Open Label Study of Adalimumab in Subjects Who Have a Sub-optimal Response to Systemic Therapy or Phototherapy
NCT ID: NCT00566722
Last Updated: 2011-04-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
152 participants
INTERVENTIONAL
2008-01-31
2009-04-30
Brief Summary
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Detailed Description
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Approximately 150 participants were planned for 3 sub-studies: 80 participants with sub-optimal response to etanercept, 40 participants with sub-optimal response to MTX, and 30 participants with sub-optimal response to NB-UVB. Actual enrollment was 82 participants with sub-optimal response to etanercept, 41 participants with sub-optimal response to MTX, and 29 participants with sub-optimal response to NB-UVB.
Screening was performed at least 96 hours and no more than 31 days before the Baseline visit (Week 0). A participant who was eligible for the study based on sub-optimal response to one treatment (MTX, NB-UVB, or etanercept) was required to discontinue that treatment within a specified time before first dose of adalimumab (see descriptions of sub-study groups). In addition, if the participant was also receiving another qualifying treatment, he/she was required to have discontinued the other treatment at least 30 days before the Baseline visit (Week 0).
Adalimumab was administered by subcutaneous (SC) injection. At the Baseline Visit (Week 0), all participants received an initial dose of 80 mg adalimumab SC. Every other week (odd-numbered weeks) from Week 1 to Week 15, participants received 40 mg adalimumab SC.
This was a single group assignment study, that is, all participants received the same treatment; however, data were summarized for 3 groups (sub-studies) that were defined by psoriasis treatments participants received before entering this study: methotrexate, etanercept, or narrow-band, ultraviolet-B.
Efficacy was evaluated using the Physician's Global Assessment (PGA) of disease severity, and patient-reported outcomes: Patient's Global Assessment (PTGA) of disease severity, the Psoriasis-related Pruritus Assessment, the Dermatology Life Quality Index (DLQI), a visual analog scale (VAS) for plaque psoriasis and psoriatic arthritis pain, the Medical Outcomes Study (MOS) Sleep Scale, and the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI: SHP).
Serious and nonserious adverse events were summarized by sub-study of participants (suboptimal response to MTX, suboptimal response to NB-UVB, and suboptimal response to etanercept).
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Open Label
adalimumab
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.
Interventions
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adalimumab
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Sub-optimal response to treatment with etanercept, methotrexate, or narrow-band UVB phototherapy
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Abbott
Principal Investigators
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Martin M Okun, M.D., Ph.D.
Role: STUDY_DIRECTOR
Abbott
Locations
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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
Countries
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References
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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.
Other Identifiers
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M10-238
Identifier Type: -
Identifier Source: org_study_id
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