Efficacy and Safety Study of BG00012 With Methotrexate in Patients With Active Rheumatoid Arthritis

Biogen153 enrolled

Overview

The purpose of this study is to investigate whether the drug BG00012 can improve the symptoms of rheumatoid arthritis (RA) in patients who are already taking methotrexate for RA, but who still suffer symptoms of RA. The purpose is also to ensure that the combination of methotrexate is safe for patients to take and that any side effects are acceptable to patients with RA.

The study is a double-blind, placebo-controlled study of BG00012 plus methotrexate, versus methotrexate alone, in patients with active RA, who have had an incomplete response to other conventional disease modifying anti-rheumatic (DMARD) therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

153

Conditions

Rheumatoid Arthritis

Interventions

BG00012DRUG

oral

BG00012DRUG

Oral

placeboDRUG

oral placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * must be taking methotrexate * inadequate response to at least one conventional DMARD * swollen and tender joint count Exclusion Criteria: * previous treatment with TNF or any other biologic or prosorba column Other criteria also apply.

Locations (24)

Research Site

Woolloongabba, Queensland, Australia

Research Site

Woodville, South Australia, Australia

Outcomes

Primary Outcomes

The primary objective is the proportion of subjects with ACR20 response in their RA at Week 12.

Time frame: 12 weeks

Secondary Outcomes

To determine the safety and tolerability of BG00012 with methotrexate in this population.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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