N/A
Completed N=9
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)
Source: ClinicalTrials.gov NCT01309282 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcomePrimary: Mean Change From Baseline in Disease-activity Score 28-Erythrocyte Sedimentation Rate at Month 24 — -2.31 Scores on a scale — p=0.0078
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Disease-activity Score 28-Erythrocyte Sedimentation Rate at Month 24 |
-2.31 | 0.0078 sig |
| SECONDARY Mean Change From Baseline in TJC at Month 24 |
-7.5 | 0.0078 sig |
| SECONDARY Mean Change From Baseline in SJC at Month 24 |
-4.13 | 0.01403 sig |
| SECONDARY Mean Change From Baseline in ESR at Month 24 |
-28.50 | 0.0355 sig |
| SECONDARY Mean Change From Baseline in C-reactive Protein at Month 24 |
-8.11 | 0.5469 |
| SECONDARY Mean Change From Baseline in Physician's Global Assessment of Disease Activity At Month 24 |
-34.29 | 0.0225 sig |
| SECONDARY Mean Change From Baseline in Patient's Global Assessment of Disease Activity at Month 24 |
-28.50 | 0.0225 sig |
| SECONDARY Mean Change From Baseline in Severity of Pain at Month 24 |
-23.15 | 0.0904 |
| SECONDARY Mean Change Form Baseline in Functional Capacity at Month 24 |
-0.27 | 0.2969 |
| SECONDARY Reason for Change From First TNF-inhibitor Therapy to Rituximab |
1; 1; 6; 1 | — |
| SECONDARY Number of Participants on Each Pattern of Re-treatment |
9; 0 | — |
| SECONDARY Number of Participants With Incidence of Infusion Reactions or Injection Site Reactions |
0; 0; 1 | — |
| SECONDARY Number of Participants With Incidence of Infectious Events |
0; 2; 0 | — |
| SECONDARY Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events |
5; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01309282). 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.