A clinical trial to study the effect of drug, CF101 Administered Orally as Monotherapy for 12 Weeks in Patients with Active Rheumatoid Arthritis

Phase 2

Completed

• Conditions: Active Rheumatoid Arthritis

• Registration Number: CTRI/2012/12/003205
• Lead Sponsor: CanFiteBioPharma Ltd

Brief Summary

This will be a multi-center, randomized, double-blind, parallel-group, placebo-controlled, dose-finding study. Approximately 80 patients will be enrolled, with the expectation of randomizing 40 patients to each of the 2 treatment groups. Enrollment will occur at sites in countries that may include xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" /Israel, Bulgaria, India.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-15
• Last Update Posted: 2015-05-30

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 1.Males and females ages 40-65 years 2.Meet the criteria of the American College of Rheumatology for RA (Arnett FC et al.
• Arthritis Rheum 1988;31:315-324, Appendix 1) 3.Not bed- or wheelchair-bound 4.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 5.Elevated PBMC A3AR expression level, defined as 1.5-fold over a predetermined normal population standard within 2 weeks of beginning dosing 6.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 7.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 8.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 9.Negative screening serum pregnancy test for female patients of childbearing potential 10.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) 11.All aspects of the protocol explained and written informed consent obtained.

Exclusion Criteria

1.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 2.Receipt of etanercept for at least a 6 week washout period prior to the A3AR Qualification Visit 3.Receipt of chloroquine, hydroxychloroquine, cyclosporine, infliximab, golimumab or adalimumab for at least a 2 month washout period prior to the A3AR Qualification Visit 4.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 5.Receipt of cyclophosphamide for at least a 6 month period prior to the A3AR Qualification Visit 6.Receipt of rituximab at any previous time 7.Previous failure to respond to methotrexate or any anti-rheumatic biological agent (Not applicable for subjects from India) 8.Participation in a previous trial CF101 trial 9.Use of oral corticosteroids 10 mg of prednisone, or equivalent, per day 10.Change in NSAID dose level for 1 month prior to the A3AR Qualification Visit 11.Change in oral corticosteroid dose level during the 1 month prior to the A3AR Qualification Visit 12.Receipt of parenteral or intra-articular corticosteroids during the 1 month prior to the A3AR Qualification Visit 13.Presence or history of uncontrolled arterial hypertension or symptomatic hypotension 14.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) 15.Hemoglobin level 9.0 gm/dL at the screening visit 16.Platelet count 125,000/mm3 at the screening visit 17.White blood cell count 3000/mm3 at the screening visit 18.Serum creatinine level outside the central laboratory’s normal limits at the screening visit 19.Liver aminotransferase (ALT and/or AST) levels greater than 2 times the central laboratory’s upper limit of normal at the screening visit 20.Known or suspected immunodeficiency, including a Screening serum globulin value of 2.0 g/dL, or human immunodeficiency virus positivity 21.Pregnancy, lactation, or inadequate contraception as judged by the Investigator 22.Participation in another investigational drug or vaccine trial concurrently or within 30 days prior to screening 23.History of active drug or alcohol dependence 24.History of malignancy within the past 5 years (excluding excised basal or squamous cell carcinoma of the skin) 25.Diagnosis of Parkinson’s Disease 26.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 Additional India-specific Exclusion Criteria: 27.Prior receipt of any DMARD, including but not limited to those mentioned in the Exclusion Criteria 1-6 above.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ACR 20 Response at the Week 12 visit using non-responder imputation	At the Week 12 visit

Secondary Outcome Measures

Name	Time	Method
ACR 20/50/70 Responses over time [ITT, LOCF], mean changes in individual components of the ACR response criteria, DAS28, EULAR responses, and biomarkers	4 times i.e. at visit 2,4,8 and 12

Trial Locations

Locations (7)

Arthritis Research and Care Foundation Center for Rheumatic Diseases; 🇮🇳 Pune, MAHARASHTRA, India

Kokilaben Dhirubhai Ambani Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Malpani Multispeciality Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Mumbai Arthritis Clini and Research Centre; 🇮🇳 Mumbai, MAHARASHTRA, India

Olive Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Sri Deepti Rheumatology Centre; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Sushrut Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Arthritis Research and Care Foundation Center for Rheumatic Diseases

🇮🇳Pune, MAHARASHTRA, India

Dr Arvind Chopra

Principal investigator

20-26345624

crdp@vsnl.net