Controlled Study of Humira in Subjects With Chronic Plaque Psoriasis of the Hands and/or Feet
NCT ID: NCT00735787
Last Updated: 2010-11-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
81 participants
INTERVENTIONAL
2008-08-31
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo/Adalimumab
Loading dose of 2 placebo injections at Week 0 and placebo injections every other week (eow) from Week 1 through Week 15.
In second period of study, subjects who continued in the study received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
Placebo
Loading dose of 2 placebo subcutaneous (SC) injections (0.8 ml) at Week 0 followed by 1 injection SC eow from Week 1 to Week 15.In second period of study, subjects who continued in the study received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
Adalimumab
Loading dose of 80 mg adalimumab SC (two 40 mg injections) followed by 40 mg adalimumab SC eow.
Adalimumab
80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 15. For subjects who continued in the second period of the study, subjects received 2 placebo injections at Week 16 to maintain the blind. Open-label 40 mg adalimumab eow was administered from Week 17 through Week 27.
Adalimumab
Loading dose of 80 mg adalimumab SC (two 40 mg injections) followed by 40 mg adalimumab SC eow.
Interventions
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Placebo
Loading dose of 2 placebo subcutaneous (SC) injections (0.8 ml) at Week 0 followed by 1 injection SC eow from Week 1 to Week 15.In second period of study, subjects who continued in the study received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
Adalimumab
Loading dose of 80 mg adalimumab SC (two 40 mg injections) followed by 40 mg adalimumab SC eow.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Abbott
Principal Investigators
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Martin Okun, MD
Role: STUDY_DIRECTOR
Abbott
Locations
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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
Countries
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References
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Leonardi C, Langley RG, Papp K, Tyring SK, Wasel N, Vender R, Unnebrink K, Gupta SR, Valdecantos WC, Bagel J. Adalimumab for treatment of moderate to severe chronic plaque psoriasis of the hands and feet: efficacy and safety results from REACH, a randomized, placebo-controlled, double-blind trial. Arch Dermatol. 2011 Apr;147(4):429-36. doi: 10.1001/archdermatol.2010.384. Epub 2010 Dec 20.
Related Links
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prescribing information
Other Identifiers
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M10-405
Identifier Type: -
Identifier Source: org_study_id