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: November 2, 2015
Last verified: November 2015
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
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

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT01641952     History of Changes
Other Study ID Numbers: ML27953
Study First Received: July 13, 2012
Last Updated: November 2, 2015
Health Authority: Romania: Romanian National Medicine and Medical Devices Agency

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on November 24, 2015