SCORE Study: A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00578305

Purpose

This 3 arm study will assess the efficacy of MabThera in the prevention of progression of structural joint damage in patients with active rheumatoid arthritis who have an inadequate clinical response to methotrexate. Patients will be randomized to receive MabThera 1000mg i.v., MabThera 500mg i.v. or placebo i.v. on days 1 and 15; all patients will receive concomitant methotrexate at a stable dosage of 12.5-25mg/week throughout the study. Further courses of MabThera will be provided to eligible patients. Structural joint damage will be assessed by magnetic resonance imaging (MRI) at baseline, and at intervals during the study. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: rituximab [MabThera/Rituxan] Drug: Placebo Drug: Methotrexate	Phase III

MedlinePlus related topics: MRI Scans Rheumatoid Arthritis

Drug Information available for: Methotrexate Rituximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Placebo Controlled, Multicenter Clinical Study Investigating Efficacy of Rituximab (Mabthera/Rituxan) in the Inhibition of Joint Structural Damage Assessed by Magnetic Resonance Imaging in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate - the R.A. SCORE Stud

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Changes in MRI bone erosion score from baseline [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in MRI erosion, synovitis and osteitis [ Time Frame: Week 12, 24 and 52 ] [ Designated as safety issue: No ]
DAS 28-CRP, ACR 20/50/70, and HAQ. [ Time Frame: Week 24 and 52 ] [ Designated as safety issue: No ]
AEs, laboratory parameters, C-reactive protein, ESR. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	November 2007
Estimated Study Completion Date:	April 2010

Arms	Assigned Interventions
1: Experimental	Drug: rituximab [MabThera/Rituxan] 1000mg iv on days 1 and 15 Drug: Methotrexate 12.5-25mg/week
2: Experimental	Drug: rituximab [MabThera/Rituxan] 500mg iv on days 1 and 15 Drug: Methotrexate 12.5-25mg/week
3: Placebo Comparator	Drug: Placebo iv on days 1 and 15 Drug: Methotrexate 12.5-25mg/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;
active rheumatoid arthritis for >=3 months and <=10 years;
evidence of erosive disease and/or clinical synovitis in a signal joint;
inadequate response to 12.5-25mg/week methotrexate for >=12 weeks.

Exclusion Criteria:

rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
any surgical procedure within 12 weeks prior to baseline;
previous treatment with a biologic agent or with a B cell modulating or cell depleting therapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578305

Contacts

Contact: Please reference Study ID Number: MA21056	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Show 63 Study Locations

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:	MA21056
Study First Received:	December 19, 2007
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00578305
Health Authority:	Latvia: State Agency of Medicines

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