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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01592292
First received: April 11, 2012
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

This prospective, multi-center, observational study will evaluate the efficacy a nd 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. Pa tients have commenced MabThera or an alternative anti-TNF alpha treatment as a s econd biological therapy. Data will be collected for 12 months.


Condition
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: 89
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   20 Years and older
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

Criteria

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 ClinicalTrials.gov identifier: NCT01592292

Locations
Korea, Republic of
Busan, Korea, Republic of, 612-896
Daegu, Korea, Republic of, 705-718
Daegu, Korea, Republic of, 700-712
Daejeon, Korea, Republic of, 302-799
Goyang-si, Korea, Republic of, 411-706
Gwangju, Korea, Republic of, 501-757
Jeju, Korea, Republic of, 690-767
Jeollabuk-do, Korea, Republic of, 561-712
Seoul, Korea, Republic of, 143-729
Seoul, Korea, Republic of, 130-702
Seoul, Korea, Republic of, 135-720
Seoul, Korea, Republic of, 134-722
Seoul, Korea, Republic of, 150-713
Suwon, Korea, Republic of, 442-723
Ulsan, Korea, Republic of, 682-714
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: NCT01592292     History of Changes
Other Study ID Numbers: ML27923
Study First Received: April 11, 2012
Last Updated: October 6, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 19, 2014