CF101 in Rheumatoid Arthritis - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Rheumatoid Arthritis

Intervention / Treatment

Drug: CF101

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, CF101 4 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, duration of morning stiffness, 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, 12, and 14.

Study Type

Interventional

Enrollment (Actual)

254

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Bulgaria
- - Plovdiv, Bulgaria, 4002
    - Can-Fite Investigational Site
  - Sofia, Bulgaria, 1233
    - Can-Fite Investigational Site
  - Sofia, Bulgaria, 1612
    - Can-Fite Investigational Site
  - Stara Zagora, Bulgaria, 6000
    - Can-Fite Investigational Site
Israel
- - Afula, Israel
    - Can-Fite Investigational Sites
  - Ashkelon, Israel, 78278
    - Can-Fite Investigational Site
  - Beer Yaakov, Israel, 70300
    - Can-Fite Investigational Site
  - Haifa, Israel, 31096
    - Can-Fite Investigational Site
  - Haifa, Israel, 77479
    - Can-Fite Investigational Site
  - Jerusalem, Israel, 91031
    - Can-Fite Investigational Site
  - Jerusalem, Israel, 91120
    - Can-Fite Investigational Site
  - Jerusalem, Israel
    - Can-Fite Investigational Site
  - Kfar-Saba, Israel, 44281
    - Can-Fite Investigational Site
  - Tel Hashomer, Israel, 52621
    - Can-Fite Investigational Site
Poland
- - Białystok, Poland, 15-297
    - Can-Fite Investigational Site
  - Lublin, Poland, 20-022
    - Can-Fite Investigational Site
  - Sopot, Poland, 81-759
    - Can-Fite Investigational Site
  - Szczecin, Poland, 71-252
    - Can-Fite Investigational Site
Romania
- - Brasov, Romania, 500356
    - Can-Fite Investigational Site
  - Bucharest, Romania, 020125
    - Can-Fite Investigational Site
  - Bucharest, Romania, 020983
    - Can-Fite Investigational Site
  - Cluj Napoca, Romania, 400006
    - Can-Fite Investigational Site
  - Iasi, Romania, 700661
    - Can-Fite Investigational Site
Serbia
- - Belgrade, Serbia, 11000
    - Can-Fite Investigational Site
  - Niska Banja, Serbia, 18205
    - Can-Fite Investigational Site
  - Zemun, Serbia, 11080
    - Can-Fite Investigational Site
Ukraine
- - Kiev, Ukraine, 03680
    - Can-Fite Investigational Site
  - Kiev, Ukraine, 04053
    - Can-Fite Investigational Site
  - Kiev,, Ukraine, 01023
    - Can-Fite Investigational Site
  - Kiev,, Ukraine, 01103
    - Can-Fite Investigational Site
United States
- Arizona
  - Peoria, Arizona, United States, 85381
    - Can-Fite Investigational Site
- New York
  - Albany, New York, United States, 12206
    - Can-Fite Investigational Site
- Ohio
  - Cleveland, Ohio, United States, 44195
    - Can-Fite Invesitigational Site
  - Perrysburg, Ohio, United States, 43551
    - Can-Fite Investigational Site
- Texas
  - Sugar Land, Texas, United States, 77479
    - Can-Fite Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Males and females ages 18-75 years
Meet the criteria of the American Rheumatism Association 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 at least one of the following: (c) Westergren ESR of >=28 mm/hour; OR (d) CRP level above the upper limit of normal for the central reference laboratory; OR (e) morning stiffness for >=45 minutes
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, administration duration has been >=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 washout period, and will remain stable through the washout and entire treatment and follow-up period
Absence of clinically significant findings, such as interstitial pneumonitis or active pulmonary infection, on chest X-ray taken within 6 months prior to screening

Exclusion Criteria:

Receipt of any of the following for at least a 1 month washout 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
Receipt of CF101 in a previous 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 washout period
Change in hydroxychloroquine dose level during the 2 months prior to, or during, the washout period
Receipt of parenteral or intra-articular corticosteroids during the 1 month prior to, or during, the washout period
Presence or history of uncontrolled asthma
Presence or history of uncontrolled arterial hypertension or symptomatic hypotension
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/L
Platelet count <125,000/mm3
White blood cell count <3000/mm3
Serum creatinine level outside the laboratory's normal limits
Liver aminotransferase levels greater than 1.2 times the laboratory's upper limit of normal
Known or suspected immunodeficiency or human immunodeficiency virus positivity
Pregnancy, lactation, or inadequate contraception as judged by the Investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Parallel Assignment
Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACR Efficacy Criteria Time Frame: 12 weeks	ACR 20 response (20% improvnent in RA based on swollen and tender joint counts, physician and patient global assessments of disease activity, a patient pain score) at endpoint (Week 12), with all-cause dropouts considered as nonresponders (nonresponder imputation) in the Intent-To-Treat (ITT) population	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACR Criteria Components Time Frame: 12 weeks	ACR 20 response at all visits in the evaluable population and ACR 50 and ACR 70 responses at all visits in the ITT and evaluable populations using both nonresponder imputation and Last Observation Carried Forward (LOCF) analyses; change and percent change from baseline at each visit in the ITT and evaluable populations, analyzed using LOCF, in ACR response components [tender joint count, swollen joint count, patient assessment of pain by VAS, patient global assessment of disease activity by VAS, physician global assessment of disease activity by VAS, HAQ DI, CRP (by central laboratory, using an standard-sensitivity assay capable of detecting changes below the upper limit of normal) and ESR], Disease Activity Score (DAS28), and duration of morning stiffness.	12 weeks
Safety Time Frame: 12 weeks	Vital signs and weight, physical examinations, adverse event (AE) reporting, clinical laboratory testing, including liver function, renal function, complete blood count and clinical chemistries, urinalysis, and hematologic testing and 12-lead resting ECGs	12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Can-Fite BioPharma

Investigators

Study Director: Michael H Silverman, MD, BioStrategics Consulting Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

January 23, 2006

First Submitted That Met QC Criteria