A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a TNF-Blocker.
- Conditions
- Rheumatoid Arthritis
- Interventions
- Registration Number
- NCT00424502
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This single arm study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis whose current treatment with one or more TNF blocker had produced an inadequate response. Patients will receive MabThera (1g infusion) on day 1 and day 15, and will continue on their basic methotrexate therapy (10-25mg/week). The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- adult patients, >=18 years of age;
- diagnosed RA for >=3 months prior to first administration of study medication;
- inadequate response or intolerance to >=1 anti-TNF therapies, alone or in combination with methotrexate;
- if using NSAIDS, analgesics or oral corticosteroids, must be on a stable dose for >=2 weeks prior to start of study.
- other chronic inflammatory diseases;
- use of parental corticosteroids within 4 weeks prior to screening;
- severe heart failure, or severe, uncontrolled cardiac disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 rituximab [MabThera/Rituxan] - 1 Methotrexate -
- Primary Outcome Measures
Name Time Method Disease Activity Score Based on 28-Joint Count (DAS28) 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.
- Secondary Outcome Measures
Name Time Method Health Assessment Questionnaire - Disability Index (HAQ-DI) Scores 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) Day 0 and Week 24 Anti-CCP measured as absorbance units per milliliter (AU/mL).
Erythrocyte Sedimentation Rate (ESR) Day 0 and Week 24 ESR was measured in mm/hr.
C-Reactive Protein (CRP) Day 0 and Week 24 CRP was measured in milligrams per liter (mg/L).
Vascular Endothelial Growth Factor (VEGF) Day 0 and Week 24 VEGF was measured as picograms per milliliter (pg/mL).