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

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ClinicalTrials.gov Identifier: NCT00664573
Recruitment Status : Terminated (Analysis of data from 104RA202 failed to meet primary endpoint)
First Posted : April 23, 2008
Last Update Posted : January 21, 2016
Sponsor:
Information provided by (Responsible Party):
Biogen

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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: Baminercept alfa (BG9924) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 339 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of Safety and Efficacy of BG9924 in Subjects With RA Who Have Participated in Study 104RA202.
Study Start Date : November 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00664573


Locations
Argentina
Coordinating Research Site
Tucuman, Argentina, T4000AXL
Brazil
Coordinating Research Site
Sao Paulo, Brazil
Hungary
Coordinating Research Site
Budapest, Hungary, H-1036
Mexico
Coordinating Research Site
Cuernavaca, Mexico, 62270
Poland
Coordinating Research Site
Torun, Poland, 87-100
Romania
Coordinating Research Site
Braila, Romania, 810112
Russian Federation
Coordinating Research Site
Moscow, Russian Federation, 127644
United Kingdom
Coordinating Research Site
Leeds, Yorkshire, United Kingdom, LS74SA
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00664573     History of Changes
Other Study ID Numbers: 104RA204
2007-000733-19 ( EudraCT Number )
First Posted: April 23, 2008    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: December 2015

Keywords provided by Biogen:
Safety
Rheumatoid Arthritis
Baminercept alfa
Methotrexate
BG9924
Efficacy

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases