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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00523328
Recruitment Status : Terminated (Analysis of data from 104RA203 failed to meet primary endpoint.)
First Posted : August 31, 2007
Last Update Posted : January 21, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study is to observe the long-term treatment of BG9924

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: BG9924 Phase 2

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2007
Primary Completion Date : October 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: BG9924
dosage administered as per Biogen-idec protocol
Drug: BG9924
dosage administered as per Biogen-idec protocol
Other Name: LTbeta


Outcome Measures

Primary Outcome Measures :
  1. 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. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ( EudraCT Number )
First Posted: August 31, 2007    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: December 2015

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