An Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab IV

Study Description

N/A

Description of Treatment or Intervention (Mechanism of Action)

This is an open label, single group, safety and efficacy study. The drug being tested in this study is called vedolizumab. Vedolizumab is being tested in adults who have Crohn's disease (CD). This study will look at whether vedolizumab can help improve the health of the digestive system (mucosal healing). This multi-centre study will be conducted worldwide and will enroll approximately 100 patients. In the United States, vedolizumab has been approved by the U.S. Food and Drug Administration (FDA) for use in adult patients with moderately to severely active ulcerative colitis or CD who have failed conventional therapy (i.e., immunomodulators, corticosteroids, or tumor necrosis factor-alpha blockers). The use of vedolizumab in this study is investigational.

Patient Participation Requirements

• The overall time to participate in this study is approximately 44 weeks. Participants will make multiple visits to the clinic. All participants included in the study will also have a 6 month safety follow-up telephone call following his/her last dose of study drug. Eligible participants will receive vedolizumab by an infusion directly into their vein at the study center. Participants will receive five infusions of vedolizumab over 6 months of the study. During each study visit, a number of tests/assessments will be done, which may include: a physical examination; measurements of body temperature, breathing rate, blood pressure, and pulse rate; blood and urine tests; an electrocardiogram (ECG); QoL questionnaires. Participants will be asked to record their symptoms of CD every day throughout the study via an automated telephone diary (approximately 30 weeks). 
• Participants will have three colonoscopies during the first 7 months of the study, during screening, weeks 14 and 26 to assess the health of the inside of the colon. 
• Some sites will be participating in an imaging substudy using magnetic resonance enterography (MREn). MREn is a test done on an MRI scanner which is able to view and take pictures of the entire thickness of the small and large bowel wall. Participants at these MREn sites, unless they have a contraindication to the procedure, will have two magnetic resonance enterography (MREn) scans during the study.

Possible Risks & Side Effects

The most common side effects from taking Vedolizumab, reported in more than 10% of patients, include:

• common cold
• headache
• joint pains
• worsening of Crohn’s disease in patients with Crohn’s disease

Other side effects, reported in 2-9% of patients, include:

• nausea
• fever
• stomach pain
• upper respiratory tract infection
• worsening of ulcerative colitis in patients with ulcerative colitis
• tiredness
• vomiting
• low levels of red blood cells (anemia)
• cough
• back pain
• tubes that carry air to the lungs become inflamed and irritated (bronchitis)
• flu
• urinary tract infection
• dizziness
• diarrhea
• sinus infection
• flu-like illness
• rash
• sore throat
• itching
• swollen ankles
• pains in arms or legs
• stomach flu
• an infected cavity filled with pus near the anus or rectum (anal abscess)
• small tunnel which connects an infected gland inside the anus to an opening on the skin around the anus (anal fistula)
• Allergic reactions may occur.

The following are possible discomforts or risks associated with a colonoscopy:

• Cramping, pain, abdominal bloating (common)
• Nausea, vomiting, bloating, or rectal irritation caused by the bowel cleanse prep (common)
• Side effects, like drowsiness following sedative or pain medication (less common)
• Peritonitis (inflammation of the lining of the abdominal cavity) (rare)
• Perforation (a hole) of the intestinal wall (rare). Surgery may be needed if a perforation occurs (rare)
• You may feel pressure as the scope moves inside. Following the examination, you will be kept in an observation area for an hour or so until the effects of the medications that have been given adequately wear off. Passing gas is necessary and should be expected. Feeling bloated and swollen are also common due to the air inflated into the bowel; this usually lasts only 30 to 60 minutes.

The risks and discomforts associated with the MREn test are:

• Nausea, vomiting, bloating, or rectal irritation caused by the bowel cleanse prep (common)
• Abdominal bloating (common) from drinking fluid prior to scan
• Discomfort from lying on the scanner table or the noise during the scan
• Feeling of being closed in while in the large tube of the scanner (claustrophobic). If you feel too claustrophobic, the test can be stopped
• Allergic reaction to medication used to slow bowel motion (rare)
• When the MRI contrast agent containing gadolinium is injected: cool feeling in the area of the injection. Nausea (uncommon), allergic reaction (rare)
• Irritation, bruising or infection (rare) at the injection site for the bowel medication or MRI contrast