An Observational Study of MabThera in Participants With Severe Active Rheumatoid Arthritis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

135 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2015-09-30

Brief Summary

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This observational study will evaluate the effect on disease activity and the safety in routine clinical practice of MabThera (rituximab) in participants with active seropositive rheumatoid arthritis, who have an inadequate response to one or more tumour necrosis factor inhibitor (anti-TNF) therapies.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Rituximab

Rituximab administered according to prescribing information and normal clinical practice.

Rituximab

Intervention Type BIOLOGICAL

Rituximab administered according to prescribing information and normal clinical practice.

Interventions

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Rituximab

Rituximab administered according to prescribing information and normal clinical practice.

Intervention Type BIOLOGICAL

Other Intervention Names

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MabThera®

Eligibility Criteria

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Inclusion Criteria

* Age \>18 years with rheumatoid arthritis (RA)
* Seropositive participants with RA (positive for rheumatoid factor (RF) and/or anti-Citrullinated Cyclic Peptide \[CCP\])
* Active disease despite receiving one or more TNF inhibitors
* Absence of serious or active infection

Exclusion Criteria

* Participants with serious history of heart failure (class New York Heart Association \[NYHA\] IV) or severe uncontrolled heart disease
* Participants pregnant or lactating
* Prior treatment with Mabthera®
* Participants receiving any other investigational product in the context of other clinical study
* Participants with known hypersensitivity to rituximab or to any of the excipients

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No