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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00645814
First received: March 26, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose
Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multicenter Study of the Safety and Efficacy 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 1, 2, 4, 8, 12 ]
  • DLQI, SF-36, Zung Depression Self-Rating Scale, EQ-5D [ Time Frame: Week 12 ]

Enrollment: 148
Study Start Date: March 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A Drug: placebo for adalimumab
80 mg at Week 0 and 40 mg eow through Week 11
Other Name: placebo
Active Comparator: B Drug: adalimumab
80 mg at Week 0 and 40 mg eow through Week 11
Other Names:
  • ABT-D2E7
  • Humira
Active Comparator: C Drug: adalimumab
80 mg at Week 0 and 40 mg weekly through Week 11
Other Names:
  • ABT-D2E7
  • Humira

  Eligibility

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

Inclusion Criteria:

  • Diagnosis of moderate to severe chronic plaque psoriasis
  • Active psoriasis, despite topical therapies

Exclusion Criteria:

  • Other active skin diseases or skin infections
  • Prior exposure to any anti-TNF therapy
  • 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Beverly Paperiello / Director, Clinical Program Management, Abbott
ClinicalTrials.gov Identifier: NCT00645814     History of Changes
Other Study ID Numbers: M02-528
Study First Received: March 26, 2008
Last Updated: March 26, 2008

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

ClinicalTrials.gov processed this record on June 23, 2017