A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Agents.

Hoffmann-La Roche36 enrolled

Overview

This single arm study will assess the safety and efficacy of MabThera in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response or intolerance to one or more anti-TNF agents. Patients will receive MabThera 1000mg i.v. on days 1 and 15, and methotrexate (10-25mg/week p.o. or parenteral), together with methylprednisolone 100mg i.v. prior to infusion of MabThera. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

rituximab [MabThera/Rituxan]

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * adult patients, \>=18 years of age; * active rheumatoid arthritis; * receiving outpatient treatment; * an inadequate response, or intolerance, to \>=1 anti-TNF agent. Exclusion Criteria: * other rheumatic autoimmune disease or inflammatory joint disease; * concurrent treatment with any anti-TNF-alpha therapy; * joint or osseous surgery during 8 weeks prior to recruitment.

Locations (10)

Unnamed facility

Changhua, Taiwan

Unnamed facility

Kaohsiung City, Taiwan

Unnamed facility

Kaohsiung City, Taiwan

Unnamed facility

Kaohsiung City, Taiwan

Unnamed facility

Taichung, Taiwan

Unnamed facility

Taichung, Taiwan

Unnamed facility

Taichung, Taiwan

Unnamed facility

Taipei, Taiwan

Unnamed facility

Taoyuan, Taiwan

Unnamed facility

Tapei, Taiwan

Outcomes

Primary Outcomes

Change From Baseline in Disease Activity Score Based on 28-Joint Count (DAS28)

DAS28 was calculated from the number of swollen joints, or swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (measured in millimeters per hour \[mm/hr\]), and Patient Global Assessment of Disease Activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. A clinically significant improvement in DAS28 was a change of at least 1.2 units.

Time frame: Week 24

Secondary Outcomes

Percentage of Participants Achieving American College of Rheumatology (ACR) Response

ACR20/50/70 response defined as greater than or equal to (≥)20 percent (%), 50%, or 70% improvement, respectively, in TJC and SJC, and ≥20%/50%/70% improvement in at least 3 of 5 remaining ACR core measures: Patient Assessment of Pain, Patient Global Assessment of Disease Activity, Physician Global Assessment of Disease Activity, self-assessed disability based on the Health Assessment Questionnaire-Disability Index (HAQ-DI), and C-Reactive Protein (CRP).

Time frame: Week 24

Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Category

Percentage of participants with a EULAR response at Week 24 based on a scale of good response, moderate response, or no response. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders have a change from baseline greater than (\>)1.2 with DAS28 less than or equal to (≤)3.2; moderate responders have a change from baseline \>1.2 with DAS28 \>3.2 to ≤5.1 or change from baseline \>0.6 to ≤1.2 with DAS28 ≤5.1; non-responders have a change from baseline ≤0.6 or change from baseline \>0.6 and ≤1.2 with DAS28 \>5.1.

Time frame: Week 24

Change From Baseline in HAQ-DI Score

The Stanford HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Responses in each component set are scored from 0 (without any difficulty) to 3 (unable to do). The highest score recorded for any question in a category determines the score for the category, unless aids, devices, or help from another person is required. The HAQ-DI score is calculated as the sum of the category scores divided by the number of categories scored, giving a possible range of scores from 0 to 3. Scores of 0 to 1 are generally considered to represent "mild to moderate difficulty", 1 to 2 as "moderate to severe disability", and 2 to 3 as "severe to very severe disability".

Time frame: Week 24