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NCT01877668 · ClinicalTrials.gov registry record · Phase 3
Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 422
- Enrollment target
NCT01877668: Completed Phase 3 study, sponsored by Pfizer.
NCT01877668 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 422 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01877668, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 422 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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).
Interventions
- DRUG Placebo
- DRUG Adalimumab
- DRUG Tofacitinib 5 mg BID
- DRUG Tofacitinib 10 mg BID
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 422 participants |
| Start Date | 2014-01-20 |
| Est. Completion | 2015-12-18 |
| Phase | Phase 3 |
What the finished NCT01877668 record still lists
NCT01877668 is an interventional study that assigns participants to a tested intervention. The registered 422 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01877668 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01877668 about?
NCT01877668 is a clinical study titled "Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study". 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 ant...
What is the current status of trial NCT01877668?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 422 participants. The study started on 2014-01-20. Estimated completion is 2015-12-18.
What interventions are being tested in trial NCT01877668?
The interventions under investigation include: Placebo (DRUG), Adalimumab (DRUG), Tofacitinib 5 mg BID (DRUG), Tofacitinib 10 mg BID (DRUG).
Who is sponsoring clinical trial NCT01877668?
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 NCT01877668's enrollment target sits among peer trials
422 886th of 2000 higher than 1,111 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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