An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Sero-Positive Rheumatoid Arthritis Who Are Non-Reponders or Intolerant to a Single TNF-Inhibitor (PORTSMAB)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01309282
First received: March 3, 2011
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This observational study will assess the long-term efficacy and safety of MabThe ra/Rituxan in routine clinical practice in patients with sero-positive rheumatoi d arthritis who are non-responders or intolerant to a single tumour necrosis fac tor (TNF) inhibitor. Data will be collected from each patient over 2 years.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Portuguese Observational Re-Treatment Study of MabThera (PORTSMAB) - A Two-centre Observational Study in Sero-positive Rheumatoid Arthritis (RA) Patients Who Are Non-responders or Intolerant to a Single Tumor Necrosis Factor (TNF) Inhibitor

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in disease activity as measured by the disease-activity score (DAS28) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in tender/swollen joint count (TJC/SJC) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Change in erythrocyte sedimentation rate (ESR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Change in C-reactive protein (CRP) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Change in patients and physician global assessment of disease activity according to visual analogue scale (VAS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Change in severity of pain according to visual analogue scale (VAS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Change in morning stiffness (duration in minutes) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Frequency patterns of retreatment (as decided by the treating physician) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Evolution of functional capacity (Health Assessment Questionnaire) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: July 2010
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)

  Eligibility

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 sero-positive rheumatoid arthritis starting treatment with MabThera/Rituxan following lack of response or intolerance to single TNF-inhibitor

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Rheumatoid arthritis positive for rheumatoid factor and/or anti-CCP
  • Non-responder or intolerant to single TNF-inhibitor therapy
  • Initiating treatment with MabThera/Rituxan

Exclusion Criteria:

  • Contra-indications to MabThera/Rituxan therapy
  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: NCT01309282

Locations
Portugal
Lisboa, Portugal, 1649-035
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: NCT01309282     History of Changes
Other Study ID Numbers: ML22935
Study First Received: March 3, 2011
Last Updated: August 4, 2014
Health Authority: Portugal: Instituto Nacional da Farmácia e do Medicamento INFARMED

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 August 27, 2014