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An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy

This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01592292
First received: April 11, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes

April 11, 2012
May 7, 2013
January 2012
March 2015   (final data collection date for primary outcome measure)
Mean change in Disease Activity Score (DAS) 28 [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01592292 on ClinicalTrials.gov Archive Site
  • Mean change in Disease Activity Score (DAS) 28 [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Mean change over time in tender joint count (TJC) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Mean change over time in swollen joint count (SJC) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Mean change over time in erythrocyte sedimentation rate (ESR) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Mean Quality of Life score [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy
A Non-interventional Study for Relative Efficacy Outcome of Rituximab Treatment in RA Patients Who Have Inadequate Response or Have Been Intolerant to a First Anti-TNF Agent

This prospective, multi-center, observational study will evaluate the efficacy and the safety of MabThera (rituximab) in patients with rheumatoid arthritis who have not responded or have been intolerant to a first anti-TNF alpha therapy. Patients have commenced MabThera or an alternative anti-TNF alpha treatment as a second biological therapy. Data will be collected for 12 months.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Adult patients with rheumatoid arthritis who have inadequate response or have been intolerant to a first anti-TNF alpha therapy
Rheumatoid Arthritis
Not Provided
Cohort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
March 2015
March 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/=20 years of age
  • Patients with rheumatoid arthritis, who have not responded or have been intolerant to a single anti-TNF alpha therapy and who have initiated MabThera or an alternative anti-TNF alpha therapy

Exclusion Criteria:

  • Patients whose first anti-TNF alpha treatment was, or second biological therapy is given as part of a clinical trial studying rheumatoid arthritis
  • Patients who have not signed the informed consent form
Both
20 Years and older
No
Contact: Please reference Study ID Number: ML27923 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com
Korea, Republic of
 
NCT01592292
ML27923
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP