Open Label Study of Adalimumab in Subjects Who Have a Sub-optimal Response to Systemic Therapy or Phototherapy
1 other identifier
interventional
152
2 countries
25
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2008
Shorter than P25 for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2007
CompletedFirst Posted
Study publicly available on registry
December 4, 2007
CompletedStudy Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedResults Posted
Study results publicly available
May 28, 2010
CompletedApril 12, 2011
April 1, 2011
1.2 years
December 1, 2007
April 28, 2010
April 8, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Achieved a Physician's Global Assessment (PGA) of Clear (0) or Minimal (1) at Week 16
The PGA is a 6-point scale used to measure the severity of a patient's disease. Plaque elevation, scaling, and erythema are rated from 0= clear (no plaque elevation; no scaling; erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration) to 5=very severe (plaque elevation=very marked; scaling=very coarse; erythema=very severe \[extreme red coloration, dusky to deep red coloration\]).
Week 16
Secondary Outcomes (12)
Number of Participants Achieving a PGA of Clear (0) at Week 16
Week 16
Number of Participants Achieving at Least 1 Grade of Improvement in PGA at Week 16 Compared to Screening
From Screening to Week 16
Number of Participants Achieving 0 or 1 on Patient's Global Assessment at Weeks 2, 4, and 8
Weeks 2, 4, and 8
Dermatology Life Quality Index (DLQI) Total Score
From Screening to Week 4 and Week 16
Number of Participants Achieving DLQI Total Score of 0 at Week 4 and Week 16
Week 4 and Week 16
- +7 more secondary outcomes
Study Arms (1)
Open Label
EXPERIMENTALInterventions
Participants received an 80 mg adalimumab loading dose by subcutaneous injection at Baseline (Week 0). From Week 1 to Week 15, participants received 40 mg adalimumab by subcutaneous injection every other week.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (25)
Total Skin and Beauty Dermatology Centers
Birmingham, Alabama, 35205, United States
Dermatology Research of Arkansas
Little Rock, Arkansas, 72205, United States
Therapeutics Clinical Research
San Diego, California, 92123, United States
Florida Academic Dermatology Centers
Miami, Florida, 33136, United States
Peachtree Dermatology Associates
Atlanta, Georgia, 30327, United States
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, 46256, United States
ORA Clinical Research and Development
Andover, Massachusetts, 01810, United States
New York University School of Medicine
New York, New York, 10016, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Montifiore Medical Center
The Bronx, New York, 10467, United States
Paddington Testing Co.
Philadelphia, Pennsylvania, 19103, United States
Clinical Partners
Johnston, Rhode Island, 02919, United States
Radiant Research
Greer, South Carolina, 29651, United States
Dermatology Treatment & Research Center, PA Research
Dallas, Texas, 75230, United States
Baylor Research Institute
Dallas, Texas, 75246, United States
Center for Clinical Studies
Houston, Texas, 77058, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507, United States
Dermatology Associates
Seattle, Washington, 98101, United States
Kirk Barber Research
Calgary, Alberta, T2S 3B3, Canada
Stratica Medical
Edmonton, Alberta, T5K 1X3, Canada
Eastern Canada Cutaneous Research Associates
Halifax, Nova Scotia, B3H 1Z4, Canada
Dermatrials Research
Hamilton, Ontario, L8N 1V6, Canada
K.Papp Clinical Research Inc
Waterloo, Ontario, N2J 1C4, Canada
Siena Medical Research
Montreal, Quebec, Canada
Centre de Rescherche Dermatologique Du Quebec Metropolitain
Québec, Quebec, G1V 4X7, Canada
Related Publications (1)
Strober BE, Poulin Y, Kerdel FA, Langley RG, Gu Y, Gupta SR, Okun MM, Papp KA. Switching to adalimumab for psoriasis patients with a suboptimal response to etanercept, methotrexate, or phototherapy: efficacy and safety results from an open-label study. J Am Acad Dermatol. 2011 Apr;64(4):671-81. doi: 10.1016/j.jaad.2010.03.009.
PMID: 21414495DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- Abbott
Study Officials
- STUDY DIRECTOR
Martin M Okun, M.D., Ph.D.
Abbott
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 1, 2007
First Posted
December 4, 2007
Study Start
January 1, 2008
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
April 12, 2011
Results First Posted
May 28, 2010
Record last verified: 2011-04