Osteoarthritis of the KneePhase 2NCT01111045
Dose Finding Study of Bone Morphogenetic Protein 7 (BMP-7) in Subjects With Osteoarthritis (OA) of the Knee
A Phase 2 study testing Bone morphogenetic protein 7 in people with Osteoarthritis of the Knee, run by Stryker Biotech at 25 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Bone morphogenetic protein 7
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 355 participants
- Where
- 25 sitesUnited States
- Study dates
- Apr 2010to Aug 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 27Show fewer
- 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
- Lymphocyte count ≤1000 cells/mm3
- Serum creatinine ≥1.5 x ULN
- 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.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Johns Hopkins Medical Center
Baltimore, Maryland, 21224
Billings Clinic
Billings, Montana, 59101
Rheumatology Associates of S. Florida
Boca Raton, Florida, 33486
Boulder Medical Center, PC
Boulder, Colorado, 80304
Northwestern Center for Clinical Research
Chicago, Illinois, 60611
Apex Medical Research, AMR, Inc
Chicago, Illinois, 60616
The Ohio State University Medical Center
Columbus, Ohio, 43210
Klein & Associates, MD, PA
Cumberland, Maryland, 21502
Baylor Research Institute
Dallas, Texas, 75231
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Arthritis and Osteoporosis Center of Maryland
Frederick, Maryland, 21702
Arizona Arthritis and Rheumatology Research
Glendale, Arizona, 85304
Houston Institute for Clinical Research
Houston, Texas, 77074
Houston Medical Research Associates
Houston, Texas, 77090
The Center for Pharmaceutical Research, PC
Kansas City, Missouri, 64114
David R. Mandel, MD, Inc.
Mayfield Village, Ohio, 44143
Illinois Bone and Joint Institute
Morton Grove, Illinois, 60053
The Arthritis Center
Palm Harbor, Florida, 34684
Stanford University School of Medicine
Palo Alto, California, 94304
UC Davis Medical Center, Center for Aging
Sacramento, California, 95817
Rheumatology Associates
Stuart, Florida, 34996
Tacoma Center for Arthritis Research
Tacoma, Washington, 98405
University of Arizona Arthritis Center
Tucson, Arizona, 85724
Robin Dore, MD, Inc
Tustin, California, 92780
Clinical Research Center of Reading
West Reading, Pennsylvania, 19611
About this study
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
The objectives of the study are to evaluate the safety and efficacy of intraarticular BMP-7 for the treatment of osteoarthritis of the knee.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Bone morphogenetic protein 7, Placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone morphogenetic protein 7Drug
Comparison of different doses of the drug via single intraarticular knee injection
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | 0.03 mg/ml BMP-7, single intraarticular knee injection Receives: Drug: Bone morphogenetic protein 7 |
| Arm 2 | Active comparator | 0.1 mg/ml BMP-7, single intraarticular knee injection Receives: Drug: Bone morphogenetic protein 7 |
| Arm 3 | Active comparator | 0.3 mg/ml BMP-7, single intraarticular knee injection Receives: Drug: Bone morphogenetic protein 7 |
| Arm 4 | Placebo comparator | 1 ml placebo, single intraarticular knee injection (control) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain subscale.
Measured: Baseline, and at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111045
- Sponsor's protocol ID
- 09-OA-002
- Status last verified
- Jan 2012
- First submitted
- 23 Apr 2010
- Last updated
- 1 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01111045
- Acronym / sponsor ID
- 09-OA-002
- Conditions
- Osteoarthritis of the Knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Stryker BiotechIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 27 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: Bone morphogenetic protein 70.03 mg/ml BMP-7, single intraarticular knee injection |
| Arm 2 | Active comparator | Drug: Bone morphogenetic protein 70.1 mg/ml BMP-7, single intraarticular knee injection |
| Arm 3 | Active comparator | Drug: Bone morphogenetic protein 70.3 mg/ml BMP-7, single intraarticular knee injection |
| Arm 4 | Placebo comparator | Drug: Placebo1 ml placebo, single intraarticular knee injection (control) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone morphogenetic protein 7Comparison of different doses of the drug via single intraarticular knee injection | Drug | Arm 1, Arm 2, Arm 3 |
| PlaceboPlacebo | Drug | Arm 4 |
Primary outcome
Change from baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain subscale.
Time frame: Baseline, and at 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bone morphogenetic protein 7 in people with Osteoarthritis of the Knee, run by Stryker Biotech at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain subscale. (time frame: Baseline, and at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2012.