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

November 1, 2016 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

151

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00290
      • Hämeenlinna, Finland, 13530
      • Joensuu, Finland, 80210
      • Jyvaeskylae, Finland, 40620
      • Paimio, Finland, 21540
      • Riihimäki, Finland, 11101
      • Seinäjoki, Finland, 60220
      • Tampere, Finland, 33520

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with rheumatoid arthritis on or commencing treatment with rituximab [MabThera]

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • unable/unwilling to give informed consent to data collection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort
Drug: rituximab [Mabthera/Rituxan]
As prescribed by physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy: DAS28
Time Frame: 29 months
29 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

February 24, 2010

First Submitted That Met QC Criteria

February 24, 2010

First Posted (ESTIMATE)

February 25, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML22609

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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