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OpenTrials
Completed

NCT Number: NCT00645905

Study of Two Dosing Schedules of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Study of Two Dosing Schedules 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

  • 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

Treatment and study plan

Adalimumab

Drug

OL 80 mg at Week 0, 40 mg weekly through Week 12, blinded 40 mg eow through Week 48, withdrawal and observation for 360 days after last dose

Other names: ABT-D2E7, Humira

placebo for adalimumab

Drug

OL 80 mg at Week 0, 40 mg weekly through Week 12, blinded placebo eow through Week 48, withdrawal and observation for 360 days after last dose

Other names: placebo

Primary outcomes

  1. Psoriasis Area and Severity Index

    Time frame: Week 12-Week 24

  2. Adverse Events

    Time frame: Throughout Study Participation

Secondary outcomes

  1. Psoriasis Area and Severity Index

    Time frame: Week 12, Week 24 through 360 days after last dose

  2. Physician's Global Assessment

    Time frame: Week 12, Week 24 through 360 days after last dose

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Important dates

Study start
2003
Primary completion
2005
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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