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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.)
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT00523328
First received: August 17, 2007
Last updated: December 17, 2015
Last verified: December 2015
  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:


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)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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
Investigators
Study Director: Medical Director Biogen
  More Information

Responsible Party: Biogen
ClinicalTrials.gov 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
Arthritis
BG9924
methotrexate

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
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 December 02, 2016