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

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ClinicalTrials.gov Identifier: NCT02683239
Recruitment Status : Recruiting
First Posted : February 17, 2016
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
Teva Pharmaceutical Industries, Ltd.
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE January 28, 2016
First Posted Date  ICMJE February 17, 2016
Last Update Posted Date April 16, 2019
Actual Study Start Date  ICMJE February 17, 2016
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2019)
  • Incidence of adverse events (AEs) [ Time Frame: Baseline to week 52 ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: Baseline to week 52 ]
  • Incidence of adverse events of special interest (AESI) [ Time Frame: Baseline to week 52 ]
  • Incidence of laboratory abnormalities [ Time Frame: Baseline to week 52 ]
  • Incidence of anti-fasinumab antibody formation [ Time Frame: Baseline to week 52 ]
  • Incidence of adverse events (AEs) [ Time Frame: Baseline to week 72 ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: Baseline to week 72 ]
  • Incidence of adverse events of special interest (AESI) [ Time Frame: Baseline to week 72 ]
  • Incidence of laboratory abnormalities [ Time Frame: Baseline to week 72 ]
  • Incidence of anti-fasinumab antibody formation [ Time Frame: Baseline to week 72 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 16, 2016)
  • Incidence of Adverse Events (AEs) [ Time Frame: Baseline to week 16 ]
    Includes Serious Adverse Events (SAEs) and AEs of Special Interest (AESI)
  • Percentage of patients with abnormal clinical laboratory values [ Time Frame: Baseline to week 16 ]
    Primary safety endpoint
  • Incidence of anti-fasinumab antibody formation [ Time Frame: Baseline to week 16 ]
    Primary safety endpoint
  • Change from baseline to week 16 in the Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain subscale score [ Time Frame: Baseline to week 16 ]
    Primary efficacy endpoint for sub-study
  • Change from baseline to week 16 in the WOMAC physical function subscale score [ Time Frame: Baseline to week 16 ]
    Primary efficacy endpoint for sub-study
  • Change from baseline to week 16 in the Patient Global Assessment (PGA) for OA score [ Time Frame: Baseline to week 16 ]
    Primary efficacy endpoint for sub-study
Change History Complete list of historical versions of study NCT02683239 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2016)
  • Incidence of AEs [ Time Frame: Week 16 to week 52 ]
    Includes SAEs and AESI
  • Percentage of patients with abnormal clinical laboratory values [ Time Frame: Week 16 to week 52 ]
    Secondary safety endpoint
  • Incidence of anti-fasinumab antibody formation [ Time Frame: Week 16 to week 52 ]
    Secondary safety endpoint
  • Change from baseline at time points up to week 12 in the WOMAC pain subscale score [ Time Frame: Baseline up to week 12 ]
    Secondary efficacy endpoint for sub-study
  • Change from baseline at time points up to week 12 in the WOMAC physical function subscale score [ Time Frame: Baseline up to week 12 ]
    Secondary efficacy endpoint for sub-study
  • Change from baseline at time points up to week 12 in the PGA of OA score [ Time Frame: Baseline up to week 12 ]
    Secondary efficacy endpoint for sub-study
  • Change from baseline at time points up to week 16 in the Average Daily Walking Index Joint Pain numerical rating scale (NRS) pain scale [ Time Frame: Baseline up to week 16 ]
    Secondary efficacy endpoint for sub-study
  • Change from baseline at time points up to week 16 in the WOMAC total score [ Time Frame: Baseline up to week 16 ]
    Secondary efficacy endpoint for sub-study
  • Change from baseline at time points up to week 16 in the WOMAC stiffness subscale score [ Time Frame: Baseline up to week 16 ]
    Secondary efficacy endpoint for sub-study
  • The percentage of patients who have a reduction in WOMAC pain and physical function subscale scores of 30% and 50% from baseline to week 16 [ Time Frame: Baseline to week 16 ]
    Secondary efficacy endpoint for sub-study
  • The percentage of patients who have a reduction in PGA scale of 30% and 50% from baseline to week 16 [ Time Frame: Baseline to week 16 ]
    Secondary efficacy endpoint for sub-study
  • Change in response to therapy from baseline to week 16 assessed using the Osteoarthritis Research Society International Standing Committee for Clinical Trials Response Criteria Initiative and The Outcome Measure in Rheumatology (OMERACT-OARSI) [ Time Frame: Baseline to week 16 ]
    Secondary efficacy endpoint for sub-study
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-Term Safety and Efficacy Study of Fasinumab in Patients With Pain Due to Osteoarthritis (OA) of the Knee or Hip
Official Title  ICMJE 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
Brief Summary The primary objective of the study is to describe the safety and tolerability of fasinumab, including adverse events of special interest (AESIs), in patients with pain due to radiographically-confirmed OA of the knee or hip.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis of the Knee or Hip
Intervention  ICMJE
  • Drug: Fasinumab
    Participants will receive sub-cutaneous (SC) injections of fasinumab
    Other Name: REGN475
  • Drug: Placebo
    Participants will receive sub-cutaneous (SC) injections of matching placebo
Study Arms  ICMJE
  • Experimental: Fasinumab dosing regimen 1
    Intervention: Drug: Fasinumab
  • Experimental: Fasinumab dosing regimen 2
    Intervention: Drug: Fasinumab
  • Experimental: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 11, 2019)
7000
Original Estimated Enrollment  ICMJE
 (submitted: February 16, 2016)
10000
Estimated Study Completion Date  ICMJE February 13, 2022
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  1. Male or female ≥18 years of age at the screening visit
  2. Clinical diagnosis of OA of the knee or hip based on the American College of Rheumatology criteria with radiologic evidence of OA (K-L score ≥2) for the index joint at the screening visit
  3. Moderate to severe pain in the index joint defined as a Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) average pain subscale score of ≥4
  4. A history of 12 weeks of analgesic use for OA of the knee or hip
  5. History of regular use of analgesic medications for OA pain

Key Exclusion Criteria:

  1. History or presence at the screening visit of non OA inflammatory joint disease
  2. History or presence on imaging of arthropathy, stress fracture, recent stress fracture, neuropathic joint arthropathy, hip dislocation, knee dislocation, congenital hip dysplasia with degenerative joint disease, extensive subchondral cysts, evidence of bone fragmentation or collapse, or primary metastatic tumor with the exception of chondromas or pathologic fracture during the screening period
  3. Signs or symptoms of carpal tunnel syndrome within 6 months of screening
  4. Patient is not a candidate for MRI
  5. Is scheduled for a joint replacement surgery to be performed during the study period
  6. Systemic (i.e., oral or intramuscular) corticosteroids within 30 days prior to the screening visit.
  7. History or presence at the screening visit of multiple sclerosis, autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathy, including reflex sympathetic dystrophy
  8. History or diagnosis of chronic autonomic failure syndrome including pure autonomic failure, multiple system atrophy
  9. Pregnant or breast-feeding women
  10. Women of childbearing potential who have a positive pregnancy test result or do not have their pregnancy test result at baseline

Note: Other protocol defined Inclusion/Exclusion criteria apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com
Listed Location Countries  ICMJE Bulgaria,   Chile,   Estonia,   Hong Kong,   Hungary,   Lithuania,   Poland,   Romania,   Russian Federation,   South Africa,   Spain,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02683239
Other Study ID Numbers  ICMJE R475-PN-1523
2015-003783-36 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Regeneron Pharmaceuticals
Study Sponsor  ICMJE Regeneron Pharmaceuticals
Collaborators  ICMJE Teva Pharmaceutical Industries, Ltd.
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP