Controlled Study of Humira in Subjects With Chronic Plaque Psoriasis of the Hands and/or Feet

Abbott

Status and phase: Completed; Phase 4

Conditions: Psoriasis

Treatments: Biological: Adalimumab; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00735787

M10-405

Details and patient eligibility

About

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.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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81 participants in 2 patient groups, including a placebo group

Placebo/Adalimumab

Placebo Comparator group

Description:

Loading dose of 2 placebo injections at Week 0 and placebo injections every other week (eow) from Week 1 through Week 15. In second period of study, subjects who continued in the study received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.

Treatment:

Biological: Placebo

Biological: Adalimumab

Adalimumab

Active Comparator group

Description:

80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 15. For subjects who continued in the second period of the study, subjects received 2 placebo injections at Week 16 to maintain the blind. Open-label 40 mg adalimumab eow was administered from Week 17 through Week 27.

Treatment:

Biological: Adalimumab