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Long-Term Safety and Efficacy Study of Fasinumab in Patients With Pain Due to Osteoarthritis (OA) of the Knee or Hip

NCT02683239 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5331

Last updated 2023-10-13

Study results available
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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.

Conditions

  • Osteoarthritis of the Knee or Hip

Interventions

DRUG

Fasinumab

Participants will receive sub-cutaneous (SC) injections of fasinumab

DRUG

Placebo

Participants will receive sub-cutaneous (SC) injections of matching placebo

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-17
Primary Completion
2020-12-01
Completion
2021-06-15

Countries

  • United States
  • Bulgaria
  • Chile
  • Colombia
  • Denmark
  • Estonia
  • Germany
  • Hong Kong
  • Hungary
  • Italy
  • Lithuania
  • Mexico
  • Peru
  • Poland
  • Romania
  • Russia
  • South Africa
  • Spain
  • Sweden
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02683239 on ClinicalTrials.gov