Personalized medicine: Administration of TNF-alpha inhibitor treatment due to serum concentration measuring. A randomized and investigator initiated study.

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2015
INTERVENTION: Trade Name: Enbrel Pharmaceutical Form: Solution for injection/infusion in pre‐filled syringe INN or Proposed INN: ETANERCEPT CAS Number: 185243‐69‐0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Trade Name: Humira Pharmaceutical Form: Solution for injection/infusion in pre‐filled syringe INN or Proposed INN: ADALIMUMAB CAS Number: 331731‐18‐1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40‐ Trade Name: Remsima Pharmaceutical Form: Solution for injection/infusion in pre‐filled syringe INN or Proposed INN: INFLIXIMAB CAS Number: 170277‐31‐3 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: up to Concentration number: 5‐ Trade Name: Benepali Pharmaceutical Form: Solution for injection/infusion in pre‐filled syringe INN or Proposed INN: ETANERCEPT CAS Number: 185243‐69‐0 Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 50‐ Trade Name: Remicade Pharmaceutical Form: Solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277‐31‐3 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: up to Concentration number: 7,5‐ CONDITION: Rheumatic diseases ; MedDRA version: 20.0 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 100000005156 Therapeutic area: Body processes [G] ‐ Immune system processes [G12] PRIMARY OUTCOME: Main Objective: ‐ To investigate if it is possible to make an optimal control of the TNF‐alpha inhibitor treatment with both clinical evaluation of the disease activity and serum concentration of the active medicine, instead of only monitoring treatment efficiacy for the individual through clinical observation and evaluation.; ‐ To evaluate the clinial effect and adverse events by individual adjustment of the medicine dosage (adalimumab, etanercept, and infliximab) compared with standard dosages. Primary end point(s): 10% reduvtion in the complied consumption of infiliximab, etanercept, and adalimumab (measured in total amount of standard dosages) without a reduction in clinical effect. Secondary Objective: ‐ reduction i time interval to switch in treatment medication, and faster clinical treatment effciacy measured by standard clinical parameters as reported in Danbio; ; ‐ increase the amount of patients that can be step out of treatment without reduction in clinical treatment efficacy parameters Timepoint(s) of evaluation of this end point: before and after 12 months of intervention SECONDARY OUTCOME: Secondary end point(s): ‐ reduction i time interval to switch in treatment medication, and faster clinical treatment effciacy measured by standard clinical parameters as reported in Danbio; ; ‐ increase the amount of patients that can be step out of treatment without reduction in clinical treatment efficacy parameters Timepoint(s) of evaluation of this end point: before and after 12 months of intervention INCLUSION CRITERIA: ‐ Patientes in treatment with one of the 3 IMPs due to a rheumatoid disease for minimum 3 months ‐ age 18 or more. ‐ Informed consent has been signed Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 250
Epistemonikos ID: e081f1f68325f77ac454659f7acb0054690a8984
First added on: Jul 27, 2021