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

NCT ID: NCT00523328

Last Updated: 2016-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-10-31

Brief Summary

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

Detailed Description

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Extension study for 104RA203 (NCT 00458861)

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BG9924

dosage administered as per Biogen-idec protocol

Group Type EXPERIMENTAL

BG9924

Intervention Type DRUG

dosage administered as per Biogen-idec protocol

Interventions

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BG9924

dosage administered as per Biogen-idec protocol

Intervention Type DRUG

Other Intervention Names

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LTbeta

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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Coordinating Research Site

Palo Alto, California, United States

Site Status

Coordinating Research Site

Liège, , Belgium

Site Status

Coordinating Research Site

Toronto, Ontario, Canada

Site Status

Coordinating Research Site

Newcastle, , United Kingdom

Site Status

Countries

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United States Belgium Canada United Kingdom

Other Identifiers

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2007-000734-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

104RA205

Identifier Type: -

Identifier Source: org_study_id

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