A Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients With Rheumatoid Arthritis to a Specific Biologic Mode of Action

PHASE4CompletedINTERVENTIONAL
Enrollment

115

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

August 1, 2018

Study Completion Date

August 1, 2018

Conditions
Rheumatoid Arthritis
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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©)."

Trial Locations (9)

1060

Gesundheitszentrum Mariahilf, Vienna

1090

AKH Wien, Vienna

1130

Krankenhaus Hietzing, Vienna

1140

Hanusch Krankenhaus, Vienna

1160

Wilhelminenspital, Vienna

4600

Ordination Wels (Private Medical Office), Wels

9007

Kantonsspital St.Gallen, Klinik für Rheumatologie, Sankt Gallen

12850

Institute of Rheumatology, Prague

115522

V. A. Nasonova Research Institute of Rheumatology, Moscow

All Listed Sponsors
lead

Medical University of Vienna

OTHER

NCT01638715 - A Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients With Rheumatoid Arthritis to a Specific Biologic Mode of Action | Biotech Hunter | Biotech Hunter