Open Label Study of Adalimumab in Subjects Who Have a Sub-optimal Response to Systemic Therapy or Phototherapy
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 152
- Locations
- 25
- Primary Endpoint
- Number of Participants Who Achieved a Physician's Global Assessment (PGA) of Clear (0) or Minimal (1) at Week 16
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Open Label
Intervention: adalimumab (Biological)
Outcomes
Primary Outcomes
Number of Participants Who Achieved a Physician's Global Assessment (PGA) of Clear (0) or Minimal (1) at Week 16
Time Frame: 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 \[extreme red coloration, dusky to deep red coloration\]).
Secondary Outcomes
- 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)
- Psoriasis-related Pruritus Assessment(From Screening to Week 16)
- Visual Analog Scale (VAS) for Pain Involving Psoriatic Plaques and/or Psoriatic Arthritis(From Screening to Week 16)
- Percent Work Time Missed Due to Psoriasis(From Screening to Week 16)
- Percent Overall Work Impairment Due to Psoriasis(From Screening to Week 16)
- Percent Impairment While Working Due to Psoriasis(From Screening to Week 16)
- Percent Activity Impairment Due to Psoriasis(From Screening to Week 16)
- Sleep Problems Index II(From Screening to Week 16)