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
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
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 23, 2014