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

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ClinicalTrials.gov Identifier: NCT01196780
Recruitment Status : Terminated
First Posted : September 8, 2010
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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 Design

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
Primary Completion Date : October 2015
Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

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

Groups and Cohorts

Group/Cohort
Cohort


Outcome Measures

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 ]

Eligibility Criteria

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
Criteria

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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01196780


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov 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
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents