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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01075477

Enrollment

151

Registered

2010-02-25

Start date

2009-09-30

Completion date

2011-12-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

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.

Interventions

DRUGrituximab [Mabthera/Rituxan]

As prescribed by physician

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* unable/unwilling to give informed consent to data collection

Design outcomes

Primary

Measure	Time frame
Efficacy: DAS28	29 months

Secondary

Measure	Time frame
Efficacy: TJC, SJC, ESR, HAQ, CRP, patient's assessment (VAS)	29 months
Safety: serious and non-serious adverse events	29 months

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026