Phase 4
N=72
Controlled Study of Humira in Subjects With Chronic Plaque Psoriasis of the Hands and/or Feet
Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT00735787 ↗Enrolled (actual)
72
Serious AEs
4.2%
Results posted
Nov 2010
Primary outcome: Primary: Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16 — 1; 15 subjects — p=0.014
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Placebo (Biological); Adalimumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16 |
1; 15 | 0.014 sig |
| SECONDARY Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF) |
-2.35; -6.24; -1.91; -7.73; -3.04; -9.33 | — |
| SECONDARY Mean Change From Baseline in ESIF for Palms |
-1.78; -3.33; -1.57; -4.33; -2.09; -5.35 | — |
| SECONDARY Mean Change From Baseline in ESIF for Soles |
-0.57; -2.92; -0.35; -3.39; -0.96; -4.04 | — |
| SECONDARY Number of Subjects With Moderate Improvement in ESIF From Baseline |
1; 8; 2; 10; 3; 17 | — |
| SECONDARY Number of Subjects With Marked Improvement in ESIF From Baseline |
0; 3; 0; 5; 0; 7 | — |
| SECONDARY Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) |
-0.63; -0.88; -0.13; -1.67; -1.00; -2.00 | — |
| SECONDARY Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild |
2; 15; 3; 21; 6; 21 | — |
| SECONDARY Number of Subjects With PGA of Clear or Almost Clear |
1; 4; 1; 10; 2; 12 | — |
| SECONDARY Number of Subjects With PGA of Clear |
0; 1; 0; 2; 0; 3 | — |
| SECONDARY Number of Subjects With Psoriasis Area and Severity Index (PASI) 50 |
5; 21; 8; 21 | — |
| SECONDARY Number of Subjects With PASI 75 |
2; 15; 4; 11 | — |
| SECONDARY Number of Subjects With PASI 90 |
0; 10; 4; 10 | — |
| SECONDARY Number of Subjects With PASI 100 |
0; 7; 1; 8 | — |
| SECONDARY Mean Change From Baseline in Dermatology Life Quality Index (DLQI) |
-3.43; -4.35; -3.09; -4.08; -4.22; -4.78 | — |
| SECONDARY Number of Subjects Achieving a DLQI of 0 |
1; 3; 1; 3; 0; 7 | — |
| SECONDARY Mean Change From Baseline in Visual Analog Scale (VAS) for Psoriasis and Psoriatic Arthritis Pain |
-12.45; -17.49; -16.25; -16.59 | — |
| SECONDARY Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) |
6.32; 4.70; 7.72; 5.34; 2.60; 3.16 | — |
| SECONDARY Mean Change From Baseline in Patient Health Questionnaire (PHQ-9) |
-2.85; -2.86; -2.43; -1.80; -2.64; -2.14 | — |
| SECONDARY Number of Subjects With Difficulties According to PHQ-9 |
4; 20; 9; 19; 3; 5 | — |
Summary
Evaluate the efficacy and safety of a 16-week course of Humira (adalimumab) compared to placebo in adults with chronic plaque psoriasis of the hands and/or feet and the sustainability of response for 12 additional weeks.
Eligibility Criteria
Inclusion Criteria
- Adult with Diagnosis of chronic plaque psoriasis of the Hands and Feet for at least 6 months, with a PGA >/=3 and candidates for systemic therapy;
- Patients in good general health
- Able to self-administer injections
- Negative chest x-ray (CXR) and purified protein derivative (PPD) test, unless willing to start anti-tuberculosis (TB) prophylaxis
Exclusion Criteria
- Previous treatment with HUMIRA®
- Required mediation stability or washouts for: systemic corticosteroids (28 days), other investigational agent, other systemic therapies for psoriasis, ultraviolet B (UVB), psoralen with UVA (PUVA)
- Other active skin diseases or skin infections
- Diagnosis of palmoplantar pustulosis; erythrodermic psoriasis, pustular psoriasis, medication-induced or exacerbated psoriasis or new onset of guttate psoriasis
- Evidence of dysplasia or history of malignancy (Other than a successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix);
- History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active tuberculosis (TB);
- History of moderate to severe congestive heart failure,
- Recent cerebrovascular accident and any other condition which, in the opinion of the investigator, would put the subject at risk;
- History of central nervous system (CNS) demyelinating disease or neurologic symptoms suggestive of CNS demyelinating disease;
- History of clinically significant drug or alcohol abuse in the last 12 months;
- Infection(s) requiring treatment with intravenous (IV) antibiotics, IV antivirals, or IV antifungals within 30 days prior to Baseline or oral antibiotics, oral antivirals, or oral antifungals within 14 days prior to Baseline;
- Known hypersensitivity to the excipients of HUMIRA® as stated in the label;
- Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study.
- Prior exposure to Tysabri® (natalizumab)
Data sourced from ClinicalTrials.gov (NCT00735787). 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.