BG9924 in Combination With Methotrexate for Participants With Active Rheumatoid Arthritis

This study has been terminated.
(Interim analysis of data failed to meet primary endpoint.)
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT00458861
First received: March 22, 2007
Last updated: December 17, 2015
Last verified: December 2015
  Purpose
This Phase 2b study is designed to evaluate the efficacy and safety of BG9924 given subcutaneously (SC) versus placebo in participants with active rheumatoid arthritis (RA) who have previously had an inadequate response to treatment with anti-tumor necrosis factor (anti-TNF) therapy.

Condition Intervention Phase
Rheumatoid Arthritis
Biological: BG9924
Other: Placebo Comparator
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, PK, and PD of BG9924 When Given in Combo With MTX to Subjects With Active RA Who Have Had an Inadequate Response to Anti-TNF

Resource links provided by NLM:


Further study details as provided by Biogen:

Primary Outcome Measures:
  • Evaluate efficacy of BG9924 in combination with methotrexate in RA participants who have had an inadequate response to anti-TNF therapy [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the safety and tolerability of BG9924 in this participant population. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Assess the pharmacokinetic and pharmacodynamic profile of BG9924 in this participant population. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Enrollment: 115
Study Start Date: March 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BG9924
Subcutaneous administration of BG9924 given every other week for 12 weeks
Biological: BG9924
Subcutaneous administration of BG9924 given every other week for 12 weeks
Placebo Comparator: Placebo
Subcutaneous administration of placebo given every other week for 12 weeks
Other: Placebo Comparator
Subcutaneous administration of placebo given every other week for 12 weeks

  Eligibility

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

Key Inclusion Criteria:

  • Diagnosis of rheumatoid arthritis (functional class I - III) at least 6 months prior to baseline
  • Methotrexate (10 mg/week to 25 mg/week) > 3 months prior to Day 0 (stable dose > 4 weeks prior to Day 0)
  • Must have had an inadequate response to anti-TNF therapy due to inadequate efficacy

Key Exclusion Criteria:

Medical History

  • Serious local infection or systemic infection within 3 months of Day 0
  • History (Hx) of recurrent infections requiring oral or parental anti-infective treatment
  • Hx of tuberculosis (TB) or positive purified protein derivative (PPD) test during the screening period

Laboratory Tests

  • Clinically significant lab tests at screening; or
  • Positive for hepatitis C antibody or hepatitis B at screening

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: NCT00458861

Locations
United States, California
Stanford University
Palo Alto, California, United States, 93404
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00458861     History of Changes
Other Study ID Numbers: 104RA203  2006-005467-26 
Study First Received: March 22, 2007
Last Updated: December 17, 2015
Health Authority: Canada: Canadian Institutes of Health Research
Belgium: Ministry of Social Affairs, Public Health and the Environment
United States: Food and Drug Administration
United Kingdom: Department of Health

Keywords provided by Biogen:
Active Rheumatoid Arthritis (RA)

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 July 21, 2016