Study to Examine Efficacy and Safety of Rituximab in Participants With Rheumatoid Arthritis

Sponsor
Hoffmann-La Roche
Study ID
NCT02699892
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab will be administered at the discretion of treating physician according to approved label. Protocol does not specify/enforce the criteria for initiation of treatment with rituximab and procedure of the infusion of rituximab.

Study Details

This Phase IV post-marketing, non-interventional, open label, non-comparative and prospective study will examine the efficacy and safety of rituximab in participants who had previously received rituximab in terms of everyday medical practice. Efficacy and safety of rituximab will be determined 24 weeks after receiving the first infusion, 24 weeks after the second infusion repeated courses of treatment (if the participants receive another course of rituximab) and 24 weeks after the third infusion repeated courses of treatment (if the participants receive third course of rituximab). Protocol does not specify the criteria for initiation of treatment with rituximab and procedure of the infusion of rituximab. Rituximab will be administered at the discretion of treating physician according to approved label.

Key Dates

Start date
Oct 31, 2007
Status verified
Sep 2016
Primary completion
Feb 28, 2014
Completion
Feb 28, 2014

Study Design

Enrollment
130 participants (actual)

Arms

  • Arm: Rheumatoid arthritis participants
    Participants who were on rituximab for rheumatoid arthritis and who will continue receiving rituximab treatment (at the discretion of treating physician) according to previous approved indication will be observed for a period of 72 weeks.

Primary Outcome Measure

Percentage of Participants Achieving Reduction From Baseline in Disease Activity Score Based on 28 Joints Count (DAS28) of More Than 1.2 Units After 24 Weeks of First Rituximab Infusion [ Time Frame: Baseline, 24 weeks after first rituximab infusion (Week 24) ]

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