104RA204 Assessment of the Safety and Efficacy of BG9924 in Rheumatoid Arthritis (RA) Participants (RESPOND-EXT)

December 17, 2015 updated by: Biogen

Assessment of Safety and Efficacy of BG9924 in Subjects With RA Who Have Participated in Study 104RA202.

To observe the long-term treatment with BG9924 when administered to participants with RA who previously participated in a Biogen Idec Study.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

339

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Tucuman, Argentina, T4000AXL
        • Coordinating Research Site
  • Brazil
      • Sao Paulo, Brazil
        • Coordinating Research Site
  • Hungary
      • Budapest, Hungary, H-1036
        • Coordinating Research Site
  • Mexico
      • Cuernavaca, Mexico, 62270
        • Coordinating Research Site
  • Poland
      • Torun, Poland, 87-100
        • Coordinating Research Site
  • Romania
      • Braila, Romania, 810112
        • Coordinating Research Site
  • Russian Federation
      • Moscow, Russian Federation, 127644
        • Coordinating Research Site
  • United Kingdom
    • Yorkshire
      • Leeds, Yorkshire, United Kingdom, LS74SA
        • Coordinating Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be a participant from Study 104RA202 (NCT 00664716)
  • Stable dose of Methotrexate for the duration of the study

Exclusion Criteria:

  • Participants with a significant change in their medical history from their previous BG9924 study
  • Any clinically significant infectious illness or serious local infection

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 2
Drug: BG9924 - dose administered as per Biogen-Idec protocol
Biological: Baminercept alfa (BG9924)
dosage administered as per Biogen-Idec protocol
Other Names:
  • BG9924
  • Baminercept alfa
  • LT beta
Experimental: Group 1
Drug: BG9924 - dose administered as per Biogen-Idec protocol
Biological: Baminercept alfa (BG9924)
dosage administered as per Biogen-Idec protocol
Other Names:
  • BG9924
  • Baminercept alfa
  • LT beta
Experimental: Group 3
Drug: BG9924 - dose administered as per Biogen-Idec protocol
Biological: Baminercept alfa (BG9924)
dosage administered as per Biogen-Idec protocol
Other Names:
  • BG9924
  • Baminercept alfa
  • LT beta
Experimental: Group 4
Drug: BG9924 - dose administered as per Biogen-Idec protocol
Biological: Baminercept alfa (BG9924)
dosage administered as per Biogen-Idec protocol
Other Names:
  • BG9924
  • Baminercept alfa
  • LT beta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To Observe The Long-Term treatment with BG9924 When Administered to Participants with RA who Previously Participated in a Biogen Idec Study
Time Frame: Duration of this study is 18 months
Duration of this study is 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

April 21, 2008

First Submitted That Met QC Criteria

April 22, 2008

First Posted (Estimate)

April 23, 2008

Study Record Updates

Last Update Posted (Estimate)

January 21, 2016

Last Update Submitted That Met QC Criteria

December 17, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104RA204
  • 2007-000733-19 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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