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Study of Adalimumab in Subjects With Peripheral Spondyloarthritis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01064856
First received: February 5, 2010
Last updated: March 6, 2013
Last verified: February 2013
History of Changes

February 5, 2010
March 6, 2013
February 2010
August 2011   (final data collection date for primary outcome measure)
  • Primary Outcome Measure [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Response of: >/= 40% improvement from Baseline in Patient Global Assessment of Disease Activity, Patient Global Assessment of Pain and at least 1 of the following 3 criteria: Swollen Joint & Tender Joint Count, Enthesitis Count and Dactylitis Count
  • Adverse Events [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
  • Adverse Events [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
  • Response of: >/= 40% improvement from Baseline in Patient Global Assessment of Disease Activity, Patient Global Assessment of Pain and at least 1 of the following 3 criteria: Swollen Joint and Tender Joint Count or Enthesitis Count or Dactylitis Count [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01064856 on ClinicalTrials.gov Archive Site
  • Physician's Global Assessment of Disease Activity (VAS) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Bath AS Disease Activity Index (BASDAI) Score & SF-36 v2 physical component [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Health Assessment Questionnaire modified for the Spondyloarthropathies (HAQ-S) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Physician's Global Assessment of Disease Activity (VAS) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Bath AS Disease Activity Index (BASDAI) Score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Health Assessment Questionnaire modified for the Spondyloarthropathies (HAQ-S) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • SF-36 v2 physical component [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of Adalimumab in Subjects With Peripheral Spondyloarthritis
A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Peripheral Spondyloarthritis

This study will study how well adalimumab works in the short and long term in subjects with peripheral spondyloarthritis who are not diagnosed as having either ankylosing spondylitis or psoriatic arthritis.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Peripheral Spondyloarthritis
  • Biological: adalimumab
    40mg subcutaneous injection every other week up to week 12
    Other Names:
    • ABT-D2E7
    • Humira
  • Biological: placebo
    placebo subcutaneous injection every other week up to week 12
  • Biological: adalimumab
    40mg subcutaneous injection every other week, week 12 thru week 156
    Other Names:
    • ABT-D2E7
    • Humira
  • Experimental: adalimumab- double blind
    Intervention: Biological: adalimumab
  • Placebo Comparator: placebo - double blind
    Intervention: Biological: placebo
  • Experimental: adalimumab - open label
    Intervention: Biological: adalimumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
154
May 2014
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult subjects with inadequate response to >/= 2 non-steroidal anti-inflammatories (NSAIDs)
  • Subjects must have current arthritis or enthesitis dactylitis PLUS: meeting spondyloarthritis clinical criteria
  • Negative purified protein derivative (PPD) test and Chest X-Ray performed at Baseline Visit must be Negative
  • Ability to administer subcutaneous injections
  • General good health otherwise

Exclusion Criteria:

  • Prior anti-tumor necrosis factor (TNF) therapy
  • Psoriasis or Psoriatic Arthritis
  • Fulfillment of modified New York criteria for Ankylosing Spondylitis
  • Recent infection requiring treatment
  • Significant medical events or conditions that may put patients at risk for participation
  • Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study
  • History of cancer, except successfully treated skin cancer
  • Recent history of drug or alcohol abuse
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Canada,   Czech Republic,   France,   Germany,   Greece,   Hungary,   Ireland,   Spain
 
NCT01064856
M10-883, 2009-014567-39
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Aileen Pangan, MD AbbVie
AbbVie
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP