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Extension Study of Two Dosing Schedules of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00645892
First received: March 25, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose
Extension Study of Two Dosing Schedules of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis

Condition Intervention Phase
Psoriasis Drug: adalimumab Drug: placebo for adalimumab Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Extension Study of Two Dosing Schedules of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Psoriasis Area and Severity Index [ Time Frame: Week 12 ]
  • Adverse Events [ Time Frame: Throughout Study Participation ]

Secondary Outcome Measures:
  • Psoriasis Area and Severity Index [ Time Frame: Week 12, Week 24 ]
  • Physician's Global Assessment [ Time Frame: Week 12, Week 24 ]

Enrollment: 32
Study Start Date: November 2003
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: adalimumab
OL 80 mg at Weeks 0 and 1, 40 mg weekly Week 2 - Week 11, blinded 40 mg eow through Week 24
Other Names:
  • ABT-D2E7
  • Humira
Placebo Comparator: B Drug: placebo for adalimumab
OL 80 mg at Weeks 0 and 1, 40 mg weekly Week 2 - Week 11, blinded placebo eow through Week 24
Other Name: placebo

  Eligibility

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

Inclusion Criteria:

  • Subject participated and relapsed in prior PS study

Exclusion Criteria:

  • Subject has other active skin diseases
  • Multiple concomitant therapy restrictions and/or washouts (topicals, UV, other systemic PS therapies)
  • Poorly controlled medical conditions
  • History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease.
  • History of cancer or lymphoproliferative disease
  • History of active TB or listeriosis, or persistent chronic or active infections
  • Known to have immune deficiency or is immunocompromised
  • Clinically significant abnormal laboratory test results
  • Erythrodermic psoriasis or generalized pustular psoriasis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Beverly Paperiello / Director, Clinical Program Management, Abbott
ClinicalTrials.gov Identifier: NCT00645892     History of Changes
Other Study ID Numbers: M03-596
Study First Received: March 25, 2008
Last Updated: March 25, 2008

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

ClinicalTrials.gov processed this record on August 18, 2017