Personalized medicine: Administration of TNF-alpha inhibitor treatment due to serum concentration measuring.

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004173-32-DK

Enrollment

500

Registered

2015-10-20

Start date

2015-12-18

Completion date

Unknown

Last updated

2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatic diseases MedDRA version: 20.0 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 100000005156

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: - Any malignancy - Known pregnancy

Design outcomes

Primary

Measure	Time frame
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.;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;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.;Timepoint(s) of evaluation of this end point: before and after 12 months of intervention	—

Measure

Time frame

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.;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;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.;Timepoint(s) of evaluation of this end point: before and after 12 months of intervention

—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Denmark

Contacts

Public ContactDept. of Rheumatology

Aarhus University Hospital

4578464208

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026