Personalized treatment of methotrexate in Crohn*s disease through therapeutic drug monitoring and prediction of clinical outcome: a known drug revisited

Personalized treatment of methotrexate in Crohn*s disease through therapeutic drug monitoring and prediction of clinical outcome: a known drug revisited - MTX-PG//CD

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50118

Enrollment

Registered

2019-02-05

Start date

2019-05-21

Completion date

Unknown

Last updated

2024-08-19

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: Adults (18 years or older) with Crohn's disease starting with methotrexate as primary drug.

Exclusion criteria

Exclusion criteria: - Cotreatment with biologicals at methotrexate start - Not eligible to receive methotrexate as in usual care

Design outcomes

Primary

Measure	Time frame
The primary study endpoint of MTX efficacy is Step-Up-Therapy-Free-Survival (SUT-FS) in the first 6 months after start MTX therapy. The primary study endpoint of MTX efficacy is Step-Up-Therapy-Free-Survival (SUT-FS) in the first 6 months after start MTX therapy. MTX-PG levels in red blood cells are the primary outcome measurement for the pharmacokinetic study parts.	—

Secondary

Measure	Time frame
- Harvey Bradshaw Index (disease activity score CD) - Faecal calprotectin (stool inflammation marker) - CRP (blood inflammation marker) - Hospital admissions - Quality of life (IBDQ questionnaire) - Liver and bonemarrow toxicity (blood) - Gastrointestinal intolerance (MISS questionnaire) - MTX-PG level in white blood cel (PBMC, at university medical centers only) - MTX- PG level in colonic mucosa (if additional informed consent obtained) - Disease activity at coloscopy (if coloscopy for clinical indication, SES-CD score)	—

Measure

Time frame

- Harvey Bradshaw Index (disease activity score CD) - Faecal calprotectin (stool inflammation marker) - CRP (blood inflammation marker) - Hospital admissions - Quality of life (IBDQ questionnaire) - Liver and bonemarrow toxicity (blood) - Gastrointestinal intolerance (MISS questionnaire) - MTX-PG level in white blood cel (PBMC, at university medical centers only) - MTX- PG level in colonic mucosa (if additional informed consent obtained) - Disease activity at coloscopy (if coloscopy for clinical indication, SES-CD score)

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Countries

Netherlands

Outcome results