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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00195676
First received: September 13, 2005
Last updated: April 11, 2011
Last verified: April 2011
  Purpose

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the effectiveness of adalimumab retreatment in participants who had therapeutic response to adalimumab and were then withdrawn from adalimumab treatment.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 Intervention Phase
Psoriasis
Drug: adalimumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 1469
Study Start Date: May 2004
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Adalimumab Drug: adalimumab
40 mg every other week or 40 mg every week by subcutaneous injection
Other Names:
  • ABT-D2E7
  • adalimumab
  • Humira

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00195676

  Show 104 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Martin Okun, MD, PhD Abbott
  More Information

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Martin M. Okun, MD, PhD/Medical Director, Immunology, Abbott
ClinicalTrials.gov Identifier: NCT00195676     History of Changes
Other Study ID Numbers: M03-658, 2005-000095-41
Study First Received: September 13, 2005
Results First Received: October 20, 2010
Last Updated: April 11, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 16, 2014