Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Criteria regarding Crohn´s Disease:

Established diagnosis of CD, confirmed by standard criteria (e.g. endoscopy, ultrasound, X-ray)
Patients must be in clinical remission (Crohn's Disease Activity Index [CDAI] <150 points) on steroid therapy for at least 2 weeks

Confirmed steroid-dependency of CD: patients who are either

unable to taper steroids completely within 3 months of starting steroids, without recurrent active disease, or
who have a relapse within 2 months of stopping steroids
Individual threshold* dose of previous relapses should be equal or less than 20 mg/day Prednisolone or equivalent steroid dose
Patients with stable glucocorticosteroid therapy between 20 and 40 mg/day Prednisolone or equivalent steroid dose for the previous week

Criteria regarding Ulcerative Colitis:

Established diagnosis of UC, confirmed by standard criteria (e.g. endoscopy, ultrasound, X-ray)
Patients must be in clinical remission (Clinical Activity Index [CAI] <4 points) on steroid therapy for at least 2 weeks

Confirmed steroid-dependency of UC: patients who are either

unable to taper steroids completely within 3 months of starting steroids, without recurrent active disease, or
who have a relapse within 2 months of stopping steroids
Individual threshold* dose of previous relapses should be equal or less than 20 mg/day Prednisolone or equivalent steroid dose
Patients with stable glucocorticosteroid therapy between 20 and 40 mg/day Prednisolone or equivalent steroid dose for the previous week

(* The threshold dose is that dose at which the patient experienced the relapses)

Criteria regarding general requirements:

Men and women, 18 to 70 years of age
Written informed consent
Negative pregnancy test at screening in females of child-bearing potential
Males willing to use condoms or to be sexually abstinent

Use of appropriate contraceptive methods for females of childbearing potential one month before, throughout the course of the study and one month after study termination. This must be a combination of the following:

a highly effective method of first choice = a method with a low failure rate (i.e. less than 1% per year) like sexual abstinence, combined oral contraceptives, implants, injectables, some Intra Uterine Devices (IUDs), vasectomized partner

together with

a method of second choice like condom, diaphragm, or cup pessary

Exclusion Criteria:

Criteria regarding gastrointestinal conditions:

Short bowel syndrome
Ileostomy, colostomy or rectal pouch
Relapse during screening

Criteria regarding medical history:

History of or existence of active tuberculosis
History of or existence of urolithiasis
History of or existence of human immune deficiency virus (HIV), Hepatitis B or C
History of malignancy within the past five years (excluding basal cell carcinoma of the skin)
Previous opportunistic infection
History of serious drug sensitivity

Criteria regarding concomitant diseases:

Significant cardiac arrhythmia, bradycardia or tachycardia or any other significant finding in the electrocardiogram (ECG)
Congestive heart failure
Uncontrolled arterial hypertension
Uncontrolled asthma
Renal disease
Renal insufficiency defined as glomerular filtration rate (GRF) <50 ml/min/1.73 m² (estimated GRF according to Cockcroft-Gault)
Psychiatric illness
Known or suspected immunodeficiency
Laboratory abnormalities: hemoglobin <8.5 g/dl, white blood cell count <3500/mm³, platelet count <125 000/mm³, clinically relevant elevation of liver enzymes, serum creatinine level >=1.4 mg/dl, hematuria (>=10 erythrocytes/field on dipsticks)

Criteria regarding concomitant circumstances:

Pregnancy, lactation
History of alcohol and/or drug dependence
Heavy smoking (more than 20 cigarettes per day)
Use of prohibited drugs or treatments
Patient not able or not willing to follow study procedures due to physical or psychological limitations or language problems
Participation in another investigational drug or vaccine trial within the last three months or concurrently with this study
Vaccination with life attenuated viruses within 4 weeks prior to study start
Patient with any medical condition which, in the opinion of the investigator or his designee, could jeopardize or compromise the ability of the patient to participate in the trial
Patients possibly dependent on the investigator or the sponsor