Safety and Efficacy of Adalimumab in Patients With Moderate to Severely Active Psoriatic Arthritis

Psoriatic Arthritis Clinical Trial

Official title:

A Multi-Center Continuation Trial for Patients Completing Study M02-518 and M02-570 of the Human Anti-TNF Monoclonal Antibody Adalimumab (D2E7) in Patients With Moderate to Severely Active Psoriatic Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00195689
• Other study ID #: M02-537
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: August 28, 2007
• Start date: August 2003

Study information

• Verified date: August 2007
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to assess the long-term safety and clinical efficacy of adalimumab in treatment of moderate to severely active psoriatic arthritis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject completed study M02-518 or M02-570

Exclusion Criteria:

• Subject prematurely discontinued study M02-518 or M02-570

• Female subject who is pregnant or breast-feeding or considering becoming pregnant

• Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Biological:
• Human anti-TNF monoclonal antibody/adalimumab

Locations

Country	Name	City	State
United States	Global Medical Information-Abbott Laboratories	Abbott Park	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety parameters
Primary	ACR 20/50/70
Primary	PsARC
Primary	HAQ
Primary	SF-36
Primary	FACTIT Fatigue Scale
Primary	Disease progression measurements
Secondary	Patient reported outcomes
Secondary	Clinical response indicators