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The first-line treatment strategy of moderate to severe UC was a important question at issue. The biological agents had potentiality to alter the disease course of UC. The AGA clinical guidelines had conditional recommend that IFX and other biological agene migtht be first-line therapy for high-risk UC patints but only had low grade evidence.We launched this multicenter prospective cohort trial to compare the efficacy and safety of infliximab (IFX) and corticosteroids(CS) when they was used as first-line therapy in UC patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UC cohort | the patiente of Moderate to Severe Ulcerative Colitis who recieved infliximab(IFX) or corticosteroids(CS) as induction therapy would be enrolled in this cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Drug | Infliximab was used as induction therapy in UC patients, the maintenance treatment was decided by the researcher |
|
| Measure | Description | Time Frame |
|---|---|---|
| clinical remission | defined as a total score of ≤2 on the Mayo scale and no subscore >1; partial Mayo score ≤ 2, no individual subscore > 1 | week 14 |
| Measure | Description | Time Frame |
|---|---|---|
| clinical response in induction phase | defined as a reduction in the partial Mayo score [stool frequency, rectal bleeding, and physician's global assessment] of ≥2 points and of ≥25% from baseline, with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point | week 14 |
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Inclusion Criteria:
Exclusion Criteria:
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Adults patinets of moderately to severely active ulcerative colitis who will initiate IFX or CS
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sixth Affiliated Hospital, Sun Yat-sen University | Recruiting | Guandong | China |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Corticosteroid | Drug | Corticosteroids was used as induction therapy in UC patients, the maintenance treatment was decided by the researcher |
|
|
| mucosal healing in induction phase |
defined as a subscore of 0 or 1 on the Mayo endoscopic component |
| week 14 |
| histological healing in induction phase | defined as Nancy index score of 0 | week 14 |
| clinical response in maintenance phase | defined as a reduction in the partial Mayo score [stool frequency, rectal bleeding, and physician's global assessment] of ≥2 points and of ≥25% from baseline, with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point | week 52 |
| mucosal healing in maintenance phase | defined as a subscore of 0 or 1 on the Mayo endoscopic component | week 52 |
| histological healing in maintenance phase | defined as Nancy index score of 0 | week 52 |
| quality of life in induction phase | defined as an increase of ≥16 points in IBDQ score | week 14 |
| quality of life in maintenance phase | defined as an increase of ≥16 points in IBDQ score | week 52 |
| adverse events | as assessed by the incidence of adverse events | week 52 |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |