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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 is a Phase 3 study that has completed, run by R-Pharm International. The registered enrollment target is 1,648 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02760407
The ClinicalTrials.gov registry entry for NCT02760407 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,648 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is R-Pharm International, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Olokizumab 64mg q4w is the first listed.
NCT02760407 reports 0 study locations.
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.
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