Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Moderately to Severely Active Psoriatic Arthritis
NCT ID: NCT00646386
Last Updated: 2008-03-28
Study Results
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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COMPLETED
PHASE2
315 participants
INTERVENTIONAL
2003-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
adalimumab
40 mg eow Week 0 - Week 24
B
placebo for adalimumab
40 mg eow Week 0 - Week 24
Interventions
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adalimumab
40 mg eow Week 0 - Week 24
placebo for adalimumab
40 mg eow Week 0 - Week 24
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Abbott
References
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Landewe R, Ritchlin CT, Aletaha D, Zhang Y, Ganz F, Hojnik M, Coates LC. Inhibition of radiographic progression in psoriatic arthritis by adalimumab independent of the control of clinical disease activity. Rheumatology (Oxford). 2019 Jun 1;58(6):1025-1033. doi: 10.1093/rheumatology/key417.
Mease PJ, Heckaman M, Kary S, Kupper H. Application and modifications of minimal disease activity measures for patients with psoriatic arthritis treated with adalimumab: subanalyses of ADEPT. J Rheumatol. 2013 May;40(5):647-52. doi: 10.3899/jrheum.120970. Epub 2013 Mar 15.
Other Identifiers
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M02-518
Identifier Type: -
Identifier Source: org_study_id