Oral CF101 and Methotrexate Treatment in Rheumatoid Arthritis Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00280917
• Date of registration: 23/01/2006
• Prospective Registration: Yes
• Primary sponsor: Can-Fite BioPharma
• Public title: Oral CF101 and Methotrexate Treatment in Rheumatoid Arthritis Patients
• Scientific title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Daily CF101 Administered Orally, When Added to Weekly Methotrexate, in Patients With Active Rheumatoid Arthritis
• Date of first enrolment: June 2006
• Target sample size: 254
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00280917
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Bulgaria, Former Serbia and Montenegro, Israel, Poland, Romania, Serbia, Ukraine, United States

Contacts

• Name: Michael H Silverman, MD
• Affiliation: BioStrategics Consulting Ltd

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: CF101

Primary Outcome(s)

ACR Efficacy Criteria [Time Frame: 12 weeks]

Secondary Outcome(s)

ACR Criteria Components [Time Frame: 12 weeks]

Safety [Time Frame: 12 weeks]

Secondary ID(s)

CF101-202RA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 17/03/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00280917