A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a TNF-Blocker.

Hoffmann-La Roche20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

rituximab [MabThera/Rituxan]DRUG

1g iv on days 1 and 15

MethotrexateDRUG

10-25mg po/week

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * other chronic inflammatory diseases; * use of parental corticosteroids within 4 weeks prior to screening; * severe heart failure, or severe, uncontrolled cardiac disease.

Locations (3)

Unnamed facility

Budapest, Hungary

Unnamed facility

Budapest, Hungary

Unnamed facility

Debrecen, Hungary

Outcomes

Primary Outcomes

Disease Activity Score Based on 28-Joint Count (DAS28)

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.

Time frame: Day 0 and Week 24

Secondary Outcomes

Health Assessment Questionnaire - Disability Index (HAQ-DI) Scores

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).

Time frame: Day 0 and Week 24

Anti-cyclic Citrullinated Peptide (Anti-CCP)

Anti-CCP measured as absorbance units per milliliter (AU/mL).

Time frame: Day 0 and Week 24

Vascular Endothelial Growth Factor (VEGF)

VEGF was measured as picograms per milliliter (pg/mL).

Time frame: Day 0 and Week 24

Erythrocyte Sedimentation Rate (ESR)

ESR was measured in mm/hr.

Time frame: Day 0 and Week 24

C-Reactive Protein (CRP)

Data from ClinicalTrials.gov

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