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

NCT01133613 | Completed Phase 1

• 1 other identifier: 09-OA-003
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Osteoarthritis of the Knee

Outcome Measures

Primary Outcomes (1)

• Safety (physical examination, vital signs, clinical laboratory measurements, adverse events)

  Baseline, Day 2, Week 1, Week 2, Week 4, Week 8, Week 12, Week 24

Secondary Outcomes (3)

• WOMAC pain and function

  Baseline, Week 4, Week 8, Week 12, Week 24

• Patient and physician global VAS

  Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 24

• Quality of life measurement (SF-36) and pain medication use

  Baseline, Week 4, Week 8, Week 12, Week 24

Study Arms (3)

Cohort 1

EXPERIMENTAL

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

Drug: Bone morphogenetic protein 7

Cohort 2

EXPERIMENTAL

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

Drug: Bone morphogenetic protein 7

Cohort 3

EXPERIMENTAL

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

Drug: Bone morphogenetic protein 7

Interventions

Bone morphogenetic protein 7 DRUG

Single intraarticular injection of BMP-7 or placebo on Day 1

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stryker Biotech: lead

Study Sites (2)

Florida Medical Research Institute

Gainesville, Florida, 32607, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Bone Morphogenetic Protein 7

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Bone Morphogenetic Proteins; TGF-beta Superfamily Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2010
• First Posted: May 31, 2010
• Study Start: May 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: February 1, 2012

Record last verified: 2012-01

Locations

US (2)