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

Tracking Information

First Received Date ^ICMJE

August 17, 2007

Last Updated Date

June 11, 2009

Start Date ^ICMJE

August 2007

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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. ]

Change History

Complete list of historical versions of study NCT00523328 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

BG9924 in Combination With Methotrexate Extension of Study 104RA203

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Extension study for 104RA203

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Rheumatoid Arthritis

Intervention ^ICMJE

Drug: BG9924

dosage administered as per Biogen-idec protocol

Other Name: LTbeta

Study Arm (s)

Experimental: 1

Intervention: Drug: BG9924

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

October 2008

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Belgium, Canada, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00523328

Other Study ID Numbers ^ICMJE

104RA205

Has Data Monitoring Committee

Yes

Responsible Party

Biogen Idec MD, Biogen Idec

Study Sponsor ^ICMJE

Biogen Idec

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Biogen-Idec Investigator

Biogen Idec

Information Provided By

Biogen Idec

Verification Date

June 2009

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

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