Phase 3
Completed N=120
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on One Prior Anti-TNF Therapy (RESET)
Source: ClinicalTrials.gov NCT01272908 ↗Enrolled (actual)
120
Serious AEs
9.6%
Results posted
Aug 2014
Primary outcomePrimary: Percentage of Participants With Adverse Events During the Initial Treatment Period - Overall Summary — 85.0; 41.7; 20.8; 4.2 percentage of participants
Summary
This study will evaluate the safety and effectiveness of MabThera (rituximab) in patients with active rheumatoid arthritis who are receiving methotrexate, and who have a previous or current inadequate response to one prior anti-TNF therapy. All patients will receive MabThera 1000 mg as an intravenous infusion on days 1 and 15. After the initial study phase of 24 weeks, eligible patients may receive one re-treatment with MabThera. The anticipated time on study treatment is 48 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events During the Initial Treatment Period - Overall Summary |
85.0; 41.7; 20.8; 4.2; 10.0; 47.5 | — |
| SECONDARY Percentage of Participants With Adverse Events During the Re-Treatment Period - Overall Summary |
68.8; 27.3; 13.0; 1.3; 9.1; 27.3 | — |
| SECONDARY Percentage of Participants Meeting American College of Rheumatology (ACR) Response Criteria During the Initial Treatment Period |
31.7; 50.0; 54.2; 25.0; 15.8; 5.8 | 0.253 |
| SECONDARY Percentage of Participants With Complete Clinical Response Per ACR Criteria During the Initial Treatment Period |
4.2 | — |
| SECONDARY Percentage of Participants Meeting ACR Response Criteria During the Re-treatment Period |
54.5; 58.4; 26.0; 28.6; 6.5; 9.1 | — |
| SECONDARY Percentage of Participants With Complete Clinical Response Per ACR Criteria During the Re-Treatment Period |
1.3 | — |
| SECONDARY Percentage of Participants Meeting European League Against Rheumatism (EULAR) Response Criteria During the Initial Treatment Period |
4.2; 47.5; 51.7; 46.7; 9.2; 55.0 | 0.667 |
| SECONDARY Percentage of Participants Meeting EULAR Response Criteria During the Re-Treatment Period |
20.8; 53.2; 74.0; 22.1; 19.5; 48.1 | — |
| SECONDARY Change From Baseline in DAS28 During the Initial Treatment Period |
6.4; -1.1; -1.7; -2.0; -1.7; -2.1 | <0.001 sig |
| SECONDARY Change From Baseline in DAS28 During the Re-Treatment Period |
6.4; -2.3; -2.2 | — |
| SECONDARY Change From Baseline in SJC During the Initial Treatment Period |
13.7; -3.6; -5.7; -7.1; -5.6; -7.7 | <0.001 sig |
| SECONDARY Change From Baseline in SJC During the Re-Treatment Period |
13.7; -7.6; -7.7 | — |
| SECONDARY Change From Baseline in TJC During the Initial Treatment Period |
16.1; -6.3; -7.8; -9.0; -7.4; -7.8 | <0.001 sig |
| SECONDARY Change From Baseline in TJC During the Re-Treatment Period |
16.1; -9.4; -9.7 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment of Disease Activity During the Initial Treatment Period |
68.6; -22.0; -31.4; -35.1; -28.6; -35.9 | <0.001 sig |
| SECONDARY Change From Baseline in Physician's Global Assessment of Disease Activity During the Re-Treatment Period |
68.6; -35.5; -41.5 | — |
| SECONDARY Change From Baseline in Patient Global Assessment of Disease Activity Score During the Initial Treatment Period |
67.5; -19.7; -26.3; -29.2; -23.8; -28.5 | <0.001 sig |
| SECONDARY Change From Baseline in Patient Global Assessment of Disease Activity During the Re-Treatment Period |
67.5; -32.6; -30.7 | — |
| SECONDARY Change From Baseline in Patient Global Assessment of Pain During the Initial Treatment Period |
60.2; -17.5; -24.0; -25.7; -18.0; -22.6 | <0.001 sig |
| SECONDARY Change From Baseline in Patient Global Assessment of Pain During the Re-Treatment Period |
60.2; -28.3; -26.6 | — |
| SECONDARY Change From Baseline HAQ-DI Score During the Initial Treatment Period |
1.7; -0.2; -0.3; -0.4; -0.3; -0.4 | <0.001 sig |
| SECONDARY Change From Baseline HAQ-DI Score During the Re-Treatment Period |
1.7; -0.5; -0.5 | — |
| SECONDARY Change From Baseline in ESR During the Initial Treatment Period |
37.0; -4.5; -11.3; -16.0; -9.2; -12.0 | <0.001 sig |
| SECONDARY Change From Baseline in ESR During the Re-Treatment Period |
37.0; -17.9; -18.7 | — |
| SECONDARY Change From Baseline in CRP During the Initial Treatment Period |
25.6; -7.9; -11.9; -16.1; -9.1; -7.6 | <0.001 sig |
| SECONDARY Change From Baseline CRP During the Re-Treatment Period |
25.6; -16.9; -15.3 | — |
| SECONDARY Percentage of Participants With Disease Remission According to DAS28 in the Initial Treatment Period |
0.8; 5.0; 5.8; 5.8; 5.8 | — |
| SECONDARY Percentage of Participants With Disease Remission According to DAS28 in the Re-Treatment Period |
5.0; 4.2 | — |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score During the Initial Treatment Period |
28.9; -5.4; -7.3; -9.1; -8.6; -10.9 | <0.001 sig |
| SECONDARY Change From Baseline in FACIT-F Total Score During the Re-Treatment Period |
28.9; -8.3; -8.9 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, 18-80 years of age
- Moderate to severe active rheumatoid arthritis
- Inadequate response to a single previous or current treatment with an anti-TNF agent
- Methotrexate for at least 12 weeks, at a stable dose over the past 4 weeks
Exclusion Criteria
- Previous treatment with MabThera
- Use of an anti-TNF agent within past 8 weeks (4 in the case of etanercept)
- Concurrent treatment with any Disease Modifying Anti-Rheumatic Drug (DMARD) other than methotrexate
- Active infection, or history of serious or chronic infection
Data sourced from ClinicalTrials.gov (NCT01272908). 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.