Study of Adalimumab in Subjects With Peripheral Spondyloarthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01064856
First received: February 5, 2010
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Peripheral Spondyloarthritis
Biological: adalimumab
Biological: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Peripheral Spondyloarthritis

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 165
Study Start Date: February 2010
Study Completion Date: May 2014
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: adalimumab- double blind Biological: adalimumab
40mg subcutaneous injection every other week up to week 12
Other Name: ABT-D2E7 Humira
Placebo Comparator: placebo - double blind Biological: placebo
placebo subcutaneous injection every other week up to week 12
Experimental: adalimumab - open label Biological: adalimumab
40mg subcutaneous injection every other week, week 12 thru week 156
Other Name: ABT-D2E7 Humira

  Eligibility

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

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
  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: NCT01064856

  Show 34 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: In-Ho Song, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01064856     History of Changes
Other Study ID Numbers: M10-883, 2009-014567-39
Study First Received: February 5, 2010
Last Updated: May 19, 2014
Health Authority: Australia: Human Research Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Czech Republic: State Institute for Drug Control
United States: Food and Drug Administration
Germany: Paul-Ehrlich-Institut
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Ireland: Irish Medicines Board
Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by AbbVie:
peripheral spondyloarthritis
adalimumab

Additional relevant MeSH terms:
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Antibodies, Monoclonal
Adalimumab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 28, 2014