Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Iris Dotan, MD
CONTACT
Lead
Tel-Aviv Sourasky Medical Center
With
Data evaluation: Evidence of therapeutic benefit and safety will be evaluated by the following assessments: Clinical assessments: * Crohn's disease activity will be assessed by components of the CDAI. * Mucosal healing will be assessed by VCE (data will be quantitated using the Lewis score). Patients requiring colonoscopy according to Physicians decision would also be offered to participate in an endoscopic mucosal healing evaluation substudy. Patients participating will undergo colonoscopy and biopsies at the beginning (screening±1 week) and the end (week 12±1 week) of the treatment period. Endoscopic damage will be assessed using the CDEIS * Mean (median) doses of corticosteroids and the average total aggregate dose of corticosteroids received per patient during the trial will be assessed. * Quality of life will be assessed by components of the Inflammatory Bowel Disease Questionnaire(IBDQ). Safety: * AE incidence * Physical examination * Clinical laboratory values * Vital signs Tolerability and Safety: * Adverse events, dropout rate will be registered. * Proportion of subjects who prematurely discontinue the study. * Proportion of subjects who prematurely discontinue the study due to Aes * Time to premature discontinuation * Time to premature discontinuation due to Aes. Immunologic assessment (including lymphocyte proliferation and cytokine secretion assays) will be performed at the baseline visit as well as weeks 4 and 12 and 16. Serum samples for cytokine studies 24 hours after first injection would also be collected.
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
