Correlation Between RISANKIZUMAB's Trough Levels, Clinical and Biological Remission in Moderate to Severe Crohn's Disease: a Retrospective Multicentric Study

NCT06589895 | Completed

• 1 other identifier: LOCAL/2024/LS-01
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to determine if, as with other therapeutics such as anti-TNF, trough levels of Risankizumab are correlated with clinical and biological remission in patients with moderate to severe Crohn's disease. As part of their regular biological surveillance, trough levels of Risankizumab were mesured and clinical and biological data were collected to determine if biological and clinical remission criteria were met.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• Clinical and biological remission without corticosteroids 12 months after introduction of RISANKIZUMAB treatment.

  Defined by Harvey-Bradshaw score (HBI \< 4) and CRP \< 5 mg/L and/or calprotectin \< 250 µg/g.

  12 months

Secondary Outcomes (6)

• Predictive factors for primary or secondary treatment failure

  18 months

• Risk factors for immunisation

  18 months

• Risk factors for sub-therapeutics trough levels

  18 months

• Clinical response rates

  6 months, 12 months and 18 months

• Clinical and biological remission rates

  6 months and 18 months

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 with moderate to severe Crohn's disease on Risankizumab

You may qualify if:

• Age ≥18 years
• Patients with moderate to severe Crohn's disease
• Failure of at least one immunosuppressant and one anti-TNF alpha agent
• Patients on Risankizumab
• No opposition to study participation

You may not qualify if:

• Age \< 18 years
• Unclassified colitis
• Risankizumab prescribed to prevent post-operative relapse
• Any contraindication to Risankizumab
• Refusal to participate in study

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, 30029, France

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

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

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: June 1, 2021
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)