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This study aim to identify the therapeutic effect of azathioprine during infliximab(IFX) treatment in Crohn's disease (CD).Half of patients will receive azathioprine and infliximab combination therapy at the same time. The other half patients will be given infliximab therapy first and then receive azathioprine 14 weeks later.
Anti-tumor necrosis factor agents were widely used for many years and were proved to be most reliable drugs in Crohn's disease (CD). About one-third of the patients would develop a secondary lost of response after initiating IFX therapy in one year follow-up. Immunosuppressor was thought to be a useful agent to reduce loss of response rate of infliximab.But It remain unclear when should us add immunosuppressor during infliximab therapy.This study aim to find the most valuable timepoint to initiate combination therapy to maximize therapeutic effect and minimize the adverse effect.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| infliximab and azathioprine at week 0 | Active Comparator | infliximab and azathioprine combination at week 0 |
|
| infliximab and azathioprine at week 14 | Active Comparator | infliximab and azathioprine combination at week 14 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| infliximab and azathioprine combination at week 0 | Drug | All enrolled CD patients will schedule on IF X (week 0, 2, 6 and then every 8 weeks at 5mg/kg).Experimental group will receive azathioprine at week 0. |
| Measure | Description | Time Frame |
|---|---|---|
| loss of response(LOR) rate at one year | LOR was defined as recurrence or worsening of symptoms after achieving remission or response that required IFX dose intensification, addition of concomitant therapy, or discontinuation of IFX. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Simple Endoscopic Score for Crohn's Disease(SES-CD) at one year | Patients will undergo colonscopy at one year after infliximab therapy and SES-CD which is a useful ool in evaluating endoscopic activities will be evaluated by colonoscopists. | one year |
| Mucosal healing(MH)status at one year |
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Inclusion Criteria:
- CD patients need infliximab and azathioprine combination therapy
Exclusion Criteria:
- patients had lost response to infliximab or azathioprine previously patients intolerable to infliximab or azathioprine patients need to use 5-Aminosalicylates(5-ASA) patients had participated to other clinical study in two months
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Tang, master | Contact | 8613751879964 | tangjiansys@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiang Gao, doctor | the 6th affiliated hospital of Sun Yat-sen university | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sixth Affiliated Hospital, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| infliximab and azathioprine combination at week 14 | Drug | All enrolled CD patients will schedule on IF X (week 0, 2, 6 and then every 8 weeks at 5mg/kg).Control group will receive azathioprine at week 14. |
|
Patients will undergo colonscopy at one year after infliximab therapy and mucosal healing(MH)means no ulcer in terminal ileum and colorectum. |
| one year |
| D007410 | Intestinal Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |