Trial Outcomes & Findings for Endoscopic Ultrasound (EUS) Guided Treatment With Humira for Crohn's Perianal Fistulas (NCT NCT00517296)

NCT ID: NCT00517296

Last Updated: 2017-04-21

Results Overview

Complete cessation of fistula drainage at 48 weeks

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 21 participants
• Primary outcome timeframe: at week 48
• Results posted on: 2017-04-21

Participant Flow

Participant milestones

Measure	Adalimumab With EUS Guided Therapy 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.	Adalimumab Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.
Overall Study STARTED	10	11
Overall Study COMPLETED	9	11
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Adalimumab With EUS Guided Therapy 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.	Adalimumab Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Adalimumab With EUS Guided Therapy n=9 Participants 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.	Adalimumab n=11 Participants Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	11 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: at week 48

Complete cessation of fistula drainage at 48 weeks

Outcome measures

Measure	Adalimumab With EUS Guided Therapy n=9 Participants 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.	Adalimumab n=11 Participants Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.
Number of Participants With Durable Fistula Healing	7 participants	8 participants

SECONDARY outcome

Timeframe: Baseline and 48 Weeks

Changes in Crohn's disease activity using the Harvey Bradshaw Index (HBI) at Week 48 compared to baseline HBI Scores. Higher numbers for the HBI equal more significant disease activity. Range can vary from 0 to 17 plus the number of liquid stools per day.

Outcome measures

Measure	Adalimumab With EUS Guided Therapy n=9 Participants 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.	Adalimumab n=11 Participants Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.
Changes in Disease Activity	-5.0 units on a scale Interval -7.5 to -3.0	-1.0 units on a scale Interval -9.0 to 0.0

SECONDARY outcome

Timeframe: Baseline and 48 Weeks

Changes in Crohn's disease activity at Week 48 compared to baseline based on PDAI Scores- higher numbers equal more significant disease activity. PDAI has a range from 0 to 20.

Outcome measures

Measure	Adalimumab With EUS Guided Therapy n=9 Participants 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.	Adalimumab n=11 Participants Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.
Changes in Perianal Disease Activity Index (PDAI)	-5.50 units on a scale Interval -6.0 to -5.0	-5.0 units on a scale Interval -7.25 to -3.5

Adverse Events

A, Combination Therapy Group

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

B, Control Arm

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	A, Combination Therapy Group n=9 participants at risk Group A patients will be randomized to TNF and seton placement. Seton placement: Patients randomized to the combination therapy group will have seton placement prior to initiating therapy with Certolizumab.	B, Control Arm n=11 participants at risk Group B patients will be randomized to surgical guidance / standard of care
Gastrointestinal disorders Incision and draining procedures of abscess	33.3% 3/9 • Number of events 3 • Adverse events were captured beginning with date of consent and continuing through final study visit (week 48). If an adverse event was ongoing at the time of study completion, the event was followed until resolved.	9.1% 1/11 • Number of events 1 • Adverse events were captured beginning with date of consent and continuing through final study visit (week 48). If an adverse event was ongoing at the time of study completion, the event was followed until resolved.

Additional Information

David A. Schwartz, MD

Vanderbilt University Medical Center

Phone: 615-322-4643

Email: david.a.schwartz@vanderbilt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place