A Study Comparing the Safety and Efficacy of Risankizumab to Methotrexate in Subjects With Moderate to Severe Plaque Psoriasis
- Registration Number
- NCT03219437
- Lead Sponsor
- AbbVie
- Brief Summary
The purpose of this study is to compare the safety and efficacy of risankizumab to methotrexate in participants with moderate to severe plaque psoriasis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
- Have a diagnosis of plaque psoriasis (with or without concurrent psoriatic arthritis) for at least 6 months before the first administration of study drug
- Have stable moderate to severe plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline Visits
- Be a candidate for systemic therapy for plaque psoriasis as assessed by the investigator
- Be a candidate for treatment with methotrexate (MTX) according to local label
- Subjects with non-plaque forms of psoriasis, current drug-induced psoriasis, or active ongoing inflammatory diseases other than psoriasis that might confound study evaluations according to investigator's judgment
- Previous exposure to risankizumab
- Previous exposure to MTX
- Use of any prohibited medication or any drug considered likely to interfere with the safe conduct of the study, as assessed by the investigator
- Subject has a history of clinically significant hematologic, renal, or liver disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Methotrexate methotrexate Participants to receive double-blind methotrexate. Risankizumab risankizumab Participants to receive double-blind risankizumab.
- Primary Outcome Measures
Name Time Method Percentage of participants with Static Physician Global Assessment (sPGA) score of clear or almost clear (0, 1) at Week 28. Week 28 The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
Percentage of participants with a ≥ 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 28 Week 28 PASI90 denotes greater than or equal to 90% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.
- Secondary Outcome Measures
Name Time Method Percentage of participants with a 100% reduction from Baseline PASI score (PASI 100) at Week 28 Week 28 PASI100 denotes greater than or equal to 100% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.
Percentage of participants with a ≥ 75% reduction from Baseline PASI score (PASI 75) at Week 28 Week 28 PASI75 denotes greater than or equal to 75% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.
Percentage of participants with Static Physician Global Assessment (sPGA) score of clear (0) at Week 28 Week 28 The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
Change from baseline in EQ-5D-5L at all visits collected Week 28 The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life.
Achievement of an increase of 0.1 or more points from baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) at all visits Week 28 The EQ-5D-5L has five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. These dimensions are measured on a five-level scale: no problems, slight problems, moderate problems, severe problems, and extreme problems.
Trial Locations
- Locations (11)
CETI - Centro de Estudos em Terapias Inovadoras /ID# 208593
🇧🇷Curitiba, Parana, Brazil
PUC Trials-Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR /ID# 164401
🇧🇷Curitiba, Parana, Brazil
Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu /ID# 164743
🇧🇷Botucatu, Sao Paulo, Brazil
Faculdade de Medicina do ABC /ID# 164519
🇧🇷Santo André, Sao Paulo, Brazil
Hospital de Clinicas da Universidade Estadual de Campinas - UNICAMP /ID# 164521
🇧🇷Campinas, Sao Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 164768
🇧🇷Ribeirão Preto, Sao Paulo, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 164723
🇧🇷Sao Jose Do Rio Preto, Sao Paulo, Brazil
Instituto de Dermatologia e Estética do Brasil /ID# 164754
🇧🇷Rio de Janeiro, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 164805
🇧🇷Sao Paulo, Brazil
Hospital de Clinicas de Porto Alegre /ID# 164565
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Moinhos de Vento /ID# 208592
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil