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Completed

NCT Number: NCT00810836

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Woolloongabba, Queensland, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BG00012

Drug

oral

Placebo

Drug

oral placebo

Primary outcomes

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

    Time frame: 12 weeks

Secondary outcomes

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

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

A Phase 2a, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study to Evaluate the Efficacy, Safety and Tolerability of BG00012 When Given With Methotrexate to Subjects With Active RA Who Have Had an Inadequate Response to Conventional Disease-Modifying Anti-rheumatic Drug Therapy

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 18, 2008
Registry last updated
Sep 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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