TIMEPOINT | STUDY PERIOD | ||||||
---|---|---|---|---|---|---|---|
Screening | Baseline/ treatment | Treatment period | End of study | Safety registration | |||
Within 6 weeks before baseline | Day 0 | Day 14 | Day 42 | Day 98 | Day 154 | Day 278 | |
ENROLMENT: | |||||||
 Eligibility screen | X |  |  |  |  |  |  |
 Informed consent | X |  |  |  |  |  |  |
 Medical history | X |  |  |  |  |  |  |
 MRI-scana | X |  |  |  |  | X |  |
 Chest X-ray | X |  |  |  |  |  |  |
 Urine pregnancy testb | X | X |  | X | X | X |  |
 Blood samples (hematology, clinical chemistry, CRP)c | X | X | X | X | X | X |  |
 TB, Hep C, Hep B-screening | X |  |  |  |  |  |  |
 Allocation |  | X |  |  |  |  |  |
INTERVENTION: | |||||||
 Infliximab |  | X | X | X | X |  |  |
Placebo | Â | X | X | X | X | Â | Â |
ASSESSMENTS: | |||||||
 Background datad | X | X |  |  |  |  |  |
Clinical safety evaluatione | X | X | X | X | X | X | Â |
Clinical pain/neuro evaluationf | X | Â | Â | Â | Â | Â | Â |
Blood samples for drug concentrations and antibodiesg | Â | X | X | X | X | X | Â |
Blood samples for biobank | Â | X | Â | Â | X | X | Â |
Adverse events | Â | Â | X | X | X | X | X |
Primary outcomeh | Â | X | X | X | X | Â | X |
Pain monitoringi | Â | X | X | X | X | X | X |
Concomitant medication | X | X | X | X | X | X | X |
Co-interventions (non-pharm) | X | X | X | X | X | X | X |
Sick listing | Â | X | Â | Â | X | X | X |
Questionnairesj | Â | X | Â | Â | X | X | Â |
Compliancek | Â | X | X | X | X | Â | Â |