Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Rockland, Massachusetts 02370


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


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.



Primary Contact:

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

Backup Contact:


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: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.