Please select the arm or intervention descriptions that belong 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: Arm Label: Group 1 (Guselkumab: Placebo); Type: EXPERIMENTAL; Interventions: Drug: Guselkumab, Drug: Placebo | Arm Label: Group 2 (Placebo: Guselkumab); Type: EXPERIMENTAL; Interventions: Drug: Guselkumab, Drug: Placebo | Intervention Type: DRUG; Name: Guselkumab; Assigned to Arm(s): Group 1 (Guselkumab: Placebo), Group 2 (Placebo: Guselkumab) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Group 1 (Guselkumab: Placebo), Group 2 (Placebo: Guselkumab)
B: Arm Label: Therapeutic drug monitoring; Type: EXPERIMENTAL; Interventions: Other: Therapeutic drug monitoring | Arm Label: Standard care; Type: ACTIVE_COMPARATOR; Interventions: Other: Standard care | Intervention Type: OTHER; Name: Therapeutic drug monitoring; Assigned to Arm(s): Therapeutic drug monitoring | Intervention Type: OTHER; Name: Standard care; Assigned to Arm(s): Standard care
C: Arm Label: Placebo Comparator: 1; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Voclosporin 0.2 mg/kg po BID; Type: ACTIVE_COMPARATOR; Interventions: Drug: voclosporin | Arm Label: Voclosporin 0.3 mg/kg po BID; Type: ACTIVE_COMPARATOR; Interventions: Drug: voclosporin | Arm Label: Voclosporin 0.4 mg/kg po BID; Type: ACTIVE_COMPARATOR; Interventions: Drug: voclosporin | Intervention Type: DRUG; Name: voclosporin; Assigned to Arm(s): Voclosporin 0.2 mg/kg po BID, Voclosporin 0.3 mg/kg po BID, Voclosporin 0.4 mg/kg po BID | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo Comparator: 1
D: Arm Label: Group I; Type: EXPERIMENTAL; Interventions: Drug: Guselkumab 100 mg, Drug: Placebo for guselkumab, Drug: Placebo for adalimumab | Arm Label: Group II; Type: PLACEBO_COMPARATOR; Interventions: Drug: Guselkumab 100 mg, Drug: Placebo for guselkumab, Drug: Placebo for adalimumab | Arm Label: Group III; Type: ACTIVE_COMPARATOR; Interventions: Drug: Guselkumab 100 mg, Drug: Placebo for guselkumab, Drug: Adalimumab | Intervention Type: DRUG; Name: Guselkumab 100 mg; Assigned to Arm(s): Group I, Group II, Group III | Intervention Type: DRUG; Name: Placebo for guselkumab; Assigned to Arm(s): Group I, Group II, Group III | Intervention Type: DRUG; Name: Adalimumab; Assigned to Arm(s): Group III | Intervention Type: DRUG; Name: Placebo for adalimumab; Assigned to Arm(s): Group I, Group II

Answer: B