Ulcerative ColitisPhase 4NCT05205603
Efficacy of Mesalazine Combined With Biologics in the Treatment of Moderate to Severe Ulcerative Colitis
A Phase 4 study testing Infliximab, Vedolizumab and Mesalazine in people with Ulcerative Colitis and Efficacy, Self, run by Sixth Affiliated Hospital, Sun Yat-sen University at 11 sites in China.
Trial summary
Endocopic remission rates of moderate to severe ulcerative colitis are low. Biologics including Vedolizumab, infliximab, and adalimumab are effective in induction and maintainence of ulcerative colitis. The role of 5-ASA in promoting a higher rate of endocsopic remission is unclear. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ulcerative Colitis, Efficacy, Self, Biologics
- What is being tested?
- Infliximab, Vedolizumab and Mesalazine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 438 participants
- Where
- 11 sitesChina
- Study dates
- 15 Jan 2022to 15 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with moderate and severe ulcerative colitis;
- Subjects were above 18 years old and below 80 years;
- Indications of 5-ASA or biological treatment;
- According to the clinical symptoms, ulcerative colitis was diagnosed by endoscopic changes, pathological manifestations. The disease activity of UC was assessed according to the modified Mayo scoring system (modified Mayo: 6~12 for patients with moderate to severe ulcerative colitis);
- If the subject is a woman, a pregnancy test at baseline is needed to exclude pregnancy. Female patients must follow the contraceptive recommendations of the project;
- Subjects must be able and willing to provide written informed consent and comply with the requirements of this study protocol.
Who cannot join
- No indications of 5-ASA or biological treatment;
- ulcerative colitis patients who had previously undergone a partial colectomy;
- Patients who are unable to use 5-ASA for a long time;
- Patients with severe, progressive, or uncontrolled kidney, liver, blood, or endocrine diseases or symptoms;
- Presence of infected persons, Patients with a contraindication to the use of biological agents such as C. difficile infection or other intestinal pathogens, active tuberculosis or intestinal tuberculosis infection, human immunodeficiency virus (HIV) infection, active hepatitis B or hepatitis C (defined as: ① HBV: hepatitis B surface antigen (HBs Ag) positive (+), Or patients with positive for hepatitis B core antibody (HBcAb) and the qualitative test results of HBV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) meet the detection criteria; ② HCV: Any patient with an anti-HCV antibody (HCV Ab) -positive patient with a detectable HCV ribonucleic acid (RNA);
- Patients with a history of gastrointestinal dysplasia, or dysplasia on any biopsy performed on endoscopy, excluding low-grade dysplasia lesions; known history of lymphoproliferative disease (including lymphoma), or signs and symptoms (e. g., lymphadenopathy and / or splenomegaly); patients with current or previous malignancy;
- Has been involved in other clinical studies.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites
People's Hospital of Chongqing
Chongqing, Chongqing Municipality
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
the Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 501655
First People's Hospital of Foshan
Guangzhou, Guangdong
Guangzhou Panyu Central Hospital
Guangzhou, Guangdong
Nanhai Hospital, Southern Medical University
Guangzhou, Guangdong
Shunde Hospital of Southern Medical University
Guangzhou, Guangdong
Zhejiang University
Hanzhou, Zhejiang
First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong
Shengjing Hospital
Shenyang, Liaoning
General Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality
About this study
Official title: Efficacy of Mesalazine Combined With Biologics in the Treatment of Moderate to Severe Ulcerative Colitis: a Multicenter, Prospective, Randomized, Controlled Clinical Study
Endocopic remission rates of moderate to severe ulcerative colitis are low. Biologics including Vedolizumab, infliximab, and adalimumab are effective in induction and maintainence of ulcerative colitis. The role of 5-ASA in promoting a higher rate of endocsopic remission is unclear. We aim to evaluate the efficacy of combination of 5-ASA and biologics in treating ulcerative colitis.
- Conditions
- Ulcerative Colitis, Efficacy, Self, Biologics, Mesalazine
- Being tested
- Infliximab, Vedolizumab, Mesalazine
- Keywords
- ulcerative colitis, biologics, mesalazine
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
Infliximab, 5mg/kg at week 0,2,6 and schedule administration at every 8 weeks
VedolizumabDrug
Vedolizumab, 300mg at week 0,2,6 and schedule administration at every 8 weeks
MesalazineDrug
Mesalazine, 4-6g/d, systemic and/or topical administration
| Study group | Role | What they receive |
|---|---|---|
| Biologics group | Placebo comparator | Biologics including infliximab and vedolizumab. infliximab: 5mg/kg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 5mg/kg every 8 weeks.
vedolizumab: 300mg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 300mg every 8 weeks. Receives: Drug: Infliximab; Drug: Vedolizumab |
| 5-ASA group | Experimental | 5-ASA combined with biologics (including infliximab and vedolizumab). infliximab: 5mg/kg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 5mg/kg every 8 weeks.
vedolizumab: 300mg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 300mg every 8 weeks.
mesalazine: at a dose of 4-6g/d systemic or topical therapy Receives: Drug: Infliximab; Drug: Vedolizumab; Drug: Mesalazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
endoscopic remission rate at 12 months
endoscopic remission rate at 12 months
Measured: 12 months after first intervention administration
Secondary outcomes (11)
normalization rate of serum biomarker at 12 months
normalization rate of serum biomarker at 12 months
Measured: 12 months after first intervention administration
normalization rate of serum biomarker at 6 months
normalization rate of serum biomarker at 6 months
Measured: 6 months after first intervention administration
clinical remission rate at 12 months
clinical remission rate at 12 months
Measured: 12 months after first intervention administration
clinical remission rate at 6 months
clinical remission rate at 6 months
Measured: 6 months after first intervention administration
clinical response rate at 12 months
clinical response rate at 12 months
Measured: 12 months after first intervention administration
clinical response rate at 6 months
clinical response rate at 6 months
Measured: 6 months after first intervention administration
endoscopic remission rate at 6 months
endoscopic remission rate at 6 months
Measured: 6 months after first intervention administration
endoscopic response rate at 12 months
endoscopic response rate at 12 months
Measured: 12 months after first intervention administration
endoscopic response rate at 6 months
endoscopic response rate at 6 months
Measured: 6 months after first intervention administration
life quality changes at 12 months
life quality evaluated by IBDQ (inflammatory bowel disease questionnaire) at 12 months
Measured: 12 months after first intervention administration
life quality changes at 6 months
life quality evaluated by IBDQ (inflammatory bowel disease questionnaire) at 6 months
Measured: 6 months after first intervention administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start15 Jan 2022
- Primary completion15 Jan 2024
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 438 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205603
- Sponsor's protocol ID
- 2021ZSLYEC-456
- Status last verified
- Apr 2026
- First submitted
- 5 Jan 2022
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Mesalazine Combined With Biologics in the Treatment of Moderate to Severe Ulcerative Colitis: a Multicenter, Prospective, Randomized, Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05205603
- Acronym / sponsor ID
- 2021ZSLYEC-456
- Conditions
- Ulcerative Colitis, Efficacy, Self, Biologics, Mesalazine
- Keywords
- ulcerative colitis, biologics, mesalazine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 438 participants (actual)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Endocopic remission rates of moderate to severe ulcerative colitis are low. Biologics including Vedolizumab, infliximab, and adalimumab are effective in induction and maintainence of ulcerative colitis. The role of 5-ASA in promoting a higher rate of endocsopic remission is unclear. We aim to evaluate the efficacy of combination of 5-ASA and biologics in treating ulcerative colitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biologics group | Placebo comparator | Drug: Infliximab, Drug: VedolizumabBiologics including infliximab and vedolizumab. infliximab: 5mg/kg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 5mg/kg every 8 weeks. vedolizumab: 300mg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 300mg every 8 weeks. |
| 5-ASA group | Experimental | Drug: Infliximab, Drug: Vedolizumab, Drug: Mesalazine5-ASA combined with biologics (including infliximab and vedolizumab). infliximab: 5mg/kg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 5mg/kg every 8 weeks. vedolizumab: 300mg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 300mg every 8 weeks. mesalazine: at a dose of 4-6g/d systemic or topical therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with moderate and severe ulcerative colitis;
- Subjects were above 18 years old and below 80 years;
- Indications of 5-ASA or biological treatment;
- According to the clinical symptoms, ulcerative colitis was diagnosed by endoscopic changes, pathological manifestations. The disease activity of UC was assessed according to the modified Mayo scoring system (modified Mayo: 6~12 for patients with moderate to severe ulcerative colitis);
- If the subject is a woman, a pregnancy test at baseline is needed to exclude pregnancy. Female patients must follow the contraceptive recommendations of the project;
Key exclusion criteria (7 listed)
- No indications of 5-ASA or biological treatment;
- ulcerative colitis patients who had previously undergone a partial colectomy;
- Patients who are unable to use 5-ASA for a long time;
- Patients with severe, progressive, or uncontrolled kidney, liver, blood, or endocrine diseases or symptoms;
- Presence of infected persons, Patients with a contraindication to the use of biological agents such as C. difficile infection or other intestinal pathogens, active tuberculosis or intestinal tuberculosis infection, human immunodeficiency virus (HIV) infection, active hepatitis B or hepatitis C (defined as: ① HBV: hepatitis B surface antigen (HBs Ag) positive (+), Or patients with positive for hepatitis B core antibody (HBcAb) and the qualitative test results of HBV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) meet the detection criteria; ② HCV: Any patient with an anti-HCV antibody (HCV Ab) -positive patient with a detectable HCV ribonucleic acid (RNA);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InfliximabInfliximab, 5mg/kg at week 0,2,6 and schedule administration at every 8 weeks | Drug | 5-ASA group, Biologics group |
| VedolizumabVedolizumab, 300mg at week 0,2,6 and schedule administration at every 8 weeks | Drug | 5-ASA group, Biologics group |
| MesalazineMesalazine, 4-6g/d, systemic and/or topical administration | Drug | 5-ASA group |
Primary outcome
endoscopic remission rate at 12 months
Time frame: 12 months after first intervention administration
endoscopic remission rate at 12 months
11 secondary outcomes
normalization rate of serum biomarker at 12 months
Time frame: 12 months after first intervention administration
normalization rate of serum biomarker at 6 months
Time frame: 6 months after first intervention administration
clinical remission rate at 12 months
Time frame: 12 months after first intervention administration
clinical remission rate at 6 months
Time frame: 6 months after first intervention administration
clinical response rate at 12 months
Time frame: 12 months after first intervention administration
clinical response rate at 6 months
Time frame: 6 months after first intervention administration
endoscopic remission rate at 6 months
Time frame: 6 months after first intervention administration
endoscopic response rate at 12 months
Time frame: 12 months after first intervention administration
endoscopic response rate at 6 months
Time frame: 6 months after first intervention administration
life quality changes at 12 months
Time frame: 12 months after first intervention administration
life quality changes at 6 months
Time frame: 6 months after first intervention administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
Related trials for Ulcerative Colitis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Infliximab, Vedolizumab and Mesalazine in people with Ulcerative Colitis and Efficacy, Self, run by Sixth Affiliated Hospital, Sun Yat-sen University at 11 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endoscopic remission rate at 12 months (time frame: 12 months after first intervention administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.