Phase 4
N=21
Endoscopic Ultrasound (EUS) Guided Treatment With Humira for Crohn's Perianal Fistulas
Crohn Disease · Rectal Fistula
Bottom Line
View on ClinicalTrials.gov: NCT00517296 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Number of Participants With Durable Fistula Healing — 7; 8 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- EUA with seton placement if necessary (Procedure); adalimumab (Drug); EUS (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Durable Fistula Healing |
7; 8 | — |
| SECONDARY Changes in Disease Activity |
-5.0; -1.0 | — |
| SECONDARY Changes in Perianal Disease Activity Index (PDAI) |
-5.50; -5.0 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00517296). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.