A Pharmacokinetic and Pharmacodynamic Study of MabThera (Rituximab) Plus Methotrexate in Patients With Rheumatoid Arthritis (RA)

NCT ID: NCT00422942

Last Updated: 2014-07-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2010-06-30

Brief Summary

This single arm study will investigate the pattern of B cell depletion in synovial tissue and peripheral blood of patients with active RA, after MabThera (1000mg iv x 2 on days 1 and 15) + methotrexate (10-25mg/week po) treatment. The clinical efficacy and pharmacokinetic profile of MabThera after treatment and retreatment will also be investigated. The anticipated time on study treatment is 2+ years, and the target sample size is <100 individuals.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

rituximab [MabThera/Rituxan]

Intervention Type: DRUG

1000mg iv on days 1 and 15

Methotrexate

Intervention Type: DRUG

10-25mg po weekly

Interventions

rituximab [MabThera/Rituxan]

1000mg iv on days 1 and 15

Intervention Type: DRUG

Methotrexate

10-25mg po weekly

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• adult patients 18-80 years of age;
• RA for >=3 months;
• receiving outpatient treatment;
• failed treatment with >=1 DMARD (but not anti TNF or other biologic therapy);
• inadequate response to methotrexate, having taken and tolerated it for >=12 weeks, with a stable dose for >=4 weeks.

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, or other systemic autoimmune disorder;
• diagnosis of RA before the age of 16;
• bone/joint surgery within 12 weeks of study;
• prior use of anti-TNF or other biologic therapy, an anti-alpha 4 integrin, or any cell-depleting therapies.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Amsterdam, , Netherlands

Countries

Netherlands

Other Identifiers

WA19078

Identifier Type: -

Identifier Source: org_study_id