Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis - Full Text View

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00085644

Purpose

The objective of this study is to evaluate the safety and efficacy of adalimumab 40mg every other week (eow) compared to placebo in subjects with active ankylosing spondylitis (AS) who have had an inadequate response to or intolerance to one or more non-steroidal anti-inflammatory drugs (NSAID) and who may have additionally failed one or more disease-modifying anti-rheumatic drug (DMARD) therapy.

Condition	Intervention	Phase
Ankylosing Spondylitis	Biological: adalimumab (D2E7) Biological: placebo	Phase III

Genetics Home Reference related topics: ankylosing spondylitis

MedlinePlus related topics: Ankylosing Spondylitis

Drug Information available for: Adalimumab Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 3 Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis

Further study details as provided by Abbott:

Primary Outcome Measures:

Reduction of signs and symptoms as measured with Assessments in Ankylosing Spondylitis (ASAS) Working Group response criterion (ASAS 20) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Inhibition of progression of structural damage in spine as measured by modified SASSS [ Time Frame: Week 104 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

ASAS 20, ASAS 40,50,70, BASDAI, BASFI, BAS-G, BASMI, MASES, VAS, partial remissions [ Time Frame: Week 260 ] [ Designated as safety issue: No ]

Enrollment:	250
Study Start Date:	January 2004
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Adalumimab: Experimental	Biological: adalimumab (D2E7) Adalimumab 40 mg eow
Placebo: Placebo Comparator	Biological: placebo Placebo eow

Eligibility

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

Criteria

Inclusion Criteria:

Subjects must be >=18y/o
meet Modified NY Criteria definition of AS
have diagnosis of active AS based on protocol specified criteria
inadequate response or intolerance to >= 1 NSAID
be able and willing to learn to self-administer sc injections

Exclusion Criteria:

Active TB, listeriosis,or HepB or any history of HepC
History of demyelinating disease, MS, Cancer, or lymphoproliferative disease
Previous anti-TNF therapy
DMARDs (other than methotrexate, hydroxychloroquine, and sulfasalazine)
Intra-articular corticosteroid joint injections within 4wks of study dosing
Biologic or investigational therapy within 6wks of study dosing
IV antibiotics within 30 days of study dosing
Oral antibiotics within 14 days of study dosing

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00085644

Show 22 Study Locations

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Robert Wong, M.D.

Abbott

More Information

Publications indexed to this study:

Dougados M, Luo MP, Maksymowych WP, Chmiel JJ, Chen N, Wong RL, Davis JC Jr, van der Heijde D; ATLAS STUDY GROUP. Evaluation of the patient acceptable symptom state as an outcome measure in patients with ankylosing spondylitis: data from a randomized controlled trial. Arthritis Rheum. 2008 Apr 15;59(4):553-60.

Responsible Party:	Abbott Laboratories ( Shyanne Douma, Clinical Research Manager )
Study ID Numbers:	M03-607
Study First Received:	June 10, 2004
Last Updated:	August 29, 2008
ClinicalTrials.gov Identifier:	NCT00085644
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Spinal Diseases
Joint Diseases
Spondylarthropathy
Adalimumab
Bone Diseases
Antibodies, Monoclonal
Antibodies
Musculoskeletal Diseases

Arthritis
Spondylitis, Ankylosing
Spondylarthritis
Spondylitis
Immunoglobulins
Spondylarthropathies
Ankylosis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Therapeutic Uses
Physiological Effects of Drugs

Antirheumatic Agents
Infection
Pharmacologic Actions
Bone Diseases, Infectious

ClinicalTrials.gov processed this record on January 16, 2009