Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Multi-Centre Study to Evaluate the Safety and Efficacy of Infliximab in Combination With Methotrexate for the Long-term Treatment of Crohn's Disease (CD)
Brief Summary: The primary objective is to compare the efficacy and safety of infliximab plus methotrexate to infliximab alone for the long-term control of signs and symptoms of Crohn's disease (CD) in patients with symptoms that are persistent enough to require corticosteroid therapy.


Options:
A: 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.
B: Inclusion Criteria:

NOR-DRUM A

1. A clinical diagnosis of one of the following; rheumatoid arthritis, spondyloarthritis (including ankylosing spondylitis), psoriatic arthritis\*, ulcerative colitis, Crohn's disease or chronic plaque psoriasis
2. Male or non-pregnant female
3. ≥18 and \< 75 years of age at screening
4. A clinical indication to start INX
5. Subject not in remission according to diagnosis-specific disease activity scores
6. Subject capable of understanding and signing an informed consent form

   * Patients with psoriatic arthritis with predominantly axial manifestations should be included and assessed as spondyloarthritis

NOR-DRUM B

1. A clinical diagnosis of one of the following; rheumatoid arthritis, spondyloarthritis (including ankylosing spondylitis), psoriatic arthritis\*, ulcerative colitis, Crohn's disease or chronic plaque psoriasis
2. Male or non-pregnant female
3. ≥18 and \< 75 years of age at screening
4. On maintenance therapy with infliximab for a minimum of 30 weeks and a maximum of 3 years
5. A clinical indication for further infliximab treatment
6. Subject capable of understanding and signing an informed consent form

   * Patients with psoriatic arthritis and predominantly axial manifestations should be included and assessed as spondyloarthritis

Exclusion Criteria:

NOR-DRUM A

1. Major co-morbidities, such as previous malignancies within the last 5 years, severe diabetes mellitus, severe infections (including HIV), uncontrollable hypertension, severe cardiovascular disease (NYHA class 3 or 4), severe respiratory diseases, demyelinating disease, significant chronic widespread pain syndrome, laboratory abnormalities or significant renal or hepatic disease and/or other diseases or conditions where treatment with infliximab is either found contra-indicated by the clinician or which make adherence to the protocol difficult
2. A positive screening for TB and hepatitis
3. Inadequate birth control, pregnancy or subject considering becoming pregnant during the study period
4. Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol difficult
5. Prior use of infliximab within the last 6 months

NOR-DRUM B

1. Major co-morbidities, such as previous malignancies within the last 5 years, severe diabetes mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease (NYHA class 3 or 4), severe respiratory diseases, demyelinating disease, significant chronic widespread pain syndrome, laboratory abnormalities or significant renal or hepatic disease and/or other diseases or conditions where treatment with infliximab is either found contra-indicated by the clinician or which make adherence to the protocol difficult
2. Inadequate birth control, pregnancy or subject considering becoming pregnant during the study period
3. Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol difficult
C: 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.
D: Inclusion Criteria:

* Diagnosis of Crohns Disease for at least 6 weeks
* Moderate to severe disease activity (CDAI \>= 220 and \<=450)
* No history of azathioprine, 6-MP (6 Mercaptopurine), or biologic treatments
* Are either: Corticosteriod-dependent, OR considered for a 2nd (or greater) course of corticosteriod, OR 5-ASA failures, Or Budesonide failures

Exclusion Criteria:

* History of abdominal surgery within the last 6 months
* Have an ostomy or stoma \[An operation to create an opening from an area inside the body to the outside\]
* Are pregnant, nursing, or planning pregnancy (both men and women)
* Serious simultaneous illness that could interfere with study participation
* Use of any investigational drug within 30 days
* Have a concomitant diagnosis or any history of congestive heart failure
* Weigh more than 140 kilograms (or 310 pounds)

Answer: C