An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy

Sponsor
Hoffmann-La Roche
Study ID
NCT01592292
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab as per physician's discretion.
  • Adalimumab — DRUG
    Adalimumab as per physician's discretion.
  • Etanercept — DRUG
    Etanercept as per physician's discretion.
  • Infliximab — DRUG
    Infliximab as per physician's discretion.

Study Details

This prospective, multi-center, observational study will evaluate the efficacy and the safety of MabThera (rituximab) in participants with rheumatoid arthritis who have not responded or have been intolerant to a first anti-TNF alpha therapy. Participants have commenced MabThera or an alternative anti-TNF alpha treatment as a second biological therapy. Data will be collected for 12 months.

Key Dates

Start date
Nov 30, 2011
Status verified
Mar 2016
Primary completion
Dec 31, 2014
Completion
Dec 31, 2014

Study Design

Enrollment
90 participants (actual)

Arms

  • Arm: Rituximab
    Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.
  • Arm: Other anti-TNF agent
    Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent, including adalimumab, etanercept and infliximab, as per physician's discretion for RA treatment were observed for 12 months.

Primary Outcome Measure

Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Intention to Treat (ITT) Population [ Time Frame: Baseline and Month 6 ]

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