Switching from intravenous to subcutaneous infliximab in adult patients with inflammatory bowel disease: evaluation of exposure parameters (SHUFFLE-study)

Switching from intravenous to subcutaneous infliximab in adult patients with inflammatory bowel disease: evaluation of exposure parameters (SHUFFLE-study) - SHUFFLE-study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56467

Enrollment

Registered

2024-01-12

Start date

2024-03-12

Completion date

Unknown

Last updated

2026-06-15

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

Conditions

Inlammatory bowel disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Adult patients (18-75 years) with an confirmed diagnosis of IBD according to usual criteria, including previous endoscopic examination. • Patients on IV IFX maintenance therapy at a stable dose and dosing interval for at least 16 weeks of 5-10 mg/kg every 6-8 weeks without side effects of IFX. • IBD in clinical remission for at least 16 weeks without treatment with systemic corticosteroids in the previous 16 weeks. Clinical remission in adult patients is defined as a Harvey-Bradshaw index (HBI)

Exclusion criteria

Exclusion criteria: • Patient

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics: - The first primary endpoint is the AUC at steady state normalized to a period of 8 weeks. Mean AUC SC CT-P13 will be compared to baseline AUC on IV IFX. - The second primary endpoint is the AUC of one dose interval at steady state for SC CT-P13. AUC SC CT-P13 of cohort 1 will be compared to the AUC SC CT-P13 of cohort 2.	—

Secondary

Measure	Time frame
Pharmacokinetic: IFX trough level treatment related time expenditure: - In hospital time - Travel time	—

Countries

Netherlands

Outcome results