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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00664716
First Posted: April 23, 2008
Last Update Posted: January 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Biogen
  Purpose
Safety and efficacy of BG9924 in RA participants that have had an inadequate response to disease-modifying anti-rheumatic drug (DMARD) therapy.

Condition Intervention Phase
Rheumatoid Arthritis Biological: Baminercept alfa 1 Biological: Placebo Biological: Baminercept alfa 2 Biological: Baminercept alfa 3 Biological: Baminercept alfa 4 Biological: Baminercept alfa 5 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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:

Primary Outcome Measures:
  • Evaluate efficacy of BG9924 in combination with methotrexate (MTX) in RA participants who have had an inadequate response to DMARD therapy [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Assess the safety and tolerability of BG9924 in this participant population [ Time Frame: 3 months ]

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: Placebo
subcutaneous administration of placebo given for 12 weeks
Biological: Placebo
Placebo comparator
Other Names:
  • BG9924
  • LT beta
Experimental: One Dose
BG9924 - dosage level administered as per Biogen Idec protocol
Biological: Baminercept alfa 1
experimental - one dose level
Other Names:
  • BG9924
  • LT beta
Experimental: Second Dose
BG9924 - dosage level administered as per Biogen Idec protocol
Biological: Baminercept alfa 2
experimental - second dose level
Other Names:
  • LT beta
  • BG9924
Experimental: Third Dose
BG9924 - dosage level administered as per Biogen Idec protocol
Biological: Baminercept alfa 3
experimental - third dose level
Other Names:
  • BG9924
  • LT beta
Experimental: Fourth Dose
BG9924 - dosage level administered as per Biogen Idec protocol
Biological: Baminercept alfa 4
experimental - fourth dose level
Other Names:
  • BG9924
  • LT beta
Experimental: Fifth Dose
BG9924 - dosage level administered as per Biogen Idec protocol
Biological: Baminercept alfa 5
experimental - fifth dose level
Other Names:
  • LT beta
  • BG9924

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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

  Contacts and Locations
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): 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
Investigators
Study Director: Medical Director Biogen
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00664716     History of Changes
Other Study ID Numbers: 104RA202
First Submitted: April 21, 2008
First Posted: April 23, 2008
Last Update Posted: January 21, 2016
Last Verified: December 2015

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

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