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

March 26, 2008
March 26, 2008
March 2003
September 2003   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
No Changes Posted
  • Psoriasis Area and Severity Index [ Time Frame: Week 1, 2, 4, 8, 12 ] [ Designated as safety issue: No ]
  • DLQI, SF-36, Zung Depression Self-Rating Scale, EQ-5D [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Psoriasis
  • Drug: placebo for adalimumab
    80 mg at Week 0 and 40 mg eow through Week 11
    Other Name: placebo
  • Drug: adalimumab
    80 mg at Week 0 and 40 mg eow through Week 11
    Other Names:
    • ABT-D2E7
    • Humira
    • adalimumab
  • Drug: adalimumab
    80 mg at Week 0 and 40 mg weekly through Week 11
    Other Names:
    • ABT-D2E7
    • Humira
    • adalimumab
  • Placebo Comparator: A
    Intervention: Drug: placebo for adalimumab
  • Active Comparator: B
    Intervention: Drug: adalimumab
  • Active Comparator: C
    Intervention: Drug: adalimumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
148
Not Provided
September 2003   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00645814
M02-528
No
Beverly Paperiello / Director, Clinical Program Management, Abbott
Abbott
Not Provided
Not Provided
Abbott
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP