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

Completed · Phase 4 · Has a placebo group

Conditions studied: Psoriasis

In brief

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.

Key facts

Study ID

NCT00735787

Run by

Abbott

People needed

81

Starts

2008-08-01

Expected to finish

2009-09-01

Last updated by the study team

2010-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Site Reference ID/Investigator# 10168 — Little Rock, Arkansas, United States
• Site Reference ID/Investigator# 10005 — Bakersfield, California, United States
• Site Reference ID/Investigator# 10003 — Macon, Georgia, United States
• Site Reference ID/Investigator# 10171 — St Louis, Missouri, United States
• Site Reference ID/Investigator# 10164 — East Windsor, New Jersey, United States
• Site Reference ID/Investigator# 10173 — Dallas, Texas, United States
• Site Reference ID/Investigator# 11302 — Houston, Texas, United States
• Site Reference ID/Investigator# 10166 — San Antonio, Texas, United States
• Site Reference ID/Investigator# 10180 — Edmonton, Alberta, Canada
• Site Reference ID/Investigator# 10169 — Vancouver, British Columbia, Canada
• Site Reference ID/Investigator# 10170 — Halifax, Nova Scotia, Canada
• Site Reference ID/Investigator# 10179 — Hamilton, Ontario, Canada
• Site Reference ID/Investigator# 10004 — London, Ontario, Canada
• Site Reference ID/Investigator# 10177 — North Bay, Ontario, Canada
• Site Reference ID/Investigator# 10175 — Waterloo, Ontario, Canada
• Site Reference ID/Investigator# 10165 — Montreal, Quebec, Canada
• Site Reference ID/Investigator# 10176 — Québec, Quebec, Canada

Full record on ClinicalTrials.gov

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