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CompletedNCT00237887Updated Aug 29, 2007

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

A Phase 3 interventional study of adalimumab in Psoriasis, sponsored by Abbott. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-08-29.

Sponsored by Abbott · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,212
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

A Phase III, Multicenter Study of the Efficacy and Safety of Adalimumab Treatment in Subjects with Moderate to Severe Chronic Plaque Psoriasis

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Conditions studied

  • Psoriasis

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Keywords

  • Psoriasis
  • adalimumab
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In context

Psoriasis

1,928 studies on the registry are indexed under Psoriasis; 234 are open to participants now.

This study's enrollment of 1,212 is above the median of 70 across 1,472 interventional studies indexed under Psoriasis.

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Lead sponsor

Abbott is the lead sponsor of 361 studies on the registry; 1 is open to participants now.

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Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.
  • Subject had a clinical diagnosis of psoriasis for at least 6 months, had moderate to severe plaque psoriasis.
  • Subject was able and willing to self-administer sc injections or had available qualified person(s) to administer sc injections

Exclusion criteria

Exclusion Criteria:

  • Subject had previously received anti-TNF therapy.
  • Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVB or PUVA phototherapy
  • Subject cannot avoid excessive sun exposure
  • Subject is taking or requires oral or injectable corticosteroids
  • Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
  • Female subject who is pregnant or breast-feeding or considering becoming pregnant
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
1,212 participants (actual)

Interventions

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What researchers measure

Primary outcomes

  1. Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score

    Time frame: Week 16

Secondary outcomes

  1. Safety parameters

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Armstrong AW, Villanueva Quintero DG, Echeverria CM, Gu Y, Karunaratne M, Reyes Servin O. Body Region Involvement and Quality of Life in Psoriasis: Analysis of a Randomized Controlled Trial of Adalimumab. Am J Clin Dermatol. 2016 Dec;17(6):691-699. doi: 10.1007/s40257-016-0229-x. PubMed 27815915 ↗
  • Papp KA, Armstrong AW, Reich K, Karunaratne M, Valdecantos W. Adalimumab Efficacy in Patients with Psoriasis Who Received or Did Not Respond to Prior Systemic Therapy: A Pooled Post Hoc Analysis of Results from Three Double-Blind, Placebo-Controlled Clinical Trials. Am J Clin Dermatol. 2016 Feb;17(1):79-86. doi: 10.1007/s40257-015-0161-5. PubMed 26547918 ↗
  • Gordon K, Papp K, Poulin Y, Gu Y, Rozzo S, Sasso EH. Long-term efficacy and safety of adalimumab in patients with moderate to severe psoriasis treated continuously over 3 years: results from an open-label extension study for patients from REVEAL. J Am Acad Dermatol. 2012 Feb;66(2):241-51. doi: 10.1016/j.jaad.2010.12.005. Epub 2011 Jul 14. PubMed 21752491 ↗
  • Revicki DA, Menter A, Feldman S, Kimel M, Harnam N, Willian MK. Adalimumab improves health-related quality of life in patients with moderate to severe plaque psoriasis compared with the United States general population norms: results from a randomized, controlled Phase III study. Health Qual Life Outcomes. 2008 Oct 2;6:75. doi: 10.1186/1477-7525-6-75. PubMed 18831744 ↗
  • Menter A, Tyring SK, Gordon K, Kimball AB, Leonardi CL, Langley RG, Strober BE, Kaul M, Gu Y, Okun M, Papp K. Adalimumab therapy for moderate to severe psoriasis: A randomized, controlled phase III trial. J Am Acad Dermatol. 2008 Jan;58(1):106-15. doi: 10.1016/j.jaad.2007.09.010. Epub 2007 Oct 23. PubMed 17936411 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00237887
Lead sponsor
Abbott
First posted
Oct 13, 2005
Start date
Dec 2004
Last update
Aug 29, 2007

Study contacts

Beverly Paperiello
study director · Abbott

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2007. You cannot join it, but the record below documents what was studied.

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