Success of Tocilizumab in RA Patients With Remission Induction and Sustained Efficacy After Discontinuation

Sponsor
SURPRISE Study Group
Study ID
NCT01120366
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab plus methotrexate — DRUG
    Tocilizumab 8mg/kg 4weeks (i.v.) plus methotrexate up to 52weeks.The dosage of MTX will be fixed at least 24 weeks from the start of the study.
  • Tocilizumab — DRUG
    tocilizumab 8mg/kg/4weeks (i.v.) up to 52weeks.

Study Details

The objective of this study is to investigate the efficacy and safety of the humanized anti-human IL-6 receptor monoclonal antibody tocilizumab (TCZ) either in monotherapy or in combination therapy with methotrexate (MTX) in patients with an inadequate response to treatment with MTX. Furthermore, in patients who have been able to achieve control of disease activity via the above therapy, we investigate the possibility of stopping TCZ and verify safety when TCZ is restarted after disease recurrence.

Key Dates

Start date
Oct 31, 2009
Status verified
Jan 2015
Primary completion
Dec 31, 2014
Completion
Dec 31, 2014

Study Design

Enrollment
233 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: SWITCH
    Tocilizumab monotherapy
  • Active Comparator: ADD-ON
    Tocilizumab plus methotrexate combination

Primary Outcome Measure

DAS28-ESR remission at 24 weeks [ Time Frame: at 24 week ]

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