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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 7 December 2020
Main ID:  EUCTR2015-004173-32-DK
Date of registration: 20/10/2015
Prospective Registration: Yes
Primary sponsor: Department of Clinical Biochemestry, Aarhus University Hospital
Public title: Personalized medicine: Administration of TNF-alpha inhibitor treatment due to serum concentration measuring.
Scientific title: Personalized medicine: Administration of TNF-alpha inhibitor treatment due to serum concentration measuring. A randomized and investigator initiated study.
Date of first enrolment: 18/12/2015
Target sample size: 500
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-004173-32
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: We compare to different methodes of evaluating the treatment of a patient.
Number of treatment arms in the trial: 6
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes
Countries of recruitment
Denmark
Contacts
Name: Dept. of Rheumatology   
Address:  Nørrebrogade 44 8000 Aarhus C
Telephone: 4578464208
Email:
Affiliation:  Aarhus University Hospital
Name: Dept. of Rheumatology   
Address:  Nørrebrogade 44 8000 Aarhus C
Telephone: 4578464208
Email:
Affiliation:  Aarhus University Hospital
Key inclusion & exclusion 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:
- Any malignancy
- Known pregnancy


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
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]
Intervention(s)

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-

Primary Outcome(s)
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(s)
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
Secondary ID(s)
1-10-72-164-15
Source(s) of Monetary Support
Aarhus University Hospital
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 12/10/2015
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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