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

March 26, 2008 updated by: Abbott
Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: B
Drug: adalimumab
80 mg at Week 0 and 40 mg eow through Week 11
Other Names:
  • ABT-D2E7
  • Humira
Drug: adalimumab
80 mg at Week 0 and 40 mg weekly through Week 11
Other Names:
  • ABT-D2E7
  • Humira
Active Comparator: C
Drug: adalimumab
80 mg at Week 0 and 40 mg eow through Week 11
Other Names:
  • ABT-D2E7
  • Humira
Drug: adalimumab
80 mg at Week 0 and 40 mg weekly through Week 11
Other Names:
  • ABT-D2E7
  • Humira
Placebo Comparator: A
Drug: placebo for adalimumab
80 mg at Week 0 and 40 mg eow through Week 11
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Psoriasis Area and Severity Index
Time Frame: Week 12
Week 12
Adverse Events
Time Frame: Throughout Study Participation
Throughout Study Participation

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Actual)

September 1, 2003

Study Registration Dates

First Submitted

March 26, 2008

First Submitted That Met QC Criteria

March 26, 2008

First Posted (Estimate)

March 28, 2008

Study Record Updates

Last Update Posted (Estimate)

March 28, 2008

Last Update Submitted That Met QC Criteria

March 26, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M02-528

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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