Study of Adalimumab in Subjects With Axial Spondyloarthritis - Full Text View

Sponsor:	Abbott
Information provided by (Responsible Party):	Abbott
ClinicalTrials.gov Identifier:	NCT00939003

Purpose

This study will study how well adalimumab works in the short and long term in subjects with axial spondyloarthritis who are not diagnosed as having either ankylosing spondylitis or psoriatic arthritis

Condition	Intervention	Phase
Axial Spondyloarthritis	Biological: Adalimumab Biological: Placebo Biological: Open-label Adalimumab	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 Axial Spondyloarthritis

Resource links provided by NLM:

Drug Information available for: Adalimumab

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

ASAS40 Response (ASAS: Assessment of SpondyloArthritis International Society) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Adverse Events [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
Blood and Urine Values Assessed by Central Laboratory [ Time Frame: Screening, Baseline, and Weeks, 4, 8, 12, 16, 20, 24, 28, 36, 44, 52, 60, 68, 80, 92, 104. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

ASAS20 response [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
ASAS partial remission [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
ASAS5/6 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
BASDAI50 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	194
Study Start Date:	July 2009
Estimated Study Completion Date:	July 2013
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Adalimumab	Biological: Adalimumab 40 mg Every Other week up to Week 12 Other Name: ABT-D2E7, adalimumab, Humira
Placebo Comparator: Placebo	Biological: Placebo Placebo Every Other Week up to Week 12 Other Name: placebo
Experimental: Open-label Adalimumab	Biological: Open-label Adalimumab 40 mg Every Other Week, Week 12 through Week 156 Other Name: ABT-D2E7, adalimumab, 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 >/= 1 non-steroidal anti-inflammatories (NSAIDs)
Chronic back pain with onset < 45 years of age
MRI indicating active sacroiliitis or positive HLA-B27 blood test in addition to 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-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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00939003

Show 38 Study Locations

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Aileen L Pangan, MD

Abbott

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Abbott
ClinicalTrials.gov Identifier:	NCT00939003 History of Changes
Other Study ID Numbers:	M10-791, 2009-010643-14
Study First Received:	July 10, 2009
Last Updated:	December 14, 2011
Health Authority:	Australia: Human Research Ethics Committee; Belgium: Federal Agency for Medicinal Products and Health Products; Canada: Health Canada; Czech Republic: State Institute for Drug Control; France: Afssaps - French Health Products Safety Agency; Germany: Paul-Ehrlich-Institut; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Spain: Agencia Española de Medicamentos y Productos Sanitarios; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration

Additional relevant MeSH terms:

Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis

Joint Diseases
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012