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

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02447276
• Other study ID #: R475-PN-1227
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 14, 2015
• Last updated: March 24, 2017
• Start date: May 2015
• Est. completion date: November 2016

Study information

• Verified date: October 2016
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 421
• Est. completion date: November 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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, renal osteodystrophy or tumors

2. History of osteonecrosis, destructive arthropathy (RPOA), hip dislocation, pathologic fractures, neuropathic joint arthropathy, knee dislocation 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 to be performed 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 90 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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee

Intervention

Drug:
• REGN475

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Baseline to week 16
Secondary	Change from baseline to week 16 in the WOMAC physical function subscale score		Baseline to week 16
Secondary	Change from baseline to week 16 in the Patient Global Assessment score		Baseline to week 16
Secondary	Incidence of treatment-emergent adverse events (TEAEs)		Baseline to week 36 (end of study)
Secondary	Incidence of anti-REGN475 antibody development		Baseline to week 36 (end of study)