Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Moderately to Severely Active Psoriatic Arthritis

Arthritis Clinical Trial

Official title:

Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Moderately to Severely Active Psoriatic Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00646386
• Other study ID #: M02-518
• 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

Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Moderately to Severely Active Psoriatic Arthritis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Moderate to severe PsA

• Inadequate response to DMARD therapy

• Corticosteroid stable dose <= 10 mg QD

• DMARDs must have been taken for 3 months and stable dose for 4 weeks

• MTX maximum dose = <= 30 mg/week

• Active chronic plaque PS or documented history of chronic plaque PS

Exclusion Criteria:

• No other active skin disease

Study Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic

Intervention

Drug:
• adalimumab
40 mg eow Week 0 - Week 24
• placebo for adalimumab
40 mg eow Week 0 - Week 24

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACR20		Week 12	No
Primary	Adverse Events		Throughout study participation	Yes
Primary	Sharp Score		Week 24	No
Secondary	ACR20, 50, 70		Weeks 12, 24	No
Secondary	Modified Psoriatic Arthritis Response Criteria, HAQ, SF-36, Physician's Global Assessment, PASI, DLQI		Weeks 12 and 24	No