BG9924 in Combination With Methotrexate for Participants 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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00458861

Enrollment

115

Registered

2007-04-11

Start date

2007-03-31

Completion date

2008-10-31

Last updated

2016-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Active Rheumatoid Arthritis (RA)

Brief 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.

Interventions

BIOLOGICALBG9924

Subcutaneous administration of BG9924 given every other week for 12 weeks

OTHERPlacebo Comparator

Subcutaneous administration of placebo given every other week for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion 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/

Design outcomes

Primary

Measure	Time frame
Evaluate efficacy of BG9924 in combination with methotrexate in RA participants who have had an inadequate response to anti-TNF therapy	26 weeks

Secondary

Measure	Time frame
Assess the safety and tolerability of BG9924 in this participant population.	26 weeks
Assess the pharmacokinetic and pharmacodynamic profile of BG9924 in this participant population.	26 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026