115
Participants
Start Date
May 31, 2012
Primary Completion Date
August 1, 2018
Study Completion Date
August 1, 2018
Remicade
\- Infliximab (Remicade®) will be administered i.v. at a dose of 3 mg/kg at 0 and 2 weeks, and 5 mg/kg at weeks 6, 14, and 22, 30, 38, and 46.
Orencia
\- Abatacept (Orencia®) will be given i.v. at weeks 0, 2, 4, and then every 4 weeks until week 48 at a weight adjusted dose: \<60 kg Body weight (BW): 500 mg; \>60-100 kg BW: 750 mg; alternatively, based on preference and shared decision between patient and physician, patients randomized to the abatacept arm may receive s.c. application at a dose of 125mg weekly.
Ro-Actemra
\- Tocilizumab (Ro-Actemra®) will be administered every 4 weeks at a dose of 8 mg/kg BW (maximum dose of 800 mg); The employed dosage will be calculated using manufacturer guidelines; alternatively, based on preference and shared decision between patient and physician, patients randomized to the tocilizumab arm may receive s.c. application at a dose of 162mg every week.
Mabthera
"\- Rituximab (Mabthera®) will be given as 1000mg at weeks 0 and 2, and then repeated at weeks 24 and 26.~Patients will receive 100 mg methylprednisolon i.v. before each infusion, as well as 1000mg paracetamol, as well as 50mg diphenhydramine hydrochloride (Dibondrin©)."
Gesundheitszentrum Mariahilf, Vienna
AKH Wien, Vienna
Krankenhaus Hietzing, Vienna
Hanusch Krankenhaus, Vienna
Wilhelminenspital, Vienna
Ordination Wels (Private Medical Office), Wels
Kantonsspital St.Gallen, Klinik für Rheumatologie, Sankt Gallen
Institute of Rheumatology, Prague
V. A. Nasonova Research Institute of Rheumatology, Moscow
Medical University of Vienna
OTHER