Thalidomide in Treating Crohn's Disease
Crohn's Disease
About this trial
This is an interventional treatment trial for Crohn's Disease
Eligibility Criteria
Inclusion Criteria:
A CDAI score greater than 150 at baseline was required for inclusion .(1) steroid-dependent: unable to reduce steroids below the equivalent of prednisone 10 mg/day (or budesonide below 3 mg/day) within 3 months of starting steroids, or who have a relapse within 3 months of stopping steroids.(2) thiopurines-non-responsive: active disease or clinical relapse despite administration of azathioprine (1.5-2 mg per kg per day) or 6-mercaptopurine (0.75-1.5 mg per kg per day) for 4 months. (3) thiopurines- intolerant: intolerance to or adverse events of thiopurines.
The exclusion criteria were (1) isolated L4 CD; (2) disease including symptomatic stenosis of intestine or abdominal abscess requiring immediate surgery; (3) Current or past history of malignancy or organ transplantation; (4) Serious infections within 3 months; (5) Previous history of neuropathy or symptoms of neuropathy or abnormal electromyography prior to thalidomide; (6) infliximab treatment in the previous 8 weeks; (7) progressive or uncontrolled renal, hepatic, hematological, pulmonary and cardiac disease and(8)ongoing pregnancy.
Sites / Locations
- The First Affiliated Hospital of Sun Yat-Sen University
Arms of the Study
Arm 1
Experimental
Thalidomide
Thalidomide was administered at a daily dose of 50 mg to the patients. Dosage adjustment of thalidomide from 25mg daily to 100mg daily was tailored individually according to patients' tolerance to thalidomide. To minimize the sedative effect of thalidomide, the investigators recommended patients take a single dose of the study drug in the evening before bedtime.