Infliximab dosing based on blood concentrations in patients with sarcoidosis: smart dosing

• 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
• 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

Countries of recruitment

Netherlands

Contacts

• Name: Center Interstitial Lung Disease
• Affiliation: St. Antonius Hospital

• Name: Center Interstitial Lung Disease
• 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)

Primary end point(s): FVC at week 26.

Timepoint(s) of evaluation of this end point: 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.

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.

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