Please select the eligibility criteria that correspond to the clinical trial below.
Title: Precision Dosing Versus Conventional Dosing of Infliximab Maintenance Therapy: a Randomized Controlled Multicenter Study in Patients With IBD in Clinical Remission
Brief Summary: Infliximab (IFX) is highly effective in inducing and maintaining remission in patients with inflammatory bowel disease (IBD). However, a large proportion of patients will eventually lose response to IFX. Therefore, strategies to improve the outcome of maintenance treatment with IFX are required. Retrospective analyses suggest that adjusting IFX treatment in order to achieve IFX trough levels (TL) above a well-defined therapeutic threshold will improve the outcome of IFX treatment.


Options:
A: Inclusion Criteria:

1. A clinical diagnosis of either rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease or chronic plaque psoriasis
2. Male or non-pregnant, non-nursing female
3. \>18 years of age at screening
4. Stable treatment with innovator infliximab (Remicade) during the last 6 months
5. Subject capable of understanding and signing an informed consent form
6. Provision of written informed consent

Exclusion Criteria:

1. Major co-morbidities, such as severe malignancies, severe diabetic mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease (NYHA class 3 or 4) and/or severe respiratory diseases
2. Change of major co-medication during the last 2 months prior to randomization:

   RA, SpA and PsA: Initiation of systemic corticosteroids or synthetic DMARDs or other medication which according to the investigator would interfere with the stability of the disease.

   UC and CD: Initiation of systemic corticosteroids or an immunosuppressant or other medication which according to the investigator would interfere with the stability of the disease Psoriasis: Initiation of synthetic DMARDs or other medication which according to the investigator would interfere with the stability of the disease
3. Inadequate birth control, pregnancy, and/or breastfeeding
4. Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible
5. Change in treatment with innovator infliximab (Remicade) during the last 6 months due to disease related factors, not including dose/frequency adjustments due to drug concentration measurements
B: Inclusion Criteria:

* Diagnosis of CD or UC based on endoscopy and pathology
* 18 years or older
* Clinical remission, based on a Harvey Bradshaw Index (HBI) score ≤4 or a Partial Mayo (PM) score ≤2, for CD and UC
* Scheduled IFX maintenance treatment, regardless of interval/dosing

Exclusion Criteria:

- Dilatation or resectional surgery because of stenotic IBD in the past year
C: Inclusion Criteria:

* Have a documented diagnosis of CD confirmed by endoscopic, histologic and/or radiologic studies prior to resection or by tissue obtained at resection
* Have undergone an ileocolonic surgical resection
* Patients must also be at an increased risk of recurrence of active CD
* Patients must not have previously discontinued infliximab as a result of tolerability issues or they must be naive to treatment with infliximab. Provided patients meet the above criteria pertaining to infliximab, they are eligible to enroll if they received prior treatment with adalimumab and/or certolizumab
* Patients must undergo screening for HBV
* Baseline CDAI \< 200
* Have adequate blood and liver test values

Exclusion Criteria:

* Have a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, prior to screening
* Have a chest radiograph within 3 months prior to the first infusion of study agent that shows a clinically significant abnormality, such as a malignancy or infection, or any abnormalities suggestive of TB
* Have macroscopically active CD which was not resected at the time of surgery
* Do not meet the criteria for being at an increased risk of postoperative recurrence of active CD as outlined in the inclusion criteria
* Have evidence of an active infection at the time of randomization or have had a serious infection not related to CD (e.g., hepatitis, pneumonia, or pyelonephritis), within 6 months prior to screening
* Have or have had an opportunistic infection (e.g., herpes zoster \[shingles\], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening
* Have any known malignancy or history of malignancy within the 5-year period prior to screening (with the exception of squamous or basal cell carcinoma of the skin that has been completely excised without evidence of recurrence)
* Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
D: 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

Answer: B