Expired Study
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Rockland, Massachusetts 02370


Purpose:

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 RA, inadequate response to methotrexate (MTX) and no previous exposure to anti-TNFα therapy


Criteria:

Inclusion Criteria: - Male and female subjects ≥ 18 years of age at the time of Informed Consent who have rheumatoid arthritis satisfying American College of Rheumatology criteria and 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 ≥ 10mg/L and/or ESR ≥ 28 mm/hr, despite treatment with methotrexate (MTX) at a dose of ≥ 15 mg/week for > 3 months 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-TNFα agents, rituximab, abatacept, tocilizumab, interleukin-1 receptor antagonist (IL-1Ra) and belimumab. - Treatment with DMARDs other than MTX - Participation in any interventional clinical trial within 1 month before SD1 - Methotrexate dose > 25 mg/week, prednisone dose >10 mg/day (or equivalent), or change in steroid or NSAID dosing regimen within 28 days before SD 1. - Live vaccine or Ig treatment within 28 days before SD 1 or need for such treatment during the study (including follow-up). - Any history or presence of active or latent tuberculosis, major infection requiring hospitalisation or intravenous anti-infectives within 28 days before SD 1. - Other major concurrent illness or organ dysfunction. - Serum IgG below 6 g/L. - Known hypersensitivity to atacicept or to any of the components of the formulated atacicept.


NCT ID:

NCT00595413


Primary Contact:

Study Director
Nils Kinnman
Merck Serono International SA, an affiliate of Merck KGaA Darmstadt, Germany


Backup Contact:

N/A


Location Contact:

Rockland, Massachusetts 02370
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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