Crohn's Disease, Inflammatory Bowel Disease, Pyoderma Gangrenosum, Ulcerative Colitis
Conditions
Brief summary
Subjects must be 18- 75 years old and have a history of both inflammatory bowels disease (Crohn's or ulcerative colitis) and pyoderma gangrenosum. This is a 6 month open label study of an intravenous (IV) medication. Visits occur every 2 weeks initially, then every 1-2 months later in the study.
Interventions
DRUGInfliximab
IV drug given at weeks 1,2,14,22
Sponsors
Centocor, Inc.
University Hospitals Cleveland Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Must Be ages 18-75 * Must have both inflammatory bowel disease and moderate to severe pyoderma gangrenosum * Must never have received Infliximab for the treatment of pyoderma gangrenosum
Exclusion criteria
* Have had any previous treatment with monoclonal antibodies other than infliximab used to treat IBD or antibody fragments. * Have a history of serious infections
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Efficacy of Infliximab in Pyoderma Gangrenosum in Adult Subjects Who Have Inflammatory Bowel Disease | Week 26 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Infliximab Single arm open label
Infliximab : IV drug given at weeks 1,2,14,22 | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Infliximab |
|---|---|
| Age, Customized <=18 years | 0 participants |
| Age, Customized >=75 years | 0 participants |
| Age, Customized Between 18 and 75 years | 2 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
The Efficacy of Infliximab in Pyoderma Gangrenosum in Adult Subjects Who Have Inflammatory Bowel Disease
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.
Time frame: Week 26
Population: Subjects who completed all required transfusions of infliximab were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infliximab | The Efficacy of Infliximab in Pyoderma Gangrenosum in Adult Subjects Who Have Inflammatory Bowel Disease | 1 participants |