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Clinical Trials/NCT00645814
NCT00645814
Completed
Phase 2

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

Abbott0 sites148 target enrollmentMarch 2003
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ConditionsPsoriasis
Interventionsplacebo for adalimumabadalimumab
Drugsplacebo for adalimumabadalimumab

Overview

Phase
Phase 2
Intervention
placebo for adalimumab
Conditions
Psoriasis
Sponsor
Abbott
Enrollment
148
Primary Endpoint
Psoriasis Area and Severity Index
Status
Completed
Last Updated
18 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
March 2003
End Date
September 2003
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Abbott

Eligibility 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

Arms & Interventions

A

Intervention: placebo for adalimumab

B

Intervention: adalimumab

C

Intervention: adalimumab

Outcomes

Primary Outcomes

Psoriasis Area and Severity Index

Time Frame: Week 12

Adverse Events

Time Frame: Throughout Study Participation

Secondary Outcomes

  • Psoriasis Area and Severity Index(Week 1, 2, 4, 8, 12)
  • DLQI, SF-36, Zung Depression Self-Rating Scale, EQ-5D(Week 12)

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