Clinical trial NCT01309282: An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Sero-Positive Rheumatoid Arthritis Who Are Non-Responders or Intolerant to a Single TNF-Inhibitor (PORTSMAB)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-03-07
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Mean Change From Baseline in Disease-activity Score 28-Erythrocyte Sedimentation Rate at Month 24
timeFrame: Baseline (Day 0) and Month 24
Secondary outcomes:
measure: Mean Change From Baseline in TJC at Month 24
timeFrame: Baseline (Day 0) and Month 24
measure: Mean Change From Baseline in SJC at Month 24
timeFrame: Baseline (Day 0) and Month 24
measure: Mean Change From Baseline in ESR at Month 24
timeFrame: Baseline (Day 0) and Month 24
measure: Mean Change From Baseline in C-reactive Protein at Month 24
timeFrame: Baseline (Day 0) and Month 24
measure: Mean Change From Baseline in Physician's Global Assessment of Disease Activity At Month 24
timeFrame: Baseline (Day 0) and Month 24
measure: Mean Change From Baseline in Patient's Global Assessment of Disease Activity at Month 24
timeFrame: Baseline (Day 0) and Month 24
measure: Mean Change From Baseline in Severity of Pain at Month 24
timeFrame: Baseline (Day 0) and Month 24
measure: Mean Change Form Baseline in Functional Capacity at Month 24
timeFrame: Baseline (Day 0) and Month 24
measure: Reason for Change From First TNF-inhibitor Therapy to Rituximab
timeFrame: At Screening
measure: Number of Participants on Each Pattern of Re-treatment
timeFrame: Up to Month 24
measure: Number of Participants With Incidence of Infusion Reactions or Injection Site Reactions
timeFrame: At Months 6, 12 and 24
measure: Number of Participants With Incidence of Infectious Events
timeFrame: At Months 6, 12 and 24
measure: Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events
timeFrame: Up to Month 24
Other outcomes:
Locations:
city: Lisboa
country: Portugal
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: