A study to examine the efficacy and safety of REGN5069 in patients with pain due to osteoarthritis of the knee

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 240

Inclusion Criteria

1. Generally in good health at the screening visit
2. Body mass index (BMI) =39 kg/m2 at the screening visit
3. Clinical diagnosis of OA of the knee based on the American College of Rheumatology criteria (Altman, 1986) with radiologic evidence of OA (K-L score =2) at the index joint at the screening visit
4. Moderate-to-severe pain in the index joint
5. A history of inadequate pain relief from or intolerance to analgesics used for OA
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 144
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 96

Exclusion Criteria

1. Diagnosis of systemic diseases that may affect joints
2. History or presence of osteonecrosis, destructive arthropathy, neuropathic joint arthropathy, pathologic fractures in any shoulder, hip, or knee joint(s), hip dislocation
(prosthetic hip dislocation is eligible), or knee dislocation (patella dislocation is eligible) at the screening visit. Presence of subchondral insufficiency fracture on screening films or
MRI as assessed by the central imaging reader.
3. Is scheduled for a joint replacement surgery to be performed during the study period
4. Received an intra-articular injection of hyaluronic acid in any joint within 90 days prior to the screening visit
5. Systemic (ie, IV, oral, or intramuscular) corticosteroids within 30 days prior to the screening visit. Intra-articular corticosteroids in the index joint within 12 weeks prior to the screening visit, or to any other joint within 30 days prior to the screening visit(topical, intranasal, or inhaled corticosteroids are permitted).
6. History or presence at the screening visit of multiple sclerosis, autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathy
7. Significant concomitant illness including, but not limited to, psychiatric, cardiac, renal, hepatic, neurological, endocrinological, metabolic, or lymphatic disease that, in the opinion of the investigator, would adversely affect the patient’s participation in the study
8. History of myocardial infarction, acute coronary syndromes, transient ischemic attack, or cerebrovascular accident within 12 months prior to the screening visit

Note: Other protocol defined inclusion/exclusion criteria apply

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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