Dose Finding Study of Bone Morphogenetic Protein 7 (BMP-7) in Subjects With Osteoarthritis (OA) of the Knee
NCT ID: NCT01111045
Last Updated: 2012-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
355 participants
INTERVENTIONAL
2010-04-30
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1
0.03 mg/ml BMP-7, single intraarticular knee injection
Bone morphogenetic protein 7
Comparison of different doses of the drug via single intraarticular knee injection
Arm 2
0.1 mg/ml BMP-7, single intraarticular knee injection
Bone morphogenetic protein 7
Comparison of different doses of the drug via single intraarticular knee injection
Arm 3
0.3 mg/ml BMP-7, single intraarticular knee injection
Bone morphogenetic protein 7
Comparison of different doses of the drug via single intraarticular knee injection
Arm 4
1 ml placebo, single intraarticular knee injection (control)
Placebo
Placebo
Interventions
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Bone morphogenetic protein 7
Comparison of different doses of the drug via single intraarticular knee injection
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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:
1. ALT and AST ≥2.5x ULN
2. Hemoglobin \<11.5 g/dL (Female) or \<13.2 g/dL (Male)
3. WBC \<3500 cells/mm3
4. Lymphocyte count ≤1000 cells/mm3
5. Serum creatinine ≥1.5 x ULN
6. Platelet count below the central laboratory lower limit of normal.
* History of malignancy in the past ten years (\<10 years), with the exception of resected basal cell, squamous cell of the skin, resected cervical atypia or carcinoma in situ.
* Significant hip pain, ipsilateral to the index knee that may interfere with assessments of index knee pain
* Skin breakdown at the knee where the injection would take place
* A known or clinically suspected infection with human immunodeficiency virus (HIV), or hepatitis C or B viruses
* Participated within 3 months or will participate concurrently in another investigational drug or vaccine study
* A history of drug or alcohol dependence or abuse in the past 3 years
* Previous treatment with BMP-7 or any bone morphogenetic protein
* A female with reproductive capability who is unwilling to use birth control for the duration of the study and/or intends to conceive within 12 months of dosing.
* Other serious, non-malignant, significant, acute or chronic medical or psychiatric illness that, in the judgment of the investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.
40 Years
ALL
No
Sponsors
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Stryker Biotech
INDUSTRY
Responsible Party
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Locations
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Arizona Arthritis and Rheumatology Research
Glendale, Arizona, United States
University of Arizona Arthritis Center
Tucson, Arizona, United States
Stanford University School of Medicine
Palo Alto, California, United States
UC Davis Medical Center, Center for Aging
Sacramento, California, United States
Robin Dore, MD, Inc
Tustin, California, United States
Boulder Medical Center, PC
Boulder, Colorado, United States
Rheumatology Associates of S. Florida
Boca Raton, Florida, United States
The Arthritis Center
Palm Harbor, Florida, United States
Rheumatology Associates
Stuart, Florida, United States
Northwestern Center for Clinical Research
Chicago, Illinois, United States
Apex Medical Research, AMR, Inc
Chicago, Illinois, United States
Illinois Bone and Joint Institute
Morton Grove, Illinois, United States
Johns Hopkins Medical Center
Baltimore, Maryland, United States
Klein & Associates, MD, PA
Cumberland, Maryland, United States
Arthritis and Osteoporosis Center of Maryland
Frederick, Maryland, United States
The Center for Pharmaceutical Research, PC
Kansas City, Missouri, United States
Billings Clinic
Billings, Montana, United States
The Ohio State University Medical Center
Columbus, Ohio, United States
David R. Mandel, MD, Inc.
Mayfield Village, Ohio, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Clinical Research Center of Reading
West Reading, Pennsylvania, United States
Baylor Research Institute
Dallas, Texas, United States
Houston Institute for Clinical Research
Houston, Texas, United States
Houston Medical Research Associates
Houston, Texas, United States
Tacoma Center for Arthritis Research
Tacoma, Washington, United States
Countries
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Other Identifiers
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09-OA-002
Identifier Type: -
Identifier Source: org_study_id
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