Double-Blind, Randomized, Single Dose Escalation Safety Study of Intraarticular Bone Morphogenic Protein (38A BMP-7) in Subjects With Osteoarthritis (OA) of the Knee

Stryker

Status and phase: Completed; Phase 1

Conditions: Osteoarthritis of the Knee

Treatments: Drug: Bone morphogenetic protein 7

Study type: Interventional

Funder types: Industry

Identifiers

NCT01133613

09-OA-003

Details and patient eligibility

About

The objective of the study is to determine the safety and tolerability of two different formulations of BMP-7 for the treatment of osteoarthritis of the knee.

Enrollment: 51 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Ambulatory with a diagnosis of OA of the knee with symptoms for at least 6 months and pain on the majority of days in the last 30 days.
• >40 years
• Radiographic evidence of at least one osteophyte in either knee at screening

Exclusion Criteria

• Concurrent medical or arthritis condition that could interfere with evaluation of index knee joint (including fibromyalgia)
• Unwilling to abstain from NSAIDs and/or other analgesic medications for 48 hrs prior to assessments. Subjects can remain on acetaminophen up to 3.0 g daily.
• Received arthroscopic or open surgery to the index knee within 6 months of screening
• History of joint replacement surgery (index knee).
• Corticosteroid, short acting hyaluronic acid, or other intraarticular injections of the index knee within 3 months of screening
• Long acting hyaluronic acid injection of the index knee within 6 months of screening
• History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, lymphoma, and arthritis associated with inflammatory bowel disease, sarcoidosis, amyloidosis or fibromyalgia.
• History of malignancy with the exception of resected basal cell, squamous cell of the skin, resected cervical atypia or carcinoma in situ.
• Female subject with reproductive capability.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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51 participants in 3 patient groups

Cohort 1

Experimental group

Description:

0.03 mg/ml BMP-7 or placebo via intraarticular knee injection

Treatment:

Drug: Bone morphogenetic protein 7

Cohort 2

Experimental group

Description:

0.1 mg/ml BMP-7 or placebo via intraarticular knee injection

Treatment:

Drug: Bone morphogenetic protein 7

Cohort 3

Experimental group

Description:

0.3 mg/ml BMP-7 or placebo via intraarticular knee injection

Treatment:

Drug: Bone morphogenetic protein 7