Overview

This trial is active, not recruiting.

Conditions crohn disease, rectal fistula
Treatments rectal endoscopic ultrasound(eus), rectal endoscopic ultrasound (eus)
Sponsor Vanderbilt University
Start date January 2008
End date August 2011
Trial size 30 participants
Trial identifier NCT00517296, 061178

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Group A patients will receive Adalimumab 40 mg subcutaneously every other week for maintenance therapy without any additional interventions being performed.
rectal endoscopic ultrasound (eus)
Rectal endoscopic ultrasound(EUS) performed at screening and at study completion
(Other)
Group B patients will receive Adalimumab 40mg every other week for maintenance therapy and will receive additional rectal EUS and appropriate interventions deemed necessary based on results of EUS.
rectal endoscopic ultrasound(eus)
Rectal Endoscopic Ultrasound(EUS) performed at screening and every 12 weeks with additional interventions performed as warranted based on the results of the EUS.

Primary Outcomes

Measure
Rate of durable fistula healing
time frame: at week 48

Eligibility Criteria

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.

Additional Information

Official title EUS Guided Treatment With Humira for Crohn's Perianal Fistulas
Principal investigator David A Schwartz, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2011.
Information provided to ClinicalTrials.gov by Vanderbilt University.