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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

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Trial Profile

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

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 25 Jun 2022

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At a glance

  • Drugs Piclidenoson (Primary) ; Methotrexate
  • Indications Rheumatoid arthritis
  • Focus Adverse reactions; Pharmacokinetics; Registrational; Therapeutic Use
  • Acronyms ACROBAT
  • Sponsors Can-Fite BioPharma

Most Recent Events

  • 09 Nov 2021 Interim results (n=252) presented at the ACR Convergence 2021
  • 30 Nov 2020 Primary endpoint (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): non-inferiority of CF101 vs. the comparator methotrexate) has not been met, according to a Can-Fite BioPharma media release.
  • 30 Nov 2020 Status changed from active, no longer recruiting to discontinued, according to a Can-Fite BioPharma media release.

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