Status:
COMPLETED
Controlled Study of Humira in Subjects With Chronic Plaque Psoriasis of the Hands and/or Feet
Lead Sponsor:
Abbott
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00735787
Start Date
August 1 2008
End Date
September 1 2009
Last Update
November 1 2010
Active Locations (17)
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1
Site Reference ID/Investigator# 10168
Little Rock, Arkansas, United States, 72205
2
Site Reference ID/Investigator# 10005
Bakersfield, California, United States, 93309
3
Site Reference ID/Investigator# 10003
Macon, Georgia, United States, 31217
4
Site Reference ID/Investigator# 10171
St Louis, Missouri, United States, 63117