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Immediate Response With Adalimumab and Its Impact on Quality of Life and Other Comorbidity Factors in Patients With Moderate to Severe Plaque Psoriasis

Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriasis

Intervention: Adalimumab (Biological)

Phase: Phase 4

Status: Completed

Sponsored by: AbbVie (prior sponsor, Abbott)

Official(s) and/or principal investigator(s):
Jose-Luis Canadas, Medical Director, MD, Study Director, Affiliation: AbbVie

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.

Clinical Details

Official title: Immediate Response With Adalimumab and Its Impact on Quality of Life and Other Comorbidity Factors in Patients With Moderate to Severe Plaque Psoriasis

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Percentage of Participants With Psoriasis Area and Severity Index (PASI)-75 Response at Week 4

Percentage of Participants With Psoriasis Area and Severity Index (PASI)-75 Response at Week 16

Percentage of Participants With a Dermatology Life Quality Index (DLQI) Score < 6 at Week 4

Percentage of Participants With a Dermatology Life Quality Index (DLQI) Score < 6 at Week 16

Secondary outcome:

Mean Score of Dermatology Life Quality Index (DLQI) at Baseline and Week 4

Mean Score of Dermatology Life Quality Index (DLQI) at Baseline and Week 16

Dermatology Life Quality Index (DLQI) Categories at Week 4

Dermatology Life Quality Index (DLQI) Categories at Week 16

Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-50, 90, 100 Responses at Week 4

Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-50, 90, 100 Responses at Week 16

Physician's Global Assessment (PGA) at Week 4

Physician's Global Assessment (PGA) at Week 16

Mean Lipid Profile, Triglycerides, and C-Reactive Protein (CRP) at Baseline and Week 16

Mean Homocysteine Levels at Baseline and Week 16

Percentage of Obese vs. Non-obese (Per Body Mass Index [BMI]) Participants Achieving a Psoriasis Area and Severity Index (PASI)-75 Response and a Total Dermatology Life Quality Index (DLQI) Score of <6 at Week 16

Percentage of Obese vs. Non-obese (Per Waist-Hip Ratio) Participants Achieving a Psoriasis Area and Severity Index (PASI)-75 Response and a Total Dermatology Life Quality Index (DLQI) Score of <6 at Week 16

Serum Levels of Folic Acid at Baseline and Week 4

Serum Levels of Vitamin B6 at Baseline and Week 4

Serum Levels of Vitamin B12 at Baseline and Week 4

Serum Levels of Folic Acid at Baseline and Week 16

Serum Levels of Vitamin B6 at Baseline and Week 16

Serum Levels of Vitamin B12 at Baseline and Week 16

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, 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. Safety and efficacy measures were performed throughout the study.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Site Reference ID/Investigator# 50942, Circuito Comercial Satelite, Mexico

Site Reference ID/Investigator# 40964, Iztapalapa 04230, Mexico

Site Reference ID/Investigator# 50943, Mexico City 06780, Mexico

Site Reference ID/Investigator# 40962, Monterrey 64718, Mexico

Site Reference ID/Investigator# 40965, Monterrey 64460, Mexico

Site Reference ID/Investigator# 40662, Toluca de Lerdo 50120, Mexico

Site Reference ID/Investigator# 41062, Toluca de Lerdo 50120, Mexico

Site Reference ID/Investigator# 40963, Zapopan 45190, Mexico

Additional Information

Related info

Starting date: October 2010
Last updated: February 1, 2013

Page last updated: August 23, 2015

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