Overview

This trial is active, not recruiting.

Condition plaque psoriasis
Treatments adalimumab - low dose, adalimumab - standard dose, methotrexate, adalimumab - open-label
Phase phase 3
Sponsor AbbVie (prior sponsor, Abbott)
Start date December 2010
End date December 2013
Trial size 111 participants
Trial identifier NCT01251614, 2009-013072-52, M04-717

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
adalimumab - low dose ABT-D2E7 Humira
0.4 mg/kg up to a maximum of 20mg every other week
(Experimental)
adalimumab - standard dose ABT-D2E7 Humira
0.8 mg/kg up to a maximum of 40mg every other week
(Active Comparator)
methotrexate
0.4mg/kg/week up to a maximum of 25 mg per week
(Experimental)
adalimumab - open-label ABT-D2E7 Humira
0.4 mg/kg up to a maximum of 20 mg every other week or 0.8 mg/kg up to a maximum of 40mg every other week starting at Week 0 in Open-Label Period

Primary Outcomes

Measure
Psoriasis Area and Severity Index (PASI) 75
time frame: Week 16, Period A
Physician's Global Assessment of Disease Activity (PGA) 0, 1
time frame: Week 16, Period A
Adverse Events
time frame: At every visit from Baseline (Week 0) to final Visit (Week 156)

Secondary Outcomes

Measure
Psoriasis Area and Severity Index (PASI) 90
time frame: Week 16, Period A
Psoriasis Area and Severity Index (PASI) 100
time frame: Week 16, Period A
Children's Dermatology Life Quality Index
time frame: Week 16, Period A
Change from baseline in the Paediatric Quality of Life Inventory
time frame: Week 16, Period A
Physician's Global Assessment of Disease Activity 0,1
time frame: Week 16, Period A
Time to Loss of Disease Control
time frame: Time from entry into Period B until loss of disease control

Eligibility Criteria

Male or female participants from 4 years up to 17 years old.

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 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;

Additional Information

Official title A Multicenter, Randomized, Double-dummy, Double-blind Study Evaluating Two Doses of Adalimumab Versus Methotrexate (MTX) in Pediatric Subjects With Chronic Plaque Psoriasis (Ps)
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by AbbVie.