Oral CF101 Tablets and Methotrexate Treatment in Rheumatoid Arthritis Patients

Study Description

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

This trial will test the hypothesis that the addition of CF101, a novel anti-inflammatory agent, will improve the clinical condition of patients with rheumatoid arthritis who still have active joint inflammation despite taking methotrexate for at least 6 months.

Condition or disease	Intervention/treatment	Phase
Rheumatoid Arthritis	Drug: CF101; Drug: Placebo	Phase 2

Detailed Description:

This will be a multi-center, randomized, double-blind, parallel-group, placebo-controlled, dose-finding study in which patients with active RA despite receiving methotrexate for at least 6 months (at unchanged doses for >=2 months) will be randomized to the addition of either CF101 0.1 mg, CF101 1 mg, or placebo given orally q12h for 12 weeks. Screening examinations will occur within 1 month prior to dosing. Washout of other disease-modifying antirheumatic drugs (DMARDs) (with the exception of hydroxychloroquine), including biological agents, will occur prior to dosing; if washout is necessary, patients must re-qualify for inclusion following the washout. Doses of nonsteroidal anti-inflammatory drugs (NSAIDS) and corticosteroids must be stable for >=1 month prior to dosing and remain so during protocol participation. Disease activity will be assessed using swollen and tender joint counts, physician and patient global assessments (by visual analog scale, VAS), patient reported pain (by VAS), a Health Assessment Questionnaire (HAQ) Disability Index (DI), Westergren erythrocyte sedimentation rate (ESR, Screening, Weeks 0 and12), and C-reactive protein (CRP) levels. Assessments will take place at Screening, Baseline (Week 0), and at Weeks 2, 4, 8, and 12.

Study Design

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	253 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of the Safety and Efficacy of Daily CF101 Administered Orally, When Added to Weekly Methotrexate, in Patients With Active Rheumatoid Arthritis
Study Start Date :	February 2008
Actual Primary Completion Date :	March 2009
Actual Study Completion Date :	April 2009

Arms and Interventions

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: CF101 0.1 mg; CF101 0.1 mg was given orally q12h	Drug: CF101; orally q12h; Other Name: IB-MECA
Experimental: CF101 1 mg; CF101 1 mg was given orally q12h	Drug: CF101; orally q12h; Other Name: IB-MECA
Placebo Comparator: Placebo; Matched placebo was given orally q12h	Drug: Placebo; orally q12h

Outcome Measures

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. ACR20 at Week 12 [ Time Frame: 12 weeks ]
   Number of patients that achieved 20% response at week 12 in American College of Rheumatology Criteria

Secondary Outcome Measures :

1. ACR 20/50/70, ITT and Evaluable Population, Last Observation Carried Disease Activity Score (DAS28) Change From Baseline at Each Visit in the Efficacy Parameters [ Time Frame: 12 weeks ]
   ACR20/50/70 responses over time (intent-to-treat [ITT], last observation carried forward [LOCF]), mean changes in individual components of the ACR response criteria, DAS28, European League Against Rheumatism (EULAR) responses

Eligibility Criteria

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• 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; refer to Appendix 1. diagnostic criteria for Rheumatoid Arthritis)
• 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
• Treatment with weekly oral or parenteral methotrexate for >=6 months prior to baseline
• Methotrexate route of administration has been unchanged for >=2 months prior to baseline
• Dose of methotrexate has been stable at 15-25 mg/week for >=2 months, and is expected to remain stable throughout the study; the stable dose of methotrexate may alternatively be 10-12.5 mg/week if documented toxicity has precluded a higher dose
• If taking hydroxychloroquine or chloroquine, administration duration has been for >=3 months and dose has been stable for >=2 months prior to baseline
• If taking a nonsteroidal anti-inflammatory agent (NSAID), dose has been stable for at least 1 month prior to baseline, 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 stabilization period, and will remain stable through the stabilization and entire treatment and follow-up period
• 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)

Exclusion Criteria:

• Receipt of any of the following for at least a 1 month stabilization period prior to dosing: sulfasalazine, oral or injectable gold, azathioprine, minocycline, penicillamine, anakinra
• Receipt of etanercept for at least a 6 week period prior to dosing
• Receipt of cyclosporine, infliximab or adalimumab for at least a 2 month period prior to dosing
• Receipt of leflunomide for at least a 2 month period prior to screening, unless patient has undergone cholestyramine washout at least 1 month prior to dosing
• Receipt of cyclophosphamide for at least a 6 month period prior to dosing
• Receipt of rituximab at any previous time
• Participation in a previous trial CF101 trial
• Use of oral corticosteroids >10 mg of prednisone, or equivalent, per day
• Change in NSAID dose level for 1 month prior to dosing
• Change in oral corticosteroid dose level during the 1 month prior to, or during, the stabilization period vChange in hydroxychloroquine or chloroquine dose level during the 2 months prior to, or during, the stabilization period
• Receipt of parenteral or intra-articular corticosteroids during the 1 month prior to, or during, the stabilization period
• 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 <9.0 gm/dL at the screening visit
• Platelet count <125,000/mm3 at the screening visit
• White blood cell count <3000/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 1.25 times the central laboratory's upper limit of normal at the screening visit
• 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

Contacts and Locations

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Bulgaria
Clinic of Rheumatology at MHAT 'Sveti Georgi'
Plovdiv, Bulgaria, 4002
Clinic of Rheumatology at MHAT 'Sveti Ivan Rilski'
Sofia, Bulgaria, 1612
Clinic of internal diseases at NMTH 'Tzar Boris Treti'
Sofia, Bulgaria
Second Clinic of Internal Diseases at MHAT 'Stara Zagora'
Stara Zagora, Bulgaria, 6000
Clinic of Rheumatology at MHAT 'Sveta Marina' - Varna
Varna, Bulgaria, 9010
Czechia
University Hospital Hradec Kralove
Hradec Kralove, Czechia, 50005
Institute of Rheumatology
Prague, Czechia, 12850
Rheumotology Out-patient Clinic
Zlin, Czechia, 76001
Israel
Haemek Medical Center
Afula, Israel
Barzilai Medical Center
Ashkelon, Israel, 78278
Rambam Medical Center
Haifa, Israel, 31096
Hadassah Har-Hazofim Medical Center
Jerusalem, Israel
Meir Medical Center
Kfar-Saba, Israel, 44281
Poland
Wojewodzki Szpital Zespolony w Elblagu
Elblag, Poland, 82300
Niepubliczny Zaklad Opieki Zdrowotnej
Lublin, Poland, 20607
Wojewodzki Zespol Reumatologiczny w Sopocie
Sopot, Poland, 81967
Samodzielny Publiczny Szpital Kliniczny Nr 1 P.A.M. w Szczecinie
Szczecin, Poland, 71252
Niepubliczny Zaklad Opieki Zdrowotnej "NASZ LEKARZ"
Torun, Poland, 87100
Serbia
Institute of Rheumatology - Belgrade
Belgrade, Serbia, 11000
Institute for Prevention, Treatment, and Rehabilitation of Rheumatoid and Cardiovascular Diseases Niska Banja
Niska Banja, Serbia, 18205
Ukraine
Central Municipal Clinical Hospital nº1
Donetsk, Ukraine, 83114
Kyiv Central Municipal Hospital
Kiev, Ukraine, 01023
City Clinical Hospital N12
Kiev, Ukraine, 01103
National Scientific Centre of AMS of Ukraine
Kiev, Ukraine, 03680
O.O. Bogomolets National Medical University
Kiev, Ukraine, 04053
Vinnitsya Regional Clinical Hospital
Vinnycia, Ukraine, 21018

Sponsors and Collaborators

Can-Fite BioPharma

Investigators

Study Director:	Michael H Silverman, MD	BioStrategics Consulting Ltd

More Information

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Can-Fite BioPharma
ClinicalTrials.gov Identifier:	NCT00556894 History of Changes
Other Study ID Numbers:	CF101-203RA
First Posted:	November 12, 2007
Results First Posted:	March 9, 2015
Last Update Posted:	March 29, 2018
Last Verified:	August 2011

Additional relevant MeSH terms:

Arthritis; Arthritis, Rheumatoid; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Methotrexate; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Reproductive Control Agents	Physiological Effects of Drugs; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Dermatologic Agents; Enzyme Inhibitors; Folic Acid Antagonists; Immunosuppressive Agents; Immunologic Factors; Antirheumatic Agents; Nucleic Acid Synthesis Inhibitors