Crohn‘s Disease
Conditions
Interventions
1:Thalidomide 75-100mg qd
2:Thalidomide 150-200mg qd
3:Thalidomide 75-100mg qd+MTX 20-25mg /W
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
16 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed as CD based on the established criteria and without a history of colon surgery B) Meeting at least one of the following conditions: (1) Steroid refractory: After receiving steroid (prednisone at a dose of 0.75-1mg/kg/day) by oral for more than 4 weeks, or equivalent intravenous formulationsfor more than 1 week, CD patients still have active disease with a CDAI greater than 150 and the reduction of CDAI less than 70; (2) Resistance to immunosuppressor or intolerance ofimmunosuppressor. The former suggests that CD patients still have active disease with a CDAI greater than 150 and the reduction of CDAI less than 70 following theadministration of azathioprine (1.5-2mg per kg per day) over 4 months or accumulated dose of azathioprine greater than 4g, or methotrexate (15-20mg per week) over 3months. The latter is defined as intolerance to the adverse effects of immunosuppressor, eg, allergy, damage of liver or renal disorders; (3) Resistance to Infliximab have active disease with a CDAI greater than 150 and the reduction of CDAI less than 70 following the administration of infliximab (5mg per kg) after 3 times (0, 2 weeks and 6 weeks). C) A CDAI score greater than 150 2. A SES-CD score greater than 2; 3. Aged 16 to 70 years.
Exclusion criteria
Exclusion criteria: 1. Severe renal or liver dysfunction; 2. Uncontrolled heart failure; 3. diagnosed as cancer or lymphoma d) Active tuberculosis infection; 4. Active viral hepatitis: significantly elevated aminotransferase levels (twice the upper limit of normal range), or HBeAg-positive with HBV-DNA greater tan 10S5copies/ml, or HBeAg-negative with HBV-DNA greater than 10S4 copies/ml; 5. Ongoing pregnancy or breastfeeding; 6. Uncontrolled bacterial or viral infection; 7. Acute abdomen disease requiring emergent surgery, or other operation indications including complex fistula, intestinal obstruction due to fibrotic stenosis, etc.; 8. Infliximab treatment in the previous 8 weeks; 9. eripheral neuropathy; 10. tranplanted organs; 11. plan to be pregnancy; 12. Previous history of deep venous thrombosis or other thromboembolic events.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| remission rate;mucosal healing rate; | — |
Countries
China
Contacts
Public ContactQian Jiaming
Peking Union Medical College Hospital
Outcome results
None listed