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

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: Rituximab

Study type: Observational

Funder types: Industry

Identifiers

NCT02699892

ML21619

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-Participants receiving rituximab no longer than 4 weeks before the start of monitoring

Exclusion criteria

-Not Applicable

Trial design

130 participants in 1 patient group

Rheumatoid arthritis participants

Description:

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.

Treatment:

Drug: Rituximab