Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female; 18-75 years old
Diagnosis of Crohn's disease for at least 3 months prior to screening
Confirmation of Crohn's disease by endoscopic or imaging examination
Moderately active Crohn's disease at baseline, defined as:
CDAI ≥220 and ≤450
Active disease despite prior treatment with corticosteroids for at least 2 weeks, or immunosuppressants for at least 3 months. Treatment with azathioprine, 6-MP or MTX is allowed but must have been on a stable dose for at least 10 weeks, corticosteroids are allowed but must have been on a stable doses of prednisolone not exceeding 40 mg for two weeks prior to baseline. Immunosuppressants other than those listed above, such as cyclosporine, tacrolimus and mycophenolate, are not allowed and must be stopped (wash-out periods defined in the protocol);
You may not be if
Body Mass Index \>34
Positive PPD tuberculin skin test or QuantiFeron test
Any subject with evidence of active pulmonary disease or evidence of latent tuberculosis or fungal infection at screening or within past 3 months
Symptoms associated with active bowel structuring disease and pre-stenotic dilation on radiographs
Fistulizing disease if complicated by sepsis and/or untreated abscess
Multiple bowel surgeries and clinically important short bowel syndrome defined as an inability to maintain caloric intake
Use of certain medications as specified in the protocol
