Long-Term Safety and Efficacy Study of Fasinumab in Patients With Pain Due to Osteoarthritis (OA) of the Knee or Hip

Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Phase 3 Randomized, Double-blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Long-Term Safety and the Efficacy of Fasinumab in Patients With Pain Due to Osteoarthritis of the Knee or Hip

ClinicalTrials.gov ID

NCT02683239

Acronym / sponsor ID

FACT LTS & OA / R475-PN-1523

Conditions

Osteoarthritis of the Knee or Hip

Phase

Phase 3

Study type

Interventional

Recruitment status

Completed

Enrolment

5,331 participants (actual)

Lead sponsor

Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)

Collaborators

Teva Pharmaceutical Industries, Ltd.

Study start

17 Feb 2016 (actual)

Primary completion

1 Dec 2020 (actual)

Study completion

15 Jun 2021 (actual)

First posted

17 Feb 2016 (estimated)

Results

Posted 13 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

Quadruple blind (participant, care provider, investigator, outcomes assessor)

Number of arms

3

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Number of Participants With Any Treatment-Emergent Adverse Event (TEAE)

   Time frame: Baseline up to week 52

2. Number of Participants With Any Serious TEAE

   Time frame: Baseline up to week 52

3. Number of Participants With Any Adverse Event (AE) up to Week 72

   Time frame: Baseline up to week 72

4. Number of Participants With Any Serious AE up to Week 72

   Time frame: Baseline up to week 72

5. Number of Participants With Adjudicated Arthropathy (AA)

   Time frame: Baseline up to week 52 and week 72

   Adjudicated arthropathy (AA) is a composite term that encompasses the following conditions: Rapidly progressive OA type 1 and 2, Subchondral insufficiency fractures, and Primary Osteonecrosis. AAs were also evaluated to determine if they met Destructive Arthropathy criteria.

6. Number of Participants With Adjudicated Arthropathy (AA) Meeting Destructive Arthropathy (DA) Criteria

   Time frame: Baseline up to week 52 and week 72

   DA is a unique clinical form of rapidly destructive arthropathy over and above that seen in the normal progression of OA. DA criteria can be associated with Rapidly Progressive OA type 2, Subchondral Insufficiency fracture, and Primary Osteonecrosis confirmed by an arthropathy adjudication committee.

7. Number of Participants With at Least One Peripheral Sensory Event That Required a Neurology Consultation

   Time frame: Baseline up to week 72

   Any participant with a peripheral sensory event that persisted for 2 months was referred for a neurology or other specialty consultation and reported as an adverse event of special interest (AESI).

8. Number of Participants With Sympathetic Nervous System (SNS) Dysfunction

   Time frame: Baseline up to week 72

   Potential events of sympathetic nervous system (SNS) dysfunction were monitored throughout the study through physical examination, AE reporting, assessment of orthostatic hypotension, and the Survey of Autonomic Symptoms. Sympathetic nervous system dysfunction was diagnosed after consultation with an appropriate specialist, such as a neurologist and/or cardiologist.

9. Number of Participants With at Least One All-Cause Joint Replacement (JR) Surgery

   Time frame: Baseline up to weeks 52, 72, and end of study (52 weeks post last dose)

   All joint replacement surgery events regardless of cause at weeks 52 and 72. An end of study phone contact was also conducted approximately 52 weeks following the last dose of study drug.

10. Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values up to Week 52

    Time frame: Baseline to week 52

    Number of participants with potentially clinically significant abnormal values in hematology, chemistry, and urinalysis during the treatment period were reported. Clinical significance was determined by the investigator.

11. Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values Post-Treatment up to Week 72

    Time frame: End of treatment up to week 72

    Number of participants with potentially clinically significant abnormal values in hematology, chemistry, and urinalysis during the post-treatment period were reported. Clinical significance was determined by the investigator.

12. Number of Participants With Anti-drug Antibody (ADA) up to Week 72

    Time frame: Baseline up to week 72

    Immunogenicity was characterized by ADA responses \& titers. Responses categories: Negative - ADA negative response at all time points, regardless of missing samples; Pre-existing immunoreactivity - ADA positive response at baseline with all post first dose negative results or positive response at baseline with all post first dose ADA responses less than (<) 9-fold over baseline titer levels; Treatment-boosted response - positive response in the assay post first dose, greater than or equal to (≥) 9-fold over baseline titer levels, when baseline results are positive; Treatment-emergent response - ADA positive response in the fasinumab ADA assay post first dose when baseline results = negative or missing.

13. Change From Baseline to Week 16 in the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale Score

    Time frame: Baseline to Week 16

    The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

14. Change From Baseline to Week 16 in WOMAC Physical Function Subscale Score

    Time frame: Baseline to Week 16

    The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 41545313DiMartino SJ, Cicirello H, Magyar A, Eng S, Ho T, Manvelian G, Patel Y, Pervin K, Trinh N, Fetell M, Braunstein N, Geba GP, Dakin P. A phase III, randomised, double-blind, multi-dose, placebo- and naproxen-controlled study to evaluate the efficacy and safety of fasinumab in patients with pain due to osteoarthritis of the knee or hip. RMD Open. 2026 Jan 16;12(1):e006436. doi: 10.1136/rmdopen-2025-006436.
• Derived from this study: PubMed 39004211DiMartino SJ, Gao H, Neogi T, Fuerst T, Zaim S, Eng S, Ho T, Manvelian G, Braunstein N, Geba GP, Dakin P. Prevalence of preexisting articular bone pathology in patients with osteoarthritis screened for fasinumab clinical trials identified by X-ray or magnetic resonance imaging. Osteoarthritis Cartilage. 2024 Dec;32(12):1601-1609. doi: 10.1016/j.joca.2024.07.001. Epub 2024 Jul 14.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

149 sites in 21 countries: see every site and its status.