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Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severely Active Psoriatic Arthritis Subjects With Inadequate Response to Disease Modifying Anti-Rheumatic Drug Therapy

NCT ID: NCT00646178

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

PHASE3

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Brief Summary

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Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severely Active Psoriatic Arthritis Subjects with Inadequate Response to Disease Modifying anti-Rheumatic Drug Therapy

Detailed Description

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Conditions

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Arthritis Psoriatic

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

40 mg adalimumab eow Week 0 - Week 12

B

Group Type PLACEBO_COMPARATOR

placebo for adalimumab

Intervention Type DRUG

placebo eow Week 0 - Week 12

Interventions

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adalimumab

40 mg adalimumab eow Week 0 - Week 12

Intervention Type DRUG

placebo for adalimumab

placebo eow Week 0 - Week 12

Intervention Type DRUG

Other Intervention Names

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ABT-D2E7 Humira placebo

Eligibility Criteria

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Inclusion Criteria

* Moderate to severe PsA
* Inadequate response to DMARD therapy
* Corticosteroid stable dose \<=10 mg QD
* DMARDs must have been taken for 3 months and stable dose for 4 weeks
* MTX maximum dose = \<=30 mg/week
* Active chronic plaque PS or documented history of chronic plaque PS

Exclusion Criteria

* No other active skin disease
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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M02-570

Identifier Type: -

Identifier Source: org_study_id