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.
The subcutaneaous formulation of infliximab CT-P13 represents a promising approach in the treatment of inflammatory bowel disease (IBD), with an efficacy/safety/immunogenicity profile similar or even improved compared to the intravenous formulation of CT-P13. For patients, SC administration can offer benefits over their daily activities by reducing the frequency of days spent in the hospital to receive infusions. The SC administration may offer convenience for the healthcare system, optimizing the organizational impact due to the preparation and administration of the IV infusion, allowing resources to be used more efficiently, and reducing direct costs associated with the infusion. There are no clinical trials with Remsima® 120 mg given subcutaneously without IV loading doses of CT-P13 in patients with IBD. However, population pharmacokinetic and pharmacokinetic/pharmacodynamic modelling and simulation predicted comparable CT-P13 exposure (AUC over 8 weeks) and efficacy from Week 6 onward in rheumatoid arthritis patients treated with Remsima® 120 mg given without IV loading doses of CT-P13 when compared with Remsima® 3 mg/kg given intravenously at weeks 0, 2 and 6, and then every 8 weeks. For the dosing regimen with subcutaneous loading in patients with rheumatoid arthritis, the predicted median AUC value was 17,400 μg·h/mL from Week 0 to 6 which was approximately 1.8 fold lower than the predicted median AUC value for the dosing regimen with CT-P13 IV loading doses (32,100 μg·h/mL). Whereas the predicted median AUC values from Week 6 to 14 were comparable between the two dosing regimens with SC loading and IV loading (19,600 and 18,100 μg·h/mL, respectively).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Induction treatment.
Institut des MICI
Neuilly-sur-Seine, France
RECRUITINGRatio SC/IV
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%.
Time frame: Week 6
Ctrough at week 24 (non-inferiority)
Time frame: Week 24
AUC at week 24
Time frame: Week 24
Clinical response at week 6 and week 24
* Defined for UC as a decrease of at least 50% in PRO2. * Defined for CD as a decrease from baseline in CDAI score of at least 100 points or a total CDAI score \< 150 and defined as achieving a total HBI \< 4
Time frame: Weeks 6 and 24
IBD disability index at week 6
Time frame: Week 6
Fecal calprotectin at week 24
Time frame: Week 24
Clinical remission at week 6 and week 24
* Defined for UC as a symptomatic remission score with a stool frequency subscore of 0 or a subscore of 1 with a decrease of ≥1 point from baseline, and a rectal-bleeding subscore of 0. * Defined for CD as a CDAI score \< 150 evaluated in semi-blind (assessment will be done by another investigator without information on the treatment) and defined as achieving a total HBI \< 4.
Time frame: Weeks 6 and 24
Presence of antibodies to infliximab at Week 6 and Week 24
Time frame: Weeks 6 and 24
Concentration of C-reactive protein up to week 6 (the samples are collected at weeks 0, 6 and 24)
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Masking
SINGLE
Enrollment
130
Time frame: Up to Week 6
Adverse events, including injection site reactions and hypersensitivity reactions
Number of participants, number of AEs per patient, number of injection site reactions and hypersensitivity reactions per patient.
Time frame: From Baseline up to 6 weeks and 24 weeks
TSQM collected at Week 6 and Week 24
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.
Time frame: 24 months