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Completed

NCT Number: NCT00646191

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

Completed

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adalimumab

Drug

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

Primary outcomes

  1. Psoriasis Area and Severity Index

    Time frame: Week 12

  2. Adverse Events

    Time frame: Throughout Study Participation

Secondary outcomes

  1. Psoriasis Area and Severity Index

    Time frame: Week 0, 4, 8, 12, 16, 20, 24, 32, 40 and 48

  2. DLQI, SF-36, Zung Depression Self-Rating Scale, EQ-5D, VAS

    Time frame: Week 12, 24 and 48

  3. Physician's Global Assessment

    Time frame: Week 12, 16, 20, 24, 32, 40 and 48

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2004
First posted
Mar 28, 2008
Registry last updated
Mar 28, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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