A Double Blind Study in Pediatric Subjects With Chronic Plaque Psoriasis, Studying Adalimumab vs. Methotrexate
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Adalimumab; Methotrexate; Placebo to Adalimumab; Placebo to Methotrexate
Intervention description: Adalimumab by subcutaneous injection every other week (eow); Methotrexate 0.1 mg/kg at Week 0 and up to 0.4 mg/kg per week (maximum dose of 25 mg/week) orally.; A single subcutaneous loading dose at Week 0 followed by eow dosing beginning at Week 1.; Orally once a week
Intervention MeSH terms: Adalimumab; Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 114.0
Sex: All
Minimum age: 4 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Randomized; Double-blind; Chronic plaque psoriasis; Pediatric

Summary:

      This study will compare how well adalimumab works versus methotrexate (MTX) in children with
      moderate to severe psoriasis in the short term. It will also study how safe and how well
      adalimumab works in the long term and how long disease response can be maintained after
      stopping therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject is ≥ 4 years and < 18 years of age;

          2. Subject weighs ≥ 13 kg;

          3. Subject must have failed to respond to topical therapy;

          4. Subject must need systemic treatment to control his/her disease and meet one of the
             following:

               -  Physician's Global Assessment (PGA) ≥ 4

               -  Body surface area (BSA) involved > 20%

               -  Very thick lesions with BSA > 10%

               -  Psoriasis Area and Severity Index (PASI) > 20

               -  PASI > 10 and at least one of the following:

                    -  Active psoriatic arthritis unresponsive to non-steroid anti-inflammatory
                       drugs (NSAIDs)

                    -  Clinically relevant facial involvement

                    -  Clinically relevant genital involvement

                    -  Clinically relevant hand and/or foot involvement

                    -  Children's Dermatology Life Quality Index (CDLQI) > 10

          5. If subject is < 12 years of age and resides in a geographic region where heliotherapy
             is practical, subject must have failed to respond, be intolerant, or have a
             contraindication to heliotherapy, or is not a suitable candidate for heliotherapy;

          6. If ≥ 12 years of age, subject must have failed to respond, be intolerant, or have a
             contraindication to phototherapy, or is not a suitable candidate for phototherapy;

          7. Subject must have a clinical diagnosis of psoriasis for at least 6 months as
             determined by the subject's medical history and confirmation of diagnosis through
             physical examination by the Investigator;

          8. Subject must have stable plaque psoriasis for at least 2 months prior to Baseline

        Exclusion Criteria:

          1. Prior biologic use other than prior treatment with etanercept;

          2. Treatment with etanercept therapy within 4 weeks prior to the Baseline visit; 3.
             Methotrexate (MTX) use within the past year or prior MTX use at any time where the
             subject did not respond, or did not tolerate MTX;

        4. Contraindication for treatment with MTX during the study; 5. Erythrodermic psoriasis,
        generalized or localized pustular psoriasis, medication-induced or medication exacerbated
        psoriasis or new onset guttate psoriasis; 6. Infection(s) requiring treatment with
        intravenous (IV) anti-infectives within 30 days prior to the Baseline Visit or oral
        anti-infectives within 14 days prior to the Baseline Visit; 7. Treatment of psoriasis with
        topical therapies such as corticosteroids, vitamin D analogs, or retinoids within 7 days
        prior to the Baseline visit; 8. Treatment of psoriasis with ultraviolet (UV)B phototherapy,
        excessive sun exposure, or the use of tanning beds within 7 days prior to the Baseline
        visit; 9. Treatment of psoriasis with ultraviolet A with psoralen (PUVA) phototherapy,
        non-biologic systemic therapies for the treatment of psoriasis, or systemic therapies known
        to improve psoriasis within 14 days prior to the Baseline visit.