Phase 4 Completed N=18 Treatment

A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Rheumatoid Arthritis

Source: ClinicalTrials.gov NCT01000610 ↗

Enrolled (actual)

Serious AEs

33.3%

Results posted

Mar 2015

Primary outcomePrimary: Number of Participants Reporting Adverse Events (AEs) — 11; 7 number of participants

Summary

In this open-label single arm study the safety and efficacy of Mabthera will be evaluated in patients with active rheumatoid arthritis who have had an inadequate response to methotrexate. Patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and background methotrexate (10-25mg po or sc weekly). After the initial study period of 24 weeks, eligible patients may receive up to 3 re-treatments with MabThera. The anticipated time on study treatment is 1-2 years and target sample size is <50

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Reporting Adverse Events (AEs)	11; 7	—
SECONDARY Percentage Change in Disease Activity Score 28 (DAS28) From Baseline to Week 24	-1.7	—
SECONDARY Percentage of Participants Whose DAS28 Improved by >1.2 at Week 24	75.0	—
SECONDARY Change in Bone Density (in Participants Untreated With Bisphosphonates)	-1.82; -1.6	—

Eligibility Criteria

Inclusion Criteria

adult patients >/= 18 years of age
rheumatoid arthritis DAS28 >/= 3.2
receiving treatment on an outpatient basis
experienced an inadequate response to previous or current treatment with methotrexate

Exclusion Criteria

rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA
history of or current inflammatory joint disease other than RA
previous treatment with any cell-depleting therapies

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01000610). 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.