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Extension Study of Two Dosing Schedules of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

NCT ID: NCT00645892

Last Updated: 2008-03-28

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Brief Summary

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Extension Study of Two Dosing Schedules of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis

Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Group Type ACTIVE_COMPARATOR

adalimumab

Intervention Type DRUG

OL 80 mg at Weeks 0 and 1, 40 mg weekly Week 2 - Week 11, blinded 40 mg eow through Week 24

B

Group Type PLACEBO_COMPARATOR

placebo for adalimumab

Intervention Type DRUG

OL 80 mg at Weeks 0 and 1, 40 mg weekly Week 2 - Week 11, blinded placebo eow through Week 24

Interventions

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adalimumab

OL 80 mg at Weeks 0 and 1, 40 mg weekly Week 2 - Week 11, blinded 40 mg eow through Week 24

Intervention Type DRUG

placebo for adalimumab

OL 80 mg at Weeks 0 and 1, 40 mg weekly Week 2 - Week 11, blinded placebo eow through Week 24

Intervention Type DRUG

Other Intervention Names

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ABT-D2E7 Humira placebo

Eligibility Criteria

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Inclusion Criteria

* Subject participated and relapsed in prior PS study

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott

Other Identifiers

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M03-596

Identifier Type: -

Identifier Source: org_study_id