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Efficacy of Mesalazine Combined With Biologics in the Treatment of Moderate to Severe Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05205603
Recruitment Status : Not yet recruiting
First Posted : January 25, 2022
Last Update Posted : January 25, 2022
Sponsor:
Information provided by (Responsible Party):
Sixth Affiliated Hospital, Sun Yat-sen University

Brief 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. We aim to evaluate the efficacy of combination of 5-ASA and biologics in treating ulcerative colitis.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Efficacy, Self Biologics Mesalazine Drug: Infliximab Drug: Vedolizumab Drug: Mesalazine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 438 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Mesalazine Combined With Biologics in the Treatment of Moderate to Severe Ulcerative Colitis: a Multicenter, Prospective, Randomized, Controlled Clinical Study
Estimated Study Start Date : January 15, 2022
Estimated Primary Completion Date : January 15, 2024
Estimated Study Completion Date : January 15, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Biologics group

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.

Drug: Infliximab
Infliximab, 5mg/kg at week 0,2,6 and schedule administration at every 8 weeks

Drug: Vedolizumab
Vedolizumab, 300mg at week 0,2,6 and schedule administration at every 8 weeks

Experimental: 5-ASA group

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

Drug: Infliximab
Infliximab, 5mg/kg at week 0,2,6 and schedule administration at every 8 weeks

Drug: Vedolizumab
Vedolizumab, 300mg at week 0,2,6 and schedule administration at every 8 weeks

Drug: Mesalazine
Mesalazine, 4-6g/d, systemic and/or topical administration




Primary Outcome Measures :
  1. endoscopic remission rate at 12 months [ Time Frame: 12 months after first intervention administration ]
    endoscopic remission rate at 12 months


Secondary Outcome Measures :
  1. normalization rate of serum biomarker at 12 months [ Time Frame: 12 months after first intervention administration ]
    normalization rate of serum biomarker at 12 months

  2. normalization rate of serum biomarker at 6 months [ Time Frame: 6 months after first intervention administration ]
    normalization rate of serum biomarker at 6 months

  3. clinical remission rate at 12 months [ Time Frame: 12 months after first intervention administration ]
    clinical remission rate at 12 months

  4. clinical remission rate at 6 months [ Time Frame: 6 months after first intervention administration ]
    clinical remission rate at 6 months

  5. clinical response rate at 12 months [ Time Frame: 12 months after first intervention administration ]
    clinical response rate at 12 months

  6. clinical response rate at 6 months [ Time Frame: 6 months after first intervention administration ]
    clinical response rate at 6 months

  7. endoscopic remission rate at 6 months [ Time Frame: 6 months after first intervention administration ]
    endoscopic remission rate at 6 months

  8. endoscopic response rate at 12 months [ Time Frame: 12 months after first intervention administration ]
    endoscopic response rate at 12 months

  9. endoscopic response rate at 6 months [ Time Frame: 6 months after first intervention administration ]
    endoscopic response rate at 6 months

  10. life quality changes at 12 months [ Time Frame: 12 months after first intervention administration ]
    life quality evaluated by IBDQ (inflammatory bowel disease questionnaire) at 12 months

  11. life quality changes at 6 months [ Time Frame: 6 months after first intervention administration ]
    life quality evaluated by IBDQ (inflammatory bowel disease questionnaire) at 6 months



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with moderate and severe ulcerative colitis;
  2. Subjects were above 18 years old and below 80 years;
  3. Indications of 5-ASA or biological treatment;
  4. 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);
  5. 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;
  6. Subjects must be able and willing to provide written informed consent and comply with the requirements of this study protocol.

Exclusion Criteria:

  1. No indications of 5-ASA or biological treatment;
  2. ulcerative colitis patients who had previously undergone a partial colectomy;
  3. Patients who are unable to use 5-ASA for a long time;
  4. Patients with severe, progressive, or uncontrolled kidney, liver, blood, or endocrine diseases or symptoms;
  5. 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);
  6. 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;
  7. Has been involved in other clinical studies.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05205603


Contacts
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Contact: Min Zhi 13825086505 zhimin@mail.sysu.edu.cn

Locations
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China, Chongqing
People's Hospital of Chongqing
Chongqing, Chongqing, China
Contact: Hong Guo    13508389768      
China, Guangdong
the Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China, 501655
First People's Hospital of Foshan
Guangzhou, Guangdong, China
Guangzhou Panyu Central Hospital
Guangzhou, Guangdong, China
Nanhai Hospital, Southern Medical University
Guangzhou, Guangdong, China
Shunde Hospital of Southern Medical University
Guangzhou, Guangdong, China
First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China
China, Liaoning
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Contact: Xiaoying Feng    17709870699      
Shengjing Hospital
Shenyang, Liaoning, China
China, Tianjin
General Hospital of Tianjin Medical University
Tianjin, Tianjin, China
China, Zhejiang
Zhejiang University
Hanzhou, Zhejiang, China
Contact: Yan Chen    13757118653      
Sponsors and Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University
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Responsible Party: Sixth Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT05205603    
Other Study ID Numbers: 2021ZSLYEC-456
First Posted: January 25, 2022    Key Record Dates
Last Update Posted: January 25, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sixth Affiliated Hospital, Sun Yat-sen University:
ulcerative colitis
biologics
mesalazine
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Mesalamine
Infliximab
Vedolizumab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents