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NCT03120949 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis
A Phase 3 study of Rheumatoid Arthritis, sponsored by R-Pharm International.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,106
- Enrollment target
- 20
- Study locations
NCT03120949: Completed Phase 3 study of Rheumatoid Arthritis, sponsored by R-Pharm International.
NCT03120949 is a Phase 3 study of Rheumatoid Arthritis that has completed, run by R-Pharm International. The registered enrollment target is 2,106 participants, below the 4,680-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03120949, a Phase 3 study of Rheumatoid Arthritis, has completed, sponsored by R-Pharm International.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,106 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this study was to evaluate the long-term safety and tolerability of olokizumab (OKZ) 64 mg administered subcutaneously (SC) once every 2 weeks (q2w) or once every 4 weeks (q4w) in subjects with moderately to severely active rheumatoid arthritis (RA) who previously had completed 24 weeks of double-blind treatment in Study CREDO 1, 2 or 3 (core studies). The long-term efficacy, immunogenicity, the physical function and quality of life of subjects received long-term treatment with OKZ were assessed as well.
Primary Outcome
Incidence of Treatment-Emergent Adverse Events Reported for ≥5% of Subjects in Any Treatment Group by System Organ Class or Preferred Term
Conditions Studied
Interventions
- DRUG Olokizumab 64 mg SC q4w
- DRUG Olokizumab 64 mg SC q2w
- DRUG Concomitant treatment
Study Locations (20)
California
- Medvin Clinical Research - Covina
- C.V Mehta MD Med Corp.. - Hemet
- Advanced Medical Research, LLC - La Palma
- Valerius Medical Group - Los Alamitos
- Stanford University School of Medicine - Palo Alto
- Rheumatology Center of San Diego - San Diego
- East Bay Rheumatology Medical Group, Inc. - San Leandro
- Inland Rheumatology Clinical Trials, Inc. - Upland
- Center for Rheumatology Research, Comprehensive Rheumatology Center - West Hills
- Medvin Clinical Research - Whittier
Arizona
- AZ Arthritis & Rheum' Research - Mesa
- Arizona Arthritis & Rheumatology Associates, P.C. - Phoenix
- Arizona Arthritis & Rheumatology Research, PLLC - Sun City
Florida
- RASF - Clinical Research Center - Boca Raton
- Reliable Clinical Research, LLC - Hialeah
- Pharmax Research Clinic - Miami
Arkansas
- CHI St. Vincent Hot Springs - Hot Springs
Colorado
- Denver Arthritis Clinic - Denver
Connecticut
- New England Research Associates LLC - Bridgeport
Delaware
- Javed Rheumatology Associates - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,106 participants |
| Start Date | 2017-07-04 |
| Est. Completion | 2021-09-01 |
| Phase | Phase 3 |
What the finished NCT03120949 record still lists
NCT03120949 is an interventional study that assigns participants to a tested intervention. Its 2,106 participants enrollment target places it among the larger protocols in the corpus, below the 4,680-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (55% lower).
The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 3 interventions - of which Olokizumab 64 mg SC q4w is the first listed.
NCT03120949 names 20 study sites across 7 states, led by California, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT03120949 about?
NCT03120949 is a clinical study titled "Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis". The primary objective of this study was to evaluate the long-term safety and tolerability of olokizumab (OKZ) 64 mg administered subcutaneously (SC) once every 2 weeks (q2w) or once every 4 weeks (q4w) in subjects with moderately to severely active rheumatoid arthritis (RA) who previously had comple...
What is the current status of trial NCT03120949?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,106 participants. The study started on 2017-07-04. Estimated completion is 2021-09-01.
What conditions does trial NCT03120949 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis.
What interventions are being tested in trial NCT03120949?
The interventions under investigation include: Olokizumab 64 mg SC q4w (DRUG), Olokizumab 64 mg SC q2w (DRUG), Concomitant treatment (DRUG).
Who is sponsoring clinical trial NCT03120949?
This trial is sponsored by R-Pharm International, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03120949 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03120949's enrollment target sits among peer trials
2,106 11th of 197 higher than 187 of 197 other Rheumatoid Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rheumatoid Arthritis 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.
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