An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNF Therapy (REPEAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01196780
Recruitment Status : Terminated
First Posted : September 8, 2010
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This observational study will assess the efficacy and safety of MabThera/Rituxan (Rituximab) in patients with active rheumatoid arthritis who have had an inadequate response or are intolerant to anti-TNF therapy. Data will be collected from patients initiated on MabThera/Rituxan therapy according to standard of care in routine clinical practice. For each patient data will be collected for 92 weeks.

Condition or disease
Rheumatoid Arthritis

Study Type : Observational
Actual Enrollment : 1240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: MabThera Post Marketing Observational Study in TNF-IR Patients to Assess Efficacy and Safety of REPeated Courses in routinE ClinicAl pracTice
Study Start Date : February 2010
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab
U.S. FDA Resources


Primary Outcome Measures :
  1. Efficacy: Change in Disease Activity Score - erythrocyte sedimentation rate (DAS28 - ESR) [ Time Frame: from baseline to Week 92 ]

Secondary Outcome Measures :
  1. Safety: Incidence of adverse events [ Time Frame: 4 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with an inadequate response to prior anti-TNF therapy

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Active Rheumatoid Arthritis
  • Inadequate response to anti-TNF
  • Eligible for MabThera/Rituxan therapy according to physician's decision

Exclusion Criteria:

  • According to Summary of Product Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01196780

Bucuresti, Romania, 020983
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01196780     History of Changes
Other Study ID Numbers: ML25228
First Posted: September 8, 2010    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents