To compare the efficacy of switching to a different molecular target (from TNF to IL6) versus cycling to a second TNF inhibitor in patients with active RA, who have not adequately responded to a previous treatment with a first anti-TNF.
New drugs for the treatment of rheumatoid arthritis (RA) with action on specific molecular target (e.g. anti-TNF) have improved the prognosis of patients with an inadequate response to conventional therapy such as methotrexate (MTX). However, approximately 50% of patients treated with first-line anti-TNF discontinue treatment after two years due to ineffectiveness or adverse events. The second line treatment involves the use of another anti-TNF drug or switching to a different molecular target (anti-IL6, -CD20 or CTLA-4-Ig) in combination with MTX.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
208
8 mg/kg i.v. every 4 weeks OR 162 mg s.c every seven days
a. Etanercept if initial failure to monoclonal antibodies: infliximab, adalimumab, golimumab or certolizumab
infliximab if initial failure to the receptor fusion protein, etanercept.
Azienda Consorziale Ospedaliera Policlinico
Bari, Italy
Azienda Socio Sanitaria Territoriale - Papa Giovanni XXIII
Proportion of patients with good EULAR
the proportion of patients with good EULAR response
Time frame: 24 weeks
Proportion of patients with a good/moderate EULAR
Proportion of patients with a good/moderate EULAR response
Time frame: 12 weeks
Proportion of patients with a good/moderate EULAR
Proportion of patients with a good/moderate EULAR response
Time frame: 24 weeks
Proportion of patients with ACR20/50/70 response
Proportion of patients with ACR20/50/70 response
Time frame: 12 weeks
Proportion of patients with ACR20/50/70 response
Proportion of patients with ACR20/50/70 response
Time frame: 24 weeks
Proportion of patients with a remission according to DAS28/SDAI/CDAI
Proportion of patients with a remission according to DAS28/SDAI/CDAI
Time frame: 24 weeks
Proportion of patients with a remission according to DAS28/SDAI/CDAI
Proportion of patients with a remission according to DAS28/SDAI/CDAI
Time frame: 48 weeks
Proportion of patients with a remission according to DAS28/SDAI/CDAI
Proportion of patients with a remission according to DAS28/SDAI/CDAI
Time frame: 96 weeks
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adalimumab if initial failure to the receptor fusion protein, etanercept.
golimumab if initial failure to the receptor fusion protein, etanercept.
Certolizumab Pegol if initial failure to the receptor fusion protein, etanercept.
Bergamo, Italy
Policlinico Sant'Orsola Malpighi
Bologna, Italy
Ospedale Centrale di Bolzano
Bolzano, Italy
Azienda Ospedaliera Universitaria Policlinico Vittorio Emanuele
Catania, Italy
Azienda Ospedaliera-Universitaria S.Anna c/o Nuovo Arcispedale S. Anna
Cona, Italy
Azienda Ospedaliera Santa Croce e Carle
Cuneo, Italy
Università di Firenze
Florence, Italy
Azienda Ospedaliera Universitaria Di Messina
Messina, Italy
Istituto Ortopedico Gaetano Pini
Milan, Italy
...and 12 more locations
Van Der Heijde Modified Total Sharp Score [X-ray score]
Van Der Heijde Modified Total Sharp Score \[X-ray score\]
Time frame: 48 weeks
Van Der Heijde Modified Total Sharp Score [X-ray score]
Van Der Heijde Modified Total Sharp Score \[X-ray score\]
Time frame: 96 weeks
Health Assessment Questionnaire (HAQ) score
Health Assessment Questionnaire (HAQ) score
Time frame: 24 weeks
Health Assessment Questionnaire (HAQ) score
Health Assessment Questionnaire (HAQ) score
Time frame: 48 weeks
Health Assessment Questionnaire (HAQ) score
Health Assessment Questionnaire (HAQ) score
Time frame: 96 weeks