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Osteoarthritis of the KneePhase 2NCT00837291

A Study of the Efficacy and Safety of CF101 to Patients With Osteoarthritis of the Knee

A Phase 2 study testing CF101 in people with Osteoarthritis of the Knee, run by Can-Fite BioPharma at 1 site in Israel.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Osteoarthritis of the Knee
What is being tested?
CF101
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteIsrael
Study dates
Nov 2018to Jan 2019
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 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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
Show all 23Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Barzilai Medical Center

    Ashkelon

Other trials in Israel

About this study

Official title: 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.

Read the 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.

Being tested
CF101, Placebo
Keywords
osteoarthritis, knee, CF101
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis

What participants receive

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

  • CF101Drug

    Also called IB-MECA

    CF101 tablets 1 mg BID

  • PlaceboDrug

    Also called Inactive tablets

    Placebo tablets BID

Study groups in NCT00837291
Study groupRoleWhat they receive
CF101 1 mg BIDExperimentalNot described
Receives: Drug: CF101
PlaceboPlacebo comparatorPlacebo tablets BID
Receives: Drug: Placebo

What is being measured

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

  1. Proportion of responders by OMERACT-OARSI definition

    Measured: 12 weeks

Secondary outcomes (3)

  1. Safety, as assessed through vital signs, physical examinations, adverse event reporting, clinical laboratory testing, and ECGs

    Measured: 14 weeks

  2. Change from baseline in total WOMAC score, and pain, physical function, and stiffness subscale scores

    Measured: 12 weeks

  3. Change from baseline in physician's and patient's global assessments

    Measured: 12 weeks

Timeline

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

  1. First posted5 Feb 2009 (estimated)
  2. Study startNov 2018 (estimated)
  3. Primary completionDec 2018 (estimated)
  4. Study completionJan 2019 (estimated)

Why it stopped: The company has decided not to conduct the study

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00837291
Sponsor's protocol ID
CF101-221OA
Status last verified
Jan 2018
First submitted
3 Feb 2009
Last updated
1 Feb 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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.

    PubMed 15742438

  • 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.

    PubMed 17922624

  • 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.

    PubMed 15516022

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CF101 in people with Osteoarthritis of the Knee, run by Can-Fite BioPharma at 1 site in Israel.

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 13 inclusion and 23 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: withdrawn, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. 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 was withdrawn before enrolling participants, so there are no results.

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?

Proportion of responders by OMERACT-OARSI definition (time frame: 12 weeks). 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 NCT00837291, which also lists 3 linked publications.

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 2018.

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