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

Study to Evaluate Arthroplasty Specimens in the Phase 3 Fasinumab Program for Osteoarthritis of the Knee and Hip

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001618-13-GB

Enrollment

Registered

2018-09-25

Start date

2018-11-28

Completion date

Unknown

Last updated

2020-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain due to osteoarthritis of the knee or hip MedDRA version: 20.0 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 100000004859 MedDRA version: 20.0 Level: LLT Classification code 10020108 Term: Hips osteoarthritis System Organ Class: 100000004859

Interventions

Product Name: Fasinumab Product Code: REGN475 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Fasinumab CAS Number: 1190239-42-9 Current Sponsor code: REGN475 Ot

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: There are no exclusion criteria for this study.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Poland, United Kingdom, United States

Contacts

Public ContactClinical Trial Information

Regeneron Pharmaceuticals, Inc.

clinicaltrials@regeneron.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026