A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies.
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00462345
First received: April 18, 2007
Last updated: October 15, 2009
Last verified: October 2009
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Purpose
This single arm study will evaluate the efficacy and safety of MabThera in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response to one or more anti-TNF therapies. 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. After week 24, eligible patients may receive re-treatment. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: rituximab [MabThera/Rituxan] Drug: Methotrexate |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Treatment Response in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Percentage of patients with ACR 20 response [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- ACR 50/70; change in DAS; EULAR response; changes in ACR core set; SF-36; radiographic analysis. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
- AEs, laboratory parameters, immunology parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Enrollment: | 40 |
| Study Completion Date: | July 2009 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: rituximab [MabThera/Rituxan]
1000mg iv on days 1 and 15
Drug: Methotrexate
10-25mg po or parenteral/week
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- adult patients, 18-80 years of age;
- rheumatoid arthritis for >=6 months;
- receiving outpatient treatment;
- an inadequate response to at least one anti-TNF therapy;
- stable methotrexate for >=12 weeks.
Exclusion Criteria:
- other rheumatic autoimmune disease or inflammatory joint disease;
- previous treatment with MabThera;
- concurrent treatment with any DMARD (apart from methotrexate), anti-TNF alpha therapy, or other biologic agent.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00462345
Locations
| Korea, Republic of | |
| Seoul, Korea, Republic of, 137701 | |
| Seoul, Korea, Republic of, 110-744 | |
| Seoul, Korea, Republic of, 138-736 | |
| Seoul, Korea, Republic of, 133-792 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Disclosures Group, Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00462345 History of Changes |
| Other Study ID Numbers: | ML20934 |
| Study First Received: | April 18, 2007 |
| Last Updated: | October 15, 2009 |
| Health Authority: | Korea: Food and Drug Administration |
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 May 16, 2013