21 results
Primary objective:- To demonstrate that CT-P13 is noninferior to Remicade at Week 6 (Dose 3), in terms of efficacy, asdetermined by the Crohn*s Disease Activity Index (CDAI)-70 response rate.Secondary objectives:-To evaluate long-term secondary…
Aim of this study is to investigate the efficacy of *precision dosing* IFX maintenance treatment in comparison with standard IFX maintenance treatment in IBD patients in clinical remission.
The purpose of this study is to assess the safety and effectiveness of the Freedom SCS (spinal cord stimulation) System for the treatment of chronic back and leg pain secondary to failed back surgery syndrome (FBSS) over a follow-up period of one…
To assess the efficacy of a loading dose of intravenous salbutamol in children admitted to a PICU for severe acute wheeze or severe acute asthma. Efficacy is measured by the reduction in asthma score (Qureshi) at 1 hour after administration of the…
Primary objective of this study is to evaluate the clinical effect of a long term treatment (8 weeks) with oral B2-agonists in CF patients with residual CFTR function, especially on lung function (spirometry and airway resistance). Secondary…
To examine the influence of genetic predisposition, genetic factors, infections and lifestyle of mother and child in relation to 1) allergic diseases and childhood astma;2) childhood overweight and obesity; 3) cardiopulmonary fitness and…
The primary objective of the study is to demonstrate that patients with very early arthritis have a higher probability of achieving a state of clinical remission at end of infliximab therapy if treated with infliximab plus MTX when compared to MTX…
To assess the effect of two withdrawal strategies over two years in patients with stable remission for more than 8 months on combination therapy with infliximab and antimetabolites, and demonstrate that continued combination of infliximab and…
Primary:To compare the effect of 6 months use of the CIS on adherence to ELLIPTA maintenance therapy when both the subject and the HCP are supplied with data from the maintenance sensor versus no data supplied to the subject and HCP (Arm 1 vs Arm 5…
Certain drugs are administered by using an inhaler (puffs). An inhaler may contain propellant to get the right amount of the medicine into the lungs in the right way. Some of the propellants used in inhalers are greenhouse gasses and are therefore…
To investigate whether sustained trough levels of IFX can be achieved using IFX trough level measurements and adjustment of dosing based upon these levels by means of two different standardized algorithms in comparison with *standard of care* IFX…
Primary objective of this pilot study is to evaluate the in vivo effect of a B2-agonists in CF patients with residual CFTR function, using dosages which are clinically used in patients with asthma. Secondary objective is to evaluate the difference…
The primary efficacy objective for this study is as follows:* To evaluate the efficacy of etrolizumab (105 mg subcutaneous [SC] every 4 weeks [Q4W]) compared with infliximab in achieving both clinical response at Week (W) 10, and clinical remission…
The objective of this study is to compare the efficacy of Infliximab-biosimilar to Infliximab-innovator and to demonstrate its noninferiority up to 30 weeks, in patients with ulcerative colitis or Crohn*s disease in remission under treatment with…
Primary objectives:- To identify whether EBC can be used as a non-invasive method to measure the PK of salbutamol and tobramycin.- To determine whether the relationship in mild-moderate asthmatics between pulmonary lung function parameters and…
Currently, there is no guideline for the treatment of perianal Crohn's fistulas. the aim of this study, in which surgical strategies (seton drainage and surgical closure with advancement plasty/LIFT) will be compared to medical treatment. We…
To determine 1) interindividual variation in pharmacokinetic parameters in patients with non-detectable trough levels of IFX and 2) whether the area under the curve (AUC) of the IFX serum concentration during one infusion cycle predicts relapse…
With this study we hope to improve the closure rate of perianal Crohn*s fistulas.
The primary objectives of this study are:Part A 1. To characterize the effects of single doses of beta-adrenoceptor (*-AR) agonists CST-101, CST-103 and * AR partial agonist CST-109 on the functional domains of the central nervous system (CNS), as…
1. To investigate the acute effect of ADRB2 activation, via intravenous administration of salbutamol (250 µg), on 18F-FDG uptake by BAT.2. To assess the acute effect of ADRB2 activation via intravenous administration of salbutamol (250 µg) on…