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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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01309282
First received: March 3, 2011
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

This observational study will assess the long-term efficacy and safety of MabThera/Rituxan in routine clinical practice in patients with sero-positive rheumatoid arthritis who are non-responders or intolerant to a single tumour necrosis factor (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:

Drug Information available for: Rituximab
U.S. FDA Resources

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
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 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
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: May 7, 2013
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 May 19, 2013