An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: April 11, 2012
Last updated: March 1, 2016
Last verified: March 2016
This prospective, multi-center, observational study will evaluate the efficacy and the safety of MabThera (rituximab) in patients with rheumatoid arthritis who have not responded or have been intolerant to a first anti-TNF alpha therapy. Patients have commenced MabThera or an alternative anti-TNF alpha treatment as a second biological therapy. Data will be collected for 12 months.

Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Non-interventional Study for Relative Efficacy Outcome of Rituximab Treatment in RA Patients Who Have Inadequate Response or Have Been Intolerant to a First Anti-TNF Agent

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Mean change in Disease Activity Score (DAS) 28 [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in Disease Activity Score (DAS) 28 [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Mean change over time in tender joint count (TJC) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Mean change over time in swollen joint count (SJC) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Mean change over time in erythrocyte sedimentation rate (ESR) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Mean Quality of Life score [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: November 2011
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients with rheumatoid arthritis who have inadequate response or have been intolerant to a first anti-TNF alpha therapy

Inclusion Criteria:

  • Adult patients, >/=20 years of age
  • Patients with rheumatoid arthritis, who have not responded or have been intolerant to a single anti-TNF alpha therapy and who have initiated MabThera or an alternative anti-TNF alpha therapy

Exclusion Criteria:

  • Patients whose first anti-TNF alpha treatment was, or second biological therapy is given as part of a clinical trial studying rheumatoid arthritis
  • Patients who have not signed the informed consent form
  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: NCT01592292

Korea, Republic of
Busan, Korea, Republic of, 48108
Daegu, Korea, Republic of, 41931
Daegu, Korea, Republic of, 42472
Daejeon, Korea, Republic of, 302-799
Gwangju, Korea, Republic of, 61469
Gyeonggi-do, Korea, Republic of, 10380
Jeju Special Self-Governing Province, Korea, Republic of, 63241
Jeollabuk-do, Korea, Republic of, 561-712
Seoul, Korea, Republic of, 05030
Seoul, Korea, Republic of, 06273
Seoul, Korea, Republic of, 130-702
Seoul, Korea, Republic of, 134-722
Seoul, Korea, Republic of, 150-713
Suwon, Korea, Republic of, 442-723
Ulsan, Korea, Republic of, 44033
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01592292     History of Changes
Other Study ID Numbers: ML27923 
Study First Received: April 11, 2012
Last Updated: March 1, 2016
Health Authority: Korea: Food and Drug Administration

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 21, 2016