Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Multicenter Extension Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00646191

Enrollment

137

Registered

2008-03-28

Start date

2003-03-31

Completion date

Unknown

Last updated

2008-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Brief summary

Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis

Interventions

DRUGadalimumab

40 mg eow through Week 12 followed by OL 40 mg eow through Week 48, permitted to escalate to weekly dosing upon relapse

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

Inclusion criteria

* Subject completed 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 0, 4, 8, 12, 16, 20, 24, 32, 40 and 48
DLQI, SF-36, Zung Depression Self-Rating Scale, EQ-5D, VAS	Week 12, 24 and 48
Physician's Global Assessment	Week 12, 16, 20, 24, 32, 40 and 48

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026