Pharmacokinetics of Infliximab

niversitätsklinik für Innere Medizin III, Klinische Abteilung für Gastroenterologie und Hepatologie0 个研究点开始时间: 2013年11月7日最近更新: 2014年10月27日

适应症

试验速览

暂无简介。

•1.Patients with established diagnosis of Crohn’s disease or ulcerative colitis by standard criteria for at least 3 months between the age of 19 to 75. Males and females.
•2.Able and willing to sign informed consent
•3.For maintenance cohort: Patients with maintenance Infliximab therapy after having received week 0, 2 and 6 infusions. Earliest possible measurement for trough level being Week 14 (immediately prior to 4th infusion), earliest possible week 4 serum infliximab level measurement at infusion week 10.
•4.For infliximab starter cohort: Patients planned for IFX induction and maintenance therapy according to current guidelines without prior exposition to IFX.
•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 180
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•1.History of malignancy, lymphoproliferativen disorders or untreated or unsuccessfully treated cutaneous squamous cell or basal cell carcinoma or carcinoma-in-situ of the cervix.
•2.Active or untreated latent tuberculosis, as diagnosed by the current screening recommendations
•3.Severe infections, sepsis, abscess or opportunistic infections
•4.Subjects with an oostomy or ileoanal pouch
•5.Signs and symptoms of intestinal obstruction, clinically or indicated by imaging (praestenotic dilatation, significant prolongation of transition time, ileus signs)
•6.Impending or planned surgery for condition under study
•7.Heart failure NYHA class 3 and 4
•8.Severe unstable hepatic, gastrointestinal, cardiovascular, respiratory, neurological, psychiatric, hematological or renal disease
•9.Pregnacy, planning conception or currently breast feeding
•10.Investigational agents within 5 halfe lives prior to entry or within the past 30 days
•11.Sigificant drug or alcohol abusus, current or past, or other mental condition impairing study participation

发起方

niversitätsklinik für Innere Medizin III, Klinische Abteilung für Gastroenterologie und Hepatologie