Randomized, Phase IV, Placebo-controlled, Comparative Study to Evaluate the Efficacy and Safety of Tapering Methotrexate (MTX) Dosage Versus Maintaining the Dosage in Patients With Severe Active Rheumatoid Arthritis (RA) Who Have Demonstrated an Inadequate Response (IR) to Prior Disease-modifying Anti-rheumatic Drugs (DMARDs) Treatment and Have Initiated RoActemra (RoActemra, TCZ) in Combination With MTX

Trial Profile

Randomized, Phase IV, Placebo-controlled, Comparative Study to Evaluate the Efficacy and Safety of Tapering Methotrexate (MTX) Dosage Versus Maintaining the Dosage in Patients With Severe Active Rheumatoid Arthritis (RA) Who Have Demonstrated an Inadequate Response (IR) to Prior Disease-modifying Anti-rheumatic Drugs (DMARDs) Treatment and Have Initiated RoActemra (RoActemra, TCZ) in Combination With MTX

Discontinued
Phase of Trial: Phase IV

Latest Information Update: 09 Oct 2017

At a glance

  • Drugs Methotrexate (Primary) ; Tocilizumab (Primary)
  • Indications Rheumatoid arthritis
  • Focus Therapeutic Use
  • Acronyms ACT-TAPER
  • Sponsors Roche
  • Most Recent Events

    • 09 Oct 2017 Primary endpoint (Percentage of Participants Maintaining Previous Disease Activity (European League Against Rheumatism [EULAR] Response) From Week 24 (Time of Randomization) to Week 60: non-inferiority criteria for tocilizumab + tapering MTX vs tocilizumab + stable MTX) has been met despite the reduced recruitment, according to results published in the Rheumatology Journal.
    • 09 Oct 2017 Results published in the Rheumatology Journal.
    • 26 Jan 2015 Planned End Date changed from 1 May 2016 to 1 Sep 2016 as reported by ClinicalTrials.gov record.
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