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NCT02760433 · ClinicalTrials.gov registry record · Phase 3
Evaluation of the Efficacy and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo, in Subjects With Rheumatoid Arthritis (RA) Who Were Taking an Existing Medication Called a Tumour Necrosis Factor Alpha Inhibitor But Had Active Disease
A Phase 3 study, sponsored by R-Pharm International.
- Completed
- Registry status
- Phase 3
- Development phase
- 368
- Enrollment target
NCT02760433: Completed Phase 3 study, sponsored by R-Pharm International.
NCT02760433 is a Phase 3 study that has completed, run by R-Pharm International. The registered enrollment target is 368 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02760433, a Phase 3 study, has completed, sponsored by R-Pharm International.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 368 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 an existing medication called a tumour necrosis factor alpha inhibitor The primary objective of this study was to evaluate the efficacy of olokizumab (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 rheumatoid arthritis (RA) inadequately controlled by TNF-α inhibitor (TNFi) 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. A responder is defined as any subject satisfying ACR20 criteria and remaining on randomized treatment and in the study at Week 12. American College of Rheumatology 20 % response is a composite defined as a ≥ 20% improvement from baseline in the swollen joint counts assessed in 66 joints and in the tender joint count assessed in 68 jo
Interventions
- DRUG Placebo
- DRUG Olokizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 368 participants |
| Start Date | 2017-01-25 |
| Est. Completion | 2019-10-01 |
| Phase | Phase 3 |
What the finished NCT02760433 record still lists
NCT02760433 is an interventional study that assigns participants to a tested intervention. The registered 368 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 (52% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02760433 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02760433 about?
NCT02760433 is a clinical study titled "Evaluation of the Efficacy and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo, in Subjects With Rheumatoid Arthritis (RA) Who Were Taking an Existing Medication Called a Tumour Necrosis Factor Alpha Inhibitor But Had 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 an existing medication called a tumour necrosis factor alpha inhibitor The primary ob...
What is the current status of trial NCT02760433?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 368 participants. The study started on 2017-01-25. Estimated completion is 2019-10-01.
What interventions are being tested in trial NCT02760433?
The interventions under investigation include: Placebo (DRUG), Olokizumab (DRUG).
Who is sponsoring clinical trial NCT02760433?
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 NCT02760433's enrollment target sits among peer trials
368 996th of 2000 higher than 1,003 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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