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NCT02187055 · ClinicalTrials.gov registry record · Phase 4
An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate
A Phase 4 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,152
- Enrollment target
NCT02187055: Completed Phase 4 study, sponsored by Pfizer.
NCT02187055 is a Phase 4 study that has completed, run by Pfizer. The registered enrollment target is 1,152 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (122% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02187055, a Phase 4 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,152 participants
- Enrollment target
Study Summary
To assess the efficacy of tofacitinib monotherapy or tofacitinib with methotrexate as compared to adalimumab with methotrexate. To compare the efficacy of tofacitinib monotherapy compared to tofacitinib combined with methotrexate. To compare effects on all health outcomes measures in the study. To evaluate the safety and tolerability of tofacitinib and adalimumab. To evaluate the safety of the zoster vaccine given prior to the initiation of tofacitinb or adalimumab.
Primary Outcome
ACR50 is a greater than or equal to (≥) 50 percent (%) improvement in tender joint count (TJC) or swollen joint count (SJC) and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment (PGA) of disease activity, 2) participant's assessment (PtGA) of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein (CRP) at each visit.
Interventions
- DRUG Tofacitinib with methotrexate
- DRUG Tofacitinib without methotrexate
- BIOLOGICAL Adalimumab with methotrexate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,152 participants |
| Start Date | 2014-08 |
| Est. Completion | 2016-12 |
| Phase | Phase 4 |
What the finished NCT02187055 record still lists
NCT02187055 is an interventional study that assigns participants to a tested intervention. Its 1,152 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (122% higher).
The record links to 0 conditions, and to 3 interventions - of which Tofacitinib with methotrexate is the first listed.
NCT02187055 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02187055 about?
NCT02187055 is a clinical study titled "An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate". To assess the efficacy of tofacitinib monotherapy or tofacitinib with methotrexate as compared to adalimumab with methotrexate. To compare the efficacy of tofacitinib monotherapy compared to tofacitinib combined with methotrexate. To compare effects on all health outcomes measures in the study. To e...
What is the current status of trial NCT02187055?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,152 participants. The study started on 2014-08. Estimated completion is 2016-12.
What interventions are being tested in trial NCT02187055?
The interventions under investigation include: Tofacitinib with methotrexate (DRUG), Tofacitinib without methotrexate (DRUG), Adalimumab with methotrexate (BIOLOGICAL).
Who is sponsoring clinical trial NCT02187055?
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 NCT02187055's enrollment target sits among peer trials
1,152 63rd of 2000 higher than 1,938 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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