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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51798

Enrollment

Registered

2022-03-28

Start date

2022-06-07

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The primary endpoint is intra-individual differences in Rac1 and pSTAT3 expression before and during 4 weeks of thiopurine treatment.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results