Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous as Induction Therapy in Patients With Active CD or UC

Inclusion Criteria

• •1. Male or female, aged at least 18 years old.
• •2. Diagnosis of inflammatory bowel disease according to the ECCO criteria for at least 3 months:
• •* moderately to severely active CD (Crohn's disease)
• •* moderately to severely active UC (Ulcerative colitis)
• •3. 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.
• •4. Patient has active CD or UC with at least one objective sign of disease activity on biology, endoscopy or imaging.
• •5. Initiation of infliximab CT-P13 as part of standard of care.
• •6. Patient suffering from anal suppuration related to CD can be included.
• •7. 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.
• •8. Person affiliated to or beneficiary of a social security plan.
• •Women of childbearing age should consider the use of appropriate contraception to prevent pregnancy and continue its use for at least 6 months after the last infliximab treatment. Women should choose one of the following methods of contraception:
• •Combined hormonal contraception containing estrogen and progesterone (oral, IUD, transdermal, injectable) combined with ovulation inhibition.
• •Initiated at least 30 days before Baseline Day 1.
• •Progestin-only hormonal contraception (oral, injectable, implantable) associated with ovulation inhibition initiated at least 30 days before the first injection.
• •Bilateral tubal occlusion (can be performed by hysteroscopy, provided that hysterosalpingography confirms the success of the procedure).
• •Intrauterine device (IUD).
• •Practicing true abstinence, defined as: abstaining from heterosexual intercourse when this corresponds to the subject's preferred and usual lifestyle (periodic abstinence \[e.g. calendar method, ovulation method, symptothermal method, post-ovulation methods\] and withdrawal are not acceptable)
• •Women do not need to use contraception during or after treatment with study drug if they are considered not of childbearing age due to one of the following situations:
• •Premenopausal women with permanent infertility following hysterectomy, bilateral salpingectomy or bilateral oophorectomy.
• •Postmenopausal women
• •Age \> 55 years without menstruation for 12 months or more without alternative medical cause.
• •Age ≤ 55 years without menstruation for 12 months or more without alternative medical cause AND a folliculostimulin (FSH) level \> 30 IU/L.