Phase 4 N=36 Treatment

A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Agents.

Rheumatoid Arthritis

Bottom Line

View on ClinicalTrials.gov: NCT00504777 ↗

Enrolled (actual)

Serious AEs

8.3%

Results posted

Aug 2014

Primary outcome: Primary: Change From Baseline in Disease Activity Score Based on 28-Joint Count (DAS28) — 5.51; 4.39; -1.12 scores on a scale — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: rituximab [MabThera/Rituxan] (Drug); Methotrexate (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: Mar 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Disease Activity Score Based on 28-Joint Count (DAS28)	5.51; 4.39; -1.12	<0.0001 sig
SECONDARY Percentage of Participants Achieving American College of Rheumatology (ACR) Response	2.78; 0; 0	—
SECONDARY Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Category	0; 58.33; 41.67	—
SECONDARY Change From Baseline in HAQ-DI Score	1.07; 0.81; -0.26	0.0054 sig

Summary

This single arm study will assess the safety and efficacy of MabThera in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response or intolerance to one or more anti-TNF agents. Patients will receive MabThera 1000mg i.v. on days 1 and 15, and methotrexate (10-25mg/week p.o. or parenteral), together with methylprednisolone 100mg i.v. prior to infusion of MabThera. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Eligibility Criteria

Inclusion Criteria

adult patients, >=18 years of age;
active rheumatoid arthritis;
receiving outpatient treatment;
an inadequate response, or intolerance, to >=1 anti-TNF agent.

Exclusion Criteria

other rheumatic autoimmune disease or inflammatory joint disease;
concurrent treatment with any anti-TNF-alpha therapy;
joint or osseous surgery during 8 weeks prior to recruitment.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00504777). 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.