N/A
Completed N=505
An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response or Intolerance to One Anti-Tumor Necrosis Factor (Anti-TNF) Agent
Source: ClinicalTrials.gov NCT01641952 ↗Enrolled (actual)
505
Serious AEs
2.8%
Results posted
Aug 2016
Primary outcomePrimary: Percentage of Participant With Good or Moderate Response According to European League Against Rheumatism (EULAR) Response Criteria — 0; 8.20; 43.03; 9.00 percentage of participants
Summary
This observational, prospective, multicenter study will evaluate the efficacy and safety of MabThera/Rituxan in participants with active rheumatoid arthritis and an inadequate response or intolerance to one anti-TNF therapy. Participants who receive MabThera/Rituxan according to the current standard and in line with the summary of product characteristics at a dose of 1000 milligram (mg) intravenously on Days 1 and 15 will be followed for 20 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participant With Good or Moderate Response According to European League Against Rheumatism (EULAR) Response Criteria |
0; 8.20; 43.03; 9.00; 14.54 | — |
| PRIMARY Change From Baseline in DAS28-ESR at Week 20 |
-1.53458 | — |
| PRIMARY Mean DAS28-ESR Score at Visit 4 (Week 20) |
3.8218 | — |
| PRIMARY Percentage of Participants With Change in DAS28-ESR of Greater Than or Equal (>=) 1.2 After First Course of Treatment |
57.99 | — |
| PRIMARY Percentage of Participants With EULAR Response |
0; 8.20; 17.62; 43.03; 9.00; 0 | — |
| PRIMARY Percentage of Participants With EULAR Response in Subgroup of Participants Who Had Been Treated With Anti-TNF Previously |
0; 0.83; 0; 4.16; 0; 0.83 | — |
| PRIMARY Percentage of Participants With Remission (DAS28 <2.6) and Low Disease Activity Following Each Treatment Course |
16.19; 15 | — |
| PRIMARY Number of Participants With Remission (DAS28 <2.6) and Low Disease Activity Following Each Treatment Course for Subgroup of Participants Who Had Been Treated With Etanercept or Adalimumab or Infliximab Before Rituximab |
18; 18; 24 | — |
| PRIMARY Number of Participants With Adverse Events (AE) |
16 | — |
| SECONDARY Health Assessment Questionnaire (HAQ) Score at Week 20 |
2.62; 1.85 | — |
Eligibility Criteria
Inclusion Criteria
- Adult participants, >/= 18 years of age
- Participants with rheumatoid arthritis, eligible for treatment with MabThera/Rituxan in accordance with summary of product characteristics (SPC)
- Inadequate response to a single TNF inhibitor defined as change in disease activity score-28 erythrocyte sedimentation rate (DAS28-ESR) 3.5 at 5 months after first course of anti-TNF therapy
- Participants with a clinical and biological evaluation performed within 12 weeks prior to enrollment may be included
Exclusion Criteria
- More than one previous anti-TNF therapies
- Any other biological therapy apart from the one anti-TNF therapy
- Hypersensitivity to rituximab or any of the excipients or to murine proteins
- Active severe infections
- Participants in a severely immunocompromised state
- Severe heart failure [New York Heart Association (NYHA) Class IV] or severe, uncontrolled cardiac disease
- Women of childbearing potential not willing to use contraception
- Pregnant or breastfeeding women
- Participation in another trial
Data sourced from ClinicalTrials.gov (NCT01641952). 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.