Clinical trial NCT01251614 (phase 3, status: completed)
Conditions: plaque psoriasis
ICD codes: L40.0, L40.4, L40.8, L40.9, L40.1, L40.50
Drugs: methotrexate, placebo to methotrexate
SMILES: CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O, CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O
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.