Efficacy and Safety Study of BG00012 With Methotrexate in Patients With Active Rheumatoid Arthritis - Full Text View

Sponsored by:	Biogen Idec
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00810836

Purpose

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 II

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Biogen Idec:

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 ]

Estimated Enrollment:	150
Study Start Date:	December 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator BG00012 480 mg/day	Drug: BG00012 oral
2: Active Comparator BG00012 720 mg/day	Drug: BG00012 Oral
3: Placebo Comparator	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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810836

Contacts

Contact: Immunology Department Biogen Idec

immunologyclinicaltrials@biogenidec.com

Locations

Australia
Research Site	Recruiting
Woodville, Australia, SA 5011
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com
Research Site	Not yet recruiting
Woolloongabba, Australia, QLD 4102
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com
Canada
Research Site	Not yet recruiting
Sarnia, Canada, ON N7T 4X3
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com
Research Site	Recruiting
Ottawa, Canada
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com
Research Site	Recruiting
Rothesay, Canada
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com
Research Site	Not yet recruiting
New Market, Canada
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com
Czech Republic
Research Site	Not yet recruiting
Prague, Czech Republic
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com
Research Site	Not yet recruiting
Pardubice, Czech Republic
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com
Research Site	Not yet recruiting
Zlin, Czech Republic
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com
Research Site	Not yet recruiting
Uh. Hradiste, Czech Republic
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com
India
Research Site	Not yet recruiting
Bangalore, India
Contact: BIogen Idec Immunology Dept immunologyclinialtrials@biogenidec.com
Research Site	Not yet recruiting
Bangalore, India
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com
Research Site	Not yet recruiting
Hyderabaad, India
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com
Research Site	Not yet recruiting
Lucknow, India
Contact: Biogen Idec Immunology Dept immunologyclinialtrials@biogenidec.com
Poland
Research Site	Not yet recruiting
Bialystock, Poland
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com
Research Site	Not yet recruiting
Lublin, Poland
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com
Research Site	Not yet recruiting
Grodzisk Mazowiecki, Poland
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com
Research Site	Not yet recruiting
Warsaw, Poland
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com
Research Site	Not yet recruiting
Poznan, Poland
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com
Slovakia
Research Site	Not yet recruiting
Kosice, Slovakia
Contact: Biogen Idec Imunology Dept immunologyclinicaltrials@biogenidec.com
Research Site	Not yet recruiting
Piestany, Slovakia
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com
Research Site	Not yet recruiting
Bratislava, Slovakia
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com
Research Site	Not yet recruiting
Banska Bysterica, Slovakia
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com

Sponsors and Collaborators

Biogen Idec

More Information

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

Study placed in the following topic categories:

Folic Acid
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Methotrexate
Rheumatic Diseases

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents

Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009