Assessment Of The Safety And Efficacy Of BG9924 In Rheumatoid Arthritis (RA) Patients (RESPOND)

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00664716
First received: April 21, 2008
Last updated: March 4, 2010
Last verified: March 2010
  Purpose

Safety and efficacy of BG9924 in RA patients that have had an inadequate response to DMARD therapy


Condition Intervention Phase
Rheumatoid Arthritis
Biological: Placebo
Biological: baminercept alfa
Biological: Baminercept alfa
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Assessment Of Safety, Efficacy, PK&PD Of BG9924 in RA Patients Who Have Had An Inadequate Response To Conventional DMARD Therapy.

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Evaluate efficacy of BG9924 in combination with MTX in RA patients who have had an inadequate response to DMARD therapy [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the safety and tolerability of BG9924 in this patient population [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 391
Study Start Date: July 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
subcutaneous administration of placebo given for 12 weeks
Biological: Placebo
Placebo comparator
Other Names:
  • LT beta
  • BG9924
Experimental: 2
BG9924 - dosage level administered as per Biogen Idec protocol
Biological: baminercept alfa
experimental - one dose level
Other Names:
  • LT beta
  • BG9924
Experimental: 3
BG9924 - dosage level administered as per Biogen Idec protocol
Biological: Baminercept alfa
Experimental - second dose level
Other Names:
  • LT beta
  • BG9925
Experimental: 4
BG9924 - dosage level administered as per Biogen Idec protocol
Biological: Baminercept alfa
Experimental - third dose level
Other Names:
  • LT beta
  • BG9924
Experimental: 5
BG9924 - dosage level administered as per Biogen Idec protocol
Biological: Baminercept alfa
Experimental - fourth dose level
Other Names:
  • LT beta
  • BG9924
Experimental: 6
BG9924 - dosage level administered as per Biogen Idec protocol
Biological: Baminercept alfa
Experimental - fifth dose level
Other Names:
  • LT beta
  • BG9924

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Diagnosis of RA (functional class I - III)
  • Stable dose of MTX
  • Inadequate response to at least one conventional DMARD therapy

Key Exclusion Criteria:

  • Serious local infection or systemic infection.
  • History (Hx) of recurrent infections requiring oral or parenteral anti-infective treatment.
  • Hx of tuberculosis (TB) or positive purified protein derivative (PPD) test during the screening period.
  • Clinical significant lab tests at screening.
  • Positive for Hep C or Hep B at screening.
  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: NCT00664716

Locations
Argentina
Coordinating Research Site
Tucuman, Argentina, T4000AXL
Brazil
Coordinating Research Site
Sao Paulo, Brazil, 04027-000
Hungary
Coordinating Research Site
Budapest, Hungary, H2143
Mexico
Coordinating Research Site
Cuernavaca, Mexico, 62270
Poland
Coordinating Research Site
Torun, Poland, 87100
Romania
Coordinating Research Site
Braila, Romania, 810112
Russian Federation
Coordinating Research Site
Moscow, Russian Federation, 115522
United Kingdom
Coordinating Research Site
Leeds, Yorkshire, United Kingdom, LS7 4SA
Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Biogen-Idec Investigator, MD Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec (Biogen Idec MD), Biogen Idec
ClinicalTrials.gov Identifier: NCT00664716     History of Changes
Other Study ID Numbers: 104RA202
Study First Received: April 21, 2008
Last Updated: March 4, 2010
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Committee of Ethics in Research
Hungary: National Institute of Pharmacy
Mexico: Ministry of Health
Poland: Ministry of Health
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Biogen Idec:
Rheumatoid Arthritis
RA
Methotrexate
DMARD inadequate response

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 October 01, 2014