Psoriasis
Conditions
Keywords
Psoriasis
Brief summary
This study is being conducted to compare the efficacy of ABT-874 versus Methotrexate in subjects with moderate to severe plaque psoriasis.
Detailed description
This study is only being conducted in the EU and Canada
Interventions
DRUGABT-874
200 mg at week 0 and 4 and 100mg at week 8 and every 4 weeks there after administered as aSQ injection
DRUGMethotrexate
5.0 to 25 mg weekly
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Psoriasis for 6 MO.. BSA 10%, PASI 12 or above, PGA 3 or above
Exclusion criteria
* Previous exposure to anti-IL 12
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects who achieve a PGA score of 0 or 1 at Week 52 | Week 52 |
| Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 24 | Week 24 |
| The proportion of subjects who achieve a PGA score of 0 or 1 at Week 24 | Week 24 |
| Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 52 | Week 52 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 24 | Week 24 |
| Changes from Baseline in the DLQI total score at Week 24 | Week 24 |
| Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 52 | Week 52 |
| Changes from Baseline in the DLQI total score at Week 52 | Week 52 |
Countries
Austria, Belgium, Canada, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom
Outcome results
None listed