An Observational Study on Patients With Rheumatoid Arthritis Treated With MabThera (Rituximab)

This observational study will assess the execution, efficacy and safety of treatment with MabThera in patients with rheumatoid arthritis. Data from patients receiving MabThera according to local treatment guidelines will be collected for 29 months. Target sample size is 100-200 patients.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Helsinki, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

adult patients, >/= 18 years of age
rheumatoid arthritis
treatment with rituximab

Exclusion criteria

unable/unwilling to give informed consent to data collection

Treatment and study plan

rituximab [MabThera/Rituxan]

Drug

As prescribed by physician

Primary outcomes

Efficacy: DAS28

Time frame: 29 months

Secondary outcomes

Efficacy: TJC, SJC, ESR, HAQ, CRP, patient's assessment (VAS)

Time frame: 29 months
Safety: serious and non-serious adverse events

Time frame: 29 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Naturalistic Prospective Non-interventional Study on Rheumatoid Arthritis (RA) Patients Treated With Rituximab According to Local Treatment Guidelines

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Feb 25, 2010
Registry last updated: Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed