The Quality of Life Study in Psoriasis Patients After Ustekinumab Treatment

NCT01511315 | Completed Phase 4 Results

• 1 other identifier: Stelara QoL
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to see if patient quality of life can be approved after treatment with an injectable medication called ustekinumab for the treatment of generalized psoriasis. The investigators hypothesize that the investigators will see improvement in quality of life.

Conditions

Psoriasis

Keywords

Moderate to severe psoriasis

Outcome Measures

Primary Outcomes (1)

• Improvement in Quality of Life Measured by Change in Psychological General Well-Being Scale (PGWB) at Week 36 From Baseline.

  The PGWB is a self-administered validated psychometric instrument that measures a person's emotional well-being. It is specifically designed to be suitable for assessing psychological well being in the general medical population as opposed to a psychiatric population. The 22 questions of the PGWB can be further divided into 6 domains: anxiety, depressed mood, positive well being, self-control, general health, and vitality. The PGWB is graded on a Likert scale, which is commonly used in psychometric questionnaires where the answers range from strongly agree to strongly disagree with gradations in between. Total scores range from 0 to 110, with higher scores indicating better psychological well being. This instrument has been validated and used in many countries on large samples of the general population and on various subsets of medical patients.

  Baseline, 36 weeks

Secondary Outcomes (6)

• Change in Psychological General Well-Being Scale (PGWB) Over Time (at Weeks 12 and 24) From Baseline

  Baseline, 12 and 24 weeks

• Change in Work Productivity and Activity Impairment Scale (WPAI-PSO) Over Time at Week 36 From Baseline

  Baseline, 36 Weeks

• Change in Psoriasis Quality of Life - 12 Items (PQOL-12) Over Time (at Weeks 12, 24, and 36) From Baseline

  Baseline, 12, 24, and 36 Weeks

• Change in Dermatology Life Quality Index (DLQI) Over Time (at Weeks 12, 24, and 36) From Baseline

  Baseline, 12, 24, and 36 Weeks

• Percentage of Patients Achieving PGA of Clear or Almost Clear at Weeks 12, 24, and 36

  Weeks 12, 24, and 36

Study Arms (1)

Ustekinumab

EXPERIMENTAL

Drug: Ustekinumab

Interventions

Ustekinumab DRUG

Biologic agent: sub-cutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter.

Ustekinumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects are non-immunocompromised males or females 18 years of age or older
• Subjects have moderate-to-severe (≥10% total body surface area) plaque psoriasis
• Subject diagnosed at least 6 months prior to entering the study
• Negative urine pregnancy test within 7 days before the first dose of ustekinumab in all women (except those surgically sterile or at least 5 years postmenopausal)
• Sexually active subjects of childbearing potential must agree to use medically acceptable form of contraception during screening and throughout the study.
• Are considered eligible according to the following tuberculosis (TB) screening criteria:
• Have no history of latent or active TB prior to screening. An exception is made for subjects currently receiving treatment for latent TB with no evidence of active TB, or who have a history of latent TB and documentation of having completed appropriate treatment for latent TB within 3 years prior to the first administration of study agent. It is the responsibility of the investigator to verify the adequacy of previous antituberculous treatment and provide appropriate documentation.
• Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
• Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study agent.
• Within 1 month prior to the first administration of study agent, have a negative QuantiFERON-TB Gold test result, or have a newly identified positive QuantiFERON-TB Gold test result in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study agent. The QuantiFERON-TB Gold test are not required at screening for subjects with a history of latent TB and ongoing treatment for latent TB or documentation of having completed adequate treatment as described above; Subjects with documentation of having completed adequate treatment as described above are not required to initiate additional treatment for latent TB.
• Have a chest radiograph both posterior-anterior and lateral views, taken within 3 months prior to the first administration of study agent and read by a qualified radiologist, with no evidence of current, active TB or old, inactive TB.
• Subject meets concomitant medication requirements or agrees to complete a washout for restricted medications prior to starting the study.
• Washout Period :
• Must not have initiated or changed any other medications that could affect psoriasis (e.g. beta blockers, lithium salts, antimalarials) within the 4 week period prior to Week 0 or during the study
• Subjects must not have received immunosuppressive, chemotherapy and/or systemic therapy including oral calcineurin inhibitors (such as cyclosporine), retinoids (Vitamin A and analogues), Methotrexate, Azathioprine, 6-thioguanine, Mycophenolate mofetil (MMF), Hydroxyurea, or cytokines (such as interferon-gamma) within the 4 week period prior to Week 0 or during the study

You may not qualify if:

• Subject is younger than 18 years of age.
• Subject has less than 10% body surface involvement of his/her psoriasis.
• Subjects with erythrodermic, pustular, or guttate psoriasis
• History of known or suspected intolerance to any of the ingredients of the investigational study product.
• Evidence of skin conditions other than psoriasis that would interfere with study-related evaluations of psoriasis.
• Evidence of active infections such as fevers, chills, sweats, or history of untreated Lyme disease and active severe infections within 4 weeks before screening visit, or between the screening and Week 0 visits
• Subject has a history of listeriosis, untreated TB, persistent or active infections requiring hospitalization or treatment with IV antibiotics, IV antiretrovirals, or IV antifungals within 30 days of baseline, or oral antibiotics, antivirals, or antifungals for purpose of treating infection, within 14 days of baseline.
• Have a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, prior to screening.
• Have had a Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening.
• Have a chest radiograph within 3 months prior to the first administration of study agent that shows an abnormality suggestive of malignancy or current active infection, including TB.
• Have had a nontuberculous mycobacterial infection or opportunistic infection (eg. Cytomegalovirus, pneumocystosis, aspergillosis) within 6 months prior to screening.
• History of immune compromised status \[e.g. human immunodeficiency virus (HIV) positive status or other immune suppressing drug\] or a congenital or acquired immunodeficiency or subject testing positive for HIV, Hepatitis B, and/or Hepatitis C during screening procedures.
• Subject has a poorly controlled medical condition including, but not limited to, unstable cardiovascular disease, poorly controlled diabetes, recent stroke, history of recurrent infections, or any other condition for which, in the opinion of the investigator, participation in the study would place the subject at risk
• Subject has a history of or ongoing drug or alcohol abuse
• Subject is not willing to comply with wash-out requirements (see above)

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Psoriasis and Skin Treatment Center

San Francisco, California, 94118, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Mio Nakamura, MD
• Organization: UCSF Psoriasis Center

mio.nakamura@ucsf.edu

4154764701

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2012
• First Posted: January 18, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 12, 2016
• Results First Posted: February 12, 2016

Record last verified: 2016-01

Locations

US (1)