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

NCT00837291 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: CF101-221OA
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis of the Knee

Keywords

osteoarthritis; knee; CF101

Outcome Measures

Primary Outcomes (1)

• Proportion of responders by OMERACT-OARSI definition

  12 weeks

Secondary Outcomes (3)

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

  14 weeks

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

  12 weeks

• Change from baseline in physician's and patient's global assessments

  12 weeks

Study Arms (2)

CF101 1 mg BID

EXPERIMENTAL

Drug: CF101

Placebo

PLACEBO COMPARATOR

Placebo tablets BID

Drug: Placebo

Interventions

CF101 DRUG

CF101 tablets 1 mg BID

Also known as: IB-MECA

CF101 1 mg BID

Placebo DRUG

Placebo tablets BID

Also known as: Inactive tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Can-Fite BioPharma: lead

Study Sites (1)

Barzilai Medical Center

Ashkelon, Israel

Location

Related Publications (3)

• 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.

  PMID: 15742438 BACKGROUND

• 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.

  PMID: 17922624 BACKGROUND

• 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.

  PMID: 15516022 BACKGROUND

Related Links

• Sponsor
• Additional publications

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

CF101; N(6)-(3-iodobenzyl)-5'-N-methylcarboxamidoadenosine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Michael H Silverman, MD

  Can-Fite BioPharma Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2009
• First Posted: February 5, 2009
• Study Start: November 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2019
• Last Updated: February 1, 2018

Record last verified: 2018-01

Locations

IL (1)