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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.)
Information provided by (Responsible Party):
Biogen Identifier:
First received: March 22, 2007
Last updated: December 17, 2015
Last verified: December 2015
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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 ]

Secondary Outcome Measures:
  • Assess the safety and tolerability of BG9924 in this participant population. [ Time Frame: 26 weeks ]
  • Assess the pharmacokinetic and pharmacodynamic profile of BG9924 in this participant population. [ Time Frame: 26 weeks ]

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


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

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
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Please refer to this study by its identifier: NCT00458861

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

Responsible Party: Biogen Identifier: NCT00458861     History of Changes
Other Study ID Numbers: 104RA203
2006-005467-26 ( EudraCT Number )
Study First Received: March 22, 2007
Last Updated: December 17, 2015

Keywords provided by Biogen:
Active Rheumatoid Arthritis (RA)

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases processed this record on May 24, 2017