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BG9924 in Combination With Methotrexate Extension of Study 104RA203

This study has been terminated.
(Analysis of data from 104RA203 failed to meet primary endpoint.)
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00523328
First received: August 17, 2007
Last updated: June 11, 2009
Last verified: June 2009
History of Changes
  Purpose

This study is to observe the long-term treatment of BG9924


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: BG9924
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Extension Study to Evaluate the Safety and Efficacy of BG9924 When Given in Combination With Methotrexate to Subjects With Rheumatoid Arthritis Who Previously Participated in Study 104RA203

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • To observe the long-term treatment with BG9924 when administered to subjects with RA who previously participated in a Biogen Idec Study. [ Time Frame: The duration of this study is 18 months. ] [ Designated as safety issue: Yes ]

Enrollment: 72
Study Start Date: August 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: BG9924
dosage administered as per Biogen-idec protocol
Other Name: LTbeta

Detailed Description:

Extension study for 104RA203

  Eligibility

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

Inclusion Criteria:

  • Must be a subject from Study 104RA203

Exclusion Criteria:

  • Subjects with a significant change in medical history from their previous BG9924 study (Study 104RA203).
  • Nursing mothers, pregnant women, or women who are planning to become pregnant while in the study.
  • Male and female subjects of child-bearing potential not willing to practice effective birth control for the duration of the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00523328

Locations
United States, California
Coordinating Research Site
Palo Alto, California, United States, 94305
Belgium
Coordinating Research Site
Liège, Belgium, 4000
Canada, Ontario
Coordinating Research Site
Toronto, Ontario, Canada, H9P 2V4
United Kingdom
Coordinating Research Site
Newcastle, United Kingdom, NE1 4LP
Sponsors and Collaborators
Biogen Idec
Investigators
Principal Investigator: Biogen-Idec Investigator Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00523328     History of Changes
Other Study ID Numbers: 104RA205
Study First Received: August 17, 2007
Last Updated: June 11, 2009
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Belgium: Ministry of Social Affairs, Public Health and the Environment
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Biogen Idec:
Rheumatoid Arthritis
Arthritis
methotrexate
BG9924

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

ClinicalTrials.gov processed this record on May 19, 2013