A Study of MabThera/Rituxan (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis and Inadequate Response to DMARD Therapy

Phase 3CompletedNCT02006706

Hoffmann-La Roche15 enrolled

Overview

This study will evaluate the efficacy and safety of MabThera/Rituxan plus methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to at least 1 DMARD treatment. All patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and methotrexate (10-25mg po) weekly. The anticipated time on study treatment is 3-12 months.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

rituximab [MabThera/Rituxan]DRUG

1000 mg iv Days 1 and 15

methotrexateDRUG

10 - 25 mg/week

methylprednisoloneDRUG

iv administration on Day 1 and 15 prior to MabThera/Rituxan infusion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * adult patients, 18-80 years of age; * rheumatoid arthritis after inadequate response to \>=1 DMARD treatment; * active disease; * DMARDs other than methotrexate withdrawn for at least 4 weeks prior to start of study treatment. Exclusion Criteria: * autoimmune disease other than rheumatoid arthritis; * bone/joint surgery within 8 weeks prior to screening, or joint surgery planned within 24 weeks of MabThera infusion; * concurrent treatment with any DMARD or antiTNF-alfa; * intra-articular or parenteral corticosteroids within 4 weeks prior to screening.

Locations (3)

Unnamed facility

Belgrade, Serbia

Unnamed facility

Niška Banja, Serbia

Unnamed facility

Nova Sad, Serbia

Outcomes

Primary Outcomes

Change From Baseline Disease Activity Score Based on 28-Joint Count (DAS28) at Week 24

DAS28 was calculated from the number of swollen joints and painful joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PGA) of disease activity (participant-rated arthritis activity assessment using visual analog scale \[VAS\]) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (\>)3.2 to 5.1 = moderate to high disease activity.

Time frame: Baseline, Week 24

Secondary Outcomes

Health Assessment Questionnaire-Disability Index (HAQ-DI)

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

Time frame: Baseline, Week 24

Data from ClinicalTrials.gov

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