A Study of Combination Treatment With MabThera (Rituximab) and RoActemra (Tocilizumab) Versus RoActemra in Patients With Rheumatoid Arthritis With an Incomplete Response to Methotrexate

Roche

Status and phase

Terminated

Phase 2

Conditions

Rheumatoid Arthritis

Treatments

Drug: tocilizumab [RoActemra/Actemra]

Drug: rituximab [MabThera/Rituxan]

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00845832

WX21956

2008-005525-11

Details and patient eligibility

About

This 2 part study will investigate the safety, tolerability and efficacy of MabT hera in combination with RoActemra in patients with active rheumatoid arthritis despite a stable dose of methotrexate. In Part 1 of the study, patients will be randomized to receive either MabThera 0.5g iv or placebo on days 1 and 15, follo wed by RoActemra at one of the ascending doses between 2mg/kg and 8mg/kg at week s 4, 8 and 12 (MabThera arm) or 8mg/kg (placebo arm). In Part 2, additional pati ents will be randomized to one of 2 groups to receive MabThera 0.5g on days 1 an d 15 followed by the selected dose (from Part 1)of RoActemra at weeks 4, 8 and 1 2, or placebo on days 1 and 15 followed by RoActemra 8mg/kg at weeks 4,8 and 12.

All patients will then be eligible to receive extension treatment withRoActemra every 4 weeks. The anticipated time on study treatment is 12 months, and the tar get sample size is <100 individuals.

Enrollment

24 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

adult patients, 18-65 years of age;
rheumatoid arthritis, functional status I-III;
SJC>=4 (28 joint count) and TJC>=4 (28 joint count) at screening and baseline;
RF and/or anti-CCP positive;
may have failed up to 1 approved anti-TNF agent (infliximab, etanercept or adalimumab);
inadequate response to methotrexate, at a dose of 7.5-25mg weekly for at least 12 weeks, at a stable dose for past 4 weeks.

Exclusion criteria

rheumatic autoimmune disease other than rheumatoid arthritis, or significant systemic involvement secondary to rheumatoid arthritis;
history of, or current, inflammatory joint disease other than rheumatoid arthritis;
diagnosis of juvenile idiopathic arthritis and/or rheumatoid arthritis before age 16;
significant cardiac or pulmonary disease;
previous treatment with any biologic agent for rheumatoid arthritis (other than infliximab, etanercept or adalimumab).