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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00523328
• Other study ID #: 104RA205
• Secondary ID: 2007-000734-38
• Status: Terminated
• Phase: Phase 2
• First received: August 17, 2007
• Last updated: December 17, 2015
• Start date: August 2007
• Est. completion date: October 2008

Study information

• Verified date: December 2015
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the EnvironmentCanada: Health CanadaUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

Extension study for 104RA203 (NCT 00458861)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 72
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• BG9924
dosage administered as per Biogen-idec protocol

Locations

Country	Name	City	State
Belgium	Coordinating Research Site	Liège
Canada	Coordinating Research Site	Toronto	Ontario
United Kingdom	Coordinating Research Site	Newcastle
United States	Coordinating Research Site	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To observe the long-term treatment with BG9924 when administered to participants with RA who previously participated in a Biogen Idec Study.		The duration of this study is 18 months.	Yes