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CF101 Therapy Compared to Methotrexate Therapy for Active Rheumatoid Arthritis

NCT02647762 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2020-12-19

No results posted yet for this study

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

Interventions

DRUG

CF101 1 mg

CF101 tablets, 1mg BID for 12 weeks

DRUG

CF101 2 mg

CF101 tablets, 2 mg BID for 12 weeks

DRUG

Placebo

Placebo tablets, 1mg BID for 12 weeks

DRUG

MTX

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.

Sponsors & Collaborators

  • Can-Fite BioPharma

    lead INDUSTRY

Principal Investigators

  • Michael H Silverman, MD · Can-Fite BioPharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-30
Primary Completion
2020-11-30
Completion
2020-11-30

Countries

  • Bosnia and Herzegovina
  • Canada
  • Israel
  • Moldova
  • Poland
  • Romania
  • Serbia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02647762 on ClinicalTrials.gov