Trial Outcomes & Findings for Open Label Study for Adults With Pyoderma Gangrenosum and Inflammatory Bowel Disease (NCT NCT00791557)

Results Overview

Outcome was measured by clinical assessment of pyoderma gangrenosum. The number of patients who had improvement and/or clearance of the pyoderma grangrenosum after the infusions and through the follow up visit was assessed.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

Week 26

Results posted on

2016-11-02

Participant Flow

Participant milestones

Participant milestones
Measure	Infliximab Single arm open label Infliximab : IV drug given at weeks 1,2,14,22
Overall Study STARTED	2
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Infliximab Single arm open label Infliximab : IV drug given at weeks 1,2,14,22
Overall Study Adverse Event	1

Baseline Characteristics

Open Label Study for Adults With Pyoderma Gangrenosum and Inflammatory Bowel Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Infliximab n=2 Participants Single arm open label Infliximab : IV drug given at weeks 1,2,14,22
Age, Customized <=18 years	0 participants n=5 Participants
Age, Customized Between 18 and 75 years	2 participants n=5 Participants
Age, Customized >=75 years	0 participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 26

Population: Subjects who completed all required transfusions of infliximab were analyzed.

Outcome was measured by clinical assessment of pyoderma gangrenosum. The number of patients who had improvement and/or clearance of the pyoderma grangrenosum after the infusions and through the follow up visit was assessed.

Outcome measures

Outcome measures
Measure	Infliximab n=1 Participants Single arm open label Infliximab : IV drug given at weeks 1,2,14,22
The Efficacy of Infliximab in Pyoderma Gangrenosum in Adult Subjects Who Have Inflammatory Bowel Disease	1 participants

Adverse Events

Infliximab

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Infliximab n=2 participants at risk Single arm open label Infliximab : IV drug given at weeks 1,2,14,22
Blood and lymphatic system disorders Infusion reaction	50.0% 1/2 • Number of events 1
Blood and lymphatic system disorders Bone marrow suppression	50.0% 1/2 • Number of events 1
Infections and infestations Infection	50.0% 1/2 • Number of events 1

Additional Information

Dr. Amanda Suggs, MD

University Hospitals of Cleveland

Phone: 216-844-7546

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place