Brief Summary

The objective of this exploratory study is to evaluate the cellular and connective tissue composition of joints from patients with Osteoarthritis (OA) who have been treated with fasinumab, compared with those treated with placebo or Non-steroidal anti-inflammatory drugs (NSAIDs).

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Apr 2019

Shorter than P25 for phase_2

Geographic Reach

3 countries

15 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.4 years study duration

First Submitted

Initial submission to the registry

April 5, 2019

Completed

3 days until next milestone

Study Start

First participant enrolled

April 8, 2019

Completed

1 month until next milestone

First Posted

Study publicly available on registry

May 14, 2019

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2020

Completed

3.1 years until next milestone

Results Posted

Study results publicly available

October 17, 2023

Completed

Last Updated

October 17, 2023

Status Verified

September 1, 2023

Enrollment Period

1.4 years

First QC Date

April 5, 2019

Results QC Date

August 15, 2023

Last Update Submit

September 25, 2023

Conditions

Osteoarthritis, Knee Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (3)

Number of Participants by Degree of Synovial Lymphocytic Inflammation
Inflammatory cells including lymphocytes, mast cells, neutrophils, and eosinophils were scored by presence and degree (None present, Slight/Mild, Moderate, Marked/Band).
Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months
Number of Participants by Degree of Cartilage Loss
Microscopic articular features including degree of cartilage were evaluated and scored (Superficial Fibrillation, Deep fissuring, Loss to Tide Mark, Loss to Exposed Bone).
Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months
Number of Participants by Degree of Bony Changes
Microscopic articular features including degree of bony changes were evaluated and scored (Normal, Sclerosis \[Lamellar/Mixed\], Subarticular Fracture/Collapse).
Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months

Study Arms (1)

Knee or Hip Joint Arthroplasty

OTHER

Patients with OA of the knee or hip who are participating in an ongoing fasinumab phase 3 parent study

Drug: FasinumabDrug: NaproxenDrug: DiclofenacDrug: CelecoxibDrug: Placebo

Interventions

FasinumabDRUG

Study drug will be administered in the parent study. Samples will be collected for participants who voluntarily elect to have knee or hip joint arthroplasty during the parent study

Also known as: REGN475