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: 21.1Level: LLTClassification code 10020108Term: Hips osteoarthritisSystem Organ Class: 100000004859; MedDRA version: 21.1Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-12
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 7000

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) A history of 12 weeks of analgesic use of OA of the knee or hip as defined by:
- Inadequate pain relief from paracetamol / acetaminophen, and
- Intolerance or inadequate pain relief from at least 1 oral NSAID, and
- Intolerance to or inadequate pain relief from opioid therapy, unwillingness to take opioid therapy for a medical acceptable reason, or lack of access to opioid therapy
5) History of regular use of analgesic medications for OA

Additional Inclusion Criteria for Sub-study Patients
1) Willing to discontinue glucosamine sulphate and chodroitin sulphate treatments during the initial 16 weeks of treatment.
2) Stable treatment with glucosamine sulphate and chondroitin sulphate treatments must be stopped during the pre-randomized period.
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 2000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5000

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) Member of the clinical site study team and/or his/her immediate family
8) Pregnant or breastfeeding women

Study & Design

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