A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Agents.

This study has been completed.

First Received: July 19, 2007 Last Updated: August 26, 2009 History of Changes

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00504777

Purpose

This single arm study will assess the safety and efficacy of MabThera in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response or intolerance to one or more anti-TNF agents. 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. 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 IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open Label Study to Evaluate the Safety, and Effect on Treatment Response, of MabThera in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to One or More Anti-TNF Agents.

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Rituximab

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Adverse event incidence and profile [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in DAS 28 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
ACR / EULAR 20/50/70 / HAQ [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	June 2007

Arms	Assigned Interventions
1: Experimental	Drug: rituximab [MabThera/Rituxan] 1000mg iv on days 1 and 15 Drug: Methotrexate 10-25mg/week po or parenteral

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients, >=18 years of age;
active rheumatoid arthritis;
receiving outpatient treatment;
an inadequate response, or intolerance, to >=1 anti-TNF agent.

Exclusion Criteria:

other rheumatic autoimmune disease or inflammatory joint disease;
concurrent treatment with any anti-TNF-alpha therapy;
joint or osseous surgery during 8 weeks prior to recruitment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504777

Locations

Taiwan

TAPEI, Taiwan, 114

TAICHUNG, Taiwan, 404

KAOHSIUNG, Taiwan, 833

TAOYUAN, Taiwan, 333

TAICHUNG, Taiwan, 407

CHANGHUA, Taiwan, 500

KAOHSIUNG, Taiwan, 807

TAIPEI, Taiwan, 112

TAICHUNG, Taiwan, 402

KAOHSIUNG, Taiwan, 813

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML20798
Study First Received:	July 19, 2007
Last Updated:	August 26, 2009
ClinicalTrials.gov Identifier:	NCT00504777 History of Changes
Health Authority:	Taiwan: Department of Health

Study placed in the following topic categories:

Antimetabolites
Autoimmune Diseases
Immunologic Factors
Rituximab
Joint Diseases
Arthritis, Rheumatoid
Folate
Rheumatic Diseases
Folinic Acid

Folic Acid Antagonists
Immunosuppressive Agents
Vitamin B9
Folic Acid
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases
Methotrexate
Antirheumatic Agents

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Arthritis, Rheumatoid
Reproductive Control Agents
Musculoskeletal Diseases
Arthritis
Therapeutic Uses
Abortifacient Agents
Connective Tissue Diseases
Methotrexate

Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Autoimmune Diseases
Immune System Diseases
Rituximab
Joint Diseases
Enzyme Inhibitors
Rheumatic Diseases
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Immunosuppressive Agents
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 11, 2009