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

NCT ID: NCT01265823

Last Updated: 2013-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-02-29

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.

Conditions

Psoriasis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adalimumab

Group Type: EXPERIMENTAL

Adalimumab

Intervention Type: BIOLOGICAL

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.

Interventions

Adalimumab

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 Type: BIOLOGICAL

Other Intervention Names

ABT-D2E7; Humira

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose-Luis Canadas, Medical Director, MD

Role: STUDY_DIRECTOR

AbbVie

Locations

Site Reference ID/Investigator# 50942

Circuito Comercial Satelite, , Mexico

Site Reference ID/Investigator# 40964

Iztapalapa, , Mexico

Site Reference ID/Investigator# 50943

Mexico City, , Mexico

Site Reference ID/Investigator# 40965

Monterrey, , Mexico

Site Reference ID/Investigator# 40962

Monterrey, , Mexico

Site Reference ID/Investigator# 40662

Toluca, , Mexico

Site Reference ID/Investigator# 41062

Toluca, , Mexico

Site Reference ID/Investigator# 40963

Zapopan, , Mexico

Countries

Mexico

Related Links

http://rxabbvie.com

Related info

Other Identifiers

W11-050

Identifier Type: -

Identifier Source: org_study_id