SCORE Study: A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate.
This study is ongoing, but not recruiting participants.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00578305
First received: December 19, 2007
Last updated: May 13, 2013
Last verified: May 2013
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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 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 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: rituximab [MabThera/Rituxan]
1000mg iv on days 1 and 15
Drug: Methotrexate
12.5-25mg/week
|
| Experimental: 2 |
Drug: rituximab [MabThera/Rituxan]
500mg iv on days 1 and 15
Drug: Methotrexate
12.5-25mg/week
|
| Placebo Comparator: 3 |
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
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| Argentina | |
| Buenos Aires, Argentina, C1280AEB | |
| Brazil | |
| Curitiba, Brazil, 80060-240 | |
| Goiania, Brazil, 74110010 | |
| Porto Alegre, Brazil, 90610-000 | |
| Sao Paulo, Brazil, 04023-062 | |
| 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, 62500 | |
| Ceské Budejovice, Czech Republic, 370 01 | |
| Praha, Czech Republic, 128 50 | |
| Denmark | |
| Hillerød, 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, 31054 | |
| Germany | |
| Bad Aibling, Germany, 83043 | |
| Berlin, Germany, 10117 | |
| Dresden, Germany, 01307 | |
| Erlangen, Germany, 91054 | |
| Halle, Germany, 06120 | |
| Hannover, Germany, 30625 | |
| Greece | |
| Athens, Greece, 11527 | |
| Patras, Greece, 26504 | |
| Thessaloniki, Greece, 54636 | |
| Latvia | |
| Riga, Latvia, 1002 | |
| Riga, Latvia, LV1038 | |
| Lithuania | |
| Vilnius, Lithuania, LT-08661 | |
| Netherlands | |
| Amsterdam, Netherlands, 1105 AZ | |
| Norway | |
| Oslo, Norway, 0319 | |
| Romania | |
| Bucharest, Romania, 020475 | |
| Cluj-napoca, Romania, 400006 | |
| Russian Federation | |
| Kazan, Russian Federation, 420097 | |
| Moscow, Russian Federation, 115522 | |
| St Petersburg, Russian Federation, 191015 | |
| 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: | May 13, 2013 |
| Health Authority: | Latvia: State Agency of Medicines |
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 19, 2013