N/A
Completed N=90
An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy
Source: ClinicalTrials.gov NCT01592292 ↗Enrolled (actual)
90
Serious AEs
4.6%
Results posted
Aug 2016
Primary outcomePrimary: Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Intention to Treat (ITT) Population — 6.35; 5.54; -1.89; -1.80 units on a scale — p=0.3037
Summary
This prospective, multi-center, observational study will evaluate the efficacy and the safety of MabThera (rituximab) in participants with rheumatoid arthritis who have not responded or have been intolerant to a first anti-TNF alpha therapy. Participants have commenced MabThera or an alternative anti-TNF alpha treatment as a second biological therapy. Data will be collected for 12 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Intention to Treat (ITT) Population |
6.35; 5.54; -1.89; -1.80 | 0.3037 |
| PRIMARY Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Standard Population Set (SPS) |
6.30; 5.47; -1.74; -1.91 | 0.0951 |
| SECONDARY Efficacy: Mean Change From Baseline in DAS28 at Month 12 |
6.28; 5.49; -2.30; -2.29 | 0.2390 |
| SECONDARY Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Intention to Treat (ITT) Population |
13.38; 8.81; -8.21; -6.32; -9.48; -5.96 | 0.3212 |
| SECONDARY Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Standard Population Set (SPS) |
12.87; 7.79; -7.68; -5.79; -8.62; -5.80 | 0.2444 |
| SECONDARY Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Intention to Treat (ITT) Population |
11.24; 7.52; -7.00; -5.10; -8.62; -4.29 | 0.5306 |
| SECONDARY Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Standard Population Set (SPS) |
11.16; 7.13; -6.74; -5.21; -8.31; -5.00 | 0.2549 |
| SECONDARY Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Intention to Treat (ITT) Population |
67.00; 60.77; -19.35; -15.55; -20.36; -21.64 | 0.8987 |
| SECONDARY Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Standard Population Set (SPS) |
67.55; 61.58; -19.13; -23.21; -21.54; -22.10 | 0.2282 |
| SECONDARY Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Intention to Treat (ITT) Population |
3.53; 2.56; -1.84; -0.74; -0.69; -1.51 | 0.4900 |
| SECONDARY Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Standard Population Set (SPS) |
3.53; 2.59; -1.79; -1.63; -0.60; -1.59 | 0.1894 |
| SECONDARY Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Intention to Treat (ITT) Population |
0.69; 0.40 | 0.0568 |
| SECONDARY Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Standard Population Set (SPS) |
0.73; 0.46 | 0.1167 |
| SECONDARY Safety: Number of Participants With Adverse Events (AE), Adverse Drug Reactions (ADR) and Serious Adverse Events |
8; 8; 4; 5; 3; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Adult participants, >/=20 years of age
- Participants with rheumatoid arthritis, who have not responded or have been intolerant to a single anti-TNF alpha therapy and who have initiated MabThera or an alternative anti-TNF alpha therapy
Exclusion Criteria
- Participants whose first anti-TNF alpha treatment was, or second biological therapy is given as part of a clinical trial studying rheumatoid arthritis
- Participants who have not signed the informed consent form
Data sourced from ClinicalTrials.gov (NCT01592292). 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.