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NCT02760407 · ClinicalTrials.gov registry record · Phase 3
Evaluation of the Efficacy and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo and Adalimumab, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Have Active Disease
A Phase 3 study, sponsored by R-Pharm International.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,648
- Enrollment target
NCT02760407: Completed Phase 3 study, sponsored by R-Pharm International.
NCT02760407 is a Phase 3 study that has completed, run by R-Pharm International. The registered enrollment target is 1,648 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (113% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02760407, a Phase 3 study, has completed, sponsored by R-Pharm International.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,648 participants
- Enrollment target
Study Summary
The purpose of this study was to determine how effective and safe the study drug Olokizumab was in patients with Rheumatoid Arthritis (RA) who had been already receiving but not fully responding to treatment with methotrexate (MTX). The primary objective of this study was to evaluate the efficacy of OKZ 64 mg administered subcutaneously (SC) once every 2 weeks (q2w) or once every 4 weeks (q4w) relative to placebo in subjects with moderately to severely active RA inadequately controlled by MTX therapy. The secondary objective was to evaluate the efficacy of OKZ relative to adalimumab in subjects with moderately to severely active RA inadequately controlled by MTX therapy.
Primary Outcome
The difference between OKZ and placebo in the percentage of subjects achieving an ACR20 response and remaining on randomized treatment and in the study at Week 12. (where a responder was defined as any subject satisfying ACR20 criteria and remaining on randomized treatment and in the study at Week 12) This endpoint served to demonstrate that the efficacy of OKZ was superior to placebo. American College of Rheumatology 20 % response is a composite defined as a ≥ 20% improvement from baseline in t
Interventions
- DRUG Olokizumab 64mg q4w
- DRUG Olokizumab 64mg q2w
- DRUG Adalimumab 40mg q2w
- DRUG Placebo q2w
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,648 participants |
| Start Date | 2016-06-06 |
| Est. Completion | 2019-11-05 |
| Phase | Phase 3 |
What the finished NCT02760407 record still lists
NCT02760407 is an interventional study that assigns participants to a tested intervention. Its 1,648 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (113% higher).
The record links to 0 conditions, and to 4 interventions - of which Olokizumab 64mg q4w is the first listed.
NCT02760407 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02760407 about?
NCT02760407 is a clinical study titled "Evaluation of the Efficacy and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo and Adalimumab, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Have Active Disease". The purpose of this study was to determine how effective and safe the study drug Olokizumab was in patients with Rheumatoid Arthritis (RA) who had been already receiving but not fully responding to treatment with methotrexate (MTX). The primary objective of this study was to evaluate the efficacy o...
What is the current status of trial NCT02760407?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,648 participants. The study started on 2016-06-06. Estimated completion is 2019-11-05.
What interventions are being tested in trial NCT02760407?
The interventions under investigation include: Olokizumab 64mg q4w (DRUG), Olokizumab 64mg q2w (DRUG), Adalimumab 40mg q2w (DRUG), Placebo q2w (DRUG).
Who is sponsoring clinical trial NCT02760407?
This trial is sponsored by R-Pharm International, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02760407's enrollment target sits among peer trials
1,648 140th of 2000 higher than 1,861 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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