Assessment Of The Safety And Efficacy Of BG9924 In Rheumatoid Arthritis (RA) Participants

Biogen391 enrolled

Overview

Safety and efficacy of BG9924 in RA participants that have had an inadequate response to disease-modifying anti-rheumatic drug (DMARD) therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

391

Conditions

Rheumatoid Arthritis

Interventions

Baminercept alfa 1BIOLOGICAL

experimental - one dose level

PlaceboBIOLOGICAL

Placebo comparator

Baminercept alfa 2BIOLOGICAL

experimental - second dose level

Baminercept alfa 3

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Diagnosis of RA (functional class I - III) * Stable dose of MTX * Inadequate response to at least one conventional DMARD therapy Key Exclusion Criteria: * Serious local infection or systemic infection * History (Hx) of recurrent infections requiring oral or parenteral anti-infective treatment * Hx of tuberculosis (TB) or positive purified protein derivative (PPD) test during the screening period * Clinical significant lab tests at screening * Positive for Hep C or Hep B at screening NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (8)

Coordinating Research Site

San Miguel de Tucumán, Argentina

Coordinating Research Site

São Paulo, Brazil

Coordinating Research Site

Budapest, Hungary

Coordinating Research Site

Cuernavaca, Mexico

Outcomes

Primary Outcomes

Evaluate efficacy of BG9924 in combination with methotrexate (MTX) in RA participants who have had an inadequate response to DMARD therapy

Time frame: 3 months

Secondary Outcomes

Assess the safety and tolerability of BG9924 in this participant population

Time frame: 3 months

Data from ClinicalTrials.gov

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