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

Conditions: Inlammatory bowel disease
10017969
10003816

Registration Number: NL-OMON56467

Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 36

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) < 4 for CD [18] or a
partial Mayo Index (PMI) <2 for UC [19], with faecal calprotectin levels <250
µg/g faeces and CRP <10 mg/L.
• Concomitant immunomodulators are allowed, i.e. in stable doses were received
for at least 12 weeks prior to study enrolment. These doses will be continued
throughout the study, including azathioprine (AZA), 6-mercaptopurine (6-MP),
tioguanine (TG) and MTX.
• Written informed consent

Exclusion Criteria

• Patient <18 years of age.
• Allergy or hypersensitivity to any of the excipients of SC CT-P13.
• Patient with active perianal fistula.
• Patient with another autoimmune disease in addition to IBD.
• Patient treated concomitantly with another Mab in addition to IFX.
• Patients who, after starting IV IFX, have developed new contraindications to
IFX according to European Public Assessment Report (EPAR).[3]
• Female patient who is currently pregnant or breastfeeding, or is planning to
become pregnant or breastfeed within 6 months of the last dose of IFX.
• Patient has a serious acute or chronic medical or psychiatric condition that
might increase the risk associated with study participation or investigational
product administration or that might interfere with the interpretation of study
results.
• Patients who, in the opinion of their general practitioner or investigator,
should not participate in the study (e.g. non-adherence, mental health
problems, illiteracy).

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures