Text Size

BG9924 in Combination With Methotrexate for Subjects With Active Rheumatoid Arthritis

This study has been terminated.
(Interim analysis of data failed to meet primary endpoint.)
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00458861
First received: March 22, 2007
Last updated: June 11, 2009
Last verified: June 2009
History of Changes

March 22, 2007
June 11, 2009
March 2007
October 2008   (final data collection date for primary outcome measure)
Evaluate efficacy of BG9924 in combination with methotrexate in RA patients who have had an inadequate response to anti-TNF therapy [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Evaluate efficacy of BG9924 in combination with methotrexate in RA pts who've had an inadequate response to anit-TNF therapy.
Complete list of historical versions of study NCT00458861 on ClinicalTrials.gov Archive Site
  • Assess the safety and tolerability of BG9924 in this patient population. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Assess the pharmacokinetic and pharmacodynamic profile of BG9924 in this patient population. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
BG9924 in Combination With Methotrexate for Subjects With Active Rheumatoid Arthritis
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

This Phase 2b study is designed to evaluate the efficacy and safety of BG9924 given subcutaneously (SC) versus placebo in subjects with active rheumatoid arthritis (RA) who have previously had an inadequate response to treatment with anti-tumor necrosis factor (anti-TNF) therapy.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: BG9924
    Subcutaneous administration of BG9924 given every other week for 12 weeks
  • Other: Placebo Comparator
    Subcutaneous administration of placebo given every other week for 12 weeks
  • Experimental: 1
    Intervention: Drug: BG9924
  • Placebo Comparator: 2
    Intervention: Other: Placebo Comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
115
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00458861
104RA203, EUDRA CT: 2006-005467-26
Yes
Biogen Idec Medical Director, Biogen Idec
Biogen Idec
Not Provided
Study Director: Biogen Idec Medical Director Biogen Idec, Cambridge, MA USA
Biogen Idec
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP