Open Label Study of Adalimumab in Subjects Who Have a Sub-optimal Response to Systemic Therapy or Phototherapy

Completed · Phase 3

Conditions studied: Psoriasis

In brief

The objective of this study was to evaluate the safety and efficacy profile of Humira (adalimumab) in patients who had a sub-optimal response to prior systemic therapy. This open-label study was conducted in a patient population of moderate to severe chronic plaque psoriasis patients, which is an approved patient population for adalimumab.

Key facts

Study ID

NCT00566722

Run by

Abbott

People needed

152

Starts

2008-01-01

Expected to finish

2009-04-01

Last updated by the study team

2011-04-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of chronic plaque psoriasis with disease duration of at least 6 months
• Sub-optimal response to treatment with etanercept, methotrexate, or narrow-band UVB phototherapy

You may not qualify if…

• Prior treatment with adalimumab
• Multiple concomitant therapy restrictions and/or washouts (topicals, ultraviolet, other systemic psoriasis therapies)
• Prior treatment with natalizumab
• Concurrent active skin diseases/infections
• Poorly controlled medical conditions
• History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease
• History of certain cancers

Where it is running

• Total Skin and Beauty Dermatology Centers — Birmingham, Alabama, United States
• Dermatology Research of Arkansas — Little Rock, Arkansas, United States
• Therapeutics Clinical Research — San Diego, California, United States
• Florida Academic Dermatology Centers — Miami, Florida, United States
• Peachtree Dermatology Associates — Atlanta, Georgia, United States
• Dawes Fretzin Clinical Research Group — Indianapolis, Indiana, United States
• ORA Clinical Research and Development — Andover, Massachusetts, United States
• New York University School of Medicine — New York, New York, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Montifiore Medical Center — The Bronx, New York, United States
• Paddington Testing Co. — Philadelphia, Pennsylvania, United States
• Clinical Partners — Johnston, Rhode Island, United States
• Radiant Research — Greer, South Carolina, United States
• Dermatology Treatment & Research Center, PA Research — Dallas, Texas, United States
• Baylor Research Institute — Dallas, Texas, United States
• Center for Clinical Studies — Houston, Texas, United States
• Virginia Clinical Research, Inc. — Norfolk, Virginia, United States
• Dermatology Associates — Seattle, Washington, United States
• Kirk Barber Research — Calgary, Alberta, Canada
• Stratica Medical — Edmonton, Alberta, Canada
• Eastern Canada Cutaneous Research Associates — Halifax, Nova Scotia, Canada
• Dermatrials Research — Hamilton, Ontario, Canada
• K.Papp Clinical Research Inc — Waterloo, Ontario, Canada
• Siena Medical Research — Montreal, Quebec, Canada
• Centre de Rescherche Dermatologique Du Quebec Metropolitain — Québec, Quebec, Canada

Full record on ClinicalTrials.gov

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