Phase 3
Completed N=1,468
Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Source: ClinicalTrials.gov NCT00195676 ↗Enrolled (actual)
1,468
Serious AEs
12.9%
Results posted
Nov 2010
Primary outcomePrimary: Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R — 76.5 percentage of participants
Summary
The two objectives of this study were to evaluate long-term efficacy and safety of adalimumab treatment in participants who had moderate to severe chronic plaque psoriasis and to evaluate the effectiveness of adalimumab retreatment in participants who had therapeutic response to adalimumab and were then withdrawn from adalimumab treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R |
76.5 | — |
Eligibility Criteria
Inclusion Criteria
- Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.
- Subjects who met the requirements from previous adalimumab psoriasis study participation.
Exclusion Criteria
- Subject considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
- Female subject who was pregnant or breast-feeding or considering becoming pregnant.
Data sourced from ClinicalTrials.gov (NCT00195676). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.