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Controlled Study of Humira in Subjects With Chronic Plaque Psoriasis of the Hands and/or Feet

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriasis

Intervention: Placebo (Biological); Adalimumab (Biological)

Phase: Phase 4

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Martin Okun, MD, Study Director, Affiliation: Abbott

Summary

Evaluate the efficacy and safety of a 16-week course of Humira (adalimumab) compared to placebo in adults with chronic plaque psoriasis of the hands and/or feet and the sustainability of response for 12 additional weeks.

Clinical Details

Official title: Controlled Study of Humira in Subjects With Chronic Plaque Psoriasis of the Hands and/or Feet

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16

Secondary outcome:

Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF)

Mean Change From Baseline in ESIF for Palms

Mean Change From Baseline in ESIF for Soles

Number of Subjects With Moderate Improvement in ESIF From Baseline

Number of Subjects With Marked Improvement in ESIF From Baseline

Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI)

Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild

Number of Subjects With PGA of Clear or Almost Clear

Number of Subjects With PGA of Clear

Number of Subjects With Psoriasis Area and Severity Index (PASI) 50

Number of Subjects With PASI 75

Number of Subjects With PASI 90

Number of Subjects With PASI 100

Mean Change From Baseline in Dermatology Life Quality Index (DLQI)

Number of Subjects Achieving a DLQI of 0

Mean Change From Baseline in Visual Analog Scale (VAS) for Psoriasis and Psoriatic Arthritis Pain

Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO)

Mean Change From Baseline in Patient Health Questionnaire (PHQ-9)

Number of Subjects With Difficulties According to PHQ-9

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adult with Diagnosis of chronic plaque psoriasis of the Hands and Feet for at least 6

months, with a PGA >/=3 and candidates for systemic therapy;

- Patients in good general health

- Able to self-administer injections

- Negative chest x-ray (CXR) and purified protein derivative (PPD) test, unless willing

to start anti-tuberculosis (TB) prophylaxis Exclusion Criteria:

- Previous treatment with HUMIRA®

- Required mediation stability or washouts for: systemic corticosteroids (28 days),

other investigational agent, other systemic therapies for psoriasis, ultraviolet B (UVB), psoralen with UVA (PUVA)

- Other active skin diseases or skin infections

- Diagnosis of palmoplantar pustulosis; erythrodermic psoriasis, pustular psoriasis,

medication-induced or exacerbated psoriasis or new onset of guttate psoriasis

- Evidence of dysplasia or history of malignancy (Other than a successfully treated

non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix);

- History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection,

human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active tuberculosis (TB);

- History of moderate to severe congestive heart failure,

- Recent cerebrovascular accident and any other condition which, in the opinion of the

investigator, would put the subject at risk;

- History of central nervous system (CNS) demyelinating disease or neurologic symptoms

suggestive of CNS demyelinating disease;

- History of clinically significant drug or alcohol abuse in the last 12 months;

- Infection(s) requiring treatment with intravenous (IV) antibiotics, IV antivirals, or

IV antifungals within 30 days prior to Baseline or oral antibiotics, oral antivirals, or oral antifungals within 14 days prior to Baseline;

- Known hypersensitivity to the excipients of HUMIRA® as stated in the label;

- Female subjects who are pregnant or breast-feeding or considering becoming pregnant

during the study.

- Prior exposure to Tysabri® (natalizumab)

Locations and Contacts

Site Reference ID/Investigator# 10176, Quebec G1V 4X7, Canada

Site Reference ID/Investigator# 10180, Edmonton, Alberta T5K 1X3, Canada

Site Reference ID/Investigator# 10168, Little Rock, Arkansas 72205, United States

Site Reference ID/Investigator# 10169, Vancouver, British Columbia V5Z 4E8, Canada

Site Reference ID/Investigator# 10005, Bakersfield, California 93309, United States

Site Reference ID/Investigator# 10003, Macon, Georgia 31217, United States

Site Reference ID/Investigator# 10171, St. Louis, Missouri 63117, United States

Site Reference ID/Investigator# 10164, East Windsor, New Jersey 08520, United States

Site Reference ID/Investigator# 10170, Halifax, Nova Scotia B3H 1Z4, Canada

Site Reference ID/Investigator# 10179, Hamilton, Ontario L8N 1V6, Canada

Site Reference ID/Investigator# 10004, London, Ontario N5X 2P1, Canada

Site Reference ID/Investigator# 10177, North Bay, Ontario P1B 3Z7, Canada

Site Reference ID/Investigator# 10175, Waterloo, Ontario N2J 1C4, Canada

Site Reference ID/Investigator# 10165, Montreal, Quebec H2K 4L5, Canada

Site Reference ID/Investigator# 10173, Dallas, Texas 75246-1613, United States

Site Reference ID/Investigator# 11302, Houston, Texas 77030, United States

Site Reference ID/Investigator# 10166, San Antonio, Texas 78258, United States

Additional Information

prescribing information

Starting date: August 2008
Last updated: October 11, 2010

Page last updated: August 23, 2015

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