BG9924 in Combination With Methotrexate for Participants With Active Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00458861
• Other study ID #: 104RA203
• Secondary ID: 2006-005467-26
• Status: Terminated
• Phase: Phase 2
• First received: March 22, 2007
• Last updated: December 17, 2015
• Start date: March 2007
• Est. completion date: October 2008

Study information

• Verified date: December 2015
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health ResearchBelgium: Ministry of Social Affairs, Public Health and the EnvironmentUnited States: Food and Drug AdministrationUnited Kingdom: Department of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 115
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• 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

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate efficacy of BG9924 in combination with methotrexate in RA participants who have had an inadequate response to anti-TNF therapy		26 weeks	No
Secondary	Assess the safety and tolerability of BG9924 in this participant population.		26 weeks	No
Secondary	Assess the pharmacokinetic and pharmacodynamic profile of BG9924 in this participant population.		26 weeks	No