Please select the outcome measures that correspond to the clinical trial below.
Title: A NORwegian Multicentre Randomised Controlled Trial Assessing the Effectiveness of Tailoring Infliximab Treatment by Therapeutic DRUg Monitoring - The NOR-DRUM Study
Brief Summary: Infliximab and other TNF-inhibitors have revolutionised the treatment of several immunological inflammatory diseases. Still, more than half of the patients either do not respond sufficiently to infliximab therapy or loose efficacy over time. The large individual variation in the serum drug concentrations on standard doses and the development of anti-drug antibodies are thought to be main reasons for these treatment failures. An individualised treatment strategy based on systematic assessments of serum drug concentrations, therapeutic drug monitoring, has been proposed as a clinical tool to optimise efficacy of infliximab treatment. Therapeutic drug monitoring seems reasonable both from a clinical and an economical point of view, but the effectiveness of this treatment strategy still remain to be shown. The NOR-DRUM study is planned as a national, randomised controlled multicentre trial in two parts aiming to assess the effectiveness of therapeutic drug monitoring in order to achieve remission in patients with immunological inflammatory diseases starting infliximab treatment (part A) and in order to maintain disease control in patients on maintenance infliximab treatment (part B). The results of the NOR-DRUM study will hopefully contribute to an implementation of a personalised medicine approach to treatment with infliximab and other biological drugs.


Options:
A: Proportion of patients in remission defined by disease specific composite scores Study part A (30 weeks); Sustained disease control throughout the study period without disease worsening defined by disease specific composite scores Study part B (52 weeks)
B: Change in Vascular Inflammation (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Vascular Inflammation (52 weeks of adalimumab treatment); Change in Cardiometabolic Biomarker - Total Cholesterol (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Cardiometabolic Biomarker - Cholesterol Efflux (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Cardiometabolic Biomarker - Low-density Lipoprotein Particle (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Cardiometabolic Biomarker - High-density Lipoprotein Particle (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Cardiometabolic Biomarker - Log Insulin (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Cardiometabolic Biomarker - Log Adiponectin (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Cardiometabolic Biomarker - Log Leptin (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Cardiometabolic Biomarker - Log C-reactive Protein (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Cardiometabolic Biomarker - Log Tumor Necrosis Factor-Alpha (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Cardiometabolic Biomarker - Log Interleukin 6 (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Cardiometabolic Biomarker - GlycA (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Cardiometabolic Biomarkers: - Total Cholesterol (52 weeks of adalimumab treatment); Change in Cardiometabolic Biomarker - Cholesterol Efflux (52 weeks of adalimumab treatment); Change in Cardiometabolic Biomarker - Low-density Lipoprotein Particle (52 weeks of adalimumab treatment); Change in Cardiometabolic Biomarker - High-density Lipoprotein Particle (52 weeks of adalimumab treatment); Change in Cardiometabolic Biomarker - Log Insulin (52 weeks of adalimumab treatment); Change in Cardiometabolic Biomarker - Log Adiponectin (52 weeks of adalimumab treatment); Change in Cardiometabolic Biomarker - Log Leptin (52 weeks of adalimumab treatment); Change in Cardiometabolic Biomarker - Log C-reactive Protein (52 weeks of adalimumab treatment); Change in Cardiometabolic Biomarker - Log Tumor Necrosis Factor-Alpha (52 weeks of adalimumab treatment); Change in Cardiometabolic Biomarker - Log Interleukin 6 (52 weeks of adalimumab treatment); Change in Cardiometabolic Biomarker - GlycA (52 weeks of adalimumab treatment)
C: Psoriasis Area-and-severity Index (PASI) 75% Improvement From Baseline at Week 12. (Week 12)
D: Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12 (12 Weeks); Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12 (12 Weeks)

Answer: A