BG9924 in Combination With Methotrexate Extension of Study 104RA203 (NCT 00458861)

This study has been terminated.
(Analysis of data from 104RA203 failed to meet primary endpoint.)
Information provided by (Responsible Party):
Biogen Identifier:
First received: August 17, 2007
Last updated: December 17, 2015
Last verified: December 2015
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:

Further study details as provided by Biogen:

Primary Outcome Measures:
  • To observe the long-term treatment with BG9924 when administered to participants 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: BG9924
dosage administered as per Biogen-idec protocol
Drug: BG9924
dosage administered as per Biogen-idec protocol
Other Name: LTbeta

Detailed Description:
Extension study for 104RA203 (NCT 00458861)

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

Inclusion Criteria:

  • Must be a participant from Study 104RA203 (NCT 00458861)

Exclusion Criteria:

  • Participants with a significant change in medical history from their previous BG9924 Study 104RA203 (NCT 00458861).
  • Nursing mothers, pregnant women, or women who are planning to become pregnant while in the study.
  • Male and female participants of child-bearing potential not willing to practice effective birth control for the duration of the study.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00523328

United States, California
Coordinating Research Site
Palo Alto, California, United States, 94305
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
Study Director: Medical Director Biogen
  More Information

Responsible Party: Biogen Identifier: NCT00523328     History of Changes
Other Study ID Numbers: 104RA205  2007-000734-38 
Study First Received: August 17, 2007
Last Updated: December 17, 2015
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Biogen:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Physiological Effects of Drugs
Reproductive Control Agents processed this record on May 26, 2016