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
Information provided by:

December 17, 2008
December 18, 2008
September 16, 2013
December 2008
February 2010   (Final data collection date for primary outcome measure)
The primary objective is the proportion of subjects with ACR20 response in their RA at Week 12. [ Time Frame: 12 weeks ]
Same as current
Complete list of historical versions of study NCT00810836 on Archive Site
To determine the safety and tolerability of BG00012 with methotrexate in this population. [ Time Frame: 12 weeks ]
Same as current
Not Provided
Not Provided
Efficacy and Safety Study of BG00012 With Methotrexate in Patients With Active Rheumatoid Arthritis
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
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.
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: BG00012
  • Drug: BG00012
  • Drug: placebo
    oral placebo
  • Active Comparator: 1
    BG00012 480 mg/day
    Intervention: Drug: BG00012
  • Active Comparator: 2
    BG00012 720 mg/day
    Intervention: Drug: BG00012
  • Placebo Comparator: 3
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2010
February 2010   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   Czech Republic,   India,   Poland,   Slovakia
Not Provided
Not Provided
Biogen Idec,Immunology department, Biogen Idec
Not Provided
Not Provided
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP