Endoscopic Ultrasound (EUS) Guided Treatment With Humira for Crohn's Perianal Fistulas - Full Text View

Purpose

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.

Condition	Intervention
Crohn Disease Rectal Fistula	Procedure: Rectal Endoscopic Ultrasound(EUS) Procedure: Rectal endoscopic ultrasound (EUS)

Genetics Home Reference related topics:

Crohn disease

MedlinePlus related topics:

Crohn's Disease Endoscopy Fistulas Ultrasound

ChemIDplus related topics:

Adalimumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Official Title:	EUS Guided Treatment With Humira for Crohn's Perianal Fistulas

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

Rate of durable fistula healing [ Time Frame: at week 48 ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A, Control Group A patients will receive Adalimumab 40 mg subcutaneously every other week for maintenance therapy without any additional interventions being performed.	Procedure: Rectal endoscopic ultrasound (EUS) Rectal endoscopic ultrasound(EUS) performed at screening and at study completion
B, Intervention 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.	Procedure: 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517296

Contacts


Contact: Tonya Givens, BSN	615-936-1745	tonya.givens@vanderbilt.edu

Contact: Kathy Price, MBA	615-322-4643	kathy.price@vanderbilt.edu

Locations


United States, Tennessee
	Vanderbilt University Medical Center	Recruiting
	Nashville, Tennessee, United States, 37232
	Principal Investigator: David A. Schwartz, MD
	Sub-Investigator: Alan Herline, MD
	Sub-Investigator: Paul Wise, MD
	Sub-Investigator: Roberta Muldoon, MD
	Sub-Investigator: Julianne Wagnon, APRN-BC
	Sub-Investigator: Caroline Duley, APRN-BC

Sponsors and Collaborators

Vanderbilt University

Investigators


Principal Investigator:	David A Schwartz, MD	Vanderbilt University

More Information

Responsible Party:	Vanderbilt University Medical Center ( David A. Schwartz MD / Principal Investigator )
Study ID Numbers:	061178
First Received:	August 15, 2007
Last Updated:	August 7, 2008
ClinicalTrials.gov Identifier:	NCT00517296
Health Authority:	United States: Food and Drug Administration