A new dosing strategy of infliximab versus standard dosing in patients with severe sarcoidosis: optimization of treatment

INTERVENTION: Trade Name: Remicade Product Name: Remicade Pharmaceutical Form: Powder for concentrate for solution for injection/infusion CONDITION: Sarcoidosis Therapeutic area: Diseases [C] ‐ Immune System Diseases [C20] PRIMARY OUTCOME: 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: 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 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