function (bilirubin\[total,direct,indirect\], AST, ALT, alkaline phosphatase, gamma-glutamyl transferase, albumin, total protein), renal function (blood urea nitrogen, creatinine), Lipids(cholesterol, HDL, LDL, triglyceride, apolipoprotein \[A-1, B\]), electrolytes (sodium, potassium, chloride, calcium, biocarbonate), chemistry (glucose, HbA1c, creatinine kinapse), urinalysis dipstick(urine-pH, glucose, ketones, protein, blood, leukocyte, esterase), urinalysis microscopy(urine- RBC, WBC, bacteria, epithelial cells),C-reactive protein. Clinically significant change: determined by investigator per pre-defined criteria. |
| Primary | Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6 | Sub-study: Baseline (Day 1), Month 6 | HAQ-DI assessed the degree of difficulty a participant had experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, reach, grip, hygiene, and other activities. There were total of 2-3 items distributed in each of these 8 domains. Each item was scored for level of difficulty on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible HAQ-DI score ranged from 0 (least difficulty) to 3 (extreme difficulty), where higher score indicated more difficulty while performing daily living activities. |
| Primary | Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6 | Sub-study: Baseline (Day 1), Month 6 | PASDAS was composite PsA disease activity score that included following components: Physician and patient global assessment of disease activity (assessed on a 0-100 VAS) in millimeter (mm), swollen (66 joints) and tender joint counts (68 joints), Leeds enthesitis index (enthesitis assessed at 6 sites; total score of 0-6), tender dactylitic digit score (scored on a scale of 0-3, where 0= no tenderness and 3= extreme tenderness), short form-36 questionnaire (SF-36) physical component summary (norm-based domain scores were used in analyses; with a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity) and C-reactive protein (CRP) in milligram per liter (mg/L). PASDAS was composite score and was a weighted index with score range of 0 to 10, where higher score indicated more severe disease. |
| Secondary | Main Study: Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response | Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | Participants with 20% improvement from baseline in tender and swollen joint counts and 20% improvement in at least 3 of the 5 measures: Patient's global assessment of arthritis (PtGA), Physician's global assessment of arthritis (PhyGA), participant's assessment of arthritis pain, HAQ-DI and C-reactive protein (CRP) in mg/L. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. Participant's assessment of arthritis pain: participant assessed pain on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability. |
| Secondary | Main Study: Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response | Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | Participants with 50% improvement from baseline in tender and swollen joint counts and 50% improvement in at least 3 of the 5 measures: PtGA, PhyGA, participant's assessment of arthritis pain, HAQ-DI and CRP in mg/L. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. Participant's assessment of arthritis pain: participant assessed pain on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability. |
| Secondary | Main Study: Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response | Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | Participants with 70% improvement from baseline in tender and swollen joint counts and 70% improvement in at least 3 of the 5 measures: PtGA, PhyGA, participant's assessment of arthritis pain, HAQ-DI and CRP in mg/L. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. Participant's assessment of arthritis pain: participant assessed pain on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability. |
| Secondary | Main Study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | HAQ-DI assessed the degree of difficulty a participant had experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, reach, grip, hygiene, and other activities. There were total of 2-3 items distributed in each of these 8 domains. Each item was scored for level of difficulty on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain score and divided by the number of domains answered. Total possible HAQ-DI score range 0 (least difficulty) and 3 (extreme difficulty), where higher score indicated more difficulty while performing daily living activities. |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 registered outcomesOutcomes75
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study) | SAS included all participants enrolled in this study who were part of a prior qualifying study, and who received at least one dose of open-label study medication in A3921092. Safety analysis included cumulative data for main and sub-study as pre-specified in protocol. | percentage of participants | NUMBER |
| PRIMARY | Number of Adverse Events (AEs) by Severity | Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study) | SAS included all participants enrolled in this study who were part of a prior qualifying study, and who received at least one dose of open-label study medication in A3921092. Safety analysis included cumulative data for main and sub-study as pre-specified in protocol. | adverse events | NUMBER |
| PRIMARY | Number of Participants With Abnormal Clinical Laboratory Values | Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study) | SAS included all participants enrolled in this study who were part of prior qualifying study, and who received at least 1 dose of open-label study medication in A3921092. Safety analysis include cumulative data for main and sub-study as pre-specified in protocol.Overall number of participants analyzed=participants evaluable for this measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values | Date of first dose of study medication (Baseline) up to 48 months (36 months of main study and 12 months of sub-study) | SAS included all participants enrolled in this study who were part of a prior qualifying study, and who received at least one dose of open-label study medication in A3921092. Safety analysis included cumulative data for main and sub-study as pre-specified in protocol. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6 | Sub-study: Baseline (Day 1), Month 6 | FAS of sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo). | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6 | Sub-study: Baseline (Day 1), Month 6 | FAS of sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Main Study: Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response | Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | FAS population for main study included all enrolled participants who were part of prior qualifying study, and who received at least 1 dose of tofacitinib in A3921092. Number analyzed=participants evaluable for this outcome measure at specified time points. | percentage of participants | NUMBER |
| SECONDARY | Main Study: Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response | Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | FAS population for main study included all enrolled participants who were part of prior qualifying study, and who received at least 1 dose of tofacitinib in A3921092. Number analyzed=participants evaluable for this outcome measure at specified time points. | percentage of participants | NUMBER |
| SECONDARY | Main Study: Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response | Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | FAS population for main study included all enrolled participants who were part of prior qualifying study, and who received at least 1 dose of tofacitinib in A3921092. Number analyzed=participants evaluable for this outcome measure at specified time points. | percentage of participants | NUMBER |
| SECONDARY | Main Study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | FAS population for main study included all enrolled participants who were part of prior qualifying study, and who received at least 1 dose of tofacitinib in A3921092. Number analyzed=participants evaluable for this outcome measure at specified time points. | units on a scale | MEAN |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 outcomesResults by group708
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | All Participants | AEs | 83.7 | percentage of participants | |
| Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | All Participants | SAEs | 16.8 | percentage of participants | |
| Number of Adverse Events (AEs) by Severity | All Participants | Number of adverse events: Mild | 1632 | adverse events | |
| Number of Adverse Events (AEs) by Severity | All Participants | Number of adverse events: Moderate | 1045 | adverse events | |
| Number of Adverse Events (AEs) by Severity | All Participants | Number of adverse events: Severe | 136 | adverse events | |
| Number of Participants With Abnormal Clinical Laboratory Values | All Participants | 646 | Participants | ||
| Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values | All Participants | 9 | Participants | ||
| Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6 | Tofacitinib 5 mg BID + Methotrexate (MTX) | 0.0174 | Standard Error 0.02775 | units on a scale | |
| Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6 | Tofacitinib 5 mg BID + Placebo | 0.0428 | Standard Error 0.02714 | units on a scale | |
| Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6 | Tofacitinib 5 mg BID + Methotrexate (MTX) | 0.138 | Standard Error 0.0805 | units on a scale |
1 to 10 of 708Source ClinicalTrials.gov
See all 708 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Main Study (36 Months) | STARTED | Tofacitinib | 686 | |
| Main Study (36 Months) | STARTED | Tofacitinib 5 mg BID + Methotrexate (MTX) | 0 | |
| Main Study (36 Months) | STARTED | Tofacitinib 5 mg BID + Placebo | 0 | |
| Main Study (36 Months) | COMPLETED | Tofacitinib | 465 | |
| Main Study (36 Months) | COMPLETED | Tofacitinib 5 mg BID + Methotrexate (MTX) | 0 | |
| Main Study (36 Months) | COMPLETED | Tofacitinib 5 mg BID + Placebo | 0 | |
| Main Study (36 Months) | NOT COMPLETED | Tofacitinib | 221 | |
| Main Study (36 Months) | NOT COMPLETED | Tofacitinib 5 mg BID + Methotrexate (MTX) | 0 | |
| Main Study (36 Months) | NOT COMPLETED | Tofacitinib 5 mg BID + Placebo | 0 | |
| Sub-study (12 Months) | STARTED | Tofacitinib | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events540
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | All Tofacitinib | 15 | 686 | |
| other | Anaemia | Blood and lymphatic system disorders | Tofacitinib 5 mg BID + Methotrexate (MTX) | 0 | 89 | |
| other | Anaemia | Blood and lymphatic system disorders | Tofacitinib 5 mg BID + Placebo | 0 | 90 | |
| other | Diarrhoea | Gastrointestinal disorders | All Tofacitinib | 25 | 686 | |
| other | Diarrhoea | Gastrointestinal disorders | Tofacitinib 5 mg BID + Methotrexate (MTX) | 0 | 89 | |
| other | Diarrhoea | Gastrointestinal disorders | Tofacitinib 5 mg BID + Placebo | 3 | 90 | |
| other | Abdominal pain upper | Gastrointestinal disorders | All Tofacitinib | 17 | 686 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Tofacitinib 5 mg BID + Methotrexate (MTX) | 0 | 89 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Tofacitinib 5 mg BID + Placebo | 0 | 90 | |
| other | Dyspepsia | Gastrointestinal disorders | All Tofacitinib | 15 | 686 |
1 to 10 of 540Source ClinicalTrials.gov
See all 540 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Tofacitinib | 6 | 686 |
| Total, all-cause mortality | Tofacitinib 5 mg BID + Methotrexate (MTX) | 0 | 89 |
| Total, all-cause mortality | Tofacitinib 5 mg BID + Placebo | 0 | 90 |
| Total, other adverse events | All Tofacitinib | 457 | 686 |
| Total, other adverse events | Tofacitinib 5 mg BID + Methotrexate (MTX) | 25 | 89 |
| Total, other adverse events | Tofacitinib 5 mg BID + Placebo | 24 | 90 |
| Total, serious adverse events | All Tofacitinib | 115 | 686 |
| Total, serious adverse events | Tofacitinib 5 mg BID + Methotrexate (MTX) | 3 | 89 |
| Total, serious adverse events | Tofacitinib 5 mg BID + Placebo | 4 | 90 |
Source ClinicalTrials.gov
Papers13
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01976364
GET https://conductscience.org/api/trials/v1/NCT01976364/registered?page=2