CF101 Therapy Compared to Methotrexate Therapy for Active Rheumatoid Arthritis

NCT02647762 | Terminated Phase 3

• 1 other identifier: CF101-301RA
• Study Type: interventional
• Target: 244
• Locations: 7 countries
• Sites: 35

Brief Summary

This trial will test the hypothesis that the administration of CF101, a novel anti-inflammatory agent, to patients with rheumatoid arthritis will relieve signs and symptoms of the disease. CF101 effect will be in comparison to MTX in this study population.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (3)

• 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)

  Proportion of subjects achieving Disease Activity Score (DAS) (based on Erythrocyte Sedimentation Rate) of Low Disease Activity (\<3.2, where lower scores indicate lower disease activity) at Week 12

  12 weeks

• Assess the adverse event profile of daily oral CF101 under the conditions of the trial

  Nature, incidence and severity of treatment-emergent adverse events (TEAEs)

  24 weeks

• Describe the pharmacokinetics (PK) of CF101 under the conditions of the trial

  Plasma CF101 levels will be determined

  24 weeks

Secondary Outcomes (2)

• 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

  24 weeks

• Explore the relationship between whole blood adenosine A3 receptor (A3AR) expression and treatment response

  24 weeks

Study Arms (4)

CF101 1mg

EXPERIMENTAL

CF101 1mg, orally q12 hours

Drug: CF101 1 mg

CF101 2mg

EXPERIMENTAL

CF101 2mg, orally q12 hours

Drug: CF101 2 mg

MTX once weekly

ACTIVE COMPARATOR

MTX 5 mg tablets, given once weekly at 10 mg/week (2 tablets) for the first 2 weeks, then 15 mg/week (3 tablets) for the next 2 weeks, then 20 mg/week (4 tablets) thereafter.

Drug: MTX

Placebo

PLACEBO COMPARATOR

Placebo control , orally q12 hours

Drug: Placebo

Interventions

CF101 1 mg DRUG

CF101 tablets, 1mg BID for 12 weeks

Also known as: IB-MECA, Piclidenosone

CF101 1mg

CF101 2 mg DRUG

CF101 tablets, 2 mg BID for 12 weeks

Also known as: IB-MECA, Piclidenosone

CF101 2mg

Placebo DRUG

Placebo tablets, 1mg BID for 12 weeks

Placebo

MTX DRUG

MTX 5 mg tablets, given once weekly at 10 mg/week (2 tablets) for the first 2 weeks, then 15 mg/week (3 tablets) for the next 2 weeks, then 20 mg/week (4 tablets) thereafter, for 12 weeks.

MTX once weekly

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, Appendix 1).
• Not bed- or wheelchair-bound.
• Active RA, as indicated by EULAR Disease Activity Score (Fransen, vanRiel, 2005, DAS28, 2015) (DAS28) \>3.2.
• Demonstrate at least 6 swollen and at least 6 tender joints.
• 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.
• 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.
• 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.
• Negative Screening serum pregnancy test for female subjects 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).
• All aspects of the protocol explained and written informed consent obtained.

You may not qualify if:

• Prior receipt of MTX.
• Prior receipt of \>1 regimen of synthetic small-molecule DMARDs.
• 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.
• Receipt of tofacitinib at any time during the 4-week period prior to the Screening Visit or concomitantly during the trial.
• 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.
• 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.
• Receipt of parenteral or intra-articular corticosteroids during the 1 month prior to the Screening Visit.
• Participation in a previous trial CF101 trial.
• Presence or history of uncontrolled arterial hypertension or symptomatic hypotension.
• 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).
• Clinical laboratory abnormalities at the Screening Visit as follows:
• Hemoglobin level \<9.0 gm/dL
• Platelet count \<125,000/mm3
• White blood cell (WBC) count \<3000/mm3
• Serum creatinine level outside the central laboratory's normal limits

Sponsors & Collaborators

• Can-Fite BioPharma: lead

Study Sites (35)

Can-Fite Investigational Site #252

Banja Luka, Bosnia and Herzegovina

Location

Can-Fite Investigational Site #256

Banja Luka, Bosnia and Herzegovina

Location

Can-Fite Investigational Site #253

Mostar, Bosnia and Herzegovina

Location

Can-Fite Investigational Site #251

Sarajevo, Bosnia and Herzegovina

Location

Can-Fite Investigational Site #255

Tuzla, Bosnia and Herzegovina

Location

Can-Fite Investigational Site #751

Barrie, Canada

Location

Can-Fite Investigational Site #309

Ashkelon, Israel

Location

Can-Fite Investigational Site #302

Haifa, Israel

Location

Can-Fite Investigational Site #581

Chisinau, Moldova

Location

Can-Fite Investigational Site #582

Chisinau, Moldova

Location

Can-Fite Investigational Site #583

Chisinau, Moldova

Location

Can-Fite Investigational Site #401

Bialystok, Poland

Location

Can-Fite Investigational Site #402

Bochnia, Poland

Location

Can-Fite Investigational Site #403

Poznan, Poland

Location

Can-Fite Investigational Site #559

Brăila, Romania

Location

Can-Fite Investigational Site #551

Bucharest, Romania

Location

Can-Fite Investigational Site #552

Bucharest, Romania

Location

Can-Fite Investigational Site #553

Bucharest, Romania

Location

Can-Fite Investigational Site #562

Bucharest, Romania

Location

Can-Fite Investigational Site #564

Bucharest, Romania

Location

Can-Fite Investigational Site #565

Bucharest, Romania

Location

Can-Fite Investigational Site #558

Constanța, Romania

Location

Can-Fite Investigational Site #563

Craiova, Romania

Location

Can-Fite Investigational Site #561

Iași, Romania

Location

Can-Fite Investigational Site #555

Oradea, Romania

Location

Can-Fite Investigational Site #554

Timișoara, Romania

Location

Can-Fite Investigational Site #212

Belgrade, Serbia

Location

Can-Fite Investigational Site #223

Bor, Serbia

Location

Can-Fite Investigational Site #219

Kragujevac, Serbia

Location

Can-Fite Investigational Site #215

Niš, Serbia

Location

Can-Fite Investigational Site #213

Novi Sad, Serbia

Location

Can-Fite Investigational Site #222

Pirot, Serbia

Location

Can-FIte Investigational Site #221

Sremska Mitrovica, Serbia

Location

Can-Fite Investigational Site #214

Šabac, Serbia

Location

Can-Fite Investigational Site #220

Zrenjanin, Serbia

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

Study Officials

• Michael H Silverman, MD

  Can-Fite BioPharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: January 6, 2016
• Study Start: October 30, 2017
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: December 19, 2020

Record last verified: 2020-03

Locations

RO (12); SE (9); PL (3); BO (5); IL (2); CA (1); MO (3)