Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03120949
The ClinicalTrials.gov registry entry for NCT03120949 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,106 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,680-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (55% lower). The listed sponsor is R-Pharm International, which has 3 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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
Similar trials for Rheumatoid Arthritis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response
RECRUITING · Phase 3
-
Ra-pro Pragmatic Trial
RECRUITING · Phase 3
-
Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis
ACTIVE NOT RECRUITING · Phase 3
-
Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib Compared to Subcutaneous Adalimumab in Adult Participants With Moderate to Severe Rheumatoid Arthritis
ACTIVE NOT RECRUITING · Phase 3
-
A Study to Compare the Response to Treatment With Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive, and Shared Epitope-positive Rheumatoid Arthritis and an Inadequate Response to Methotrexate
ACTIVE NOT RECRUITING · Phase 3
-
A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate
ACTIVE NOT RECRUITING · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.