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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: December 17, 2008
Last updated: September 12, 2013
Last verified: March 2011
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 Intervention Phase
Rheumatoid Arthritis
Drug: BG00012
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Further study details as provided by Biogen:

Primary Outcome Measures:
  • The primary objective is the proportion of subjects with ACR20 response in their RA at Week 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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

Enrollment: 153
Study Start Date: December 2008
Study Completion Date: March 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Biogen Idec,Immunology department, Biogen Idec
ClinicalTrials.gov Identifier: NCT00810836     History of Changes
Other Study ID Numbers: 109RA201 
Study First Received: December 17, 2008
Last Updated: September 12, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Czech Republic: State Institute for Drug Control
Poland: Ministry of Health
Czech Republic: Ethics Committee
Slovakia: State Institute for Drug Control
Australia: Human Research Ethics Committee
Canada: Health Canada
India: Indian Council of Medical Research

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Dimethyl fumarate
Dermatologic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 27, 2016