Back to resultsBG9924 in Combination With Methotrexate Extension of Study 104RA203 (NCT 00458861)
Primary Purpose
Rheumatoid Arthritis
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BG9924
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Arthritis, BG9924, methotrexate
Eligibility 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.
Sites / Locations
- Coordinating Research Site
- Coordinating Research Site
- Coordinating Research Site
- Coordinating Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BG9924
Arm Description
dosage administered as per Biogen-idec protocol
Outcomes
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00523328
Brief Title
BG9924 in Combination With Methotrexate Extension of Study 104RA203 (NCT 00458861)
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 Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
Analysis of data from 104RA203 failed to meet primary endpoint.
Study Start Date
August 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is to observe the long-term treatment of BG9924
Detailed Description
Extension study for 104RA203 (NCT 00458861)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, Arthritis, BG9924, methotrexate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BG9924
Arm Type
Experimental
Arm Description
dosage administered as per Biogen-idec protocol
Intervention Type
Drug
Intervention Name(s)
BG9924
Other Intervention Name(s)
LTbeta
Intervention Description
dosage administered as per Biogen-idec protocol
Primary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Coordinating Research Site
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Coordinating Research Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Coordinating Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
H9P 2V4
Country
Canada
Facility Name
Coordinating Research Site
City
Newcastle
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
12. IPD Sharing Statement
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BG9924 in Combination With Methotrexate Extension of Study 104RA203 (NCT 00458861)
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