- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00837291
A Study of the Efficacy and Safety of CF101 to Patients With Osteoarthritis of the Knee
January 30, 2018 updated by: Can-Fite BioPharma
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Daily CF101 Administered Orally for 12 Weeks to Patients With Osteoarthritis of the Knee
This study will test the effectiveness of CF101 in treating the symptoms of osteoarthritis (OA) of the knee.
Eligible patients will be given either CF101 or matching placebo tablets and their symptoms will be evaluated over the 12 week treatment period.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
This will be a randomized, double-blind, placebo-controlled, parallel-group study in which patients with knee OA will be randomized to either CF101 1 mg or matching placebo tablets every 12 hours and followed for 12 weeks on treatment.
For patients with bilateral knee involvement, only 1 knee will be selected for evaluation, namely, the most severely involved knee that meets study criteria (the "index knee").
Screening examinations will occur within 1 month prior to dosing.
Washout of non-specific non-steroidal anti-inflammatory drugs (nsNSAIDs) and cyclo-oxygenase-2 (COX-2) inhibitors will occur prior to dosing, and must be followed by requalification before dosing.
Disease activity will be assessed using changes from baseline in Patient's Global Assessment (PGA) and Investigator's Global Assessment (IGA) scores, and the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index and subscales for pain, physical function, stiffness, according to the Outcome Measures in Rheumatology Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) criteria.
Assessments will take place at Screening, Baseline (Week 0), and at Weeks 2, 4, 8, 12, and 14.
Study Type
Interventional
Phase
- 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
-
-
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Ashkelon, Israel
- Barzilai Medical Center
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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
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males and females age 40 years or above
Clinical evidence of knee OA, as indicated by:
- Pain requiring treatment with NSAID or coxib medication for analgesia for at least 6 months prior to the screening visit, and
- Pain requiring treatment with NSAID or coxib medication for analgesia on the majority of days during the preceding month
- Radiographic evidence of knee OA, as indicated by findings of Kellgren-Lawrence Grade 2 or 3 within 1 year prior to the screening visit2
- American College of Rheumatology functional class I, II, or III3
- WOMAC pain subscale score ≥40 mm at baseline
- WOMAC function subscale score >20 mm at baseline
- PGA >10 mm at baseline
- In the Investigator's opinion, the ability to understand the nature of the study and any hazards of participation, and to communicate satisfactorily with the Investigator and to participate in, and to comply with, the requirements of the entire protocol
- Negative screening serum pregnancy test for female patients of childbearing potential
- Females of childbearing potential must utilize, throughout the course of the trial, 2 methods of contraception deemed adequate by the Investigator (for example, oral contraceptive pills plus a barrier method)
- All aspects of the protocol explained and written informed consent obtained
Exclusion Criteria:
- Predominant patellofemoral disease
- Concomitant local or systemic inflammatory arthropathy which could confound evaluation of the knee
- Ipsilateral hip or extremity disease which could confound evaluation of the knee
- History of clinical significant trauma or surgery to the index knee
- Arthroscopy to the index knee within 6 months prior to the screening visit
- Corticosteroid, hyaluronic acid, or other intraatricular injection to the index knee within 3 months prior to the screening visit
- Use of chondroitin sulfate and/or glucosamine, or diacerin, within 2 weeks prior to the screening visit
- Concomitant requirement for NSAID, coxib medication, or opioid analgesics (acetaminophen is allowed)
- Use of systemic corticosteroids >10 mg/d of prednisone, or equivalent
- Presence or history of uncontrolled arterial hypertension or symptomatic hypotension
- Significant cardiac arrhythmia or conduction block, congestive heart failure, or any other evidence of clinically significant heart disease; other clinically significant findings on screening electrocardiogram (ECG)
- Hemoglobin level <10.0 gm/dL at the screening visit
- White blood cell count <3000/mm3 at the screening visit
- Platelet count <125,000/mm3 at the screening visit
- Serum creatinine level outside the central laboratory's normal limits at the screening visit
- Liver aminotransferase (ALT and/or AST) levels greater than the upper limit of normal at the screening visit
- Known or suspected immunodeficiency or human immunodeficiency virus positivity
- Pregnancy, lactation, or inadequate contraception as judged by the Investigator
- Participation in another investigational drug or vaccine trial concurrently or within 30 days prior to screening
- History of drug or alcohol dependence
- History of malignancy within the past 5 years (excluding excised basal or squamous cell carcinoma of the skin)
- Diagnosis of Parkinson's Disease
- Significant acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise patient safety, limit the patient'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: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CF101 1 mg BID
|
CF101 tablets 1 mg BID
Other Names:
|
Placebo Comparator: Placebo
Placebo tablets BID
|
Placebo tablets BID
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of responders by OMERACT-OARSI definition
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety, as assessed through vital signs, physical examinations, adverse event reporting, clinical laboratory testing, and ECGs
Time Frame: 14 weeks
|
14 weeks
|
Change from baseline in total WOMAC score, and pain, physical function, and stiffness subscale scores
Time Frame: 12 weeks
|
12 weeks
|
Change from baseline in physician's and patient's global assessments
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Michael H Silverman, MD, Can-Fite BioPharma Ltd
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Baharav E, Bar-Yehuda S, Madi L, Silberman D, Rath-Wolfson L, Halpren M, Ochaion A, Weinberger A, Fishman P. Antiinflammatory effect of A3 adenosine receptor agonists in murine autoimmune arthritis models. J Rheumatol. 2005 Mar;32(3):469-76.
- Bar-Yehuda S, Silverman MH, Kerns WD, Ochaion A, Cohen S, Fishman P. The anti-inflammatory effect of A3 adenosine receptor agonists: a novel targeted therapy for rheumatoid arthritis. Expert Opin Investig Drugs. 2007 Oct;16(10):1601-13. doi: 10.1517/13543784.16.10.1601.
- van Troostenburg AR, Clark EV, Carey WD, Warrington SJ, Kerns WD, Cohn I, Silverman MH, Bar-Yehuda S, Fong KL, Fishman P. Tolerability, pharmacokinetics and concentration-dependent hemodynamic effects of oral CF101, an A3 adenosine receptor agonist, in healthy young men. Int J Clin Pharmacol Ther. 2004 Oct;42(10):534-42. doi: 10.5414/cpp42534.
Helpful Links
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 (Anticipated)
November 1, 2018
Primary Completion (Anticipated)
December 1, 2018
Study Completion (Anticipated)
January 1, 2019
Study Registration Dates
First Submitted
February 3, 2009
First Submitted That Met QC Criteria
February 4, 2009
First Posted (Estimate)
February 5, 2009
Study Record Updates
Last Update Posted (Actual)
February 1, 2018
Last Update Submitted That Met QC Criteria
January 30, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CF101-221OA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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