N/A
Completed N=1,653
An Observational Study on the Safety and Effectiveness of Rituximab in Patients With Severe Active Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01071798 ↗Enrolled (actual)
1,653
Serious AEs
9.0%
Results posted
Feb 2016
Primary outcomePrimary: DAS28 Score — 5.3; 5.0; 5.4; 4.8 units on a scale
Summary
This prospective observational study aims to evaluate safety, application and onset of effect of rituximab in clinical routine treatment of severe active rheumatoid arthritis during the first 6 months (in case of re-therapy: 12 months).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY DAS28 Score |
5.3; 5.0; 5.4; 4.8; 4.6; 4.9 | — |
| PRIMARY HAQ Disability Index (HAQ-DI) |
1.5; 1.5; 1.5; 1.4; 1.4; 1.4 | — |
| SECONDARY Percentage of Participants With a Treatment-Emergent Adverse Event (TEAE) |
28.5; 21.1; 34.8; 8.7; 5.7; 10.9 | — |
| SECONDARY Number of Participants Who Received Only One Treatment Cycle With Clinically Relevant Changes in HAQ-Score at Last Visit During Therapy Compared to Baseline (Categorized) |
10; 28; 6; 2; 17; 0 | — |
| SECONDARY Number of Participants Who Received Two Cycles With Clinically Relevant Changes in HAQ-Score at Last Visit During Therapy Compared to Baseline (Categorized) |
7; 17; 9; 4; 6; 1 | — |
Eligibility Criteria
Inclusion Criteria
- No pretreatment with rituximab
- Age 18 years or older
- Patients with active, severe rheumatoid arthritis with prescription of rituximab according to German Summary of Product Characteristics (SmPC - "Fachinformation")
- Patients with signed informed consent
- Female patients with secure contraception
Exclusion Criteria
- Violation of Selection criteria:
- Active severe infection
- Severe heart failure (NYHA class IV) or severe, uncontrollable heart disease
- Participation in an interventional study within the last 3 months before therapy start with rituximab
- Pretreatment with rituximab
- Age <18 years
- Known intolerability of monoclonal antibodies or chimeric monoclonal antibodies
- Known pregnancy or breastfeeding
- Data of patients without approval of data by the physician
- Patients without informed consent
- Double documentation
Data sourced from ClinicalTrials.gov (NCT01071798). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.