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

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 and of at least 12 weeks' disease duration 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.

1.Patient who has previously received a biological agent for the treatment of Crohn's disease and/or a TNFa inhibitor for the treatment of other 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-γ 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:
<Please see Protocol Section 3.3.2 for detailed listing> updated and extended in V2.2
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 randomisation.
•Uncontrolled hypertension (as defined by systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmHg)
•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
- Stoma (e.g. ileostomy or colostomy) within 6 months prior to randomization.
•History of any malignancy within the 5 years prior to randomization except completely excised and cured squamous carcinoma of the uterine cervix in situ, 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 within the 6 months prior to randomization
•History of organ transplantation, including corneal graft/transplantation
•Any uncontrolled, clinically significant respiratory disease (in the opinion of the investigator), including but not limited to chronic obstructive pulmonary disease, asthma, bronchiectasis, or pleural effusion
•Previous diagnosis or symptoms suggestive of demyelinating disorders, including multiple sclerosis and Guillain Barré syndrome
•Any conditions significantly affecting the nervous system (ie, neuropathic conditions or nervous system damage)
•Any other serious acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration or that may interfere with the interpretation of study results
9.Patient who has a current or past history of drug or alcohol abuse.
10.Patient who has had treatment with any other investigational device or medical product within 4 weeks of randomization or 5 half-lives, whichever is longer.
11.Female patient who is currently pregnant, breastfeeding, or planning to become pregnant or breastfeed within 6 months of the last dose of study drug.
12.Patient who, in the opinion of his or her general practitioner or the investigator, should not participate in the study.