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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: 10 July 2015
Main ID:  EUCTR2014-002224-26-NL
Date of registration: 03/02/2015
Prospective Registration: Yes
Primary sponsor: St. Antonius Hospital
Public title: Infliximab dosing based on blood concentrations in patients with sarcoidosis: smart dosing
Scientific title: A new dosing strategy of infliximab versus standard dosing in patients with severe sarcoidosis: optimization of treatment - Concentration guided dosing of infliximab in sarcoidosis
Date of first enrolment: 07/05/2015
Target sample size:
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-002224-26
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: infliximab dosing based on bodyweight is compared to concentration guided dosing Number of treatment arms in the trial: 2  
Phase: 
Countries of recruitment
Netherlands
Contacts
Name: Center Interstitial Lung Disease   
Address:  Koekoekslaan 1 3435 CM Nieuwegein Netherlands
Telephone:
Email: v.deneer@antoniusziekenhuis.nl
Affiliation:  St. Antonius Hospital
Name: Center Interstitial Lung Disease   
Address:  Koekoekslaan 1 3435 CM Nieuwegein Netherlands
Telephone:
Email: v.deneer@antoniusziekenhuis.nl
Affiliation:  St. Antonius Hospital
Key inclusion & exclusion criteria
Inclusion criteria:
patients diagnosed with sarcoidosis being treated with infliximab or with an indication for infliximab

capability of giving informed consent

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 70
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
• vaccination with live viral or bacterial vaccines within the previous 3 months, or with the last dose within the previous 3 months
• active or untreated latent tuberculosis (by mantoux-Elispot/TBC-IGRA)
• serious infections within the last 2 months
• serious right ventricular heart failure or cor polmunale
• Active hepatitis B
history of allergic reactions to monocolonal antibodies or their fragments

oppotunistic infections with the last 6 months

HIV

transplantation

known malignancy

pregnancy or breastfeeding



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Sarcoidosis
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Intervention(s)

Trade Name: Remicade
Product Name: Remicade
Pharmaceutical Form: Powder for concentrate for solution for injection/infusion

Primary Outcome(s)
Main Objective: To determine whether serum concentration guided dosing of infliximab is not inferior to standard dosing based on bodyweight in patients with severe sarcoidosis in terms of FVC change from baseline at week 26.
Primary end point(s): FVC at week 26.

Secondary Objective: To compare both treatment strategies in terms of FVC change from baseline at week 50, DLCO change from baseline at week 26 and 50.

To compare both treatment strategies in terms of X-Thorax, HRCT and PET activity change from baseline at week 26 and 50.

To compare both treatment strategies in terms of sIL2R, ACE concentration change from baseline at week 26 and 50.

To compare both treatment strategies in terms of changes in 6MWT, quality of life and fatigue at several time points.

To compare both treatment strategies in terms of safety e.g. development of infections and infusion reactions.
Timepoint(s) of evaluation of this end point: week 26.
Secondary Outcome(s)
Secondary end point(s): Symptoms, CRP-, ACE-, sIL2R-concentrations at week 0, 14, 26 and 50.
Lung function i.e. FVC and DLCO at week 0, 26 and 50.

Imaging: X-Thorax, HRCT and PET scanning at week 0, 26 and 50.

Endpoints in terms of Quality of Life are measurements obtained with EuroQol 5D and SF36 questionnaires at week 0, 14, 26 and 50.

Endpoints in terms of fatigue are measurements obtained with Checklist Individual Strength (CIS) at week 0, 14, 26 and 50.

Safety endpoints such as infusion reactions, infections.
Timepoint(s) of evaluation of this end point: Depends on endpoint; at several of the following timepoints i.e. 0, 14, 26 and 50 weeks
Secondary ID(s)
INFLIXIMABDOSE01
Source(s) of Monetary Support
St. Antonius Hospital Nieuwegein
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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