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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00646191
• Other study ID #: M02-529
• Status: Completed
• Phase: Phase 2
• First received: March 26, 2008
• Last updated: March 26, 2008
• Start date: March 2003

Study information

• Verified date: March 2008
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• adalimumab
40 mg eow through Week 12 followed by OL 40 mg eow through Week 48, permitted to escalate to weekly dosing upon relapse
• adalimumab
40 mg weekly through Week 48 (OL Week 12 - 48)
• adalimumab
80 mg W0, 40 mg eow through Week 12 followed by OL 40 mg eow through Week 48, permitted to escalate to weekly dosing upon relapse

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psoriasis Area and Severity Index		Week 12	No
Primary	Adverse Events		Throughout Study Participation	Yes
Secondary	Psoriasis Area and Severity Index		Week 0, 4, 8, 12, 16, 20, 24, 32, 40 and 48	No
Secondary	DLQI, SF-36, Zung Depression Self-Rating Scale, EQ-5D, VAS		Week 12, 24 and 48	No
Secondary	Physician's Global Assessment		Week 12, 16, 20, 24, 32, 40 and 48	No