Safety and Efficacy Study of Humira in Treatment of Pyoderma Gangrenosum

NCT00730717 | Withdrawn Phase 2 DMC

• 1 other identifier: HUM 04-37
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety and efficacy of Humira in the treatment of pyoderma gangrenosum.

Conditions

Pyoderma Gangrenosum

Outcome Measures

Primary Outcomes (2)

• Mean change in the number of ulcers from baseline to the end of study

  week 0, week 1, week 4 and then very 4 weeks until week 24.

• Mean change in ulcer area from baseline to end of study

  week 0, week 1, week 4 and then very 4 weeks until week 24.

Secondary Outcomes (7)

• Number of complete responders, partial responders, minimal responders and non-responders at the end of study.

  week 0, week 1, week 4 and then very 4 weeks until week 24.

• Mean change in the number of ulcer by visit

  week 0, week 1, week 4 and then very 4 weeks until week 24.

• Mean change in the ulcer area from baseline by visit

  week 0, week 1, week 4 and then very 4 weeks until week 24.

• Mean change in subject's evaluation of severity measured by visual analogue scale

  week 0, week 1, week 4 and then very 4 weeks until week 24.

• Mean change in subject's evaluation of pain by visual analogue scale

  week 0, week 1, week 4 and then very 4 weeks until week 24.

Study Arms (2)

1

EXPERIMENTAL

Patients who are not concurrently receiving methotrexate treatment for pyoderma gangrenosum

Drug: Humira

2

EXPERIMENTAL

Patients who are receiving concurrent methotrexate for pyoderma gangrenosum

Drug: Humira

Interventions

Humira DRUG

Will receive 80 mg of Humira injection at week 0 followed by 40 mg weekly Humira injection from Week 1 to Week 23

1

Eligibility Criteria

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

You may qualify if:

• Subject is willing and able to give informed consent.
• Subject is willing and able to participate in the study as an outpatient and is willing to comply with study requirements.
• Subject is 18 years of age or older.
• Subject has a diagnosis of pyoderma gangrenosum that involves total area of 3 cm2 or greater and is of sufficient severity to warrant systemic agents.
• If female of childbearing potential, subject will have a negative urine pregnancy test at Screening and Week 0.
• If female, subject will be either post-menopausal for \> 1 year, surgically sterile (hysterectomy or bilateral tubal ligation), or practicing one form of birth control (abstinence, oral contraceptive, estrogen patch, implant contraception, injectable contraception, IUD, diaphragm, condom, sponge, spermicides, or vasectomy of partner). Female subjects will continue to use contraception for 6 months following the last injection.
• Screening laboratory results are within the following parameters:
• Hemoglobin \> 9 g/dL
• White blood cells \> 3.0 x 10 to the 9th power/L, \<14.0 x 10 to the 9th power/L (unless on oral corticosteroids and no signs/symptoms of infection)
• Neutrophils \> 1.5 x 10 to the 9th power/L
• Platelets \> 100 x 10 to the 9th power/L
• Lymphocytes \> 0.5 x 10 to the 9th power/L
• Serum creatinine within 1.5 times the upper limit of normal range
• AST and ALT within 2 times the upper limit of normal range
• Subject has been on a stable dose of antibiotics, oral corticosteroids or other immunosuppressives, such cyclosporine, tacrolimus, azathioprine, methotrexate, or mycophenolate mofetil over the previous 4 weeks

You may not qualify if:

• Subject has evidence of a clinically significant, unstable or poorly controlled medical condition.
• Subject has a chest X-ray consistent with an active infection or previous exposure to TB and/or a positive purified protein derivative test at screening (\>5 mm). (Subjects may participate if they are being actively treated in accordance with CDC guidelines.)
• Subject has a serious, active or recurrent bacterial, viral, or fungal infection. This includes hepatitis B and C, and HIV.
• Subject has been hospitalized for infection or received IV antibiotics within the previous 2 months prior to baseline.
• Subject has clinical evidence as determined by the investigator of acutely infected pyoderma gangrenosum or subject is receiving systemic antibiotics for the treatment of acute infection. Subjects receiving minocycline, tetracycline, dapsone, or other antibiotics for anti-inflammatory purposes are permitted.
• Subject has a history of tuberculosis without documented adequate therapy.
• Subject has a history of a central nervous system disorder/demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis.
• Subject has current signs or symptoms or history of systemic lupus erythematosus.
• Subject has been diagnosed with a malignancy within the past 5 years except for successfully treated non-melanoma skin cancer.
• Subject has signs or symptoms suggestive of a possible lymphoproliferative disease.
• Subject has a diagnosis of severe congestive heart failure (Class III or IV NYHA).
• Subject has had a substance abuse problem within the previous 3 years.
• Subject has been treated with an anti-TNF biologic immune response modifier, such as infliximab, adalimumab, or etanercept within the past 8 weeks.
• Subject has any dermatologic disease in the target site that may be exacerbated by treatment or interfere with examination.
• Subject has been administered an investigational drug in another clinical study within 30 days prior to baseline (or 5 half-lives, whichever is longer).

Sponsors & Collaborators

• Wright State University: lead
• Stanford University: collaborator
• Wake Forest University Health Sciences: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Pyoderma Gangrenosum

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Pyoderma; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular; Skin Ulcer

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• David F Fiorentino, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 4, 2008
• First Posted: August 8, 2008
• Study Start: May 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 15, 2022

Record last verified: 2022-02

Locations

US (1)