Clinical trial · Observational
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)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rheumatoid Arthritis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Rituximab
- description
- Sero-positive \[Rheumatoid Factor (RF) and/or anti-Cyclic Citrullinated Peptide (CCP+)\] rheumatoid arthritis (RA) patients, who had initiated therapy with Rituximab (MabThera) following lack of response or intolerance to a single tumour necrosis factor (TNF)-inhibitor will be included in this arm
Primary outcomes (1)
- measure
- Mean Change From Baseline in Disease-activity Score 28-Erythrocyte Sedimentation Rate at Month 24
- timeFrame
- Baseline (Day 0) and Month 24
- description
- The disease-activity score 28 (DAS28) score is a measure of validated instrument for the assessment of the overall severity of RA disease activity calculated using the tender joint count (TJC), swollen joint count (SJC), patient's global assessment of disease activity, and erythrocyte sedimentation rate (ESR) for a total possible score of 2 to 10. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.
Secondary outcomes (13)
- measure
- Mean Change From Baseline in TJC at Month 24
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available