Clinical trial NCT01265823: Immediate Response With Adalimumab and Its Impact on Quality of Life and Other Comorbidity Factors in Patients With Moderate to Severe Plaque Psoriasis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Keywords: Humira
Adalimumab
Plaque Psoriasis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2010-12-23
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 failed prior conventional systemic psoriasis treatment or who are candidates for systemic therapy.

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 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

Primary outcomes:
measure: Percentage of Participants With Psoriasis Area and Severity Index (PASI)-75 Response at Week 4
timeFrame: Week 4
measure: Percentage of Participants With Psoriasis Area and Severity Index (PASI)-75 Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants With a Dermatology Life Quality Index (DLQI) Score < 6 at Week 4
timeFrame: Week 4
measure: Percentage of Participants With a Dermatology Life Quality Index (DLQI) Score < 6 at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Mean Score of Dermatology Life Quality Index (DLQI) at Baseline and Week 4
timeFrame: Baseline, Week 4
measure: Mean Score of Dermatology Life Quality Index (DLQI) at Baseline and Week 16
timeFrame: Baseline, Week 16
measure: Dermatology Life Quality Index (DLQI) Categories at Week 4
timeFrame: Week 4
measure: Dermatology Life Quality Index (DLQI) Categories at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-50, 90, 100 Responses at Week 4
timeFrame: Week 4
measure: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-50, 90, 100 Responses at Week 16
timeFrame: Week 16
measure: Physician's Global Assessment (PGA) at Week 4
timeFrame: Week 4
measure: Physician's Global Assessment (PGA) at Week 16
timeFrame: Week 16
measure: Mean Lipid Profile, Triglycerides, and C-Reactive Protein (CRP) at Baseline and Week 16
timeFrame: Baseline, Week 16
measure: Mean Homocysteine Levels at Baseline and Week 16
timeFrame: Baseline, Week 16
measure: 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
timeFrame: Week 16
measure: 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
timeFrame: Week 16
measure: Serum Levels of Folic Acid at Baseline and Week 4
timeFrame: Baseline, Week 4
measure: Serum Levels of Vitamin B6 at Baseline and Week 4
timeFrame: Baseline, Week 4
measure: Serum Levels of Vitamin B12 at Baseline and Week 4
timeFrame: Baseline, Week 4
measure: Serum Levels of Folic Acid at Baseline and Week 16
timeFrame: Baseline, Week 16
measure: Serum Levels of Vitamin B6 at Baseline and Week 16
timeFrame: Baseline, Week 16
measure: Serum Levels of Vitamin B12 at Baseline and Week 16
timeFrame: Baseline, Week 16
Other outcomes:
Locations:
city: Circuito Comercial Satelite
country: Mexico
facility: Site Reference ID/Investigator# 50942
city: Iztapalapa
country: Mexico
facility: Site Reference ID/Investigator# 40964
city: Mexico City
country: Mexico
facility: Site Reference ID/Investigator# 50943
city: Monterrey
country: Mexico
facility: Site Reference ID/Investigator# 40965
city: Monterrey
country: Mexico
facility: Site Reference ID/Investigator# 40962
city: Toluca de Lerdo
country: Mexico
facility: Site Reference ID/Investigator# 40662
city: Toluca de Lerdo
country: Mexico
facility: Site Reference ID/Investigator# 41062
city: Zapopan
country: Mexico
facility: Site Reference ID/Investigator# 40963
Study officials:
affiliation: AbbVie
name: Jose-Luis Canadas, Medical Director, MD
role: STUDY_DIRECTOR
References: