Safety and Efficacy of Adalimumab in Patients Who Showed an Unsatisfactory Response to Etanercept
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Adalimumab every other week; Adalimumab Every Week
Intervention description: Adalimumab 40mg injection every other week for 24 weeks; Adalimumab 40mg injection every week for the last 12 weeks of study.
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 85.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Adalimumab

Summary:

      This study will provide data on additional therapeutic benefits in administering Adalimumab
      in patients with plaque psoriasis that showed an unsatisfactory response after at least 3
      months of treatment with etanercept.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject with plaque psoriasis with documentation of an unsatisfactory response to
             etanercept as defined by either:

               1. Failure to present a PGA of clear or almost clear after at least 3 months of
                  etanercept at 50 mg twice a week OR;

               2. Failure to present a PGA of clear or almost clear after at least 3 months of
                  etanercept at 50 mg twice a week followed by a dose reduction to 50 mg once a
                  week. To be eligible these patients must have reached a PGA of clear or almost
                  clear after at least 3 months of etanercept at 50 mg twice a week followed by a
                  loss of PGA of clear or almost clear at anytime after a dose reduction to 50 mg
                  of etanercept once a week.

          -  Subject presents a PGA of 3 or more at baseline visit.

          -  Subject with plaque psoriasis at screening that is severe enough to be candidate for
             systemic therapy.

          -  Subject is 18 to 80 years of age .

          -  Female subject is either not of childbearing potential, defined as postmenopausal for
             at least 1 year or surgically sterile (bilateral tubal ligation, bilateral
             oophorectomy or hysterectomy), or is of childbearing potential and practicing one of
             the following methods of birth control throughout the study and for 150 days after
             study completion:

               1. condoms, sponge, foams, jellies, diaphragm or IUD;

               2. contraceptives (oral or parenteral) for three months prior to study drug
                  administration;

               3. a vasectomized partner;

          -  Female subjects of childbearing potential must have a negative serum pregnancy test at
             the Screening visit.

          -  Subject is judged to be in good general health as determined by the principal
             investigator based upon the results of medical history, laboratory profile, physical
             examination, and CXR performed at Screening.

          -  Subjects will be evaluated for latent TB infection with a PPD test and CHX. Subjects
             who demonstrate evidence of latent TB infection (either PPD more than or equal to 5 mm
             of induration, irrespective of BCG vaccination status and negative CXR findings for
             active TB, and/or suspicious CXR findings will not be allowed to participate in the
             study.

          -  Subjects must be able and willing to provide written informed consent and comply with
             the requirements of this study protocol.

          -  Subjects must be able and willing to self-administer SC injections or have a qualified
             person available to administer SC injections.

        Exclusion Criteria:

          -  Subject has other active skin diseases or skin infections (bacterial, fungal, or
             viral) that may interfere with evaluation of psoriasis or with subject's safety.

          -  Subject has a history of an allergic reaction or significant sensitivity to
             constituents of study drug, including latex (a component of the pre-filled syringe).

          -  Subject who has used topical treatments in the last 4 weeks of the etanercept
             treatment period when the response to etanercept was evaluated as unsatisfactory must
             use the same topical therapy with the same agents applied in the same manner and with
             the same application frequency for two weeks prior to the baseline visit as well as
             during the entire trial. The use of any other topical treatment for psoriasis is
             prohibited except for allowed treatments.

          -  Subject who has used UVB phototherapy, excessive sun exposure, phototherapy or any
             non-biological systemic therapy for the treatment of psoriasis less than 30 days
             before day 0. Investigational chemical agents must be discontinued at least 30 days or
             5 half-lives prior to the Baseline visit (whichever is longer).

          -  Subject who has used any biological therapy (apart from etanercept) for the treatment
             of psoriasis less than 3 months (90 days) before day 0. Etanercept must be
             discontinued before baseline but a washout period is not required.

          -  Subject is taking or requires oral or injectable corticosteroids during the study.
             Inhaled corticosteroids for stable medical conditions are allowed.

          -  Subjects for whom documentation of unsatisfactory response to etanercept was obtained
             while the subject was under combination treatment with any of the following: UVB
             phototherapy, PUVA therapy, prednisone, methotrexate, acitretin, cyclosporine or any
             other systemic or biologic drug (apart from etanercept).

          -  Subject has a poorly controlled medical condition, such as uncontrolled diabetes with
             documented history of recurrent infections, unstable ischemic heart disease,
             congestive heart failure, recent stroke and any other condition which, in the opinion
             of the investigator, would put the subject at risk if participating in the study.

          -  Subject has history of neurologic symptoms suggestive of central nervous system (CNS)
             demyelinating disease.

          -  Subject has history of cancer or lymphoproliferative disease other than a successfully
             treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or
             localized carcinoma in situ of the cervix.

          -  Subject has a history of listeriosis, treated or untreated TB, persistent chronic
             infections, or recent active infections requiring hospitalization or treatment with
             intravenous anti-infectives within 30 days or oral anti-infectives within 14 days
             prior to the Baseline visit.

          -  Subject who has received any live attenuated vaccine 28 days or less before baseline.

          -  Subject with hepatitis B or hepatitis C viral infection.

          -  Subject with any of the following: hemoglobin ≤ 10 g/L, white blood cells ≤ 3.0 X
             109/L, platelet counts ≤130 X 109/L, ALT ≥ 2 times the upper limit of normal, AST ≥ 2
             times the upper normal limit, total bilirubin ≥ 2 times the upper normal limit or
             creatinine ≥ 150 mmol/L.

          -  Subject currently uses or plans to use anti-retroviral therapy at any time during the
             study.

          -  Subject is known to have immune deficiency or is immunocompromised.

          -  Female subject who is pregnant or breast-feeding or considering becoming pregnant
             during the study or for 150 days after the last dose of study medication.

          -  Subject has a history of clinically significant drug or alcohol abuse in the last
             year.

          -  Subject is considered by the investigator, for any reason, to be an unsuitable
             candidate for the study.

          -  Subject has erythrodermic psoriasis, generalized or localized pustular psoriasis,
             medication-induced or medication-exacerbated psoriasis, or new onset guttate
             psoriasis.