Oral CF101 Tablets Treatment in Patients With Rheumatoid Arthritis

NCT01034306 | Completed Phase 2 Results

• 1 other identifier: CF101-204RA
• Study Type: interventional
• Target: 79
• Locations: 2 countries
• Sites: 5

Brief Summary

This trial will test the hypothesis that the administration of CF101, a novel anti-inflammatory agent, to patients with rheumatoid arthritis and high A3AR expression at baseline will relieve signs and symptoms of the disease.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Achieving an American College of Rheumatology 20 (ACR20) Response (20% Improvement)

  ACR20 Response is defined as a 20% improvement from baseline in disease: 1. \>20% improvement in tender joint count (TJC), and 2. \>20% improvement in swollen joint count (SJC), and 3. \>20% improvement in at least 3 of following 5: 1. Physician global assessment (PGA), 2. Patient global assessment (PAGA), 3. Patient pain assessment (PPA), 4. Patient's assessment of physical function using Health Assessment Questionnaire (HAQ), and 5. Most improved response of ESR and CRP

  12 weeks

Secondary Outcomes (2)

• Number of Subjects Achieving an ACR50 Response (50% Improvement)

  12 weeks

• Number of Subjects Achieving an ACR70 Response (70% Improvement)

  12 weeks

Study Arms (2)

CF101 1 mg

EXPERIMENTAL

piclidenoson (CF101) 1 mg tablet oral, Q12h for 12 weeks

Drug: CF101

Placebo

PLACEBO COMPARATOR

placebo tablet to match the active, oral dosage, Q12h for 12 weeks

Drug: Placebo control

Interventions

CF101 DRUG

orally q12h

Also known as: IB-MECA

CF101 1 mg

Placebo control DRUG

orally q12 hours

Also known as: Inactive pill

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females ages 18-75 years
• Meet the criteria of the American College of Rheumatology for RA (Arnett FC et al. Arthritis Rheum 1988;31:315-324, Appendix 1)
• Not bed- or wheelchair-bound
• Active RA, as indicated by the presence of (a) \>=6 swollen joints (28 joint count); AND (b) \>=6 tender joints (28 joint count); AND either: (c) Westergren ESR of \>=28 mm/hour; OR (d) CRP level above the upper limit of normal for the central reference laboratory

You may not qualify if:

• If taking a nonsteroidal anti-inflammatory agent (NSAID), dose has been stable for at least 1 month prior to the A3AR Qualification Visit, and will remain unchanged during protocol participation
• If taking an oral corticosteroid, dose is \<=10 mg/day prednisone or equivalent, has been stable for at least 1 month prior to the A3AR Qualification Visit, and will remain unchanged during protocol participation
• 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
• Receipt of any of the following for at least a 1 month washout period prior to the A3AR Qualification Visit: methotrexate, sulfasalazine, oral or injectable gold, azathioprine, minocycline, penicillamine, anakinra
• Receipt of etanercept for at least a 6 week washout period prior to the A3AR Qualification Visit
• Receipt of chloroquine, hydroxychloroquine, cyclosporine, infliximab, golimumab or adalimumab for at least a 2 month washout period prior to the A3AR Qualification Visit
• Receipt of leflunomide for at least a 2 month washout period prior to the A3AR Qualification Visit, unless patient has undergone cholestyramine washout at least 1 month prior to testing
• Receipt of cyclophosphamide for at least a 6 month period prior to the A3AR Qualification Visit
• Receipt of rituximab at any previous time
• Previous failure to respond to methotrexate or any anti-rheumatic biological agent
• Participation in a previous trial CF101 trial
• Use of oral corticosteroids \>10 mg of prednisone, or equivalent, per day

Sponsors & Collaborators

• Can-Fite BioPharma: lead

Study Sites (5)

Multiprofile Hospital for Active Treatment

Sofia, 1359, Bulgaria

Location

Diagnostic Consultative Center Sofia

Sofia, 1505, Bulgaria

Location

Military Medical Academy

Sofia, 1606, Bulgaria

Location

UMHAT "Sveti Ivan Rilski", Rheumatoloty Clinic

Sofia, 1612, Bulgaria

Location

Barzilai Medical Center

Ashkelon, Israel

Location

Related Links

• Sponsor

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

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

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Pnina Fishman, PhD
• Organization: Can-Fite Biopharma

pnina@canfite.co.il

011972 39241114

Study Officials

• Michael H Silverman, MD

  BioStrategics Consulting Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: December 16, 2009
• First Posted: December 17, 2009
• Study Start: October 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 24, 2022
• Results First Posted: March 9, 2015

Record last verified: 2022-02

Locations

IL (1); BU (4)