Efficacy and safety of thalidomide for patients with Crohn's Disease: a prospective multicenter observational study from China

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-OPC-16008655
• Date of registration: 2016-06-16
• Prospective Registration: No
• Primary sponsor: Peking Union Medical College Hospital
• Public title: Efficacy and safety of thalidomide for patients with Crohn's Disease: a prospective multicenter observational study from China
• Scientific title: Efficacy and safety of thalidomide for patients with Crohn's Disease: a prospective multicenter observational study from China
• Date of first enrolment: 2016-05-01
• Target sample size: 1:90;2:90;3:90;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=13831
• Study type: Observational study
• Study design: Cohort study
• Phase: Post-market

Countries of recruitment

China

Contacts

• Name: Qian Jiaming
• Affiliation: Peking Union Medical College Hospital

• Name: Yang Hong
• Affiliation: Peking Union Medical College Hospital

Key inclusion & exclusion 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: 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.

Age minimum: 16
Age maximum: 70
Gender: Both

Health Condition(s) or Problem(s) studied

Crohn‘s Disease

Intervention(s)

1:Thalidomide 75-100mg qd;2:Thalidomide 150-200mg qd;3:Thalidomide 75-100mg qd+MTX 20-25mg /W;

Primary Outcome(s)

remission rate;mucosal healing rate;

Source(s) of Monetary Support

None