Clinical trial · Observational
An Observational Study of MabThera in Participants With Severe Active Rheumatoid Arthritis
A Multicenter Observational Study of the Response to Rituximab (MabThera®) in Seropositive Patients With Rheumatoid Arthritis With Inadequate Response or Intolerance to Treatment With One or More Tumor Necrosis Factor Inhibitors (TNFi)
- 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 evaluate the effect on disease activity and the safety in routine clinical practice of MabThera (rituximab) in participants with active seropositive rheumatoid arthritis, who have an inadequate response to one or more tumour necrosis factor inhibitor (anti-TNF) therapies.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Rituximab
- description
- Rituximab administered according to prescribing information and normal clinical practice.
- interventionNames
- Biological: Rituximab
Primary outcomes (1)
- measure
- Change From Baseline in Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) at Month 6 and Month 12
- timeFrame
- Baseline, Month 6, Month 12
- description
- DAS28-ESR is a measure of the participant's disease activity and was calculated using the swollen joint count of 28 joints (SJC28), tender joint count of 28 joints (TJC28), erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment of disease activity (100-millimeter \[mm\] horizontal visual analog scale with 0=no disease activity to 100=maximum disease activity). DAS28-ESR scores range from 0 to 10, with higher scores corresponding to greater disease activity.
Secondary outcomes (15)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18 years with rheumatoid arthritis (RA) * Seropositive participants with RA (positive for rheumatoid factor (RF) and/or anti-Citrullinated Cyclic Peptide \[CCP\]) * Active disease despite receiving one or more TNF inhibitors * Absence of serious or active infection Exclusion Criteria: * Participants with serious history of heart failure (class New York Heart Association \[NYHA\] IV) or severe uncontrolled heart disease * Participants pregnant or lactating * Prior treatment with Mabthera® * Participants receiving any other investigational product in the context of other clinical study * Participants with known hypersensitivity to rituximab or to any of the excipients
References
Publications (0)
Data not yet available