Trial record 3 of 45 for:    regeneron | Open Studies

Study of REGN475 in Patients With Pain Due to Osteoarthritis of the Knee or Hip

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Regeneron Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02447276
First received: May 14, 2015
Last updated: June 4, 2015
Last verified: June 2015
  Purpose

The primary objective of this study is to evaluate the effectiveness of REGN475 compared to placebo in participants with pain due to osteoarthritis (OA) of the knee or hip and a history of inadequate joint pain relief or intolerance to current analgesic therapy.


Condition Intervention Phase
Osteoarthritis, Knee
Osteoarthritis, Hip
Drug: REGN475
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of REGN475 in Patients With Pain Due to Osteoarthritis of the Knee or Hip

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • The primary endpoint in the study is the change from baseline to week 16 in the Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain subscale score. [ Time Frame: Baseline to week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to week 16 in the WOMAC physical function subscale score [ Time Frame: Baseline to week 16 ] [ Designated as safety issue: No ]
  • Change from baseline to week 16 in the Patient Global Assessment score [ Time Frame: Baseline to week 16 ] [ Designated as safety issue: No ]
  • Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Baseline to week 36 (end of study) ] [ Designated as safety issue: Yes ]
  • Incidence of anti-REGN475 antibody development [ Time Frame: Baseline to week 36 (end of study) ] [ Designated as safety issue: No ]

Estimated Enrollment: 375
Study Start Date: May 2015
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Group A will receive REGN475 dosing regimen 1
Drug: REGN475
Experimental: Group B
Group B will receive REGN475 dosing regimen 2
Drug: REGN475
Experimental: Group C
Group C will receive REGN475 dosing regimen 3
Drug: REGN475
Experimental: Group D
Group D will receive REGN475 dosing regimen 4
Drug: REGN475
Experimental: Group E
Group E will receive matching placebo
Drug: Placebo

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Body mass index ≤39
  2. Clinical diagnosis of OA of the knee or hip
  3. History of inadequate pain relief or intolerance to analgesics used for OA
  4. Moderate to severe pain in the index joint
  5. History of regular use of analgesic medications for OA pain
  6. Willing to discontinue current non-steroidal anti-inflammatory drug (NSAID) and opioid pain medications

Key Exclusion Criteria:

  1. Other diseases that may involve index knee or hip, including inflammatory joint diseases, crystalline disease (gout or pseudogout), endocrinopathies, metabolic joint disease, lupus erythematosus, rheumatoid arthritis, joint infections, neuropathic disorders, avascular necrosis, Paget's disease or tumors
  2. History of osteonecrosis, destructive arthropathy (RPOA), hip dislocation, pathologic fractures, neuropathic joint arthropathy, or hip dislocation
  3. Trauma to the index joint in the 30 days before screening
  4. Active fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to severe pain that may confound assessments or self-evaluation of the pain associated with OA
  5. Prior to the start of the study has received a recommendation for, or is scheduled for joint replacement surgery during the study period
  6. Presence of subchondral insufficiency fracture on screening films or MRI
  7. Received an intra-articular injection of hyaluronic acid in the affected index joint within 30 days prior to the screening visit
  8. Systemic (ie, oral or intramuscular) corticosteroids within 30 days prior to the screening visit. Intra-articular corticosteroids in the index joint within 12 weeks of the screening visit, or to any other joint within 30 days prior to the screening visit.
  9. History of autonomic neuropathy, diabetic neuropathy, or presence of clinically relevant peripheral neuropathy at the time of screening
  10. Women of childbearing potential who have a positive pregnancy test result, or who do not have their pregnancy test results at baseline
  11. Pregnant or breastfeeding women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02447276

Contacts
Contact: Clinical Trials Administrator clinicaltrials@regeneron.com

  Show 55 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02447276     History of Changes
Other Study ID Numbers: R475-PN-1227
Study First Received: May 14, 2015
Last Updated: June 4, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 03, 2015