Phase
Condition
Inflammatory Bowel Disease
Crohn's Disease
Treatment
N/AClinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Confirmed diagnosis of UC by endoscopy and histopathology
Patients between 18 and 80 years of age
Active disease, despite oral treatment with at least 2g/day 5-ASA
Treatment with oral corticosteroids is required
Exclusion
Exclusion Criteria:
Prior treatment with thiopurines
Prior treatment with biologics (e.g. anti-TNF agents and vedolizumab)
Current pregnancy (a pregnancy test will be performed if necessary according to thetreating physician)
Chronic Obstructive Pulmonary Disease (COPD)
Acute coronary heart disease
(Bacterial) gastroenteritis has to be treated first
Coagulation disorders
Active malignancy
History of colonic dysplasia/cancer
Extensive colonic resection, i.e. subtotal colectomy with <15 cm colon in situ
Concomitant therapy with drugs interfering with MP metabolism, like allopurinol,ribavirin or anti-epileptics.
Known systemic fungal infections or parasitic infections have to be treated first
Known duodenal or ventricular ulcus
Substance abuse, such as alcohol (> 80 gram/day - one standard glass contains 10 gramof alcohol), I.V. drugs and inhaled drugs. If the subject has a history of substanceabuse, to be considered for inclusion into the protocol, the subject must haveabstained from using the abused substance for at least 2 years. Subjects receivingmethadone within the past 2 years are also excluded
Positive tuberculosis screen (when a screening is performed at the discretion of thetreating physician)
Active hepatitis B virus or hepatitis C virus infection defined as a positiveanti-HCV, HBsAg and/or anti-HBcore screening.
Leucopenia (Neutrophil count < 1,8x10^9/L)
Thrombopenia (Platelets < 90x10^9/L)
Elevated liver enzymes (>2x ULN)
Abnormal renal function (eGFR< 30 mL/min)
Other conditions which in the opinion of the investigator may interfere with thesubject's ability to comply with the study procedure
Study Design
Study Description
Connect with a study center
Noordwest Ziekenhuisgroep
Alkmaar,
NetherlandsActive - Recruiting
Flevoziekenhuis
Almere,
NetherlandsActive - Recruiting
Meander MC
Amersfoort, 3813 TZ
NetherlandsActive - Recruiting
Amstelland Hospital
Amsterdam,
NetherlandsActive - Recruiting
Amsterdam UMC, location AMC
Amsterdam, 1105AZ
NetherlandsActive - Recruiting
Amsterdam UMC, location VUMC
Amsterdam, 1081 HZ
NetherlandsActive - Recruiting
OLVG Oost
Amsterdam, 1090 HM
NetherlandsActive - Recruiting
MC Haaglanden
Den Haag, 2512 VA
NetherlandsActive - Recruiting
Tergooi Hospital
Hilversum, 1213 XZ
NetherlandsActive - Recruiting
Westfriesgasthuis
Hoorn,
NetherlandsActive - Recruiting
St. Antonius Hospital
Nieuwegein, 3435 CM
NetherlandsActive - Recruiting
Sint Franciscus Gasthuis
Rotterdam,
NetherlandsActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.