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Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT00645814
Recruitment Status : Completed
First Posted : March 28, 2008
Last Update Posted : March 28, 2008
Sponsor:
Information provided by:
Abbott

Brief Summary:
Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis

Condition or disease Intervention/treatment Phase
Psoriasis Drug: placebo for adalimumab Drug: adalimumab Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Study Start Date : March 2003
Actual Primary Completion Date : September 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Adalimumab

Arm Intervention/treatment
Placebo Comparator: A Drug: placebo for adalimumab
80 mg at Week 0 and 40 mg eow through Week 11
Other Name: placebo

Active Comparator: B Drug: adalimumab
80 mg at Week 0 and 40 mg eow through Week 11
Other Names:
  • ABT-D2E7
  • Humira

Active Comparator: C Drug: adalimumab
80 mg at Week 0 and 40 mg weekly through Week 11
Other Names:
  • ABT-D2E7
  • Humira




Primary Outcome Measures :
  1. Psoriasis Area and Severity Index [ Time Frame: Week 12 ]
  2. Adverse Events [ Time Frame: Throughout Study Participation ]

Secondary Outcome Measures :
  1. Psoriasis Area and Severity Index [ Time Frame: Week 1, 2, 4, 8, 12 ]
  2. DLQI, SF-36, Zung Depression Self-Rating Scale, EQ-5D [ Time Frame: Week 12 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of moderate to severe chronic plaque psoriasis
  • Active psoriasis, despite topical therapies

Exclusion Criteria:

  • Other active skin diseases or skin infections
  • 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