Immediate Response With Adalimumab and Its Impact on Quality of Life and Other Comorbidity Factors in Patients With Moderate to Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Adalimumab
Intervention description: Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Intervention MeSH terms: Adalimumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Humira; Adalimumab; Plaque Psoriasis

Summary:

      W11-050 is a Mexican open label multicenter study that has been designed to further assess
      the safety and efficacy of adalimumab in the treatment of patients with active plaque
      psoriasis who have failed prior conventional systemic psoriasis treatment or who are
      candidates for systemic therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Able and willing to give written informed consent prior to any study related
             procedures and to comply with the requirements of the study protocol

          2. Male and female subjects between 18 and 75 years old

          3. Diagnosis of moderate to severe types I and II plaque psoriasis (Type I : symptoms
             onset before 40 years old; Type II: symptoms onset after 40 years old), with at least
             6 months of duration

          4. Documented moderate to severe plaque psoriasis based on Psoriasis Area and Severity
             Index (PASI) score >10

          5. Subjects naïve to adalimumab therapy

          6. Subject must be evaluated for active and latent tuberculosis (TB) infection by using a
             Purified Protein Derivative (PPD) skin test, chest x-ray (posterior to anterior (PA)
             and lateral views) and a detailed review of the subject's medical history. This
             screening must be negative

          7. A negative pregnancy test (serum human chorionic gonadotrophin) for women of
             childbearing potential prior to start of study treatment. (Non-childbearing potential
             is defined as postmenopausal for at least 1 year or surgically sterile [bilateral
             tubal ligation, bilateral oophorectomy or hysterectomy])

          8. Able and willing to self-administer subcutaneous injections or have available a
             suitable person to administer subcutaneous injections

          9. Subject is judged to be in generally good health as determined by the investigator

        Exclusion Criteria:

          1. Prior treatment with any investigational agent within 30 days, or five half-lives of
             the product, which ever is longer. Subject has been treated with any investigational
             drug of chemical or biologic nature within a minimum of 30 days or five half lives
             (whichever is longer) of the drug prior to study entry (Baseline Visit)

          2. Subject has other active skin diseases or skin infections (bacterial, fungal, or
             viral) that may interfere with the evaluation of psoriasis or compromise the subject's
             safety

          3. Subject has a history of dysplasia, malignancy (including lymphoma and leukemia), or
             lymphoproliferative disease other than: a. Successfully and completely treated
             non-metastatic squamous or basal cell carcinoma of the skin with no recurrence within
             the last five years. b. Localized carcinoma in situ of the cervix or cervical
             dysplasia, with no recurrence within the last five years

          4. Persistent or recurrent infections or severe infections requiring hospitalization or
             treatment with intravenous (IV) antibiotics, IV antivirals, or IV antifungals within
             30 days, or oral antibiotics, oral antivirals or oral antifungals within 14 days prior
             to Baseline Visit

          5. Other medical conditions: uncontrolled diabetes, unstable ischemic heart disease,
             congestive heart failure New York Heart Association (NYHA) III-IV, recent stroke
             (within three months), chronic leg ulcer and any other condition (e.g., indwelling
             urinary catheter) which, in the opinion of the investigator, may place the subject at
             risk

          6. Previous diagnosis or signs highly indicative of central nervous system demyelinating
             diseases (e.g., optic neuritis, ataxia, apraxia)

          7. History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection, human
             immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring
             infections or active TB

          8. Female subjects who are pregnant or breast-feeding

          9. History of clinically significant drug or alcohol abuse in the last year

         10. Subject started receiving a new topical therapy within the last four weeks prior to
             the Baseline visit for areas other than the palms, soles of feet, axilla and groin

         11. Subject started being treated with ultraviolet B (UVB) phototherapy, within the last
             four weeks prior to the Baseline visit

         12. Subject was treated with psoralen ultraviolet A (PUVA) phototherapy within the last
             four weeks prior to the Baseline visit

         13. Subject has been initiated on a new systemic agent within the last four weeks prior to
             the Baseline visit

         14. Patients with history of atopy

         15. Patients with any other autoimmune disease such as systemic lupus erythematosus (SLE)
             , Sdx Sjögren, vasculitis etc

         16. Known hypersensitivity to the excipients of adalimumab as stated in the label

         17. Female subjects who are pregnant or breast-feeding or considering becoming pregnant
             during the study

         18. Subject is considered by the investigator, for any reason, to be an unsuitable
             candidate for the study

         19. Subject with any prior exposure to Tysabri (natalizumab), or Orencia (abatacept)

         20. Subjects with positive immunologic test for hepatitis A, B or C (Positive test of any
             of the following: hepatitis A viral antibody immunoglobulin M (HAV-IgM), hepatitis B
             surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab)

         21. Subjects with a positive immunologic test for HIV determined by enzyme-linked
             immunosorbent assay (ELISA) method