Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
NCT ID: NCT00645814
Last Updated: 2008-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
148 participants
INTERVENTIONAL
2003-03-31
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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A
placebo for adalimumab
80 mg at Week 0 and 40 mg eow through Week 11
B
adalimumab
80 mg at Week 0 and 40 mg eow through Week 11
C
adalimumab
80 mg at Week 0 and 40 mg weekly through Week 11
Interventions
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placebo for adalimumab
80 mg at Week 0 and 40 mg eow through Week 11
adalimumab
80 mg at Week 0 and 40 mg eow through Week 11
adalimumab
80 mg at Week 0 and 40 mg weekly through Week 11
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Active psoriasis, despite topical therapies
Exclusion Criteria
* Prior exposure to any anti-TNF therapy
* Subject has other active skin diseases
* Multiple concomitant therapy restrictions and/or washouts (topicals, UV, other systemic PS therapies)
* Poorly controlled medical conditions
* History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease.
* History of cancer or lymphoproliferative disease
* History of active TB or listeriosis, or persistent chronic or active infections
* Known to have immune deficiency or is immunocompromised
* Clinically significant abnormal laboratory test results
* Erythrodermic psoriasis or generalized pustular psoriasis
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Abbott
References
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Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.
Papp KA, Armstrong AW, Reich K, Karunaratne M, Valdecantos W. Adalimumab Efficacy in Patients with Psoriasis Who Received or Did Not Respond to Prior Systemic Therapy: A Pooled Post Hoc Analysis of Results from Three Double-Blind, Placebo-Controlled Clinical Trials. Am J Clin Dermatol. 2016 Feb;17(1):79-86. doi: 10.1007/s40257-015-0161-5.
Other Identifiers
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M02-528
Identifier Type: -
Identifier Source: org_study_id