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NCT01976364 · ClinicalTrials.gov registry record · Phase 3
Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 686
- Enrollment target
NCT01976364: Completed Phase 3 study, sponsored by Pfizer.
NCT01976364 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 686 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (11% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01976364, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 686 participants
- Enrollment target
Study Summary
This is a Phase 3, long-term open-label extension study to evaluate the safety, tolerability and efficacy of tofacitinib in subjects with active PsA who have previously participated in randomized studies of tofacitinib for this indication. This study will include a sub-study to evaluate the efficacy, safety and tolerability of tofacitinib 5 mg BID administered as monotherapy after methotrexate withdrawal compared to tofacitinib 5 mg BID continued in combination with methotrexate. The sub-study will be available to subjects who have completed at least 24 months of participation in the open-label extension study and meet eligibility criteria for the sub-study.
Primary Outcome
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
Interventions
- DRUG Methotrexate
- DRUG Tofacitinib
- DRUG Placebo Methotrexate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 686 participants |
| Start Date | 2014-02-17 |
| Est. Completion | 2019-05-20 |
| Phase | Phase 3 |
What the finished NCT01976364 record still lists
NCT01976364 is an interventional study that assigns participants to a tested intervention. The registered 686 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 (11% lower).
The record links to 0 conditions, and to 3 interventions - of which Methotrexate is the first listed.
NCT01976364 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01976364 about?
NCT01976364 is a clinical study titled "Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis". This is a Phase 3, long-term open-label extension study to evaluate the safety, tolerability and efficacy of tofacitinib in subjects with active PsA who have previously participated in randomized studies of tofacitinib for this indication. This study will include a sub-study to evaluate the efficac...
What is the current status of trial NCT01976364?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 686 participants. The study started on 2014-02-17. Estimated completion is 2019-05-20.
What interventions are being tested in trial NCT01976364?
The interventions under investigation include: Methotrexate (DRUG), Tofacitinib (DRUG), Placebo Methotrexate (DRUG).
Who is sponsoring clinical trial NCT01976364?
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 NCT01976364's enrollment target sits among peer trials
686 525th of 2000 higher than 1,474 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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