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:
NCT00646191
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: adalimumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Multicenter Extension 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 ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: Throughout Study Participation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Psoriasis Area and Severity Index [ Time Frame: Week 0, 4, 8, 12, 16, 20, 24, 32, 40 and 48 ] [ Designated as safety issue: No ]
  • DLQI, SF-36, Zung Depression Self-Rating Scale, EQ-5D, VAS [ Time Frame: Week 12, 24 and 48 ] [ Designated as safety issue: No ]
  • Physician's Global Assessment [ Time Frame: Week 12, 16, 20, 24, 32, 40 and 48 ] [ Designated as safety issue: No ]

Enrollment: 137
Study Start Date: March 2003
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: adalimumab
40 mg eow through Week 12 followed by OL 40 mg eow through Week 48, permitted to escalate to weekly dosing upon relapse
Other Names:
  • ABT-D2E7
  • Humira
  • adalimumab
Active Comparator: B Drug: adalimumab
40 mg weekly through Week 48 (OL Week 12 - 48)
Other Names:
  • ABT-D2E7
  • Humira
  • adalimumab
Active Comparator: C Drug: adalimumab
80 mg W0, 40 mg eow through Week 12 followed by OL 40 mg eow through Week 48, permitted to escalate to weekly dosing upon relapse
Other Names:
  • ABT-D2E7
  • Humira
  • adalimumab

  Eligibility

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

Inclusion Criteria:

  • Subject completed 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

No publications provided

Responsible Party: Beverly Paperiello / Director, Clinical Program Management, Abbott
ClinicalTrials.gov Identifier: NCT00646191     History of Changes
Other Study ID Numbers: M02-529
Study First Received: March 26, 2008
Last Updated: March 26, 2008
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 30, 2014