Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00578305
First received: December 19, 2007
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

This 3 arm study will assess the efficacy of MabThera in the prevention of progr ession of structural joint damage in patients with active rheumatoid arthritis w ho have an inadequate clinical response to methotrexate. Patients will be random ized to receive MabThera 1000mg i.v., MabThera 500mg i.v. or placebo i.v. on day s 1 and 15; all patients will receive concomitant methotrexate at a stable dosag e of 12.5-25mg/week throughout the study. Further courses of MabThera will be pr ovided to eligible patients. Structural joint damage will be assessed by magneti c resonance imaging (MRI) at baseline, and at intervals during the study. The an ticipated time on study treatment is 1-2 years, and the target sample size is 10 0-500 individuals.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: Methotrexate
Drug: Placebo
Drug: rituximab [MabThera/Rituxan]
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo Controlled, Multicenter Clinical Study Investigating Efficacy of Rituximab in the Inhibition of Joint Structural Damage Assessed by Magnetic Resonance Imaging in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate

Resource links provided by NLM:


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 ]

Enrollment: 185
Study Start Date: November 2007
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Methotrexate
12.5-25mg/week
Drug: rituximab [MabThera/Rituxan]
1000mg iv on days 1 and 15
Experimental: 2 Drug: Methotrexate
12.5-25mg/week
Drug: rituximab [MabThera/Rituxan]
500mg iv on days 1 and 15
Placebo Comparator: 3 Drug: Methotrexate
12.5-25mg/week
Drug: Placebo
iv on days 1 and 15

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
Argentina
Buenos Aires, Argentina, C1280AEB
Brazil
Goiania, GO, Brazil, 74110010
Curtiba, PR, Brazil, 80030-110
Porto Alegre, RS, Brazil, 90610-000
Sao Paulo, SP, Brazil, 04023-900
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3E0W3
Canada, Newfoundland and Labrador
St John's, Newfoundland and Labrador, Canada, A1A 5E8
Canada, Ontario
Ottawa, Ontario, Canada, K1H 1A2
Ottawa, Ontario, Canada, K2G 6E2
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Montreal, Quebec, Canada, H3Z 2Z3
Montreal, Quebec, Canada, H1T 2M4
Montreal, Quebec, Canada, H2L 1S6
Quebec City, Quebec, Canada, G1V 3M7
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada, S7M 0Z9
Czech Republic
Brno, Czech Republic, 625 00
Ceské Budejovice, Czech Republic, 370 01
Praha, Czech Republic, 128 50
Denmark
Hillerod, Denmark, 3400
Hvidovre, Denmark, 2650
København, Denmark, 2100
Estonia
Tallinn, Estonia, 11312
Tallinn, Estonia, 13419
France
Montpellier, France, 34295
Nice, France, 06202
Orleans, France, 45032
Toulouse, France, 31059
Germany
Bad Aibling, Germany, 83043
Berlin, Germany, 10117
Dresden, Germany, 01307
Erlangen, Germany, 91054
Halle, Germany, 06120
Hannover, Germany, 30625
Greece
Athens, Greece, 115 27
Patras, Greece, 265 04
Thessaloniki, Greece, 54636
Latvia
Riga, Latvia, 1002
Riga, Latvia, 1038
Lithuania
Vilnius, Lithuania, LT-08661
Netherlands
Amsterdam, Netherlands, 1105 AZ
Norway
Oslo, Norway, 0370
Romania
Bucharest, Romania, 020475
Cluj-napoca, Romania, 400006
Russian Federation
Kazan, Russian Federation, 420097
Moscow, Russian Federation, 115522
Saint-Petersburg, Russian Federation, 195067
Voronezh, Russian Federation, 394066
Serbia
Belgrade, Serbia, 11000
Niska Banja, Serbia, 18250
Spain
Barcelona, Spain, 08907
Barcelona, Spain, 08003
Madrid, Spain, 28046
Malaga, Spain, 29010
Sevilla, Spain, 41009
Valencia, Spain, 46017
Switzerland
Bern, Switzerland, 3010
Turkey
Adana, Turkey, 01330
Ankara, Turkey, 06018
Istanbul, Turkey, 34098
Izmir, Turkey, 35100
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: NCT00578305     History of Changes
Other Study ID Numbers: MA21056
Study First Received: December 19, 2007
Last Updated: November 3, 2014
Health Authority: Latvia: State Agency of Medicines

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Methotrexate
Rituximab
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014