At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 5,331 enrolled
Drug / intervention
Fasinumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Randomized, Double-blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Long-Term Safety and the Efficacy of Fasinumab in Patients With Pain Due to Osteoarthritis of the Knee or Hip
In Brief
A Phase 3 clinical trial evaluating Fasinumab and Placebo for Osteoarthritis of the Knee or Hip. Completed, enrolled 5,331 participants across 149 sites in 21 countries.
Detailed Summary
The primary objective of the study is to describe the safety and tolerability of fasinumab, including adverse events of special interest (AESIs), in patients with pain due to radiographically-confirmed OA of the knee or hip.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis of the Knee or Hip
CountriesBulgaria, Chile, Colombia, Denmark, Estonia, Germany, Hong Kong, Hungary, Italy, Lithuania, Mexico, Peru, Poland, Romania, Russia, South Africa, Spain, Sweden, Ukraine, United Kingdom, United States
CollaboratorsTeva Pharmaceutical Industries, Ltd.
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 2016
Enrollment StartFeb 2016
Primary CompletionDec 2020
Study CompletionJun 2021
TodayJul 2026
First PostedFeb 17, 2016
Enrollment StartFeb 17, 2016
Primary CompletionDec 1, 2020
Study CompletionJun 15, 2021
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 10.4 years ago
Interventions
Fasinumabdrug
Participants will receive sub-cutaneous (SC) injections of fasinumab
Placebodrug
Participants will receive sub-cutaneous (SC) injections of matching placebo