N/A
Completed N=1,111
An Observational Study of MabThera/Rituxan (Rituximab) and Alternative TNF-Inhibitors in Patients With Rheumatoid Arthritis and an Inadequate Response to a Single Previous TNF-Inhibitor
Source: ClinicalTrials.gov NCT01557348 ↗Enrolled (actual)
1,111
Serious AEs
12.4%
Results posted
Jan 2017
Primary outcomePrimary: Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month 6 — -1.5; -1.1 scores on a scale — p=0.0068
Summary
This multicenter, prospective, observational study will assess the efficacy of MabThera/Rituxan (rituximab) and alternative TNF-inhibitors in patients with rheumatoid arthritis who are non-responders or intolerant to a single previous TNF-inhibitor. Data will be collected from each patient from the time of change in biologic therapy for 12 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month 6 |
-1.5; -1.1 | 0.0068 sig |
| SECONDARY Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month12 |
-1.5; -1.2 | 0.0588 |
| SECONDARY Least Squares Mean Change From Baseline in TJC at Months 6 and 12 |
-5.7; -4.5; -4.7; -3.7 | 0.1126 |
| SECONDARY Least Squares Mean Change From Baseline in SJC at Months 6 and 12 |
-3.3; -2.8; -2.7; -2.4 | 0.4168 |
| SECONDARY Least Squares Mean Change From Baseline in C-reactive Protein at Months 6 and 12 |
-29.1; -29.9; -11.6; -15.3 | 0.8758 |
| SECONDARY Least Squares Mean Change From Baseline in ESR at Months 6 and 12 |
-13.2; -7.0; -11.6; -8.6 | 0.0086 sig |
| SECONDARY Least Squares Mean Change From Baseline in Physician Global Assessment of Disease at Months 6 and 12 |
-21.0; -14.8; -21.8; -14.3 | 0.0764 |
| SECONDARY Least Squares Mean Change From Baseline in Patient Global Assessment of Disease at Months 6 and 12 |
-17.0; -10.2; -19.7; -17.1 | 0.0443 sig |
| SECONDARY Least Squares Mean Change From Baseline in Participant's VAS Pain Score at Months 6 and 12 |
-15.7; -10.8; -19.0; -10.0 | 0.2026 |
| SECONDARY Least Squares Mean Change From Baseline in Health Assessment Questionnaire-Disability Index at Months 6 and 12 |
-0.6; -0.5; -0.3; -0.2 | 0.3370 |
| SECONDARY Least Squares Mean Change From Baseline in Duration of Morning Stiffness at Months 6 and 12 |
-19.0; -4.3; -16.7; -1.4 | 0.3253 |
| SECONDARY Percentage of Participants Who Remained on Their Second Biologic Therapy at Months 6 and 12 After Start of Second Biologic Therapy |
NA; NA | — |
| SECONDARY Reasons for Stopping the Second Biologic Therapy and Subsequent Therapy Choice |
NA; NA | — |
| SECONDARY Number of Participants With Any Adverse Events, Any Serious Adverse Event, Adverse Events Leading to Withdrawal, and Death |
291; 241; 82; 56; 17; 39 | — |
| SECONDARY Number of Participants With Reasons for Discontinuation of the First TNFi Therapy |
311; 236; 89; 79; 5; 8 | — |
| SECONDARY Number of Participants With Previous TNFi Therapy |
131; 116; 176; 162; 95; 42 | — |
| SECONDARY Number of Participants With Previous Non-biologic Disease-modifying Anti-rheumatic Drugs Therapy |
5; 6; 0; 1; 4; 4 | — |
| SECONDARY Factors Related to Selection of Second Biologic Therapy Following an Insufficient Response or Intolerance to a Single Previous TNFi |
344; 216; 256; 135; 82; 203 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Patients with rheumatoid arthritis (RA) who have not responded or have been intolerant to a single TNF-inhibitor therapy
- Initiated on treatment with MabThera/Rituxan or an alternative TNF-inhibitor therapy, in accordance with the relevant Summary of Product Characteristics
Exclusion Criteria
- Patients whose second biologic therapy is given as part of a clinical trial studying RA treatment
Data sourced from ClinicalTrials.gov (NCT01557348). 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.