A Multicentre, Randomised, Double-Dummy, Double-Blind Study Evaluating Two Doses of Adalimumab versus Methotrexate (MTX) in Paediatric Subjects with Chronic Plaque Psoriasis (Ps)
- Conditions
- Not applicable10014982
- Registration Number
- NL-OMON37563
- Lead Sponsor
- AbbVie B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
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:;• PGA >= 4;• Body surface area (BSA) involved > 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 < 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;
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;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>-The proportion of the subjects achieving a >= PASI 75 response at Week 16a<br /><br>standard dose versus MTX.<br /><br>-The proportion of subjects achieving a PGA 0, 1 at Week 16a, standard dose<br /><br>versus MTX</p><br>
- Secondary Outcome Measures
Name Time Method <p>-The proportion of subjects achieving a PASI 90 at Week 16a, standard dose<br /><br>versus MTX<br /><br>-The proportion of subjects achieving a PASI 100 at Week 16a, standard dose<br /><br>versus MTX<br /><br>-Change from baseline in the Children*s Dermatology Life Quality Index (CDLQI)<br /><br>scores at Week 16a, standard dose versus MTX<br /><br>-Change from baseline in the Paediatric Quality of life Inventory (PedsQL)<br /><br>scores at Week 16a, standard dose versus MTX<br /><br>-The proportion of subjects achieving PGA 0, 1 upon completion of retreatment<br /><br>(Period C) according to the original randomised group assignment in Period A<br /><br>(standard dose adalimumab versus low dose of adalimumab)<br /><br>-Time to loss of disease control (Period B) according to the original<br /><br>randomised group assignment in Period A (standard dose adalimumab versus low<br /><br>dose adalimumab and MTX)</p><br>