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An Observational Study of MabThera/Rituxan (Rituximab) and Alternative TNF-Inhibitors in Patients With Rheumatoid Arthritis and an Inadequate Response to a Single Previous TNF-Inhibitor

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01557348
First received: March 13, 2012
Last updated: March 4, 2013
Last verified: March 2013
History of Changes
  Purpose

This multicenter, prospective, observational study will assess the efficacy of MabThera/Rituxan (rituximab) and alternative TNF-inhibitors in patients with rheumatoid arthritis who are non-responders or intolerant to a single previous TNF-inhibitor. Data will be collected from each patient from the time of change in biologic therapy for 12 months.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Global Multi-centre Observational Study in RA Patients Who Are Non Responders or Intolerant to a Single TNF Inhibitor.

Resource links provided by NLM:

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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Mean change in Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) 6 months after change in biologic therapy [ Time Frame: approximately 14 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in DAS28-ESR 12 months after change in biologic therapy [ Time Frame: approximately 14 years ] [ Designated as safety issue: No ]
  • Mean change in tender/swollen joint count (TJC/SJC) at 6 and 12 months [ Time Frame: approximately 14 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 14 years ] [ Designated as safety issue: No ]
  • Mean change in C-reactive protein at 6 and 12 months [ Time Frame: approximately 14 years ] [ Designated as safety issue: No ]
  • Quality of life: Health assessment questionnaires (HAQ) [ Time Frame: approximately 14 years ] [ Designated as safety issue: No ]
  • Proportion of patients remaining on their second biologic therapy at 6 and 12 months after starting [ Time Frame: approximately 14 years ] [ Designated as safety issue: No ]

Enrollment: 1219
Study Start Date: April 2009
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Rheumatoid arthritis patients who are non-responders or intolerant to a single TNF-inhibitor

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Patients with rheumatoid arthritis (RA) who have not responded or have been intolerant to a single TNF-inhibitor therapy
  • Initiated on treatment with MabThera/Rituxan or an alternative TNF-inhibitor therapy, in accordance with the relevant Summary of Product Characteristics

Exclusion Criteria:

  • Patients whose second biologic therapy is given as part of a clinical trial studying RA treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01557348

  Show 239 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01557348     History of Changes
Other Study ID Numbers: MA22401
Study First Received: March 13, 2012
Last Updated: March 4, 2013
Health Authority: Greece: Ministry of Health

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013