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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: Completed Phase 3 study of Osteoarthritis, Knee and Osteoarthritis, Hip, sponsored by Regeneron Pharmaceuticals.
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 468-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (607% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of
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 |
What the finished NCT03161093 record still lists
NCT03161093 is an interventional study that assigns participants to a tested intervention. Its 3,307 participants enrollment target places it among the larger protocols in the corpus, above the 468-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (607% higher).
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 names 20 study sites across 5 states, led by 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.
Learn More About Clinical Trials
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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.
Where NCT03161093's enrollment target sits among peer trials
3,307 4th of 112 higher than 109 of 112 other Osteoarthritis, Knee trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis, Knee 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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