Psoriasis
Conditions
Brief summary
Extension Study of Two Dosing Schedules of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis
Interventions
DRUGadalimumab
OL 80 mg at Weeks 0 and 1, 40 mg weekly Week 2 - Week 11, blinded 40 mg eow through Week 24
OL 80 mg at Weeks 0 and 1, 40 mg weekly Week 2 - Week 11, blinded placebo eow through Week 24
Sponsors
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject participated and relapsed in prior PS study
Exclusion criteria
* Subject has other active skin diseases * Multiple concomitant therapy restrictions and/or washouts (topicals, UV, other systemic PS therapies) * Poorly controlled medical conditions * History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease. * History of cancer or lymphoproliferative disease * History of active TB or listeriosis, or persistent chronic or active infections * Known to have immune deficiency or is immunocompromised * Clinically significant abnormal laboratory test results * Erythrodermic psoriasis or generalized pustular psoriasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Psoriasis Area and Severity Index | Week 12 |
| Adverse Events | Throughout Study Participation |
Secondary
| Measure | Time frame |
|---|---|
| Psoriasis Area and Severity Index | Week 12, Week 24 |
| Physician's Global Assessment | Week 12, Week 24 |
Outcome results
None listed