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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 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 686 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01976364
The ClinicalTrials.gov registry entry for NCT01976364 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 686 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Methotrexate is the first listed.
NCT01976364 reports 0 study locations.
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.
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