Phase 4
N=72
Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis
Nail Psoriasis · Plaque Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT00581100 ↗Enrolled (actual)
72
Serious AEs
2.8%
Results posted
Aug 2010
Primary outcome: Primary: Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail — -4.32; -4.36 units on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- etanercept (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail |
-4.32; -4.36 | <0.0001 sig |
| SECONDARY Change From Baseline in Overall Nail Psoriasis Severity Index (NAPSI) Score |
-22.64; -22.63 | <0.0001 sig |
| SECONDARY Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24 |
60.61; 51.61; 82.86; 81.25 | <0.001 sig |
| SECONDARY Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24 |
18.18; 19.35; 57.14; 68.75 | 0.007 sig |
| SECONDARY Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24 |
54.55; 48.39; 68.57; 81.25 | <0.001 sig |
| SECONDARY Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24 |
9.09; 19.35; 62.86; 62.50 | 0.069 |
| SECONDARY Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score |
-14.81; -14.11 | <0.0001 sig |
| SECONDARY Percent of Participants Achieving a 50% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24 |
90.91; 87.10; 85.71; 84.38 | <0.001 sig |
| SECONDARY Percent of Participants Achieving a 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24 |
51.52; 58.06; 77.14; 62.50 | <0.001 sig |
| SECONDARY Change From Baseline in Physician Global Assessment (PGA) of Psoriasis |
-1.65; -1.84 | <0.0001 sig |
| SECONDARY Percent of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear or Almost Clear |
68.57; 75.00 | <0.001 sig |
| SECONDARY Percent of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Mild or Better |
82.86; 87.50 | <0.001 sig |
| SECONDARY Change From Baseline in the Dermatology Life Quality Index (DLQI) |
-8.60; -8.74 | <0.0001 sig |
| SECONDARY Change From Baseline in Physician Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS) |
-44.66; -41.03 | <0.0001 sig |
| SECONDARY Change From Baseline in Patient Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS) |
-48.89; -41.69 | <0.0001 sig |
| SECONDARY Change From Baseline in Physician Fingernail Grading Assessment Total Score |
-11.47; -12.21 | <0.0001 sig |
Summary
The purpose of this study is to evaluate if Etanercept administered at a higher initial dose provides greater improvement in nail and skin psoriasis symptoms than a regimen with a lower initial dose.
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- Active, stable plaque psoriasis defined by the following criteria:
- Body surface area (BSA) ≥ 10 % at screening and baseline
- Or, PASI >10 at screening and baseline
- Or, PGA of Psoriasis status of moderate or worse (moderate, marked, or severe) at screening and baseline
- Or, DLQI > 10 at baseline
- Active fingernail psoriasis defined as target fingernail NAPSI ≥ 2 and overall NAPSI > 14 - Target nail is defined as the nail with the highest nail score (matrix+bed scores) at baseline. Should more than one fingernail have the same score, the target fingernail will be chosen by the investigator.
- Failure of at least one systemic psoriasis therapy for nail psoriasis
- Eligible to receive biologic therapy for psoriasis in accordance to local guidelines
Exclusion Criteria
- Evidence of Skin conditions other than psoriasis
- Psoralen plus ultraviolet radiation (PUVA), cyclosporine, alefacept, methotrexate, acitretin, or any other systemic anti-psoriasis therapy within 28 days of study drug initiation
- Prior exposure to any TNF-inhibitor. Prior exposure to efalizumab
Data sourced from ClinicalTrials.gov (NCT00581100). 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.