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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00195689

Enrollment

400

Registered

2005-09-20

Start date

2003-08-31

Completion date

Unknown

Last updated

2007-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriatic Arthritis

Brief 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

Interventions

BIOLOGICALHuman anti-TNF monoclonal antibody/adalimumab

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Disease progression measurements	—
SF-36	—
FACTIT Fatigue Scale	—
Safety parameters	—
ACR 20/50/70	—
PsARC	—
HAQ	—

Secondary

Measure	Time frame
Clinical response indicators	—
Patient reported outcomes	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026