Atacicept in Anti-Tumor Necrosis Factor Alpha-naïve Subjects With Rheumatoid Arthritis (AUGUST II)

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Atacicept; Drug: Placebo matched to atacicept; Drug: Atacicept: with loading dose; Biological: Adalimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00595413

2007-002536-29

27905

Details and patient eligibility

About

The primary objective of this study is to evaluate the efficacy of atacicept compared to placebo in the treatment of signs and symptoms in a subject population with active rheumatoid arthritis (RA), inadequate response to methotrexate (MTX) and no previous exposure to anti-tumor necrosis factor alpha (anti-TNFalpha) therapy.

Enrollment: 311 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subjects greater than or equal to (>=) 18 years of age at the time of informed consent who have RA satisfying American College of Rheumatology (ACR) criteria with a disease history of at least 6 months
• Subjects must have active disease, defined by >=8 swollen joints (out of 66), >=8 tender joints (out of 68) and CRP >=10 milligram per liter (mg/L) and/or erythrocyte sedimentation rate (ESR) >=28 millimeter per hour (mm/hr), despite treatment with MTX at a dose of >=15 milligram per week (mg/week) for greater than (>) 3 months
• Other protocol-defined inclusion criteria could apply

Exclusion criteria

• Inflammatory joint disease other than RA
• Previous or concurrent treatment with any approved or investigational biological compound for RA, including but not restricted to any anti-TNFalpha agents, rituximab, abatacept, tocilizumab, interleukin-1 receptor antagonist (IL-1Ra) and belimumab
• Treatment with disease-modifying anti-rheumatic drug (DMARDs) other than MTX
• Participation in any interventional clinical trial within 1 month before study Day 1
• MTX dose >25 mg/week, prednisone dose >10 mg/day (or equivalent), or change in steroid or non-steroidal anti-inflammatory drug (NSAID) dosing regimen within 28 days before study Day 1
• Immunization with live vaccine or immunoglobulin (Ig) treatment within 28 days before study Day 1 or need for such treatment during the study (including follow-up)
• Any history or presence of active or latent tuberculosis, major infection requiring hospitalization or intravenous anti-infectives within 28 days before study Day 1
• Other major concurrent illness or organ dysfunction as specified in the protocol
• Serum IgG below 6 gram per liter (g/L)
• Known hypersensitivity to atacicept or to any of the components of the formulated atacicept
• Other protocol-defined exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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311 participants in 4 patient groups, including a placebo group

Atacicept 150 mg with loading dose

Experimental group

Treatment:

Drug: Atacicept: with loading dose

Atacicept 150 mg without loading dose

Experimental group

Treatment:

Drug: Atacicept

Adalimumab

Active Comparator group

Treatment:

Biological: Adalimumab

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo matched to atacicept