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NCT03161093 · ClinicalTrials.gov registry record · Phase 3
A Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Naproxen for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip
A Phase 3 study of Osteoarthritis, Knee and Osteoarthritis, Hip, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,307
- Enrollment target
- 20
- Study locations
NCT03161093 is a Phase 3 study of Osteoarthritis, Knee and Osteoarthritis, Hip that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 3,307 participants, above the 544-participant average among 91 other Osteoarthritis, Knee trials with a reported enrollment target (508% higher). The trial reports 20 study locations across 5 states.
The verdict
NCT03161093, a Phase 3 study of Osteoarthritis, Knee and Osteoarthritis, Hip, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,307 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of the study is to evaluate the efficacy of fasinumab compared with placebo, when administered for up to 16 weeks in patients with pain due to osteoarthritis (OA) of the knee or hip. The secondary objectives of the study are: 1. To evaluate the efficacy of fasinumab compared with naproxen, when administered for up to 16 weeks in patients with pain due to OA of the knee or hip 2. To evaluate the efficacy of fasinumab compared with placebo, when administered for up to 44 weeks in patients with pain due to OA of the knee or hip 3. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 16 weeks in patients with pain due to OA of the knee or hip 4. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 52 weeks in patients with pain due to OA of the knee or hip 5. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 104 weeks in patients with pain due to OA of the knee or hip 6. To evaluate the pharmacokinetic (PK) profile of fasinumab administered to patients with pain due to OA of the knee or hip for up to 52 weeks 7. To evaluate the PK profile of fasimumab administered to patients with pain due to OA of the knee or hip for up to 104 weeks 8. To evaluate the immunogenicity of fasinumab administered to patients with pain due to OA of the knee or hip for up to 52 weeks 9. To evaluate the immunogenicity of fasinumab administered to patients with pain due to OA of the knee or hip for up to 104 weeks 10. To evaluate the efficacy of fasinumab compared with naproxen, when administered for up to 44 weeks in patients with pain due to OA of the knee or hip
Conditions Studied
Interventions
- DRUG Naproxen
- DRUG Fasinumab
- DRUG Fasinumab-matching placebo
- DRUG Naproxen-matching placebo
Study Locations (20)
Florida
- Arthritis and Rheumatic Disease Specialties - Aventura
- Jacksonville Center for Clinical Research - Jacksonville
- Clinical Neuroscience Solutions, Inc. - Jacksonville
- Sensible Healthcare - Ocoee
- Clinical Neuroscience Solutions, Inc. - Orlando
- Jewett Orthopaedic Clinic - Orlando
- Lovelace Scientific Resources - Venice
California
- Medvin Clinical Research - Covina
- TriWest Research Associates, LLC - El Cajon
- BioSolutions Clinical Research - La Mesa
- Pacific Arthritis Care Center - Los Angeles
- Artemis Institute for Clinical Research - San Diego
- Artemis Clinical Research - San Marcos
Arizona
- Arizona Arthritis & Rheumatology Research, PLLC - Mesa
- Arizona Research Center - Phoenix
- Tucson Orthopaedic Research Center - Tucson
Colorado
- Lynn Institute of Denver - Aurora
- Lynn Institute of the Rockies - Colorado Springs
- Panorama Orthopedics & Spine Center - Golden
Arkansas
- Baptist Health Center for Clinical Research - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,307 participants |
| Start Date | 2017-08-17 |
| Est. Completion | 2021-08-27 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03161093
The ClinicalTrials.gov registry entry for NCT03161093 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3,307 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 544-participant average among 91 other Osteoarthritis, Knee trials with a reported enrollment target (508% higher). The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Osteoarthritis, Knee appearing as the primary indexed condition, and to 4 interventions - of which Naproxen is the first listed.
NCT03161093 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT03161093 about?
NCT03161093 is a clinical study titled "A Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Naproxen for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip". The primary objective of the study is to evaluate the efficacy of fasinumab compared with placebo, when administered for up to 16 weeks in patients with pain due to osteoarthritis (OA) of the knee or hip. The secondary objectives of the study are: 1. To evaluate the efficacy of fasinumab compared ...
What is the current status of trial NCT03161093?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,307 participants. The study started on 2017-08-17. Estimated completion is 2021-08-27.
What conditions does trial NCT03161093 study?
This clinical trial studies the following conditions: Osteoarthritis, Knee, Osteoarthritis, Hip.
What interventions are being tested in trial NCT03161093?
The interventions under investigation include: Naproxen (DRUG), Fasinumab (DRUG), Fasinumab-matching placebo (DRUG), Naproxen-matching placebo (DRUG).
Who is sponsoring clinical trial NCT03161093?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03161093 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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