Endoscopic Ultrasound (EUS) Guided Treatment With Humira for Crohn's Perianal Fistulas

NCT00517296 | Completed Phase 4 Results

• 1 other identifier: 061178
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Crohn Disease; Rectal Fistula

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Durable Fistula Healing

  Complete cessation of fistula drainage at 48 weeks

  at week 48

Secondary Outcomes (2)

• Changes in Disease Activity

  Baseline and 48 Weeks

• Changes in Perianal Disease Activity Index (PDAI)

  Baseline and 48 Weeks

Study Arms (2)

Adalimumab with EUS guided therapy

EXPERIMENTAL

Patients will be randomized to adalimumab treatment with EUS guided therapy decisions. Colorectal surgeon will have access to EUS data prior to EUA with possible seton placement.

Procedure: EUA with seton placement if necessary; Drug: adalimumab; Procedure: EUS

Adalimumab

ACTIVE COMPARATOR

Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.

Procedure: EUA with seton placement if necessary; Drug: adalimumab

Interventions

EUA with seton placement if necessary PROCEDURE

Patients randomized to the combination therapy group, the surgeon will have access to EUS findings.

Adalimumab; Adalimumab with EUS guided therapy

adalimumab DRUG

Patients began therapy with adalimumab using clinic standards for dosing.

Adalimumab; Adalimumab with EUS guided therapy

EUS PROCEDURE

Patients in combination therapy group had an EUS done every 12 weeks to help guide therapy.

Adalimumab with EUS guided therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Crohn Disease; Rectal Fistula

Interventions

Emergency Use Authorization; Adalimumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Intestinal Fistula; Digestive System Fistula; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Legislation, Medical; Legislation as Topic; Social Control, Formal; Health Care Economics and Organizations; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Small sample size which increases the chance of type II error.

Results Point of Contact

• Title: David A. Schwartz, MD
• Organization: Vanderbilt University Medical Center

david.a.schwartz@vanderbilt.edu

615-322-4643

Study Officials

• David A Schwartz, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Surgeon did not have access to EUS data for the control group prior to exam under anesthesia (EUA) and surgical intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 15, 2007
• First Posted: August 16, 2007
• Study Start: January 1, 2008
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: April 21, 2017
• Results First Posted: April 21, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)