An Observational Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: January 24, 2011
Last updated: May 11, 2015
Last verified: May 2015

This observational study will assess the efficacy and safety of MabThera (rituximab) in combination with methotrexate in patients with active refractory rheumatoid arthritis who have failed to respond to a single course of anti-TNF therapy in routine clinical practice. Data will be collected from patients for 12 months after the first dose of MabThera or a minimum of 6 months following a re-treatment course.

Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Non-interventional Multicenter Study of MabThera® (Rituximab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Efficacy of MabThera (rituximab) plus methotrexate in routine clinical practice following inadequate response to a single cycle of anti-TNF therapy: Disease Activity Score (DAS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reasons for re-treatment with MabThera in case of re-treatment within 6 months of the first course [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Efficacy of MabThera in case of re-treatment after 6 months of the re-treatment course: DAS [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Demographics of patients eligible to receive MabThera [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 77
Study Start Date: August 2010
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 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

Refractory rheumatoid arthritis


Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Active rheumatoid arthritis
  • Inadequate response to a single anti-TNF inhibitor
  • Eligible to receive MabThera therapy in accordance with prescribing information
  • Signed data release form
  • Women of childbearing potential must use effective form of contraception

Exclusion Criteria:

  • Contra-indication to receive MabThera according to the local labelling
  • Previous treatment with MabThera
  • Treatment with any investigational drug within 30 days prior to enrolment
  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 identifier: NCT01283399

Beirut, Lebanon, 11-236
Beirut, Lebanon, 99999
Beirut, Lebanon
Jbeil, Lebanon, 1401
Tripoli, Lebanon, 371 Tripoli
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT01283399     History of Changes
Other Study ID Numbers: ML25270
Study First Received: January 24, 2011
Last Updated: May 11, 2015
Health Authority: Lebanon: Ministry of Public Health

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on August 30, 2015