Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severely Active Psoriatic Arthritis Subjects With Inadequate Response to Disease Modifying Anti-Rheumatic Drug Therapy

Arthritis Clinical Trial

Official title:

Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Moderate to Severely Active Psoriatic Arthritis Subjects With Inadequate Response to Disease Modifying Anti-Rheumatic Drug Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00646178
• Other study ID #: M02-570
• Status: Completed
• Phase: Phase 3
• 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

Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severely Active Psoriatic Arthritis Subjects with Inadequate Response to Disease Modifying anti-Rheumatic Drug Therapy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. primary completion date: March 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 adalimumab eow Week 0 - Week 12
• placebo for adalimumab
placebo eow Week 0 - Week 12

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 the Study	Yes
Secondary	ACR50/70		Week 12	No
Secondary	Modified Psoriatic Arthritis Response Criteria		Week 12	No
Secondary	Multiple QOL Assessments		Week 12	No
Secondary	Physicians Global Assessment for Psoriasis		Week 12	No