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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 10 April 2017
Main ID:  EUCTR2013-004497-10-ES
Date of registration: 27/05/2014
Prospective Registration: Yes
Primary sponsor: Celltrion, Inc.
Public title: Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.
Scientific title: A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn´s Disease
Date of first enrolment: 25/07/2014
Target sample size: 214
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004497-10
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 4  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Belgium Brazil Canada Denmark France Germany Hungary Israel
Italy Korea, Republic of Mexico Netherlands Poland Romania Russian Federation Spain
Ukraine United Kingdom United States
Contacts
Name: SuEun Song   
Address:  13-6 Songdo-dong (same as 23 Academy-ro) 406-840 Yeongsu-gu / Incheon Korea, Republic of
Telephone: 900834223
Email: RegistroEspanolDeEstudiosClinicos@druginfo.com
Affiliation:  Celltrion, Inc.
Name: SuEun Song   
Address:  13-6 Songdo-dong (same as 23 Academy-ro) 406-840 Yeongsu-gu / Incheon Korea, Republic of
Telephone: 900834223
Email: RegistroEspanolDeEstudiosClinicos@druginfo.com
Affiliation:  Celltrion, Inc.
Key inclusion & exclusion criteria
Inclusion criteria:
1.Patient is a male or female aged 18 to 75 years old, inclusive.
2.Patient has Crohn's disease of at least 12 weeks duration with a score on the CDAI between 220 and 450 points prior to randomization.
3.Patient has been treated for active Crohn's disease but has not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who is intolerant to or has medical contraindications for such therapies. Patients receiving the following treatments are eligible:
?5-aminosalicylates or antibiotics (if the dose remained constant for at least 4 weeks prior to randomization)
?Corticosteroids (prednisone, prednisolone, or budesonide) at the equivalent of 30 mg per day of prednisone or less (stable dose for 2 weeks prior to randomization)
?Azathioprine (stable dose for 8 weeks prior to randomization)
?6-mercaptopurine (6-MP) (stable dose for 8 weeks prior to randomization)
?Methotrexate (MTX) (stable for 6 weeks prior to randomization)
4.Patient has adequate renal and hepatic function at Screening as defined by the following clinical chemistry results:
?Serum creatinine <1.5 × upper limit of normal (ULN) or an estimated creatinine clearance level >50 mL/min (by Cockcroft-Gault formula)
?Serum alanine aminotransferase <2.5 × ULN
?Serum aspartate aminotransferase <2.5 × ULN
?Serum total bilirubin <2 × ULN
5.Patient has the following hematology laboratory test results at Screening:
?Hemoglobin >=8.5 g/dL
?White blood cell count >=3.5 × 10ex3 cells/µL (SI [Système International d'Unités] units: >=3.5 × 10ex9 cells/L)
?Neutrophil count >=1.5 × 10ex3 cells/µL (SI units: >=1.5 × 10ex9 cells/L)
?Platelet count >=100 × 10ex3 cells/µL (SI units: >=100 × 10ex9 cells/L)
6.Patient has the ability to comprehend the full nature and purpose of the study, including possible risks and side effects, to cooperate with the investigator, to understand verbal and/or written instructions, and to comply with the requirements of the entire study.
7.Patient (or legal guardian, if applicable) is informed of the full nature and purpose of the study, including possible risks and side effects, is given ample time and opportunity to read and understand this information, and has signed and dated the written informed consent before inclusion in the study.
8.For both male and female patients, the patient and his or her partner of childbearing potential agree to use 2 of the following medically acceptable methods of contraception during the course of the study and for 6 months following discontinuation of study drug (excluding women who are not of childbearing potential and men who have been sterilized):
?Barrier contraceptives (male condom, female condom, or diaphragm with a spermicidal gel)
?Hormonal contraceptives (implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings)
?Intrauterine device
?Male and female patients and their partners who have been surgically sterilized for less than 6 months prior to the date of informed consent must agree to use 2 medically acceptable methods of contraception.
?Menopausal females must have experienced their last period more than 12 months prior to the date of informed consent to be classified as not of childbearing potential.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 164
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age

Exclusion criteria:
1.Patient who has previously received a biological agent for the treatment of Crohn's disease.
2.Patient who has allergies to any of the excipients of infliximab, any other murine and/or human proteins, or patient with a hypersensitivity to immunoglobulin product.
3.Patient who has a current or past history of chronic infection with hepatitis B, hepatitis C, or infection with human immunodeficiency virus (HIV)-1 or -2 or who has a positive result to the screening test for those infections.
4.Patient who has an infection requiring oral antibiotics within 2 weeks before randomization, other serious infection within 6 months before randomization, or a history of recurrent herpes zoster or other chronic or recurrent infection within 6 weeks before randomization.
5.Patient who has a history of TB or a current diagnosis of TB or other granulomatous infections or other severe or chronic infection (such as sepsis, abscess or opportunistic infection, or invasive fungal infection such as histoplasmosis) or a past diagnosis without sufficient documentation of complete resolution following treatment.
6.Patient who has had recent exposure to persons with active TB, or patient who has a positive result to the screening test for latent TB (defined as a positive result for interferon-gamma release assay [IGRA] with a negative examination of chest x-ray). A patient with sufficient documentation of prophylaxis or complete resolution following TB treatment based on local guidelines can be enrolled.
?If the result of the IGRA is indeterminate at Screening, 1 retest will be possible during the screening period. If the repeated IGRA result is again indeterminate, the patient must be excluded from the study. If the repeated IGRA result is negative, the patient may be included in the study.
?Patients who have a positive result to the IGRA at initial or repeated test with negative examination of chest x-ray during Screening. During Screening, a patient with a positive result for IGRA and a negative examination of chest x-ray who has received at least the first 30 days of country-specific TB therapy and intends to complete the entire course of that therapy can be enrolled.
7.Patient who is taking any of the following concomitant medications or treatment:

8.Patient who has a medical condition including one or more of the following:
?Classified as obese (body mass index >=30 kg/m2)
?Diabetes mellitus unless on a stable dosing regimen for at least 4 weeks prior to Screening
?Uncontrolled hypertension (as defined by systolic blood pressure >=160 mm Hg or diastolic blood pressure >=100 mm Hg)
?Active entero-vesical, entero-retroperitoneal, entero-cutaneous, and entero-vaginal fistulae for within 6 months prior to Screening. Entero-enteral fistulae without clinical significant symptoms upon investigator?s opinion and anal fistulae without draining problems are allowed
?History of short bowel syndrome
?History of any malignancy within the 5 years prior to randomization except completely excised and cured squamous carcinoma of the uterine cervix, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma
?History of lymphoma or lymphoproliferative disease or bone marrow hyperplasia
?New York Heart Association (NYHA) class III or IV heart failure, severe uncontrolled cardiac disease (unstable angina, arrhythmias, clinically significant electrocardiogram [ECG] abnormalities), or myocardial infarction with


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Active Crohn's Disease
MedDRA version: 17.0 Level: LLT Classification code 10058815 Term: Crohn's disease acute episode System Organ Class: 100000004856
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Intervention(s)

Trade Name: REMSIMA
Product Code: CT-P13
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Current Sponsor code: CT-P13
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Trade Name: REMICADE
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)
Main Objective: - To demonstrate that CT-P13 (Remsima) is non-inferior to Remicade at Week 6 (Dose 3), in terms of efficacy, as determined by the CDAI-70 response rate
Primary end point(s): The following efficacy parameter for CT-P13 (Remsima) and Remicade will be determined as the primary endpoint:
?CDAI-70 response at Week 6
This will be determined in all randomly assigned patients
Secondary Objective: - To evaluate long-term secondary efficacy of CT-P13 (Remsima) in comparison with Remicade up to Week 54
- To evaluate overall safety of CT-P13 (Remsima) in comparison with Remicade up to Week 54
Timepoint(s) of evaluation of this end point: week 6
Secondary Outcome(s)
Secondary end point(s): Secondary efficacy endpoints will be assessed at the time points specified in the schedule of events. The following efficacy parameters for CT-P13 (Remsima) and Remicade will be determined as secondary endpoints:
?CDAI-70 response
?Clinical remission
?SIBDQ

The following safety parameters for CT-P13 (Remsima) and Remicade will be determined as secondary endpoints:
?Immunogenicity testing
?IgE testing
?Hypersensitivity monitoring via vital sign measurements (including blood pressure, heart and respiratory rates, and temperature
?Vital sign measurements and weight
?ECGs
?Monitoring of TB signs and symptoms
?Interferon-gamma release assay
?Diabetes mellitus assessment
?Congestive heart failure assessment
?Physical examination findings
?AEs including SAEs
?Infections
?Infusion related reactions
?Clinical laboratory analyses, including ESR and CRP
?Pregnancy testing
?Anti-dsDNA testing
?Concomitant medications
?Colonoscopy results
Timepoint(s) of evaluation of this end point: evaluations will happen at: weeks 0, 2, 6, 14, 22, 30, 38, 46, 54 and approx. 8 weeks after last dose
Secondary ID(s)
2013-004497-10-BE
CT-P13-3.4
NCT02096861
Source(s) of Monetary Support
Celltrion, Inc.
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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