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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00810836
Recruitment Status : Completed
First Posted : December 18, 2008
Last Update Posted : September 16, 2013
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: BG00012 Drug: placebo Phase 2

Detailed Description:
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  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : December 2008
Actual Primary Completion Date : February 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
BG00012 480 mg/day
Drug: BG00012
Active Comparator: 2
BG00012 720 mg/day
Drug: BG00012
Placebo Comparator: 3 Drug: placebo
oral placebo

Primary Outcome Measures :
  1. The primary objective is the proportion of subjects with ACR20 response in their RA at Week 12. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. To determine the safety and tolerability of BG00012 with methotrexate in this population. [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00810836

Australia, Queensland
Research Site
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Research Site
Woodville, South Australia, Australia, 5011
Canada, Ontario
Research Site
Sarnia, Ontario, Canada, N7T4X3
Research Site
New Market, Canada
Research Site
Ottawa, Canada
Research Site
Rothesay, Canada
Czech Republic
Research Site
Active, not recruiting, Czech Republic
Research Site
Pardubice, Czech Republic
Research Site
Uh. Hradiste, Czech Republic
Research Site
Zlin, Czech Republic
Research Site
Bangalore, India
Research Site
Hyderabaad, India
Research Site
Hyderabad, India
Research Site
Lucknow, India
Research Site
Bialystock, Poland
Research Site
Grodzisk Mazowiecki, Poland
Research Site
Lublin, Poland
Research Site
Poznan, Poland
Research Site
Torun, Poland
Research Site
Warsaw, Poland
Research Site
Warszawa, Poland
Research Site
Banska Bysterica, Slovakia
Research Site
Bratislava, Slovakia
Research Site
Kosice, Slovakia
Research Site
Piestany, Slovakia
Sponsors and Collaborators

Responsible Party: Biogen Idec,Immunology department, Biogen Idec Identifier: NCT00810836     History of Changes
Other Study ID Numbers: 109RA201
First Posted: December 18, 2008    Key Record Dates
Last Update Posted: September 16, 2013
Last Verified: March 2011

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Dimethyl Fumarate
Antirheumatic Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Nucleic Acid Synthesis Inhibitors