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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00235885
First received: October 7, 2005
Last updated: August 28, 2007
Last verified: August 2007
  Purpose

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


Condition Intervention Phase
Psoriatic Arthritis
Drug: adalimumab
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Safety parameters
  • PsARC
  • ACR20
  • Physician Global Assessment for Psoriasis and Psoriasis Target Lesion Assessment
  • Patient reported outcomes

Secondary Outcome Measures:
  • No differentiation will be made between primary and secondary efficacy variables.

Estimated Enrollment: 445
Study Start Date: July 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 .
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235885

Locations
United States, Illinois
Global Medical Information - Abbott
Abbott Park, Illinois, United States, 60064
Sponsors and Collaborators
Abbott
Investigators
Study Director: Beverly Paperiello Abbott
  More Information

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00235885     History of Changes
Other Study ID Numbers: M04-724, EudraCT: 2005/001185-14
Study First Received: October 7, 2005
Last Updated: August 28, 2007
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Abbott:
Psoriatic Arthritis
adalimumab

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Bone Diseases
Joint Diseases
Musculoskeletal Diseases
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Spondylitis
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014