Rac1/pSTAT3 expression: Towards a potential pharmacodynamic marker to optimize and individualize thiopurine therapy in IBD patients

Recruiting

• Conditions: Crohn's disease; Ulcerative Colitis; 10017969; 10003816

• Registration Number: NL-OMON51798
• Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 43

Inclusion Criteria

- Diagnosis of Inflammatory Bowel Disease (IBD) (either Crohn's disease or
Ulcerative Colitis)
- Mild or Moderate-to-severe IBD patients who are starting thiopurine
treatment
- age between 18 - 70 years old
- both hospitalized and ambulant patients are eligible

Exclusion Criteria

- other auto-immune diseases
- previous use of thiopurines within two weeks before inclusion

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is intra-individual differences in Rac1 and pSTAT3<br /><br>expression before and during 4 weeks of thiopurine treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secundary endpoints are:<br /><br>- Assessment of number of patients with intra-individual reduction of at least<br /><br>30% of Rac1 corrected pSTAT3 expression in peripheral T cells of thiopurine<br /><br>derivative initiating adult IBD patients at week 4<br /><br>- Assessment of number of patients with intra-individual reduction of at least<br /><br>50% of Rac1 corrected pSTAT3 expression in peripheral T cells of thiopurine<br /><br>derivative initiating adult IBD patients at week 4<br /><br>- To measure early inhibition (at week 1) of the Rac1-pSTAT3 pathway after<br /><br>starting thiopurine therapy in percentual reduction and in number of patients<br /><br>with at least 30% of Rac1 corrected pSTAT3 expression in peripheral T cells<br /><br>- To evaluate the correlation between 6-TGN concentrations and Rac1-corrected<br /><br>pSTAT3 expression at week 1, and at week 4</p><br>