Effectiveness and Safety of Ustekinumab Intensification in Crohn's Disease

NCT05705856 | Unknown FDA Drug

• 1 other identifier: 2023-0004
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to evaluate the efficacy and safety of intravenous administration at regular intervals of Ustekinumab in participants with loss of response to standard regimen or have evidence of high activity clinically, biochemically or endoscopically.

Conditions

Crohn Disease

Keywords

ustekinumab; dose escalation; Crohn's disease

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with steroid-free clinical remission at Week 24

  Percentage of participants with steroid-free clinical remission at Week 24 from the escalation will be assessed. Steroid-free clinical remission (performed only in patients on prednisone or budesonide at time of initiation of UST) was defined as tapering off steroids completely and HBI ≤ 4 points or complete resolution in CD symptoms or severity assessed by PGA.

  Week24

Secondary Outcomes (6)

• Percentage of participants with biochemical remission at Week 24

  Week 24

• Percentage of participants with endoscopic remission at Week 52

  Week 52

• Percentage of participants with normal fecal calprotectin level at Week 52

  Week 52

• Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

  up to 1.5 years

• Percentage of Participants with Infections and Serious Infections

  up to 1.5 years

Study Arms (2)

intravenous maintenance at early stage

Participants who have evidence of high activity clinically, biochemically or endoscopically : HBI ≥8, inflammatory markers significantly increased (CRP \> 5mg/L, fecal calprotectin\> 200mg/g), SES-CD≥ 7, will get multiple intravenous injections of Ustekinumab maintenance after induction.

Drug: Ustekinumab

intravenous escalation when poor response

Participants who experience a loss of response or poor response to 90 mg Ustekinumab standard therapy will receive Ustekinumab intravenously at regular interval or at shorten interval.

Drug: Ustekinumab

Interventions

Ustekinumab DRUG

Patients will receive an intravenous induction (adjusted 6 mg/kg dose) followed by subcutaneous 90 mg every 12 or 8 weeks, and will receive dose escalation when response is not effective enough.

Also known as: UST, Ustekinumab antibody

intravenous escalation when poor response; intravenous maintenance at early stage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing Ustekinumab dose intensification with at least two or more intravenous infusions at the discretion of the treating physician instead of a scheduled SC dose at the discretion of the treating physician.

You may qualify if:

• Agree to participate in the study
• With active Crohn's disease
• Undergoing Ustekinumab dose intensification with at least two or more intravenous infusions at the discretion of the treating physician
• HBI ≥ 5 before Ustekinumab therapy
• Over 18 years of age

You may not qualify if:

• Who had received Ustekinumab for an indication
• Pregnant or nursing
• L4 type
• History of enterectomy or enterostomy related to disease
• Who used total enteral nutrition for more than 2 weeks due to complications such as obstruction, abscess and perforation after starting Ustekinumab therapy
• Pregnant and lactating women

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Yan Chen, MD

  2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuting Wang, MD

CONTACT

18868102022; wangyuting22@126.com

Study Design

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

Study Record Dates

• First Submitted: January 15, 2023
• First Posted: January 31, 2023
• Study Start: February 15, 2023
• Primary Completion: December 31, 2023
• Study Completion: June 1, 2024
• Last Updated: June 13, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)