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

August 17, 2007
June 11, 2009
August 2007
October 2008   (final data collection date for primary outcome measure)
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 ]
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. ]
Complete list of historical versions of study NCT00523328 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
BG9924 in Combination With Methotrexate Extension of Study 104RA203
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

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

Extension study for 104RA203

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
Drug: BG9924
dosage administered as per Biogen-idec protocol
Other Name: LTbeta
Experimental: 1
Intervention: Drug: BG9924
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
72
October 2008
October 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   United Kingdom
 
NCT00523328
104RA205
Yes
Biogen Idec MD, Biogen Idec
Biogen Idec
Not Provided
Principal Investigator: Biogen-Idec Investigator Biogen Idec
Biogen Idec
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP