A Phase 4 interventional study of Remicade and Orencia in Rheumatoid Arthritis, sponsored by Medical University of Vienna. Completed at 9 sites in 4 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-10-31.
Sponsored by Medical University of Vienna · Phase 4, Interventional, and Treatment
The purpose of this study is to find biological response patterns of patients with rheumatoid arthritis to drugs with different biologic modes of action. This study should help to predict therapeutic responses and to find the right therapy for the right patient.
The investigators propose a randomised, multi-centre strategic biomarker trial of rheumatoid arthritis (RA) patients with failure to methotrexate or leflunomide to one of the four current biological modes of action: targeting TNF (infliximab); co-stimulation (abatacept); IL-6R (tocilizumab); and B cells (rituximab); all agents are licensed for RA and have evidence for efficacy in this indication. Predictors of response to therapy after 24 weeks will be analysed, and include baseline and follow up assessments of clinical, functional, structural, laboratory tests (routine, autoantibodies, cytokines, gene expression, and susceptibility genes). In a second phase, patients not achieving LDA/REM will be randomised to one of the remaining MoA. Two hundred patients, who are started on a new biological therapy will be enrolled over an estimated period of 5 years; 50 patients per group will be included, and studied for a period of 12 months.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 115 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Have previously received other treatments for their rheumatic disease:
Have or have had a known history of
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: Remicade
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: Orencia
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: Ro-Actemra
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©).
Drug: Mabthera
- 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.
- 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.
- 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.
- 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©).
Absolute Change in the Simplified Disease Activity Index (SDAI)
Time frame: 24 Weeks
Relative Change in the SDAI in percent
Time frame: 24 Weeks
Absolute and relative change in the Clinical Disease Activity Index (CDAI) in percent
Time frame: 24 Weeks
Absolute and relative change in the Disease Activity Score 28 (DAS28) in percent
Time frame: 24 weeks
Achieving an SDAI or CDAI response (50%, 70%, 85%)
Time frame: 24 Weeks
Achieving a EULAR response (European League Against Rheumatism)
Time frame: 24 Weeks
Achieving an ACR response (20%, 50%, 70%) (American College of Rheumatology)
Time frame: 24 Weeks
Change in quality of life (EuroQoL-5D, SF-36)
Time frame: 24 weeks
Change in fatigue (Fatigue Score on the Visual Analog Scale)
Time frame: 24 Weeks
Proportion achieving a low disease activity state (SDAI ≤11)
Time frame: 24 Weeks
Proportion achieving a remission state (SDAI ≤3.3)
Time frame: 24 Weeks
Radiographic progression - (Van der Heijde/Sharp Score)
Time frame: 6 months and 12 months
Change in physical function (HAQ)
Time frame: 24 Weeks
Change in sleep (Sleep Score on the Visual Analog Scale)
Time frame: 24 Weeks
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Medical University of Vienna