Status:
COMPLETED
Immediate Response With Adalimumab and Its Impact on Quality of Life and Other Comorbidity Factors in Patients With Moderate to Severe Plaque Psoriasis
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Psoriasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 fail...
Detailed Description
Up to 150 subjects having a diagnosis of active plaque psoriasis and fulfilling the study eligibility criteria were enrolled in Mexico. Adalimumab was administered as follows: 80 mg at baseline, follo...
Eligibility Criteria
Inclusion
- Able and willing to give written informed consent prior to any study related procedures and to comply with the requirements of the study protocol
- Male and female subjects between 18 and 75 years old
- 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
- Documented moderate to severe plaque psoriasis based on Psoriasis Area and Severity Index (PASI) score \>10
- Subjects naïve to adalimumab therapy
- 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
- 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 \[bilateral tubal ligation, bilateral oophorectomy or hysterectomy\])
- Able and willing to self-administer subcutaneous injections or have available a suitable person to administer subcutaneous injections
- Subject is judged to be in generally good health as determined by the investigator
Exclusion
- 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)
- 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
- 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
- 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
- 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
- Previous diagnosis or signs highly indicative of central nervous system demyelinating diseases (e.g., optic neuritis, ataxia, apraxia)
- History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active TB
- Female subjects who are pregnant or breast-feeding
- History of clinically significant drug or alcohol abuse in the last year
- 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
- Subject started being treated with ultraviolet B (UVB) phototherapy, within the last four weeks prior to the Baseline visit
- Subject was treated with psoralen ultraviolet A (PUVA) phototherapy within the last four weeks prior to the Baseline visit
- Subject has been initiated on a new systemic agent within the last four weeks prior to the Baseline visit
- Patients with history of atopy
- Patients with any other autoimmune disease such as systemic lupus erythematosus (SLE) , Sdx Sjögren, vasculitis etc
- Known hypersensitivity to the excipients of adalimumab as stated in the label
- Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study
- Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study
- Subject with any prior exposure to Tysabri (natalizumab), or Orencia (abatacept)
- 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)
- Subjects with a positive immunologic test for HIV determined by enzyme-linked immunosorbent assay (ELISA) method
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01265823
Start Date
October 1 2010
End Date
February 1 2012
Last Update
March 11 2013
Active Locations (8)
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1
Site Reference ID/Investigator# 50942
Circuito Comercial Satelite, Mexico
2
Site Reference ID/Investigator# 40964
Iztapalapa, Mexico, 04230
3
Site Reference ID/Investigator# 50943
Mexico City, Mexico, 06780
4
Site Reference ID/Investigator# 40965
Monterrey, Mexico, 64460