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

Psoriatic Arthritis Clinical Trial

— STEREO  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00235885
• Other study ID #: M04-724
• Secondary ID: EudraCT: 2005/00
• Status: Completed
• Phase: Phase 3
• First received: October 7, 2005
• Last updated: August 28, 2007
• Start date: July 2005

Study information

• Verified date: August 2007
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 445
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 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

Drug:
• adalimumab

Locations

Country	Name	City	State
United States	Global Medical Information - Abbott	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	PsARC
Primary	ACR20
Primary	Physician Global Assessment for Psoriasis and Psoriasis Target Lesion Assessment
Primary	Patient reported outcomes
Secondary	No differentiation will be made between primary and secondary efficacy variables.