Phase 3
Completed N=152
Open Label Study of Adalimumab in Subjects Who Have a Sub-optimal Response to Systemic Therapy or Phototherapy
Source: ClinicalTrials.gov NCT00566722 ↗Enrolled (actual)
152
Serious AEs
3.3%
Results posted
May 2010
Primary outcomePrimary: Number of Participants Who Achieved a Physician's Global Assessment (PGA) of Clear (0) or Minimal (1) at Week 16 — 25; 14; 40 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Achieved a Physician's Global Assessment (PGA) of Clear (0) or Minimal (1) at Week 16 |
25; 14; 40 | — |
| SECONDARY Number of Participants Achieving a PGA of Clear (0) at Week 16 |
15; 6; 10 | — |
| SECONDARY Number of Participants Achieving at Least 1 Grade of Improvement in PGA at Week 16 Compared to Screening |
32; 23; 59 | — |
| SECONDARY Number of Participants Achieving 0 or 1 on Patient's Global Assessment at Weeks 2, 4, and 8 |
5; 0; 9; 13; 7; 20 | — |
| SECONDARY Dermatology Life Quality Index (DLQI) Total Score |
-4.8; -5.2; -3.3; -7.0; -6.5; -3.8 | — |
| SECONDARY Number of Participants Achieving DLQI Total Score of 0 at Week 4 and Week 16 |
6; 2; 2; 12; 6; 17 | — |
| SECONDARY Psoriasis-related Pruritus Assessment |
-2.9; -3.0; -1.7 | — |
| SECONDARY Visual Analog Scale (VAS) for Pain Involving Psoriatic Plaques and/or Psoriatic Arthritis |
-14.7; -21.4; -12.7 | — |
| SECONDARY Percent Work Time Missed Due to Psoriasis |
0.7; 1.3; -0.1 | — |
| SECONDARY Percent Overall Work Impairment Due to Psoriasis |
-4.0; -6.4; -2.8 | — |
| SECONDARY Percent Impairment While Working Due to Psoriasis |
-5.5; -8.0; -1.5 | — |
| SECONDARY Percent Activity Impairment Due to Psoriasis |
-13.3; -12.2; -4.7 | — |
| SECONDARY Sleep Problems Index II |
-9.7; -7.7; -2.0 | — |
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
Data sourced from ClinicalTrials.gov (NCT00566722). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.