The Quality of Life Study in Psoriasis Patients After Ustekinumab Treatment
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Ustekinumab
Intervention description: Biologic agent: sub-cutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter.
Intervention MeSH terms: Ustekinumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Moderate to severe psoriasis

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects are non-immunocompromised males or females 18 years of age or older

          2. Subjects have moderate-to-severe (≥10% total body surface area) plaque psoriasis

          3. Subject diagnosed at least 6 months prior to entering the study

          4. 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)

          5. Sexually active subjects of childbearing potential must agree to use medically
             acceptable form of contraception during screening and throughout the study.

          6. 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.

          7. 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

                    -  Subjects must not have received phototherapy (broadband or narrow-band UVB)
                       within the 2 week period prior to Week 0 or during the study.

                    -  Subjects must not have received photochemotherapy (PUVA) within the 4 week
                       period prior to week 0 or during the study

                    -  Subjects must not have received TNF-α inhibitors (such as infliximab,
                       etanercept, adalimumab) within the 12 week period prior to Week 0 or during
                       the study

                    -  Subjects must not have received alefacept within the 12 week period prior to
                       Week 0 or during the study.

                    -  Subjects must not have received ustekinumab within the 12 week period prior
                       to Week 0 or during the study.

                    -  Subjects must not have received treatment with an investigational drug
                       within the previous 4 weeks or 5 half-lives prior to Week 0 (whichever is
                       longer) or participation in another clinical trial within the 4 week period
                       prior to Week 0 or during the study

        Exclusion Criteria:

          1. Subject is younger than 18 years of age.

          2. Subject has less than 10% body surface involvement of his/her psoriasis.

          3. Subjects with erythrodermic, pustular, or guttate psoriasis

          4. History of known or suspected intolerance to any of the ingredients of the
             investigational study product.

          5. Evidence of skin conditions other than psoriasis that would interfere with
             study-related evaluations of psoriasis.

          6. 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

          7. 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.

          8. Have a history of latent or active granulomatous infection, including histoplasmosis
             or coccidioidomycosis, prior to screening.

          9. Refer to inclusion criteria for information regarding eligibility with a history of
             latent TB.

         10. Have had a Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening.

         11. 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.

         12. Have had a nontuberculous mycobacterial infection or opportunistic infection (eg.
             Cytomegalovirus, pneumocystosis, aspergillosis) within 6 months prior to screening.

         13. 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.

         14. 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

         15. Subject has a history of or ongoing drug or alcohol abuse

         16. Subject is not willing to comply with wash-out requirements (see above)

         17. Subject is known, or suspected of being unable to comply with the study protocol