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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 25, 2014