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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00235885
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : August 29, 2007
Information provided by:

Brief 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

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Drug: adalimumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 445 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : July 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Primary Outcome Measures :
  1. Safety parameters
  2. PsARC
  3. ACR20
  4. Physician Global Assessment for Psoriasis and Psoriasis Target Lesion Assessment
  5. Patient reported outcomes

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00235885

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United States, Illinois
Global Medical Information - Abbott
Abbott Park, Illinois, United States, 60064
Sponsors and Collaborators
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Study Director: Beverly Paperiello Abbott
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00235885    
Other Study ID Numbers: M04-724
EudraCT: 2005/001185-14
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: August 29, 2007
Last Verified: August 2007
Keywords provided by Abbott:
Psoriatic Arthritis
Additional relevant MeSH terms:
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Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Bone Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Anti-Inflammatory Agents
Antirheumatic Agents