Chronic Plaque Psoriasis MedDRA version: 16.1 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Humira
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Conce
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is = 4 years and 20% • Very thick lesions with BSA > 10% • 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 • CDLQI > 10 5. If subject is =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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. 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 Ps, generalized or localized pustular Ps, medication-induced or medication exacerbated Ps or new onset guttate Ps; 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 Ps with topical therapies such as corticosteroids, vitamin D analogs, or retinoids within 7 days prior to the Baseline visit; 8. Treatment of Ps with UVB phototherapy, excessive sun exposure, or the use of tanning beds within 7 days prior to the Baseline visit; 9. Treatment of Ps with PUVA phototherapy, non-biologic systemic therapies for the treatment of Ps, or systemic therapies known to improve Ps within 14 days prior to the Baseline visit;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the safety and efficacy of two doses of adalimumab versus methotrexate in pediatric subjects with chronic plaque psoriasis.;Secondary Objective: To determine the time to loss of disease control and the ability to regain response upon retreatment, and to examine the pharmacokinetics and immunogenicity of adalimumab following subcutaneous administration in this subject population.;Primary end point(s): The proportion of subjects achieving a >= PASI 75 response standard dose versus MTX. ;Timepoint(s) of evaluation of this end point: Week 16, Period A | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The proportion of subjects achieving a PASI 90, standard dose versus MTX; The proportion of subjects achieving a PASI 90, standard dose versus MTX;Change from baseline in the Children's Dermatology Life Quality Index (CDLQI) scores, standard dose versus MTX; Change from baseline in the Paediatric Quality of Life Inventory (PedsQL), standard dose versus MTX;The proportion of subjects achieving PGA 0, 1 upon completion of retreatment (Period C) according to the original randomised group assignment in Period A (standard dose adalimumab versus low dose adalimumab);Time to loss of disease control (Period B) according to the original randomised group assignment in Period A (standard dose adalimumab versus low dose adalimumab and MTX).;Timepoint(s) of evaluation of this end point: Week 16, Period A | — |
Countries
Belgium, Canada, Czech Republic, Germany, Hungary, Italy, Mexico, Netherlands, Poland, Spain, Switzerland, Turkey
Contacts
Public ContactClinical Trials Helpdesk
AbbVie Ltd.
Outcome results
None listed