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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00195676
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : November 19, 2010
Last Update Posted : April 13, 2011
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Brief Summary:
The two objectives of this study were to evaluate long-term efficacy and safety of adalimumab treatment in participants who had moderate to severe chronic plaque psoriasis and to evaluate the effectiveness of adalimumab retreatment in participants who had therapeutic response to adalimumab and were then withdrawn from adalimumab treatment.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: adalimumab Phase 3

Detailed Description:
Study M03-658 was a continuation study for participants with moderate to severe psoriasis who had participated in a prior psoriasis adalimumab study. Study M03-658 consisted of three sequential treatment periods. The first period was Period O, in which participants received open-label treatment with adalimumab (40 mg every other week or 40 mg every week) for a minimum of 104 weeks and a maximum of 252 weeks. Period O was the only period of the study until May 2008, when the subsequent periods were added via amendment to the protocol. At that time, participants who had achieved satisfactory therapeutic response (a Physician's Global Assessment [PGA] of 0, 1, or 2 [clear, minimal, or mild]) were given the opportunity to discontinue from the study or to continue and participate in the subsequent two periods. The second period was Period W, a maximum of 52 weeks, in which participants with a PGA of 2 (mild) or less were withdrawn from adalimumab treatment (i.e., participants received no treatment) until relapse of their psoriasis occurred (defined as a PGA of 3 [moderate] or worse). The third period was Period R, a 16-week period in which participants were retreated with open-label adalimumab (80 mg initial dose followed by 40 mg every other week). Period O was designed to evaluate the first objective regarding long-term efficacy and safety of adalimumab treatment, and Period R was designed to evaluate the effectiveness of adalimumab retreatment following relapse. Specific subsets of the study population that were identified as the populations of interest were the modified intent-to-treat populations for Period W and Period R, and these are described further in the outcome measures.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1469 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Open-Label Continuation Study in Moderate to Severe Chronic Plaque Psoriasis Subjects Who Completed a Preceding Psoriasis Clinical Study With Adalimumab
Study Start Date : May 2004
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Adalimumab
U.S. FDA Resources

Arm Intervention/treatment
Adalimumab Drug: adalimumab
40 mg every other week or 40 mg every week by subcutaneous injection
Other Names:
  • ABT-D2E7
  • Humira

Primary Outcome Measures :
  1. Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R [ Time Frame: Week 16 of Period R ]
    The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.
  • Subjects who met the requirements from previous adalimumab psoriasis study participation.

Exclusion Criteria:

  • Subject considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
  • Female subject who was pregnant or breast-feeding or considering becoming pregnant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00195676

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Sponsors and Collaborators
Study Director: Martin Okun, MD, PhD Abbott

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Martin M. Okun, MD, PhD/Medical Director, Immunology, Abbott Identifier: NCT00195676     History of Changes
Other Study ID Numbers: M03-658
2005-000095-41 ( EudraCT Number )
First Posted: September 20, 2005    Key Record Dates
Results First Posted: November 19, 2010
Last Update Posted: April 13, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases
Anti-Inflammatory Agents
Antirheumatic Agents