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
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Rheumatoid Arthritis
Both
Rheumatoid Arthritis
Trial Information
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
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Change in disease activity as measured by the disease-activity score (DAS28)
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Portugal: Instituto Nacional da Farmácia e do Medicamento INFARMED
Study ID:
ML22935
NCT ID:
NCT01309282
Start Date:
July 2010
Completion Date:
June 2013
Related Keywords:
- Rheumatoid Arthritis
- Arthritis
- Arthritis, Rheumatoid
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