Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase 2, Multiple Dose, Open-Label Study to Determine the Long Term Safety of MLN0002 in Patients With Ulcerative Colitis and Crohn's Disease
Brief Summary: This was an open-label study to provide an opportunity for participants with Ulcerative Colitis (UC) who previously completed Study C13002 (NCT01177228), and for treatment-naïve participants with UC or Crohn's Disease (CD) to receive treatment with vedolizumab, and to determine the long term safety of vedolizumab in patients afflicted with these diseases.


Options:
A: Inclusion Criteria:

1. Age 18 to 80
2. Diagnosis of moderately to severely active Crohn's disease (CD)
3. CD involvement of the ileum and/or colon
4. Demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents, within protocol-specified parameters:

   1. Immunomodulators
   2. Tumor necrosis factor-alpha (TNFα) antagonists
   3. Corticosteroids
5. May be receiving a therapeutic dose of conventional therapies for irritable bowel disease (IBD) defined by the protocol

Exclusion Criteria

1. Evidence of abdominal abscess at the initial screening visit, other than a minimum of 10 aphthous ulcerations involving a minimum of 10 contiguous cm of intestine
2. Extensive colonic resection, subtotal or total colectomy
3. History of \>3 small bowel resections or diagnosis of short bowel syndrome
4. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
5. Have received non permitted IBD therapies within either 30 or 60 days, depending on the medication, as stated in the protocol
6. Chronic hepatitis B or C infection
7. Active or latent tuberculosis
B: Inclusion Criteria:

Each patient must meet all of the following inclusion criteria to be enrolled in the study.

* Males or non-pregnant, non-lactating females voluntarily able to give informed consent
* All patients must agree to use 2 effective forms of contraception from screening to the end of the study
* Negative surveillance colonoscopy within the last 6 months if indicated by standard clinical practice guidelines
* Confirmed and active ulcerative colitis (UC)

  * Partial Mayo Score 1 - 7
  * Disease involvement extending proximal to the rectum
* May be receiving a therapeutic dose of conventional therapies for UC as defined by the protocol

Exclusion Criteria:

Patients meeting any of the following exclusion criteria are not to be enrolled in the study.

* Patients who require ulcerative colitis (UC) surgical intervention or for whom surgical intervention is anticipated during the study
* Patients who fail to meet laboratory values as specified in the protocol or have a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist during the screening period
* Low-grade dysplasia, high-grade dysplasia, dysplasia-associated lesion or mass, or colorectal cancer
* Treatment with cyclosporine, FK506 (tacrolimus) or infliximab within 60 days prior to study
* Patients receiving any of the following within 14-days prior to the study: antibiotics for treatment of irritable bowel syndrome, heparin or warfarin, narcotics, tube feeding, defined formula diets or parenteral alimentation
* Colostomy, fistulae or known fixed symptomatic stenosis of the intestine
* Immunologic or ischemic intestinal condition
* Toxic megacolon
* Chronic hepatitis B or C or human immunodeficiency virus (HIV) infection
* Any vaccinations within 30 days prior to study drug administration
* History of imaging abnormalities, multiple sclerosis (MS), brain tumor or neurodegenerative disease
* Significantly impaired liver or renal function
* Current or recent history of alcohol dependence
* Current use of illicit drugs
* Active or recent serious infections or serious underlying disease as specified in protocol
* Active psychiatric problems that might interfere with compliance to study
* Previous exposure to MLN0002
* Participated in an investigational study within 30 days prior to study drug administration or received treatment with an investigational monoclonal antibody within the last 6 months
C: Inclusion Criteria:

1. Previous treatment in Study C13004 (NCT00619489), Study C13006 (NCT00783718), Study C13007 (NCT00783692), or Study C13011 (NCT01224171) that, in the opinion of the investigator, was well tolerated OR b. Moderate to severe Crohn's disease or ulcerative colitis which has not been previously treated with vedolizumab (MLN0002)
2. May be receiving a therapeutic dose of conventional therapies for Crohn's disease or ulcerative colitis as defined by the protocol

Exclusion Criteria:

1. Development of any new, unstable, or uncontrolled disease
D: Inclusion Criteria:

* Confirmed and active ulcerative colitis (UC) or Crohn's Disease (CD)

  * Crohn's Disease Activity Index (CDAI) Score of 220 - 450 for participants with CD
  * Partial Mayo score of 2 - 7 for participants with UC
* Patient should be appropriate candidate for biologic therapy per guidelines
* Up-to-date on cancer screening
* No severe systemic disease
* Patients with evidence of abscess
* Agree to comply with study procedures including contraception

Exclusion Criteria:

* Low lymphocyte counts
* History of imaging abnormalities, multiple sclerosis (MS), brain tumor or other neurological illness
* Active or recent serious infections
* Recent treatment with biologic (i.e., Remicade) or investigational drug
* Impending surgery
* Any participants with vedolizumab human anti-human antibody (HAHA) titers ≥1:125 or with a previous immediate hypersensitivity reaction during or shortly after vedolizumab infusion

Answer: D