Safety and Efficacy of Adalimumab in Patients With Moderate to Severely Active Psoriatic Arthritis

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

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Brief Summary

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The purpose of the study is to assess the long-term safety and clinical efficacy of adalimumab in treatment of moderate to severely active psoriatic arthritis

Detailed Description

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Conditions

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Psoriatic Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Human anti-TNF monoclonal antibody/adalimumab

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Subject completed study M02-518 or M02-570

Exclusion Criteria

* Subject prematurely discontinued study M02-518 or M02-570

* Female subject who is pregnant or breast-feeding or considering becoming pregnant
* Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Beverly Paperiello

Role: STUDY_DIRECTOR

Abbott

Locations

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Global Medical Information-Abbott Laboratories

Abbott Park, Illinois, United States

Site Status

Countries

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United States

References

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Gladman DD, Mease PJ, Choy EH, Ritchlin CT, Perdok RJ, Sasso EH. Risk factors for radiographic progression in psoriatic arthritis: subanalysis of the randomized controlled trial ADEPT. Arthritis Res Ther. 2010;12(3):R113. doi: 10.1186/ar3049. Epub 2010 Jun 10.

Reference Type DERIVED

PMID: 20537151 (View on PubMed)

Mease PJ, Ory P, Sharp JT, Ritchlin CT, Van den Bosch F, Wellborne F, Birbara C, Thomson GT, Perdok RJ, Medich J, Wong RL, Gladman DD. Adalimumab for long-term treatment of psoriatic arthritis: 2-year data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT). Ann Rheum Dis. 2009 May;68(5):702-9. doi: 10.1136/ard.2008.092767. Epub 2008 Aug 6.