CF101 Therapy Compared to Methotrexate Therapy for Active Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02647762
• Date of registration: 16/12/2015
• Prospective Registration: Yes
• Primary sponsor: Can-Fite BioPharma
• Public title: CF101 Therapy Compared to Methotrexate Therapy for Active Rheumatoid Arthritis
• Scientific title: A Phase 3, Randomized, Double-Blind, Active- and Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of CF101 Compared to Methotrexate in the Treatment of Early Rheumatoid Arthritis
• Date of first enrolment: October 30, 2017
• Target sample size: 525
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02647762
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Bosnia and Herzegovina, Canada, Israel, Moldova, Republic of, Poland, Romania, Serbia

Contacts

• Name: Michael H Silverman, MD
• Affiliation: Can-Fite BioPharma

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Males and females ages 18-75 years.

2. Meet the criteria of the American College of Rheumatology for RA (Arnett FC et al.
Arthritis Rheum 1988;31:315-324, Appendix 1).

3. Not bed- or wheelchair-bound.

4. Active RA, as indicated by EULAR Disease Activity Score (Fransen, vanRiel, 2005,
DAS28, 2015) (DAS28) >3.2.

5. Demonstrate at least 6 swollen and at least 6 tender joints.

6. If taking an NSAID, dose has been stable for at least 1 month prior to the Screening
Visit, and will remain unchanged during protocol participation.

7. If taking an oral corticosteroid, dose is <10 mg/day prednisone or equivalent, has
been stable for at least 1 month prior to the Screening Visit, and will remain
unchanged during protocol participation.

8. In the Investigator's opinion, the ability to understand the nature of the study and
any hazards of participation, and to communicate satisfactorily with the Investigator
and to participate in, and to comply with, the requirements of the entire protocol.

9. Negative Screening serum pregnancy test for female subjects of childbearing potential.

10. 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).

11. All aspects of the protocol explained and written informed consent obtained.

Exclusion Criteria:

1. Prior receipt of MTX.

2. Prior receipt of >1 regimen of synthetic small-molecule DMARDs.

3. Receipt of any non-MTX synthetic small-molecule DMARDs (including but not limited to
sulfasalazine, chloroquine/hydroxychloroquine, azathioprine, and/or leflunomide) for
at least 1 month prior to the Screening Visit or concomitantly during the trial.

4. Receipt of tofacitinib at any time during the 4-week period prior to the Screening
Visit or concomitantly during the trial.

5. Receipt of a biologic anti-rheumatic agent (including, but not limited to, etanercept,
abatacept, infliximab, golimumab, adalimumab, tocilizumab, certolizumab, and
rituximab) at any time prior to or concomitantly during the trial.

6. Levels of rheumatoid factor (RF) and anti-cyclic citrullinated peptide (CCP) antibody
that are both >3 times the upper limit of the laboratory normal value at the Screening
Visit.

7. Receipt of parenteral or intra-articular corticosteroids during the 1 month prior to
the Screening Visit.

8. Participation in a previous trial CF101 trial.

9. Presence or history of uncontrolled arterial hypertension or symptomatic hypotension.

10. Heart disease which is, in the Investigator's judgment, clinically significant or
unstable, including coronary artery disease, congestive heart failure, uncontrolled
arrhythmia, or other significant findings on Screening electrocardiogram (ECG).

11. Clinical laboratory abnormalities at the Screening Visit as follows:

1. Hemoglobin level <9.0 gm/dL

2. Platelet count <125,000/mm3

3. White blood cell (WBC) count <3000/mm3

4. Serum creatinine level outside the central laboratory's normal limits

5. Liver aminotransferase (ALT and/or AST) levels greater than 2 times the central
laboratory's upper limit of normal.

12. Known or suspected immunodeficiency or human immunodeficiency virus positivity.

13. Pregnancy, lactation, or inadequate contraception as judged by the Investigator.

14. Participation in another investigational drug or vaccine trial concurrently or within
30 days prior to Screening.

15. Active drug or alcohol dependence.

16. History of malignancy within the past 2 years (excluding excised basal or squamous
cell carcinoma of the skin).

17. Significant acute or chronic medical or psychiatric illness that, in the judgment of
the Investigator, could compromise subject safety, limit the subject's ability to
complete the study, and/or compromise the objectives of the study.



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

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: CF101 1 mg

Drug: MTX

Drug: CF101 2 mg

Drug: Placebo

Primary Outcome(s)

Assess the adverse event profile of daily oral CF101 under the conditions of the trial [Time Frame: 24 weeks]

Efficacy of oral CF101, BID for 12 weeks to subjects with active rheumatoid arthritis (RA) relative to oral methotrexate (MTX) as assessed by the proportion of subjects achieving a Disease Activity Score (DAS) of Low Disease Activity (LDA) [Time Frame: 12 weeks]

Describe the pharmacokinetics (PK) of CF101 under the conditions of the trial [Time Frame: 24 weeks]

Secondary Outcome(s)

Explore the relationship between whole blood adenosine A3 receptor (A3AR) expression and treatment response [Time Frame: 24 weeks]

Determine the efficacy of oral CF101 when administered daily for 24 weeks to subjects with active RA relative to oral MTX, as assessed by the proportion of subjects achieving DAS remission [Time Frame: 24 weeks]

Secondary ID(s)

CF101-301RA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors