Clinical trial NCT00566722: Open Label Study of Adalimumab in Subjects Who Have a Sub-optimal Response to Systemic Therapy or Phototherapy
Official title: Open Label Study of Adalimumab in Subjects Who Have a Sub-optimal Response to Systemic Therapy or Phototherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2007-12-04
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: This 16-week multicenter, open-label study was designed to evaluate the efficacy and safety of a loading dose of 80 mg adalimumab, followed by 40 mg adalimumab every other week in the treatment of psoriasis in patients with a sub-optimal response to etanercept, methotrexate (MTX), or Narrow band Ultraviolet - B (NB-UVB).

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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants Who Achieved a Physician's Global Assessment (PGA) of Clear (0) or Minimal (1) at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Number of Participants Achieving a PGA of Clear (0) at Week 16
timeFrame: Week 16
measure: Number of Participants Achieving at Least 1 Grade of Improvement in PGA at Week 16 Compared to Screening
timeFrame: From Screening to Week 16
measure: Number of Participants Achieving 0 or 1 on Patient's Global Assessment at Weeks 2, 4, and 8
timeFrame: Weeks 2, 4, and 8
measure: Dermatology Life Quality Index (DLQI) Total Score
timeFrame: From Screening to Week 4 and Week 16
measure: Number of Participants Achieving DLQI Total Score of 0 at Week 4 and Week 16
timeFrame: Week 4 and Week 16
measure: Psoriasis-related Pruritus Assessment
timeFrame: From Screening to Week 16
measure: Visual Analog Scale (VAS) for Pain Involving Psoriatic Plaques and/or Psoriatic Arthritis
timeFrame: From Screening to Week 16
measure: Percent Work Time Missed Due to Psoriasis
timeFrame: From Screening to Week 16
measure: Percent Overall Work Impairment Due to Psoriasis
timeFrame: From Screening to Week 16
measure: Percent Impairment While Working Due to Psoriasis
timeFrame: From Screening to Week 16
measure: Percent Activity Impairment Due to Psoriasis
timeFrame: From Screening to Week 16
measure: Sleep Problems Index II
timeFrame: From Screening to Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Centers
state: Alabama
city: Little Rock
country: United States
facility: Dermatology Research of Arkansas
state: Arkansas
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Miami
country: United States
facility: Florida Academic Dermatology Centers
state: Florida
city: Atlanta
country: United States
facility: Peachtree Dermatology Associates
state: Georgia
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group
state: Indiana
city: Andover
country: United States
facility: ORA Clinical Research and Development
state: Massachusetts
city: Bronx
country: United States
facility: Montifiore Medical Center
state: New York
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Philadelphia
country: United States
facility: Paddington Testing Co.
state: Pennsylvania
city: Johnston
country: United States
facility: Clinical Partners
state: Rhode Island
city: Greer
country: United States
facility: Radiant Research
state: South Carolina
city: Dallas
country: United States
facility: Dermatology Treatment & Research Center, PA Research
state: Texas
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Seattle
country: United States
facility: Dermatology Associates
state: Washington
city: Calgary
country: Canada
facility: Kirk Barber Research
state: Alberta
city: Edmonton
country: Canada
facility: Stratica Medical
state: Alberta
city: Halifax
country: Canada
facility: Eastern Canada Cutaneous Research Associates
state: Nova Scotia
city: Hamilton
country: Canada
facility: Dermatrials Research
state: Ontario
city: Waterloo
country: Canada
facility: K.Papp Clinical Research Inc
state: Ontario
city: Montreal
country: Canada
facility: Siena Medical Research
state: Quebec
city: Quebec City
country: Canada
facility: Centre de Rescherche Dermatologique Du Quebec Metropolitain
state: Quebec
Study officials:
affiliation: Abbott
name: Martin M Okun, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.