Long-Term Safety and Efficacy Study of Fasinumab in Patients With Pain Due to Osteoarthritis (OA) of the Knee or Hip
FACT LTS & OA
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
Other study identifiers
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
NIH
interventional
5,331
21 countries
149
Study Start
February 17, 2016
Actual (reported)Primary Completion
December 1, 2020
Actual (reported)Study Completion
June 15, 2021
Actual (reported)Brief 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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- completed
- Actual enrollment (reported)
- 5,331 participants
- Study completion date
June 15, 2021
Actual (reported)- Listed locations
- 21 countries · 149 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
January 28, 2016
Actual (reported)First Posted
February 17, 2016
Actual (reported)Study Start
February 17, 2016
Actual (reported)Primary Completion
December 1, 2020
Actual (reported)Study Completion
June 15, 2021
Actual (reported)Results Posted
October 13, 2023
Actual (reported)
- Last Updated
- October 13, 2023
- Status Verified
- October 2023
- Results QC Date
- October 11, 2023
- Last Update Submitted
- October 11, 2023