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

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 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:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Dimethyl fumarate Methotrexate sodium

U.S. FDA Resources

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 ]

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 oral
Active Comparator: 2 BG00012 720 mg/day	Drug: BG00012 Oral
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.

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

Locations

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
Canada
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
India
Research Site
Bangalore, India
Research Site
Hyderabaad, India
Research Site
Hyderabad, India
Research Site
Lucknow, India
Poland
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
Slovakia
Research Site
Banska Bysterica, Slovakia
Research Site
Bratislava, Slovakia
Research Site
Kosice, Slovakia
Research Site
Piestany, Slovakia

Sponsors and Collaborators

Biogen Idec

More Information

No publications provided

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:	June 7, 2012
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
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Methotrexate
Dimethyl fumarate
Therapeutic Uses
Pharmacologic Actions
Abortifacient Agents, Nonsteroidal

Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Nucleic Acid Synthesis Inhibitors
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on May 16, 2013