Trial record 1 of 1 for:    NCT01111045
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Dose Finding Study of Bone Morphogenetic Protein 7 (BMP-7) in Subjects With Osteoarthritis (OA) of the Knee

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stryker Biotech
ClinicalTrials.gov Identifier:
NCT01111045
First received: April 23, 2010
Last updated: January 30, 2012
Last verified: January 2012
  Purpose

The objectives of the study are to evaluate the safety and efficacy of intraarticular BMP-7 for the treatment of osteoarthritis of the knee.


Condition Intervention Phase
Osteoarthritis of the Knee
Drug: Bone morphogenetic protein 7
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Stryker Biotech:

Primary Outcome Measures:
  • Change from baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain subscale. [ Time Frame: Baseline, and at 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 355
Study Start Date: April 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
0.03 mg/ml BMP-7, single intraarticular knee injection
Drug: Bone morphogenetic protein 7
Comparison of different doses of the drug via single intraarticular knee injection
Active Comparator: Arm 2
0.1 mg/ml BMP-7, single intraarticular knee injection
Drug: Bone morphogenetic protein 7
Comparison of different doses of the drug via single intraarticular knee injection
Active Comparator: Arm 3
0.3 mg/ml BMP-7, single intraarticular knee injection
Drug: Bone morphogenetic protein 7
Comparison of different doses of the drug via single intraarticular knee injection
Placebo Comparator: Arm 4
1 ml placebo, single intraarticular knee injection (control)
Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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. 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

Exclusion Criteria:

  • 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:

    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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01111045

Locations
United States, Arizona
Arizona Arthritis and Rheumatology Research
Glendale, Arizona, United States, 85304
University of Arizona Arthritis Center
Tucson, Arizona, United States, 85724
United States, California
Stanford University School of Medicine
Palo Alto, California, United States, 94304
UC Davis Medical Center, Center for Aging
Sacramento, California, United States, 95817
Robin Dore, MD, Inc
Tustin, California, United States, 92780
United States, Colorado
Boulder Medical Center, PC
Boulder, Colorado, United States, 80304
United States, Florida
Rheumatology Associates of S. Florida
Boca Raton, Florida, United States, 33486
The Arthritis Center
Palm Harbor, Florida, United States, 34684
Rheumatology Associates
Stuart, Florida, United States, 34996
United States, Illinois
Apex Medical Research, AMR, Inc
Chicago, Illinois, United States, 60616
Northwestern Center for Clinical Research
Chicago, Illinois, United States, 60611
Illinois Bone and Joint Institute
Morton Grove, Illinois, United States, 60053
United States, Maryland
Johns Hopkins Medical Center
Baltimore, Maryland, United States, 21224
Klein & Associates, MD, PA
Cumberland, Maryland, United States, 21502
Arthritis and Osteoporosis Center of Maryland
Frederick, Maryland, United States, 21702
United States, Missouri
The Center for Pharmaceutical Research, PC
Kansas City, Missouri, United States, 64114
United States, Montana
Billings Clinic
Billings, Montana, United States, 59101
United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
David R. Mandel, MD, Inc.
Mayfield Village, Ohio, United States, 44143
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Clinical Research Center of Reading
West Reading, Pennsylvania, United States, 19611
United States, Texas
Baylor Research Institute
Dallas, Texas, United States, 75231
Houston Institute for Clinical Research
Houston, Texas, United States, 77074
Houston Medical Research Associates
Houston, Texas, United States, 77090
United States, Washington
Tacoma Center for Arthritis Research
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Stryker Biotech
  More Information

No publications provided

Responsible Party: Stryker Biotech
ClinicalTrials.gov Identifier: NCT01111045     History of Changes
Other Study ID Numbers: 09-OA-002
Study First Received: April 23, 2010
Last Updated: January 30, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 31, 2014