Dose Finding Study of Bone Morphogenetic Protein 7 (BMP-7) in Subjects With Osteoarthritis (OA) of the Knee
A Phase 2, Double Blind, Randomized, Placebo-Controlled, Proof of Concept, Dose Finding Study of Intraarticular Bone Morphogenetic Protein (BMP-7) in Subjects With Osteoarthritis (OA) of the Knee
1 other identifier
interventional
355
1 country
25
Brief Summary
The objectives of the study are to evaluate the safety and efficacy of intraarticular BMP-7 for the treatment of osteoarthritis of the knee.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2010
Shorter than P25 for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 23, 2010
CompletedFirst Posted
Study publicly available on registry
April 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedFebruary 1, 2012
January 1, 2012
1.3 years
April 23, 2010
January 30, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain subscale.
Baseline, and at 24 weeks
Study Arms (4)
Arm 1
ACTIVE COMPARATOR0.03 mg/ml BMP-7, single intraarticular knee injection
Arm 2
ACTIVE COMPARATOR0.1 mg/ml BMP-7, single intraarticular knee injection
Arm 3
ACTIVE COMPARATOR0.3 mg/ml BMP-7, single intraarticular knee injection
Arm 4
PLACEBO COMPARATOR1 ml placebo, single intraarticular knee injection (control)
Interventions
Comparison of different doses of the drug via single intraarticular knee injection
Eligibility Criteria
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. Symptoms must include knee joint pain.
- A male or female adult age \>40 years
- female subjects of childbearing potential must have a negative serum pregnancy test during screening and a negative urine pregnancy test on the day of injection
- Radiographic evidence of at least one tibiofemoral osteophyte and Osteoarthritis Research Society International (OARSI) Atlas joint space narrowing grade of 1 or 2 in the index knee
- WOMAC pain score of \>8 at screening and baseline
- Able to comply with the study and give informed consent
- Able to read, write and understand English
You may not qualify if:
- A requirement for treatment with opioids for pain relief.
- Unwilling to abstain from NSAIDs and/or other analgesic medications for 48 hours and acetaminophen for 24 hours prior to pain assessments during the study. Subjects taking low dose aspirin for cardiovascular health may remain on their stable dose throughout the study.
- Using a handicap assistance device (i.e., cane, walker) \>50% of the time.
- Undergoing new physical therapy or participating in a weight loss or exercise program that has not been stable for at least 3 months prior to screening visit 1 and will not remain stable during their participation in the study.
- History of arthroscopic or open surgery to the index knee in the past 12 months or planned surgery during study.
- History of joint replacement surgery (index knee).
- Received corticosteroid, short acting hyaluronic acid, or other intraarticular injections of the index knee within 3 months of screening and/or not willing to abstain from treatments for the duration of the study
- Received long acting hyaluronic acid injection of the index knee within 6 months of screening and/or not willing to abstain from treatments for the duration of the study.
- History in the past 10 years of reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis, amyloidosis or fibromyalgia.
- Clinical signs and symptoms of active knee infection or radiographic evidence of crystal disease other than chondrocalcinosis (i.e., gout and CPPD).
- A history of abnormal laboratory results ≥2.5 x ULN indicative of any significant medical disease, which in the opinion of the investigator, would preclude the subjects participation in the study
- Any of the following abnormal laboratory results during screening:
- ALT and AST ≥2.5x ULN
- Hemoglobin \<11.5 g/dL (Female) or \<13.2 g/dL (Male)
- WBC \<3500 cells/mm3
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stryker Biotechlead
Study Sites (25)
Arizona Arthritis and Rheumatology Research
Glendale, Arizona, 85304, United States
University of Arizona Arthritis Center
Tucson, Arizona, 85724, United States
Stanford University School of Medicine
Palo Alto, California, 94304, United States
UC Davis Medical Center, Center for Aging
Sacramento, California, 95817, United States
Robin Dore, MD, Inc
Tustin, California, 92780, United States
Boulder Medical Center, PC
Boulder, Colorado, 80304, United States
Rheumatology Associates of S. Florida
Boca Raton, Florida, 33486, United States
The Arthritis Center
Palm Harbor, Florida, 34684, United States
Rheumatology Associates
Stuart, Florida, 34996, United States
Northwestern Center for Clinical Research
Chicago, Illinois, 60611, United States
Apex Medical Research, AMR, Inc
Chicago, Illinois, 60616, United States
Illinois Bone and Joint Institute
Morton Grove, Illinois, 60053, United States
Johns Hopkins Medical Center
Baltimore, Maryland, 21224, United States
Klein & Associates, MD, PA
Cumberland, Maryland, 21502, United States
Arthritis and Osteoporosis Center of Maryland
Frederick, Maryland, 21702, United States
The Center for Pharmaceutical Research, PC
Kansas City, Missouri, 64114, United States
Billings Clinic
Billings, Montana, 59101, United States
The Ohio State University Medical Center
Columbus, Ohio, 43210, United States
David R. Mandel, MD, Inc.
Mayfield Village, Ohio, 44143, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Clinical Research Center of Reading
West Reading, Pennsylvania, 19611, United States
Baylor Research Institute
Dallas, Texas, 75231, United States
Houston Institute for Clinical Research
Houston, Texas, 77074, United States
Houston Medical Research Associates
Houston, Texas, 77090, United States
Tacoma Center for Arthritis Research
Tacoma, Washington, 98405, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2010
First Posted
April 27, 2010
Study Start
April 1, 2010
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
February 1, 2012
Record last verified: 2012-01