A study to look at samples from knee and hip replacements in studies with 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: 20.0Level: LLTClassification code 10020108Term: Hips osteoarthritisSystem Organ Class: 100000004859; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]; MedDRA version: 20.0Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859

• Registration Number: EUCTR2018-001618-13-GB
• Lead Sponsor: Regeneron Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-25
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Previously randomised to R475-PN-1523, R475-OA-1611, or R475-OA-1688 and received at least 1 dose of study drug
2. Notified the site that they are planning a knee or hip arthroplasty during the parent study between randomization and 24 weeks after the last dose of SC study drug
3. Patient’s surgeon/pathologist is willing to coordinate with the site regarding preparation, storage, and shipping of joint tissue samples collected during arthroplasty surgery
4. Willing and able to comply with clinic visits and study-related procedures
5. Provide informed consent signed by study patient or legally acceptable representative

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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

There are no exclusion criteria for this study.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this exploratory study is to evaluate the cellular and connective tissue composition of joints from patients with OA who have been treated with fasinumab, compared with those treated with placebo or NSAIDs.;Secondary Objective: Not applicable;Primary end point(s): The endpoint for this exploratory study is descriptive histological evaluation of the synovium, cartilage, and bone.;Timepoint(s) of evaluation of this end point: Following joint arthroplasty.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable