Oral CF101 Tablets and Methotrexate Treatment in Rheumatoid Arthritis Patients

NCT00556894 | Completed Phase 2 Results

• 1 other identifier: CF101-203RA
• Study Type: interventional
• Target: 253
• Locations: 6 countries
• Sites: 26

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• ACR20 at Week 12

  Number of patients that achieved 20% response at week 12 in American College of Rheumatology Criteria

  12 weeks

Secondary Outcomes (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

  12 weeks

Study Arms (3)

CF101 0.1 mg

EXPERIMENTAL

CF101 0.1 mg was given orally q12h

Drug: CF101

CF101 1 mg

EXPERIMENTAL

CF101 1 mg was given orally q12h

Drug: CF101

Placebo

PLACEBO COMPARATOR

Matched placebo was given orally q12h

Drug: Placebo

Interventions

CF101 DRUG

orally q12h

Also known as: IB-MECA

CF101 0.1 mg; CF101 1 mg

Placebo DRUG

orally q12h

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; 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Can-Fite BioPharma: lead

Study Sites (26)

Clinic of Rheumatology at MHAT 'Sveti Georgi'

Plovdiv, 4002, Bulgaria

Location

Clinic of Rheumatology at MHAT 'Sveti Ivan Rilski'

Sofia, 1612, Bulgaria

Location

Clinic of internal diseases at NMTH 'Tzar Boris Treti'

Sofia, Bulgaria

Location

Second Clinic of Internal Diseases at MHAT 'Stara Zagora'

Stara Zagora, 6000, Bulgaria

Location

Clinic of Rheumatology at MHAT 'Sveta Marina' - Varna

Varna, 9010, Bulgaria

Location

University Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

Location

Institute of Rheumatology

Prague, 12850, Czechia

Location

Rheumotology Out-patient Clinic

Zlín, 76001, Czechia

Location

Haemek Medical Center

Afula, Israel

Location

Barzilai Medical Center

Ashkelon, 78278, Israel

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Hadassah Har-Hazofim Medical Center

Jerusalem, Israel

Location

Meir Medical Center

Kfar Saba, 44281, Israel

Location

Wojewodzki Szpital Zespolony w Elblagu

Elblag, 82300, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej

Lublin, 20607, Poland

Location

Wojewodzki Zespol Reumatologiczny w Sopocie

Sopot, 81967, Poland

Location

Samodzielny Publiczny Szpital Kliniczny Nr 1 P.A.M. w Szczecinie

Szczecin, 71252, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej "NASZ LEKARZ"

Torun, 87100, Poland

Location

Institute of Rheumatology - Belgrade

Belgrade, 11000, Serbia

Location

Institute for Prevention, Treatment, and Rehabilitation of Rheumatoid and Cardiovascular Diseases Niska Banja

Niška Banja, 18205, Serbia

Location

Central Municipal Clinical Hospital nº1

Donetsk, 83114, Ukraine

Location

Kyiv Central Municipal Hospital

Kiev, 01023, Ukraine

Location

City Clinical Hospital N12

Kiev, 01103, Ukraine

Location

National Scientific Centre of AMS of Ukraine

Kiev, 03680, Ukraine

Location

O.O. Bogomolets National Medical University

Kiev, 04053, Ukraine

Location

Vinnitsya Regional Clinical Hospital

Vinnycia, 21018, Ukraine

Location

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: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2007
• First Posted: November 12, 2007
• Study Start: February 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: April 1, 2009
• Last Updated: March 29, 2018
• Results First Posted: March 9, 2015

Record last verified: 2011-08

Locations

IL (5); BU (5); UA (6); PL (5); SE (2); CZ (3)