Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 Compared to Remicade in Patients With Active Crohn's Disease
Brief Summary: This study is to assess noninferiority in efficacy and to assess overall safety of CT P13 compared to Remicade in patients with active Crohn's disease up to Week 54.


Options:
A: Inclusion Criteria:

1. Males or nonpregnant, nonlactating females aged 16 to 80 years inclusive.
2. Diagnosis of IBD prior to screening using standard endoscopic, histologic, or radiologic criteria. Participants with patchy colonic inflammation initially diagnosed as indeterminate colitis would meet inclusion criteria, if the investigator feels that the findings are consistent with CD or UC. Enrollment of participants with UC will be capped at 49% of the planned study population (maximum 61 participants).
3. Moderately to severely active IBD, defined by a total CDAI score between 220 and 450 points for CD or a partial Mayo Score (PMS) \> 4 for UC (including a rectal bleeding subscore \[RBS\] ≥ 1), and at least 1 of the following:

   1. Elevated CRP (\> upper limit of normal)
   2. Elevated FC (\> 250 μg/g)
   3. SES-CD \> 6 (SES-CD \> 3 for isolated ileal disease) for CD only and a Mayo endoscopic subscore (MES) ≥ 2 for UC only.
4. Physician intends to prescribe IFX as part of the usual care of the subject.
5. No previous use of IFX prior to enrolment in the current study, unless the participant received 1 prior dose of IFX (within 2.5 weeks of enrolment) and met all eligibility criteria at the time of starting IFX and IFX was administered according to the requirements outlined in this protocol
6. Able to participate fully in all aspects of this clinical trial.
7. Written informed consent must be obtained and documented.

Exclusion Criteria:

1. Participants with any of the following IBD-related complications:

   1. Abdominal or pelvic abscess, including perianal
   2. Presence of stoma, ileal pouch-anal anastomosis, or ostomy
   3. Isolated perianal disease
   4. Obstructive disease, such as obstructive stricture
   5. Short gut syndrome
   6. Toxic megacolon or any other complications that might require surgery, or any other manifestation that precludes or confounds the assessment of disease activity (CDAI or SES-CD for CD or PMS, PRO2, or MES for UC)
   7. Total colectomy.
2. History or current diagnosis of ulcerative proctitis (UC extending \< 15 cm from the anal verge), acute severe (fulminant) UC, hospitalised IV steroid-refractory UC, indeterminate colitis, microscopic colitis, ischemic colitis, colonic mucosal dysplasia, or untreated bile acid malabsorption.
3. Current bacterial or parasitic pathogenic enteric infection, according to SOC assessments, including: Clostridioides difficile; tuberculosis; known infection with hepatitis B or C virus; known infection with HIV; sepsis; abscesses. History of the following: opportunistic infection within 6 months prior to screening; any infection requiring antimicrobial therapy within 2 weeks prior to screening; more than 1 episode of herpes zoster or any episode of disseminated zoster; any other infection requiring hospitalization or intravenous antimicrobial therapy within 4 weeks prior to screening.
4. Has any malignancy or lymphoproliferative disorder other than nonmelanoma cutaneous malignancies or cervical carcinoma in situ that has been treated with no evidence of recurrence within the last 5 years.
5. Known primary or secondary immunodeficiency.
6. PNR to adalimumab, defined as no objective evidence of clinical benefit after 14 weeks of therapy.
7. Subjects with failure to a prior biologic, defined as PNR or SLR, will be excluded when a maximum of 40% of the planned enrollment (approximately 78 subjects) have failure to prior biologic exposure.
8. Concomitant use of oral corticosteroid therapy exceeding prednisone 40 mg/day, budesonide 9 mg/day, or equivalent, unless a tapering schedule is initiated with a plan to be off CS by Week 14
9. Presence of any medical condition or use of any medication that is a contraindication for IFX use, as outlined on the product label.
10. A concurrent clinically significant, serious, unstable, or uncontrolled underlying cardiovascular, pulmonary, hepatic, renal, GI, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, might confound the study results, pose additional risk to the subject, or interfere with the subject's ability to participate fully in the study.
11. Pregnant or lactating women, to be excluded based on the physician's usual practice for determining pregnancy or lactation status.
12. Known intolerance or hypersensitivity to IFX or other murine proteins.
B: Inclusion Criteria:

* Male, or non-pregnant/non-lactating females, 18 or older
* Established Crohn's disease with active symptoms requiring prednisone therapy.
* Females of child-bearing potential must have a negative pregnancy test and must agree to use adequate contraception

Exclusion Criteria:

* Intolerance or hypersensitivity to infliximab, methotrexate, prednisone and or known allergy to murine proteins or other chimeric proteins
* Are pregnant, nursing, or planning pregnancy (both men and women) during or in the 6 months after the study
* In the 2 months prior to screening, have had a serious infection, or have been hospitalized for and/or treated with intravenous (IV) antibiotics for infection. In the 6 months prior to screening, have had an opportunistic infection.
* After screening, need to continue non-study medical therapy for CD
* In the 8 weeks prior to screening, have received any of the following: systemic steroid therapy, azathioprine, 6-mercaptopurine, cyclosporine, probiotic products, or omega-3 fatty acids
* Have received any of the following: biologics in the last 6 months; methotrexate in the last year; and/or ever received infliximab.
* Have any of the following: biopsy-proven cirrhosis, clinically important lung disease, pre-existing demyelinating disorder, systemic lupus erythematosus, congestive heart failure, diabetes mellitus (insulin dependent), increased risk for steroid-related side effects, body weight 40% higher than standard, human immunodeficiency virus and/or hepatitis B or hepatitis C
* Have any of the following: an active draining fistula as the primary manifestation of CD; documented short bowel syndrome; a stoma; or severe, and/or fixed symptomatic stenosis of the intestine.
* Have had any of the following: clinically important bowel obstruction in the last 3 months; a bowel resection in the last 3 months; and/or other intra-abdominal surgery within 6 months.
* Clinically significant impairment in cardiac, liver or renal function; central nervous system (CNS), pulmonary, hematological, immunological, vascular and gastrointestinal disease in addition to CD; current malignancy or malignancy within 5 years prior to screening.
C: Inclusion Criteria:

* Documented diagnosis of Crohn's disease
* Able to speak and understand English, French or Flemish
* Access to a telephone or email/internet service
* Written informed consent must be obtained and documented

Exclusion Criteria:

* Any conditions (e.g., history of alcohol or substance abuse) which in the opinion of the investigator , may interfere with the patients ability to comply with study procedures
* Participating in other investigational studies
D: Inclusion Criteria:

* Male or female patients with active Crohn's disease and a Crohn's disease activity index score between 220 and 450 points

Exclusion Criteria:

* Patient who has previously received a biological agent for the treatment of Crohn's disease and/or a Tumor necrosis factor (TNF)-alpha inhibitor for the treatment of other disease.
* 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.

Answer: D