Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this prospective, multicenter, real-world study is to compare the efficacy differences and influencing factors of different first-line biologics in patients with moderate to severe ulcerative colitis. The question that this study aims to answer is: When treating patients with moderate to severe ulcerative colitis, should IFX or VDZ be prioritized as the first-line choice for biologics?, Which biological agent has better therapeutic effect?. Researchers will observe and follow up with patients with moderate to severe ulcerative colitis treated with different biologics on the front line, evaluate their condition changes, eliminate relevant interfering factors, and draw the final conclusion.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The IFX group | The first-line use of IFX group regularly uses IFX treatment for 3 cycles before continuing to use IFX or adjusting to VDZ treatment. |
| |
| The VDZ group | The first-line use of VDZ group regularly uses VDZ treatment for 3 cycles before continuing to use VDZ or adjusting to IFX treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| first-line biologic：IFX | Drug | IFX is administered intravenously at a dose of 5-10mg/kg, once at weeks 0, 2, and 6 (or 0, 1, and 5), and then every 8 weeks at a dose of 5mg/kg for maintenance treatment. VDZ is administered intravenously at a dose of 300mg/time, once at weeks 0, 2, and 6, and then every 8 weeks at a dose of 300mg for maintenance treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical remission rates and endoscopic remission rates at 14 weeks, 30 weeks, 52 weeks, and 2 years after first-line biologics treatment | Evaluate the clinical remission rate and endoscopic remission rate of first-line biologics treatment at 14 weeks, 30 weeks, 52 weeks, and 2 years based on the Mayo scoring system and endoscopic examination results | From enrollment to the end of treatment at 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response rate, endoscopic response rate, and hormone free response rate at 14 weeks, 30 weeks, 52 weeks, and 2 years after first-line biologics treatment | Evaluate the clinical response rate, endoscopic response rate, and hormone free response rate at 14 weeks, 30 weeks, 52 weeks, and 2 years after first-line biologic therapy based on the Mayo scoring system and endoscopic examination results |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Moderate to severe UC patients treated with biological agents in the Xijing Hospital of Digestive Diseases
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dongdong He | Contact | 0086 + 02984771535 | 929731975@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Min Chen | Xijing Hospital of Digestive Diseases | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital of Digestive Diseases | Recruiting | Shanxi | Xi'an | 710032 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| first-line biologic:VDZ | Drug | IFX is administered intravenously at a dose of 5-10mg/kg, once at weeks 0, 2, and 6 (or 0, 1, and 5), and then every 8 weeks at a dose of 5mg/kg for maintenance treatment. VDZ is administered intravenously at a dose of 300mg/time, once at weeks 0, 2, and 6, and then every 8 weeks at a dose of 300mg for maintenance treatment. |
|
| From enrollment to the end of treatment at 2 years. |
| Factors affecting the efficacy of two biological agents in the treatment process | After balancing confounding factors through PSM, IPTW, and other methods, the factors affecting the efficacy of biologics were analyzed through survival analysis curves | From enrollment to the end of treatment at 2 years. |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |