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Osteoarthritis of the KneePhase 1Knee OANCT00456157

A Phase 1, Double-Blind, Randomized, Single Dose Escalation Safety Study of Intra-articular OP-1 in Subjects With Osteoarthritis of the Knee

A Phase 1 study testing Intra-articular Injection of OP-1 to affected knee in people with Osteoarthritis of the Knee, run by Stryker Biotech at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this research study is to investigate the safety and tolerability of OP-1 when it is injected into the knee joint of patients who have osteoarthritis on 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?
Intra-articular Injection of OP-1 to affected knee
Type of treatment
Injection or infusion
How many people
33 participants
Where
3 sitesUnited States
Study dates
Mar 2007to Nov 2008
Phase
Phase 1
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 subjects with 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, and may include crepitus, swelling and/or effusion of the knee. In subjects with bilateral knee OA, the more symptomatic knee is the index knee. Subjects may be taking NSAIDs, analgesics and/or undergoing physical therapy.
  • Age > 40 years
  • Radiographic evidence on posteroanterior (PA) and lateral standing, flexed x-rays of at least one osteophyte.
  • Subjects must be willing to abstain from other intraarticular treatments of the knee or any surgery for 12 weeks on study.
  • Ability to comply with the study and give informed consent.
  • Subjects must be willing to abstain from NSAIDs or analgesic medications (except for acetaminophen) for 48 hours prior to assessments, at screening, day 1 and week 4, 8, 12, and 24 visits.

Who cannot join

  • Concurrent medical or arthritic conditions which could interfere with evaluation of the index knee joint including fibromyalgia.
  • Subject has received arthroscopic or open surgery to the index joint within 6 months of study start
  • The presence of surgical hardware or other foreign body in the index joint
  • Corticosteroid, hyaluronic acid or other intraarticular injection within 3 months of study start
  • Use of chondroitin and/or glucosamine within 4 weeks prior to study start
  • History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, lymphoma, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis
Show all 24Show fewer
  • Clinical signs and symptoms of active knee infection or crystal disease
  • Clinically significant cardiac disease, consult study Medical Monitor
  • Have an increased predisposition for the development of infections
  • History of malignancy, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ.
  • More significant pain from the back or the hip than the knee
  • Skin breakdown at the knee where the injection would take place
  • Planned knee replacement during the study period
  • For subjects undergoing MRI, the presence of contraindications to having an MRI at the specific imaging facility.
  • For subjects undergoing MRI, an estimated Glomerular Filtration Rate (eGFR) of <45 mL/min calculated using the Cockcroft-Gault estimate for eGFR as follows:
  • eGFR = (140-age [yrs]) X weight [kg] / serum creatinine [mg/dL] X 72 (X 0.85 for women)
  • For subjects undergoing MRI, known allergy to gadolinium contrast material
  • Has known or clinically suspected infection with human immunodeficiency virus (HIV), hepatitis C or B viruses
  • Has participated within 30 days or will participate concurrently in another investigational drug or vaccine study
  • Has a history of drug or alcohol dependence in the past 3 years
  • Known sensitivity to lidocaine or OP-1
  • Female with reproductive capability
  • Has 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.
  • Prior use of a bone morphogenetic protein.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Tufts-New England Medical Center

    Boston, Massachusetts, 02111

  • Boston University Medical Center

    Boston, Massachusetts, 02118-2526

  • University of orth Carolina School of Medicine

    Chapel Hill, North Carolina, 27599-7280

Other trials in United States

About this study

Official title: A Phase 1, Double-Blind, Randomized, Single Dose Escalation Safety Study of Intra-articular Osteogenic Protein-1 OP-1 in Subjects With Osteoarthritis of the Knee

The purpose of this research study is to investigate the safety and tolerability of OP-1 when it is injected into the knee joint of patients who have osteoarthritis on the knee.

Read the detailed description

Subjects with OA will be recruited and informed consent obtained. During a screening period lasting 1 to 28 days, subjects will undergo medical and arthritis history, physical examination, collection of concomitant medications, KOOS (which contains the WOMAC questionnaire), SF-36 and global 100 mm VAS assessments, have samples obtained for urinalysis, hematology, chemistry, immunology and serum and plasma for future biomarker testing, ECG, bilateral knee x-rays and MRI of the index knee at selected sites. Subjects who meet all of the inclusion criteria and none of the exclusion criteria will be randomized into the first cohort of 8 subjects to receive either 1.0 mL lactose (placebo) (2 subjects) or 1.0 mL OP-1 (6 subjects) intraarticularly using ultrasound or fluoroscopy guidance in an outpatient setting on day 1. Each cohort will consist of 8 treated patients, with treatment allocation in a 3:1 active-to-lactose (placebo) ratio. After an observation period of at least one hour, subjects will be released and contacted via telephone on Day 2 to query for AEs and concomitant medications. Additional follow-up visits will be done on days 7, 14, 28, 56, 84 and 168 (weeks 1, 2, 4, 8, 12 and 24) and safety and efficacy parameters evaluated according to the Schedule of Events. When a minimum of 4 weeks have elapsed since the last patient of the current cohort has been treated, all safety data will be collected and reviewed by the Principal Investigators and the Sponsor. The safety review will be conducted to ensure the demonstrated safety profile of OP-1 is acceptable for the treated patients. Only after the current dose level has been judged to be safe will dose escalation to the next dosing cohort occur.

Being tested
Intra-articular Injection of OP-1 to affected knee
Keywords
Osteoarthritis, Osteophytes, Knee, Intra-articular, OP-1
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis, Osteophyte

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intra-articular Injection of OP-1 to affected kneeDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine safety and tolerability as well as dose limiting toxicity (DLT) and maximal tolerated dose (MTD) of intraarticular OP-1

Secondary outcomes (8)

  1. Determine the proportion of patients with 20%, 50%, and 70% improvement in the Western Ontario and McMaster (WOMAC) pain, and function subscales at 4, 8, 12, and 24 weeks.

  2. Determine the change from baseline to 4, 8, 12, and 24 weeks in the pain, other symptoms, function in daily living, function in sports and recreation and knee related quality of life subscales of the Knee and Osteoarthritis Outcome Score (KOOS) survey.

  3. Determine the change from baseline to 4, 8, 12, and 24 weeks in the patient's global assessment and disease status and physician's global assessment and disease status using the 100-mm visual-analogue scale (VAS).

  4. Quality of life measured by the Short Form (SF)-36 at baseline and 4, 8,12 and 24 weeks

  5. Amount of rescue medications required at 4, 8, 12 and 24 weeks

  6. Knee cartilege and surrounding saft tissue changes by magnetic resonance imaging (MRI) of the index knee and proteoglycan content by delayed gadolinium enhanced MRI of cartilage (dGEMRIC)

  7. Analysis of efficacy data using the Outcome Measures in Arthritis Clinical Trials -Osteoarthritis Research Society (OMERACT-OARSI) Responder Index

  8. Blood levels of OP-1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2007 (estimated)
  2. Study startMar 2007
  3. Study completionNov 2008

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00456157
Sponsor's protocol ID
06-OA-001
Acronym
Knee OA
Status last verified
Jun 2010
First submitted
3 Apr 2007
Last updated
17 Jun 2010
Results posted
No
Data monitoring committee
No

Publications

  • Hunter DJ, Pike MC, Jonas BL, Kissin E, Krop J, McAlindon T. Phase 1 safety and tolerability study of BMP-7 in symptomatic knee osteoarthritis. BMC Musculoskelet Disord. 2010 Oct 10;11:232. doi: 10.1186/1471-2474-11-232.

    PubMed 20932341

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Intra-articular Injection of OP-1 to affected knee in people with Osteoarthritis of the Knee, run by Stryker Biotech at 3 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 6 inclusion and 24 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 17 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Determine safety and tolerability as well as dose limiting toxicity (DLT) and maximal tolerated dose (MTD) of intraarticular OP-1. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00456157, which also lists 1 linked publication.

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 17 Jun 2010.

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