Study of Two Dosing Schedules of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Psoriasis Clinical Trial

Official title:

Study of Two Dosing Schedules of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00645905
• Other study ID #: M02-538
• Status: Completed
• Phase: Phase 2
• First received: March 26, 2008
• Last updated: March 26, 2008
• Start date: June 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 Two Dosing Schedules of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of moderate to severe chronic plaque psoriasis

• Active psoriasis, despite topical therapies

Exclusion Criteria:

• 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

Study Design

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• adalimumab
OL 80 mg at Week 0, 40 mg weekly through Week 12, blinded 40 mg eow through Week 48, withdrawal and observation for 360 days after last dose
• placebo for adalimumab
OL 80 mg at Week 0, 40 mg weekly through Week 12, blinded placebo eow through Week 48, withdrawal and observation for 360 days after last dose

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-Week 24	No
Primary	Adverse Events		Throughout Study Participation	Yes
Secondary	Psoriasis Area and Severity Index		Week 12, Week 24 through 360 days after last dose	No
Secondary	Physician's Global Assessment		Week 12, Week 24 through 360 days after last dose	No