A Study of Combination Treatment With MabThera (Rituximab) and RoActemra (Tocilizumab) Versus RoActemra in Patients With Rheumatoid Arthritis With an Incomplete Response to Methotrexate
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00845832
First received: February 17, 2009
Last updated: June 3, 2013
Last verified: June 2013
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Purpose
This 2 part study will investigate the safety, tolerability and efficacy of MabThera 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, followed by RoActemra at one of the ascending doses between 2mg/kg and 8mg/kg at weeks 4, 8 and 12 (MabThera arm) or 8mg/kg (placebo arm). In Part 2, additional patients will be randomized to one of 2 groups to receive MabThera 0.5g on days 1 and 15 followed by the selected dose (from Part 1)of RoActemra at weeks 4, 8 and 12, 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 target sample size is <100 individuals.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: tocilizumab [RoActemra/Actemra] Drug: rituximab [MabThera/Rituxan] Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomized, Active Controlled, Double-blind, Study to Compare the Safety and Reduction in Disease Activity With the Combination of Rituximab (MabThera®)and Tocilizumab (RoActemra®) Versus Tocilizumab in Patients With Active Rheumatoid Arthritis With an Incomplete Response to Methotrexate |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Proportion of patients with DAS<=3.2 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of patients in DAS-remission(<2.6) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
- Proportion of patients with a EULAR good or moderate response [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
- Change in DAS-ESR [ Time Frame: From baseline to week 48 ] [ Designated as safety issue: No ]
- Change in CDAI, SDAI, SJC28, TJC28, HAQ, CRP, ESR [ Time Frame: From baseline to week 48 ] [ Designated as safety issue: No ]
| Enrollment: | 24 |
| Study Start Date: | March 2009 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
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
Drug: rituximab [MabThera/Rituxan]
0.5g iv on days 1 and 15 (Parts 1 and 2)
|
| Active Comparator: 2 |
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
Drug: Placebo
iv on days 1 and 15 (Parts 1 and 2)
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845832
Locations
| France | |
| Le Kremlin Bicetre, France, 94275 | |
| Montpellier, France, 34295 | |
| Paris, France, 75679 | |
| Strasbourg, France, 67098 | |
| Germany | |
| Berlin, Germany, 10117 | |
| Berlin, Germany, 14059 | |
| Heidelberg, Germany, 69120 | |
| Köln, Germany, 50924 | |
| Wuerzburg, Germany, 97080 | |
| Greece | |
| Athens, Greece, 15121 | |
| Thessaloniki, Greece, 54636 | |
| Netherlands | |
| Amsterdam, Netherlands, 1105 AZ | |
| Leiden, Netherlands, 2333 ZA | |
| Poland | |
| Bytom, Poland, 41-902 | |
| Lublin, Poland, 20-607 | |
| Poznan, Poland, 60-218 | |
| Spain | |
| Santander, Cantabria, Spain, 39008 | |
| Santiago de Compostela, La Coruña, Spain, 15706 | |
| Madrid, Spain, 28007 | |
| Sevilla, Spain, 41009 | |
| Switzerland | |
| Bern, Switzerland, 3010 | |
| Lausanne, Switzerland, 1011 | |
| United Kingdom | |
| Newcastle Upon Tyne, United Kingdom, NE1 4LP | |
| Southampton, United Kingdom, SO16 6YD | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00845832 History of Changes |
| Other Study ID Numbers: | WX21956, 2008-005525-11 |
| Study First Received: | February 17, 2009 |
| Last Updated: | June 3, 2013 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Methotrexate Rituximab Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013