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: September 22, 2014
Last verified: September 2014

December 19, 2007
September 22, 2014
November 2007
May 2013   (final data collection date for primary outcome measure)
Changes in MRI bone erosion score from baseline [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Change in MRI bone erosion score between baseline and week 24.
Complete list of historical versions of study NCT00578305 on ClinicalTrials.gov Archive Site
  • 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 ]
Efficacy: Change from baseline in MRI erosion, synovitis and osteitis; DAS28-CRP, ACR 20/50/70 and HAQ at weeks 24 and 52. Safety: AEs, laboratory parameters, C-reactive protein, ESR.
Not Provided
Not Provided
 
SCORE Study: A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate.
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: Methotrexate
    12.5-25mg/week
  • Drug: Placebo
    iv on days 1 and 15
  • Drug: rituximab [MabThera/Rituxan]
    1000mg iv on days 1 and 15
  • Drug: rituximab [MabThera/Rituxan]
    500mg iv on days 1 and 15
  • Experimental: 1
    Interventions:
    • Drug: Methotrexate
    • Drug: rituximab [MabThera/Rituxan]
  • Experimental: 2
    Interventions:
    • Drug: Methotrexate
    • Drug: rituximab [MabThera/Rituxan]
  • Placebo Comparator: 3
    Interventions:
    • Drug: Methotrexate
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
185
May 2013
May 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Brazil,   Canada,   Czech Republic,   Denmark,   Estonia,   France,   Germany,   Greece,   Latvia,   Lithuania,   Netherlands,   Norway,   Romania,   Russian Federation,   Serbia,   Spain,   Switzerland,   Turkey
 
NCT00578305
MA21056
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP