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NCT02831855 · ClinicalTrials.gov registry record · Phase 4
Methotrexate Withdrawal Study of Tofacitinib Modified Release Formulation in Subjects With Rheumatoid Arthritis
A Phase 4 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 4
- Development phase
- 694
- Enrollment target
NCT02831855: Completed Phase 4 study, sponsored by Pfizer.
NCT02831855 is a Phase 4 study that has completed, run by Pfizer. The registered enrollment target is 694 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (34% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02831855, a Phase 4 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 694 participants
- Enrollment target
Study Summary
This study is designed to evaluate the efficacy and safety of tofacitinib modified release formulation (11mg QD) versus tofacitinib modified release formulation plus continued methotrexate treatment in subjects with moderate to severe rheumatoid arthritis who are insufficiently responding to their stable dose of methotrexate treatment.
Primary Outcome
DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joints count, ESR (millimeters per hour \[mm/hr\]) and participant global assessment of arthritis (PtGA) on a 100 millimeter (mm) visual analog scale (VAS: scores ranging from 0 mm \[very well\] to 100 mm \[worst\], higher scores indicate worse health condition). Total DAS28-4 (ESR) score range: 0 (none) to 9.4
Interventions
- DRUG Placebo
- DRUG Methotrexate
- DRUG CP-690,550
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 694 participants |
| Start Date | 2016-09-01 |
| Est. Completion | 2018-12-17 |
| Phase | Phase 4 |
What the finished NCT02831855 record still lists
NCT02831855 is an interventional study that assigns participants to a tested intervention. The registered 694 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (34% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02831855 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02831855 about?
NCT02831855 is a clinical study titled "Methotrexate Withdrawal Study of Tofacitinib Modified Release Formulation in Subjects With Rheumatoid Arthritis". This study is designed to evaluate the efficacy and safety of tofacitinib modified release formulation (11mg QD) versus tofacitinib modified release formulation plus continued methotrexate treatment in subjects with moderate to severe rheumatoid arthritis who are insufficiently responding to their s...
What is the current status of trial NCT02831855?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 694 participants. The study started on 2016-09-01. Estimated completion is 2018-12-17.
What interventions are being tested in trial NCT02831855?
The interventions under investigation include: Placebo (DRUG), Methotrexate (DRUG), CP-690,550 (DRUG).
Who is sponsoring clinical trial NCT02831855?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02831855's enrollment target sits among peer trials
694 119th of 2000 higher than 1,882 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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