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

This study has been completed.

Sponsor:

Information provided by:

Abbott

ClinicalTrials.gov Identifier:

NCT00645814

First received: March 26, 2008

Last updated: NA

Last verified: March 2008

History: No changes posted

Tracking Information
First Received Date ^ICMJE	March 26, 2008
Last Updated Date	March 26, 2008
Start Date ^ICMJE	March 2003
Primary Completion Date	September 2003 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 26, 2008)	Psoriasis Area and Severity Index [ Time Frame: Week 12 ] [ Designated as safety issue: No ] Adverse Events [ Time Frame: Throughout Study Participation ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: March 26, 2008)	Psoriasis Area and Severity Index [ Time Frame: Week 1, 2, 4, 8, 12 ] [ Designated as safety issue: No ] DLQI, SF-36, Zung Depression Self-Rating Scale, EQ-5D [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Official Title ^ICMJE	Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Brief Summary	Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Psoriasis
Intervention ^ICMJE	Drug: placebo for adalimumab 80 mg at Week 0 and 40 mg eow through Week 11 Other Name: placebo Drug: adalimumab 80 mg at Week 0 and 40 mg eow through Week 11 Other Names: ABT-D2E7 Humira adalimumab Drug: adalimumab 80 mg at Week 0 and 40 mg weekly through Week 11 Other Names: ABT-D2E7 Humira adalimumab
Study Arm (s)	Placebo Comparator: A Intervention: Drug: placebo for adalimumab Active Comparator: B Intervention: Drug: adalimumab Active Comparator: C Intervention: Drug: adalimumab
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	148
Completion Date	Not Provided
Primary Completion Date	September 2003 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00645814
Other Study ID Numbers ^ICMJE	M02-528
Has Data Monitoring Committee	No
Responsible Party	Beverly Paperiello / Director, Clinical Program Management, Abbott
Study Sponsor ^ICMJE	Abbott
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Abbott
Verification Date	March 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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