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

This study has been terminated.
(Analysis of data from 104RA202 failed to meet primary endpoint)
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT00664573
First received: April 21, 2008
Last updated: December 17, 2015
Last verified: December 2015
  Purpose
To observe the long-term treatment with BG9924 when administered to participants with RA who previously participated in a Biogen Idec Study.

Condition Intervention Phase
Rheumatoid Arthritis
Biological: Baminercept alfa (BG9924)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of Safety and Efficacy of BG9924 in Subjects With RA Who Have Participated in Study 104RA202.

Resource links provided by NLM:


Further study details as provided by Biogen:

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 [ Time Frame: Duration of this study is 18 months ] [ Designated as safety issue: Yes ]

Enrollment: 339
Study Start Date: November 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00664573     History of Changes
Other Study ID Numbers: 104RA204  2007-000733-19 
Study First Received: April 21, 2008
Last Updated: December 17, 2015
Health Authority: Romania: National Medicines Agency
Poland: Ministry of Health
Brazil: Ministry of Health
Mexico: Ministry of Health
Hungary: National Institute of Pharmacy
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Russia: Ministry of Health of the Russian Federation

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

ClinicalTrials.gov processed this record on August 25, 2016