Oral CF101 Tablets and Methotrexate Treatment in Rheumatoid Arthritis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Can-Fite BioPharma
ClinicalTrials.gov Identifier:
NCT00556894
First received: November 8, 2007
Last updated: August 18, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
Drug: CF101
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Can-Fite BioPharma:

Primary Outcome Measures:
  • ACR20 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 230
Study Start Date: February 2008
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
CF101 0.1 mg
Drug: CF101
orally q12h
Other Name: IB-MECA
Experimental: 2
CF101 1 mg
Drug: CF101
orally q12h
Other Name: IB-MECA
Placebo Comparator: 3
Placebo
Drug: CF101
orally q12h
Other Name: IB-MECA

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00556894

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
Czech Republic
University Hospital Hradec Kralove
Hradec Kralove, Czech Republic, 50005
Institute of Rheumatology
Prague, Czech Republic, 12850
Rheumotology Out-patient Clinic
Zlin, Czech Republic, 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
O.O. Bogomolets National Medical University
Kiev, Ukraine, 04053
City Clinical Hospital N12
Kiev, Ukraine, 01103
Kyiv Central Municipal Hospital
Kiev, Ukraine, 01023
National Scientific Centre of AMS of Ukraine
Kiev, Ukraine, 03680
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

No publications provided

Responsible Party: Can-Fite BioPharma
ClinicalTrials.gov Identifier: NCT00556894     History of Changes
Other Study ID Numbers: CF101-203RA
Study First Received: November 8, 2007
Last Updated: August 18, 2011
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Therapeutic Uses
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

ClinicalTrials.gov processed this record on April 17, 2014