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Safety and Efficacy Study of Adalimumab in Patients With Active Psoriatic Arthritis (PsA) (STEREO)
This study has been completed.
Study NCT00235885   Information provided by Abbott
First Received: October 7, 2005   Last Updated: August 28, 2007   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

October 7, 2005
August 28, 2007
July 2005
  • Safety parameters
  • PsARC
  • ACR20
  • Physician Global Assessment for Psoriasis and Psoriasis Target Lesion Assessment
  • Patient reported outcomes
  • Safety parameters
  • PsARC
  • ACR20
  • Physician Global Assessment for Psoriasis and Psoriasis Target Lesion Assessment
  • Patient reported outcomes
Complete list of historical versions of study NCT00235885 on ClinicalTrials.gov Archive Site
No differentiation will be made between primary and secondary efficacy variables.
Same as current
 
Safety and Efficacy Study of Adalimumab in Patients With Active Psoriatic Arthritis (PsA)
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

 
Phase III
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Psoriatic Arthritis
Drug: adalimumab
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
445
 
 

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 .
Both
18 Years and older
No
 
United States
 
 
NCT00235885
 
EudraCT: 2005/001185-14
Abbott
 
Study Director: Beverly Paperiello Abbott
Abbott
August 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.