A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a TNF-Blocker.
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|ClinicalTrials.gov Identifier: NCT00424502|
Recruitment Status : Completed
First Posted : January 19, 2007
Results First Posted : July 14, 2014
Last Update Posted : May 9, 2016
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: rituximab [MabThera/Rituxan] Drug: Methotrexate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||January 2007|
|Primary Completion Date :||October 2009|
|Study Completion Date :||October 2009|
Drug: rituximab [MabThera/Rituxan]
1g iv on days 1 and 15
Other Name: MabThera/RituxanDrug: Methotrexate
- Disease Activity Score Based on 28-Joint Count (DAS28) [ Time Frame: Day 0 and Week 24 ]DAS28 consists of swollen joint count (SJC) and tender joint count (TJC) measurements, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]), and Patient Global Assessment of Disease Activity (participant-rated assessment of arthritis) with transformed scores ranging from 0 to 10. Higher scores indicated greater affectation due to disease activity. DAS28 equal to or less than (≤)3.2 equals (=) low disease activity, greater than (>)3.2 to 5.1 = moderate to high disease activity.
- Health Assessment Questionnaire - Disability Index (HAQ-DI) Scores [ Time Frame: Day 0 and Week 24 ]The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific subcategory items. The standard disability score was calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered, yielding a score from 0 (without any difficulty) to 3 (unable to do).
- Anti-cyclic Citrullinated Peptide (Anti-CCP) [ Time Frame: Day 0 and Week 24 ]Anti-CCP measured as absorbance units per milliliter (AU/mL).
- Vascular Endothelial Growth Factor (VEGF) [ Time Frame: Day 0 and Week 24 ]VEGF was measured as picograms per milliliter (pg/mL).
- Erythrocyte Sedimentation Rate (ESR) [ Time Frame: Day 0 and Week 24 ]ESR was measured in mm/hr.
- C-Reactive Protein (CRP) [ Time Frame: Day 0 and Week 24 ]CRP was measured in milligrams per liter (mg/L).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00424502
|Budapest, Hungary, 1023|
|Budapest, Hungary, 1027|
|Debrecen, Hungary, 4032|
|Study Director:||Clinical Trials||Hoffmann-La Roche|