Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
1 other identifier
interventional
148
0 countries
N/A
Brief Summary
Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 26, 2008
CompletedFirst Posted
Study publicly available on registry
March 28, 2008
CompletedMarch 28, 2008
March 1, 2008
6 months
March 26, 2008
March 26, 2008
Conditions
Outcome Measures
Primary Outcomes (2)
Psoriasis Area and Severity Index
Week 12
Adverse Events
Throughout Study Participation
Secondary Outcomes (2)
Psoriasis Area and Severity Index
Week 1, 2, 4, 8, 12
DLQI, SF-36, Zung Depression Self-Rating Scale, EQ-5D
Week 12
Study Arms (3)
A
PLACEBO COMPARATORB
ACTIVE COMPARATORC
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Diagnosis of moderate to severe chronic plaque psoriasis
- Active psoriasis, despite topical therapies
You may not qualify if:
- Other active skin diseases or skin infections
- Prior exposure to any anti-TNF therapy
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Related Publications (2)
Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.
PMID: 29380251DERIVEDPapp KA, Armstrong AW, Reich K, Karunaratne M, Valdecantos W. Adalimumab Efficacy in Patients with Psoriasis Who Received or Did Not Respond to Prior Systemic Therapy: A Pooled Post Hoc Analysis of Results from Three Double-Blind, Placebo-Controlled Clinical Trials. Am J Clin Dermatol. 2016 Feb;17(1):79-86. doi: 10.1007/s40257-015-0161-5.
PMID: 26547918DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 26, 2008
First Posted
March 28, 2008
Study Start
March 1, 2003
Primary Completion
September 1, 2003
Last Updated
March 28, 2008
Record last verified: 2008-03