Safety and Efficacy Study of Adalimumab in Patients With Active Psoriatic Arthritis (PsA) (STEREO)

August 28, 2007 updated by: Abbott

Safety and Efficacy of Adalimumab in Patients With Active Psoriatic Arthritis (PsA) - An Open-Label, Multinational Study to Evaluate the Response to Every-Other Week Adalimumab When Added to Insufficient Standard Therapy, Including Patients Who Failed Prior Treatment With Other TNF-Inhibitors (STEREO)

The purpose of the study is to assess the safety and clinical efficacy of adalimumab in active psoriatic arthritis (PsA) subjects when adalimumab is added to insufficient standard therapy including patients that have failed other TNF therapies

Study Overview

Status

Completed

Conditions

Psoriatic Arthritis

Intervention / Treatment

Drug: adalimumab

Study Type

Interventional

Enrollment

445

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Illinois
  - Abbott Park, Illinois, United States, 60064
    - Global Medical Information - Abbott

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Males and females > 18 years of age
Active PsA with > 3 tender and > 3 swollen joints despite standard therapy
Unsatisfactory response or intolerance to at least one prior or ongoing DMARD (study enrollment must be in accordance with current national guidelines for treatment of PsA with TNF inhibitors)
A negative serum pregnancy test (serum HCG) for women of childbearing potential prior to the start of treatment.
Use of a reliable method of contraception by all female patients of childbearing potential
Able and willing to self-administer sc injections or have a suitable person to administer sc injections
Able and willing to give written informed consent and comply with the protocol

Exclusion Criteria:

Prior treatment with any investigational agent within 30 days or five half lives of the product, whichever is longer
Treatment within last 2 months with infliximab or within last 3 weeks with etanercept
Treatment within last 4 weeks with a combination of MTX and leflunomide
Treatment within last 4 weeks with a combination of cyclosporine with any other DMARD-Subject has received UVA phototherapy (including PUVA within 2 weeks prior to screening)
History of cancer or lymphoproliferative disease other than a successfully and completely treated squamous cell or basal cell carcinoma of the skin or cervical dysplasia
History of or current active acute inflammatory joint disease of origin other than PsA
Comorbidities (uncontrolled diabetes, unstable ischemic heart disease, CHF, active IBD, stroke within 3 months, chronic leg ulcer and other condition which would put subject at risk by participation in the protocol
Positive serology for hepatitis B or C
History of positive HIV status
Persistent or recurrent infections or severe infections requiring hospitalization or treatment with iv antibiotics within 30 days, or oral antibiotics within 14 days prior to enrollment
Females who are pregnant or breast-feeding
History of clinically significant drug or alcohol abuse in the last year
Previous diagnosis or signs of central nervous system demyelinating diseases
History of tuberculosis, histoplasmosis or listeriosis
Subjects with latent TB or having other risk factors for activation of latent TB who have not initiated a TB prophylaxis prior to the first adalimumab treatment .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Patient reported outcomes
Safety parameters
PsARC
ACR20
Physician Global Assessment for Psoriasis and Psoriasis Target Lesion Assessment

Secondary Outcome Measures

Outcome Measure
No differentiation will be made between primary and secondary efficacy variables.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Registration Dates

First Submitted

October 7, 2005

First Submitted That Met QC Criteria

October 11, 2005

First Posted (ESTIMATE)

October 12, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

August 29, 2007

Last Update Submitted That Met QC Criteria

August 28, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

M04-724
EudraCT: 2005/001185-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.