Endoscopic Ultrasound (EUS) Guided Treatment With Humira for Crohn's Perianal Fistulas
This trial is active, not recruiting.
|Conditions||crohn disease, rectal fistula|
|Treatments||rectal endoscopic ultrasound(eus), rectal endoscopic ultrasound (eus)|
|Start date||January 2008|
|End date||August 2011|
|Trial size||30 participants|
|Trial identifier||NCT00517296, 061178|
This study is to assess whether utilizing endoscopic ultrasound(EUS) to guide treatment can improve durable fistula healing in patients with Crohn's perianal fistulas and to get preliminary information regarding the effectiveness of Adalimumab for Crohn's perianal fistulas.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Rate of durable fistula healing
time frame: at week 48
Male or female participants at least 18 years old.
Inclusion Criteria: A patient may be considered for study participation if all of the following apply: - Male and Female aged 18 years or older; and - A confirmed diagnosis of Crohn's disease and one or more identifiable perianal fistulas. Exclusion Criteria: A patient will be excluded from the study if one or more of the following apply: - Females who are pregnant or breast feeding; - Infliximab received within 6 weeks prior to study entry; - Patients who cannot take, or refuse to take concomitant immunosuppressive therapy with either azathioprine, 6-mercaptopurine, or methotrexate; Unless patient has been intolerant of these therapies in the past or is contraindicated as determined by the investigator; - Patients who cannot take, or refuse to take concomitant antibiotic therapy; - Patients with severe anal stenosis or tenderness which would preclude colonoscopy and / or rectal EUS; - Patients who cannot take or refuse to take adalimumab; - Patients with active or latent tuberculosis; - Patients who have had systemic antibiotic, antiviral or antifungal treatment(s) within 3 weeks prior to Screening for all non-Crohn's related infections; - Patients concurrently taking anakinra (Kineret); - Patients with a history of cancer or lymphoproliferative disease other than a successfully and completely treated cutaneous squamous cell or basal cell carcinoma or carcinoma in-situ of the cervix; - Patients with chronic hematologic problems such as bleeding dyscrasias; - Patients with a history of demyelinating disease (i.e. multiple sclerosis); and - Patients with congestive heart failure.
|Official title||EUS Guided Treatment With Humira for Crohn's Perianal Fistulas|
|Principal investigator||David A Schwartz, MD|
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