Low Dose IL-2 for the Treatment of Crohn's Disease
Trial Parameters
Brief Summary
The purpose of this study is to determine the safety and maximum effective dose (MED) of Interleukin-2 in subjects with moderate-to-severe crohn's disease.
Eligibility Criteria
Inclusion Criteria: 1. Age 12-80 years. Maximum age limit for subjects recruited at BCH will be 30 years. 2. A diagnosis of CD made by standard clinical, radiological, endoscopic and histological criteria. a. A subset of patients with Ileostomies or colostomies will be permitted. 3. Adult subjects with moderate-to-severe CD (CDAI score 220-450) a. a modified CDAI will be used to assess patients with ileostomies/colostomies. Number of liquid stools per day will be substituted for number of bag empties per day. 4. Evidence of endoscopic inflammation accessible via ileocolonoscopy or ileoscopy 1. Simple Endoscopic Score for CD (SES-CD) ≥ 6 or ≥ 4 for isolated ileal disease 2. patients with ileostomies will be assessed as patients with isolated ileal disease via SES-CD. 5. Failure to tolerate or failure to respond to at least one conventional therapy with the intention of inducing or maintaining remission (including but not limited to oral corticosteroids, oral 5-aminosalicylates, azathiop