Association of Breg and Treg With the Clinical Effects of Infliximab in the Treatment of Patients With Crohn's Disease

NCT04272788 | Completed

• 1 other identifier: SAHoWMU-CR2020-01-205
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Aims: The main aim of this study is to access the predictive value of Treg and Breg for the clinical effect of Infliximab in the treatment through analyzing the relationship between Breg and Treg and the efficacy of Infliximab. Design: It is a prospective, observational study. In the treatment group, 32 patients with Crohn's disease (CD) about to start Infliximab-treatment are recruited. They have blood samples drawn at week 0 and 14 of Infliximab treatment. 33 healthy individuals serve as a control group. Controls are only investigated once. All treatment and follow-up are according to national guidelines. The frequencies of Treg and Breg are investigated using flow cytometry. Subjects data are extracted from various registries.

Conditions

Crohn Disease

Keywords

Crohn Disease; Infliximab; Treg; Breg

Outcome Measures

Primary Outcomes (4)

• Change of the frequency of Treg in R group

  The frequency of Treg is measured in peripheral blood by flow cytometry.

  week 0 of Infliximab treatment, week 14 of Infliximab treatment

• Change of the frequency of Breg in R group

  The frequency of Breg is measured in peripheral blood by flow cytometry.

  week 0 of Infliximab treatment, week 14 of Infliximab treatment

• Change of the frequency of Treg in N group

  The frequency of Treg is measured in peripheral blood by flow cytometry.

  week 0 of Infliximab treatment, week 14 of Infliximab treatment

• Change of the frequency of Breg in N group

  The frequency of Breg is measured in peripheral blood by flow cytometry.

  week 0 of Infliximab treatment, week 14 of Infliximab treatment

Secondary Outcomes (10)

• Change of Crohn's disease activity index (CDAI) in R group

  week 0 of Infliximab treatment, week 14 of Infliximab treatment

• Change of C-reactive protein (CRP) in R group

  week 0 of Infliximab treatment, week 14 of Infliximab treatment

• Change of leucocyte count (WBC) in R group

  week 0 of Infliximab treatment, week 14 of Infliximab treatment

• Change of platelet count (PLT) in R group

  week 0 of Infliximab treatment, week 14 of Infliximab treatment

• Change of erythrocyte sedimentation rate (ESR) in R group

  week 0 of Infliximab treatment, week 14 of Infliximab treatment

Study Arms (2)

CD patients

CD patients about to start Infliximab treatment, gives as i.v. injection of 5 mg/kg at baseline, after 2 weeks, 6 weeks, and then every 8th week.CD patients are followed for 14 weeks after the first administration of infliximab. At week 14 of Infliximab treatment, CD patients are classified as remission group (CDAI\<150 and endoscopic mucosal healing, R group) and non-remission group (CDAI≥150 and/or mucosal non-healing group, N group).

Drug: Infliximab

Healthy controls

Healthy controls without Crohn's Disease.

Interventions

Infliximab DRUG

The CD patients at initial active stage without treatment of glucocorticoids, immunosuppressants and biological agents are included in the study when the decision to treat with Infliximab is already made. This study is observational, and all treatment and clinical follow-up are according to national guidelines.

CD patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from the gastroenterology department at the Second Affiliated Hospital of Wenzhou Medical University are eligible for entry. Healthy controls are recruited at Health Examination Center of the Second Affiliated Hospital of Wenzhou Medical University.

You may qualify if:

• Crohn's Disease at initial active stage with CDAI ≥150.
• Starting Infliximab treatment

You may not qualify if:

• Significant co-morbidity (e.g. cancer, intestinal tuberculosis, ischemic enteritis, radiation enteritis)
• Other immunological disease (e.g. diabetes, rheumatoid arthritis systemic lupus erythematosus)
• Current treatment with glucocorticoids, immunosuppressants and biological agents
• Healthy controls
• No current disease
• No daily drug use
• Significant co-morbidity (e.g. cancer, intestinal tuberculosis, ischemic enteritis, radiation enteritis)
• Other immunological disease (e.g. diabetes, rheumatoid arthritis systemic lupus erythematosus)
• Current treatment with glucocorticoids, immunosuppressants and biological agents

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

SAHWenzhouMU

Wenzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Yi Jiang, PhD

  Second Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 17, 2020
• Study Start: January 24, 2017
• Primary Completion: September 29, 2019
• Study Completion: September 29, 2019
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

CN (1)