A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a TNF-Blocker. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00424502

Purpose

This single arm study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis whose current treatment with one or more TNF blocker had produced an inadequate response. Patients will receive MabThera (1g infusion) on day 1 and day 15, and will continue on their basic methotrexate therapy (10-25mg/week). 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

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Rituximab

U.S. FDA Resources

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 Effect of MabThera on Treatment Response in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Previous TNF Inhibition.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

DAS 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

ACR 20/50/70 and HAQ [ Time Frame: Weeks 2, 6, 16, 24, 36 and 48 ] [ Designated as safety issue: No ]
AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	January 2007
Estimated Study Completion Date:	April 2009

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

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;
diagnosed RA for >=3 months prior to first administration of study medication;
inadequate response or intolerance to >=1 anti-TNF therapies, alone or in combination with methotrexate;
if using NSAIDS, analgesics or oral corticosteroids, must be on a stable dose for >=2 weeks prior to start of study.

Exclusion Criteria:

other chronic inflammatory diseases;
use of parental corticosteroids within 4 weeks prior to screening;
severe heart failure, or severe, uncontrolled cardiac disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00424502

Locations

Hungary

DEBRECEN, Hungary, 4004

BUDAPEST, Hungary, 1027

BUDAPEST, Hungary, 1023

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML20538
Study First Received:	January 18, 2007
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00424502
Health Authority:	Hungary: Ministry of Health

Study placed in the following topic categories:

Folic Acid
Autoimmune Diseases
Musculoskeletal Diseases
Rituximab
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Methotrexate
Rheumatic Diseases

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents

Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009