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Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease - NCT00783692-23249(Clinical Trial 250284)



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City:  Richmond
State:  
VA
Zip Code: 23249
Conditions: Crohn's Disease
Purpose: This multicenter, phase 3, randomized, blinded, placebo-controlled study in patients with moderately to severely active CD comprises two phases: - The Induction Phase, designed to establish the efficacy and safety of vedolizumab (MLN0002) for the induction of clinical response and remission - The Maintenance Phase, designed to establish the efficacy and safety of vedolizumab(MLN0002) for the maintenance of clinical response and remission.
Study summary:
Criteria: Inclusion Criteria: 1. Age 18 to 80 2. Diagnosis of moderately to severely active Crohn's disease 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 one conventional therapy as defined by the protocol 5. May be receiving a therapeutic dose of conventional therapies for IBD as defined by the protocol Exclusion Criteria 1. Evidence of abdominal abscess at the initial screening visit 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
Study is available at: Hunter Holmes McGuire VA Medical Center
Richmond, VA 23249
United States

Primary Contact:

Phone: 804-675-5021

Secondary Contact:
For a listing of recruitment sites in your area contact: Millennium Medical and Drug Information Center
Email: medical@mlnm.com
Phone: 1-877-674-3784
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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