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

NCT ID: NCT00845832

Last Updated: 2014-12-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2013-03-31

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Group Type: EXPERIMENTAL

rituximab [MabThera/Rituxan]

Intervention Type: DRUG

0.5g iv on days 1 and 15 (Parts 1 and 2)

tocilizumab [RoActemra/Actemra]

Intervention Type: DRUG

2mg/kg-8mg/kg iv in Part 1 and selected dose in Part 2, on weeks 4, 8 and 12---Arm 1\\n8mg/kg iv on weeks 4,8 and 12 (Parts 1 and 2)--- Arm 2

2

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

iv on days 1 and 15 (Parts 1 and 2)

tocilizumab [RoActemra/Actemra]

Intervention Type: DRUG

2mg/kg-8mg/kg iv in Part 1 and selected dose in Part 2, on weeks 4, 8 and 12---Arm 1\\n8mg/kg iv on weeks 4,8 and 12 (Parts 1 and 2)--- Arm 2

Interventions

Placebo

iv on days 1 and 15 (Parts 1 and 2)

Intervention Type: DRUG

rituximab [MabThera/Rituxan]

0.5g iv on days 1 and 15 (Parts 1 and 2)

Intervention Type: DRUG

tocilizumab [RoActemra/Actemra]

2mg/kg-8mg/kg iv in Part 1 and selected dose in Part 2, on weeks 4, 8 and 12---Arm 1\\n8mg/kg iv on weeks 4,8 and 12 (Parts 1 and 2)--- Arm 2

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 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

Le Kremlin-Bicêtre, , France

Montpellier, , France

Paris, , France

Strasbourg, , France

Berlin, , Germany

Berlin, , Germany

Cologne, , Germany

Heidelberg, , Germany

Würzburg, , Germany

Athens, , Greece

Thessaloniki, , Greece

Amsterdam, , Netherlands

Leiden, , Netherlands

Bytom, , Poland

Lublin, , Poland

Poznan, , Poland

Santander, Cantabria, Spain

Santiago de Compostela, La Coruña, Spain

Madrid, Madrid, Spain

Seville, Sevilla, Spain

Bern, , Switzerland

Lausanne, , Switzerland

Newcastle upon Tyne, , United Kingdom

Southampton, , United Kingdom

Countries

Belgium; Sweden; France; Germany; Greece; Netherlands; Poland; Spain; Switzerland; United Kingdom

Other Identifiers

2008-005525-11

Identifier Type: -

Identifier Source: secondary_id

WX21956

Identifier Type: -

Identifier Source: org_study_id