N/A
Completed N=135
An Observational Study of MabThera in Participants With Severe Active Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01613027 ↗Enrolled (actual)
135
Serious AEs
6.7%
Results posted
Oct 2016
Primary outcomePrimary: Change From Baseline in Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) at Month 6 and Month 12 — 5.53; -1.52; -1.88 units on a scale — p=<0.001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) at Month 6 and Month 12 |
5.53; -1.52; -1.88 | <0.001 sig |
| SECONDARY Percentage of Participants With European League Against Rheumatism (EULAR) Response at Month 6 and Month 12 |
75.6; 45.2; 30.4; 24.4; 77.0; 40.0 | — |
| SECONDARY Change From Baseline in Swollen Joint Count (SJC) at Month 6 and Month 12 |
6.4; -3.1; -3.8 | — |
| SECONDARY Change From Baseline in Tender Joint Count (TJC) at Month 6 and Month 12 |
8.2; -4.4; -5.1 | — |
| SECONDARY Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and Month 12 |
43.1; -14.1; -16.3 | — |
| SECONDARY Change From Baseline in C-reactive Protein (CRP) at Month 6 and Month 12 |
21.8; -10.7; -14.1 | — |
| SECONDARY Percentage of Participants Who Remained on Treatment or Discontinued Treatment by Month 6 and Month 12 |
93.3; 6.7; 86.7; 13.3 | — |
| SECONDARY Reasons for Discontinuation of Treatment by Month 6 |
2; 2; 1; 1; 1; 1 | — |
| SECONDARY Reasons for Discontinuation of Treatment by Month 12 |
3; 5; 1; 1; 1; 1 | — |
| SECONDARY Percentage of Participants With Clinically Meaningful Improvement From Baseline in Modified Health Assessment Questionnaire (M-HAQ) |
65.9; 71.9 | — |
| SECONDARY Percentage of Participants With Adverse Events (AEs) and Adverse Drug Reactions (ADRs) |
37.8; 32.6; 24.4; 9.6; 6.7; 3.0 | — |
| SECONDARY Percentage of Participants With Any Non-Serious AE and Any Serious AE by Intensity |
25.9; 9.6; 0.0; 1.5; 3.0; 2.2 | — |
| SECONDARY Percentage of Non-Serious AEs |
84.8; 15.2 | — |
| SECONDARY Percentage of Non-Serious ADRs |
100.0 | — |
| SECONDARY Percentage of Serious AEs |
88.9; 11.1 | — |
| SECONDARY Percentage of Serious ADRs |
80.0; 20.0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01613027). 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.