The Therapy Effect of Azathioprine Initial or 14 Weeks After Combined With Infliximab on CD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2019-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aim to identify the therapeutic effect of azathioprine during infliximab(IFX) treatment in Crohn's disease (CD).Half of patients will receive azathioprine and infliximab combination therapy at the same time. The other half patients will be given infliximab therapy first and then receive azathioprine 14 weeks later.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

HLADQA1*05 Genotype and the Efficacy of Treatment With Infliximab in Chinese Population Crohn's Disease

NCT05813860

Crohn Disease Infliximab

NOT_YET_RECRUITING PHASE4

Efficacy and Safety of Two Regimens of Maintenance Therapy in Children With Crohn Disease

NCT01559142

Crohn Disease

UNKNOWN PHASE3

Evaluation of the Clinical and Immunological Impact of Two Therapeutic Strategies in Chronic Inflammatory Diseases

NCT03370601

Inflammatory Bowel Diseases

TERMINATED NA

Pre-treatment With Azithromycin to Reduce Immunogenicity to to Anti-TNF Agents in Patients With Crohn's Disease

NCT05599347

Crohn's Disease Relapse Biological Substance; Adverse Effect

RECRUITING PHASE2

Early Immunosuppressants in Crohn's Disease

NCT00546546

Crohn's Disease

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Anti-tumor necrosis factor agents were widely used for many years and were proved to be most reliable drugs in Crohn's disease (CD). About one-third of the patients would develop a secondary lost of response after initiating IFX therapy in one year follow-up. Immunosuppressor was thought to be a useful agent to reduce loss of response rate of infliximab.But It remain unclear when should us add immunosuppressor during infliximab therapy.This study aim to find the most valuable timepoint to initiate combination therapy to maximize therapeutic effect and minimize the adverse effect.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Crohn Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

infliximab and azathioprine at week 0

infliximab and azathioprine combination at week 0

Group Type ACTIVE_COMPARATOR

infliximab and azathioprine combination at week 0

Intervention Type DRUG

All enrolled CD patients will schedule on IF X (week 0, 2, 6 and then every 8 weeks at 5mg/kg).Experimental group will receive azathioprine at week 0.

infliximab and azathioprine at week 14

infliximab and azathioprine combination at week 14

Group Type ACTIVE_COMPARATOR

infliximab and azathioprine combination at week 14

Intervention Type DRUG

All enrolled CD patients will schedule on IF X (week 0, 2, 6 and then every 8 weeks at 5mg/kg).Control group will receive azathioprine at week 14.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

infliximab and azathioprine combination at week 0

All enrolled CD patients will schedule on IF X (week 0, 2, 6 and then every 8 weeks at 5mg/kg).Experimental group will receive azathioprine at week 0.

Intervention Type DRUG

infliximab and azathioprine combination at week 14

All enrolled CD patients will schedule on IF X (week 0, 2, 6 and then every 8 weeks at 5mg/kg).Control group will receive azathioprine at week 14.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- CD patients need infliximab and azathioprine combination therapy

Exclusion Criteria

\- patients had lost response to infliximab or azathioprine previously patients intolerable to infliximab or azathioprine patients need to use 5-Aminosalicylates(5-ASA) patients had participated to other clinical study in two months

Minimum Eligible Age

14 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No