156
Participants
Start Date
July 31, 2013
Primary Completion Date
June 30, 2019
Study Completion Date
January 10, 2020
Certolizumab Pegol
Certolizumab Pegol (Cimzia®) is an engineered, humanized antibody-Fab'-fragment with specificity for human TNF-α, that is conjugated to polyethylene glycol (PEG). Certolizumab Pegol (Cimzia®) is a humanized antibody-Fab'-fragment that is produced in Escherichia coli and subsequently PEGylated to prolong its circulating half-time to be similar to that of an intact mAB. Certolizumab Pegol has a high affinity for TNF α with a Kd90pM and is an effective TNF α inhibitor. Certolizumab pegol does not neutralize TNFß (lymphotoxin), a related cytokine, and does not activate complement or kill cells via antibody-dependent cellular toxicity.
Placebo
Placebo will be administered according to the label of the biological
Charité - Universitätsmedizin Berlin; Campus Charité Mitte Klinik für Rheumatologie und klinische Immunologie Studienambulanz, Berlin
Belgrade University School of Medicine Director of the Institute Institute of Rheumatology, Belgrade
Medizinische Universitätsklinik Freiburg Abteilung Rheumatologie und Klinische Immunologie, Freiburg im Breisgau
University of Erlangen-Nuremberg, Department of Internal Medicine 3, Rheumatology & Immunology, Erlangen
Universitätsklinikum Leipzig AÖR Department Innere Medizin Sektion Rheumatologie, Leipzig
Hospitais da Universidade (SRHUC) Reumatologia, Coimbra
University of Erlangen-Nürnberg Medical School
OTHER