Dose Finding Study of Bone Morphogenetic Protein 7 (BMP-7) in Subjects With Osteoarthritis (OA) of the Knee

January 30, 2012 updated by: Stryker Biotech

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
355

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

36 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain subscale.
Time Frame: Baseline, and at 24 weeks
Baseline, and at 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stryker Biotech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 1, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 09-OA-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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