- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06274294
Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous as Induction Therapy in Patients With Active CD or UC (PASSPORT)
The "PASSPORT Trial": Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous as Induction Therapy in Patients With Active Crohn's Disease or Ulcerative Colitis.
The goal of this clinical trial is to compare induction treatment with CT-P13 SC to induction treatment with CT-P13 IV in terms of pharmacokinetics in adult patients with inflammatory bowel disease (IBD) who have been diagnosed for at least 3 months and for whom the physician has decided to initiate treatment with infliximab CT-P13 as part of the standard of care.
The main aim of this study is to demonstrate that induction treatment with CT-P13 SC is non-inferior to CT-P13 IV in terms of pharmacokinetics at Week 6.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Angèle Benoit, M.Pharm.
- Phone Number: 0787518342
- Email: angele.benoit@institutdesmici.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male or female, aged at least 18 years old.
Diagnosis of inflammatory bowel disease according to the ECCO criteria for at least 3 months:
- CD (Crohn's disease)
- UC (Ulcerative colitis)
- Patients had received conventional therapy for active UC (corticosteroids alone or in combination with thiopurines and 5-aminosalicylates) or CD (corticosteroids and/or immunomodulators) but had not responded despite an adequate course of therapy.
- Patient has active CD or UC with at least one objective sign of disease activity on biology, endoscopy or imaging.
- Initiation of infliximab CT-P13 as part of standard of care.
- Patient suffering from anal suppuration related to CD can be included.
- Person who has received full information about the organization of the research, who has not objected to his or her participation and to the use of his or her data.
- Person affiliated to or beneficiary of a social security plan.
Exclusion Criteria:
- Combination therapy with an immunomodulator except for patients suffering from anal suppuration related to CD.
- Patient who has allergies to any of the excipients of infliximab CT-P13 or any other murine and/or human proteins or patient with a hypersensitivity to immunoglobulin product.
- Patient who had current or past history of chronic infection with hepatitis C or human immunodeficiency virus (HIV)-1 or -2 or current infection with hepatitis B.
- Patient who had acute infection requiring oral antibiotics within 2 weeks or parenteral injection of antibiotics within 4 weeks prior to the first administration of the study drug, other serious infection within 6 months prior to the first administration of study drug or recurrent herpes zoster or other chronic or recurrent infection within 6 weeks prior to the first administration of the study drug.
- Patients with a positive interferon-γ release assay (IGRA) or latent tuberculosis (TB) prior to initiation of biologic therapy.
- Person referred in articles L.1121-5, L. 1121-7 and L.1121-8 of the Public Health Code: pregnant woman, parturient, or breastfeeding woman, minor person (non-emancipated), adult person under legal protection (any form of public guardianship), adult person incapable of giving consent.
- Person deprived of liberty for judicial or administrative decision, person under psychiatric care as referred in articles L. 3212-1 and L. 3213-1.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SC CT-P13 induction
Experimental arm: SC induction of 240 mg of CT-P13 at week 1, then 120 mg at weeks 2, 3, 4 then every 2 weeks until week 24.
|
Induction treatment.
|
Other: IV CT-P13 induction
Control arm: IV induction of 5 mg/kg of CT-P13 at weeks 1 and 2 then SC (120 mg) every 2 weeks until week 24.
|
Induction treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ratio SC/IV
Time Frame: Week 6
|
The ratio (SC/IV) of log-normal means of Ctrough at W6 and its 95% CI.
Non inferiority will be considered as demonstrated if the lower limit of the 95%CI is higher than 80%.
|
Week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ctrough at week 24 (non-inferiority)
Time Frame: Week 24
|
Week 24
|
|
AUC at week 24
Time Frame: Week 24
|
Week 24
|
|
Clinical response at week 6 and week 24
Time Frame: Weeks 6 and 24
|
|
Weeks 6 and 24
|
IBD disability index at week 6
Time Frame: Week 6
|
Week 6
|
|
Fecal calprotectin at week 24
Time Frame: Week 24
|
Week 24
|
|
Clinical remission at week 6 and week 24
Time Frame: Weeks 6 and 24
|
|
Weeks 6 and 24
|
Presence of antibodies to infliximab at Week 6 and Week 24
Time Frame: Weeks 6 and 24
|
Weeks 6 and 24
|
|
Concentration of C-reactive protein up to week 6 (the samples are collected at weeks 0, 6 and 24)
Time Frame: Up to Week 6
|
Up to Week 6
|
|
Adverse events, including injection site reactions and hypersensitivity reactions
Time Frame: From Baseline up to 6 weeks and 24 weeks
|
Number of participants, number of AEs per patient, number of injection site reactions and hypersensitivity reactions per patient.
|
From Baseline up to 6 weeks and 24 weeks
|
TSQM collected at Week 6 and Week 24
Time Frame: 24 months
|
The Treatment Satisfaction Questionnaire for Medication consists of 14 items that results in four specific domains: Effectiveness, Side Effects, Convenience, and one global scale item, Global Satisfaction.
Scores for each domain are computed by adding the TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100.
|
24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yoram Bouhnik, PhD.Med., Paris IBD Center
Publications and helpful links
General Publications
- Schreiber S, Ben-Horin S, Leszczyszyn J, Dudkowiak R, Lahat A, Gawdis-Wojnarska B, Pukitis A, Horynski M, Farkas K, Kierkus J, Kowalski M, Lee SJ, Kim SH, Suh JH, Kim MR, Lee SG, Ye BD, Reinisch W. Randomized Controlled Trial: Subcutaneous vs Intravenous Infliximab CT-P13 Maintenance in Inflammatory Bowel Disease. Gastroenterology. 2021 Jun;160(7):2340-2353. doi: 10.1053/j.gastro.2021.02.068. Epub 2021 Mar 5.
- Iannone F, Conti F, Cauli A, Farina A, Caporali R. Subcutaneously-Administered Infliximab in the Management of Rheumatoid Arthritis: A Short Narrative Review of Current Clinical Evidence. J Inflamm Res. 2022 Jun 1;15:3259-3267. doi: 10.2147/JIR.S240593. eCollection 2022.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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