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Table 1 Schedule of enrollment, interventions, and assessments

From: Efficacy, safety and cost-effectiveness of a web-based platform delivering the results of a biomarker-based predictive model of biotherapy response for rheumatoid arthritis patients: a protocol for a randomized multicenter single-blind active controlled clinical trial (PREDIRA)

Visits Selection Inclusiona
M0
M3
± 2 weeks
M6
± 2 weeks
M12
± 2 weeks
Informationa     
Information and consentb      
Confirmation of eligibility      
Clinical/physical examination, rheumatoid arthritis    
Routine blood analysis    
Questionnaire EQ5D    
Questionnaire HAQ    
Biomarkersc      
Patient bookletd  
Administration/dispensation of biotherapye      
Biobankf      
Concomitant treatments   Collection throughout the study  
Adverse effects collection   Collection throughout the study  
  1. a Inclusion: The inclusion visit should be done in 2–3 weeks
  2. b Information and informed consent: The patient will sign informed consent for the main study and additional consent (optional) if they accept 6-month and 1-year inclusion samples, which will be retained for the creation of biobank
  3. c Biomarkers: A blood sample will be taken for the determination of SinnoTest® biomarkers in the intervention arm patients
  4. d Patient booklet: The rheumatologist or CRA investigator will deliver the booklet to the patient at the inclusion visit. The patient brings the notebook during each follow-up visit and will carry it with him after the visit. At the end of the follow-up, he will return his completed patient booklet to the CRA / TEC of the Investigator Center by mail using the envelope provided with the notebook
  5. e Administration/dispensation of biotherapy: Patients in the control group will receive their biotherapy prescription in current practice. For patients in the intervention group, the rheumatologist will prescribe the biotherapy selected by SinnoTest®. The results of the pregnancy test should be negative
  6. f Biobank: A blood test will be carried out in all included patients who signed the additional consent for the creation of a biobank
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