An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response or Intolerance to One Anti-TNF Agent

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: July 13, 2012
Last updated: April 2, 2016
Last verified: April 2016
This observational, prospective, multicenter study will evaluate the efficacy and safety of MabThera/Rituxan in patients with active rheumatoid arthritis and an inadequate response or intolerance to one anti-TNF therapy. Patients who receive MabThera/Rituxan according to the current standard and in line with the summary of product characteristics at a dose of 1000 mg intravenously on Days 1 and 15 will be followed for 20 weeks.

Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional, Prospective, Multicenter Study to Assess Efficacy and Safety of MabtheRA (Rituximab) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to One Anti-TNF Agent - FAST 2 SWITCH Program

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Mean change in Disease Activity Score (DAS28-ESR) at Week 20 [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life: Health Assessment Questionnaire [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

Enrollment: 505
Study Start Date: October 2011
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with active rheumatoid arthritis and an inadequate response or intolerant to one prior anti-TFN therapy initiated on treatment with MabThera/Rituxan

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Patients with rheumatoid arthritis, eligible for treatment with MabThera/Rituxan in accordance with SPC
  • Inadequate response to a single TNF inhibitor defined as change in DAS28-ESR <1.2 or DAS28-ESR >3.5 at 5 months after first course of anti-TNF therapy
  • Patients with a clinical and biological evaluation performed within 12 weeks prior to enrolment may be included

Exclusion Criteria:

  • More than one previous anti-TNF therapies
  • Any other biological therapy apart from the one anti-TNF therapy
  • Hypersensitivity to rituximab or any of the excipients or to murine proteins
  • Active severe infections
  • Patients in a severely immunocompromised state
  • Severe heart failure (NYHA Class IV) or severe, uncontrolled cardiac disease
  • Women of childbearing potential not willing to use contraception
  • Pregnant or breastfeeding women
  • Participation in another trial
  Contacts and Locations
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Please refer to this study by its identifier: NCT01641952

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

Responsible Party: Hoffmann-La Roche Identifier: NCT01641952     History of Changes
Other Study ID Numbers: ML27953 
Study First Received: July 13, 2012
Last Updated: April 2, 2016
Health Authority: Romania: Romanian National Medicine and Medical Devices Agency

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 processed this record on July 26, 2016