A study to determine the long-term safety and the efficacy of fasinumab for treatment of adults with pain from osteoarthritis of the knee or hip

Phase 1

• Conditions: Pain due to osteoarthritis of the knee or hip; MedDRA version: 19.0Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859; MedDRA version: 19.0Level: LLTClassification code 10020108Term: Hips osteoarthritisSystem Organ Class: 100000004859; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

• Registration Number: EUCTR2015-003783-36-ES
• Lead Sponsor: Regeneron Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-17
• Study Completion: 2021-06-15
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 5331

Inclusion Criteria

1) Male or female > 18 years of age at the screening visit
2) Clinical diagnosis of OA of knee or hip based on ACR criteria with radiologic evidence of OA and moderate to severe pain in an eligible joint defined by WOMAC pain subscore
3) Willing to discontinue current pain medication
4) History of inadequate pain relief or intolerance to analgesics used for OA
5) History of regular use of analgesic medications for OA
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6500

Exclusion Criteria

1) Joint diseases or other underlying conditions that can confound with the study parameters
2) Recent use of systemic or intra-articular corticosteroids
3) Evidence of destructive arthropathy
4) Evidence of autonomic or other neuropathy
5) Scheduled for joint replacement surgery during the trial
6) Other medical conditions that may interfere with participation or accurate assessments during the trial
7) Pregnant or breastfeeding women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To describe the safety and tolerability of fasinumab, including adverse events of special interest (AESIs), in patients with pain due to radiographically-confirmed osteoarthritis (OA) of the knee or hip between baseline and week 16 (treatment period 1).;Secondary Objective: To describe the safety and tolerability of fasinumab, including AESIs, in patients with pain due to radiographically-confirmed OA of the knee or hip between:<br>- week 16 and week 52 (treatment period 2).<br>- baseline and week 52 (overall study period).;Primary end point(s): Safety monitoring including adverse event (AE) incidence, serious adverse event (SAE) incidence, AESI incidence, changes<br>in safety laboratory analyses, and incidence of anti-fasinumab antibody formation between baseline and week 16 (treatment period 1).;Timepoint(s) of evaluation of this end point: At week 16

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Safety monitoring through all adverse events incidences<br>- Incidence of anti-fasinumab antibody formation;Timepoint(s) of evaluation of this end point: At week 52