Efficacy of AIN457 in Adults (18-65 Years) With Moderate to Severe Ankylosing Spondylitis - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00809159

Purpose

This study is designed as a proof of concept of AIN457 in patients with ankylosing spondylitis. The study will address the evaluation of the efficacy at 6 and up to 28 weeks after two doses of AIN457 10 mg/kg administered three weeks apart.

Condition	Intervention	Phase
Ankylosing Spondylitis	Drug: AIN457 Drug: Placebo	Phase I Phase II

Genetics Home Reference related topics: ankylosing spondylitis

MedlinePlus related topics: Ankylosing Spondylitis

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized, Double-Blind Placebo-Controlled Multi-Center Proof-of-Concept Study to Assess the Efficacy of AIN457 in Patients With Moderate to Severe Ankylosing Spondylitis

Further study details as provided by Novartis:

Primary Outcome Measures:

ASAS20 response at 6 weeks (ASAS includes measures of patient global assessment, inflammatory back pain, Bath Ankylosing Spondylitis Functional Index (BASFI) and morning stiffness by BASDAI). [ Time Frame: Interim analysis at 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

20% and 40% improvement compared to baseline as measured by ASAS response at screening, baseline and weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, 24 and 28 [ Time Frame: Up to 28 weeks post first infusion ] [ Designated as safety issue: No ]
ASAS 5/6 response (based on ASAS plus Bath Ankylosing Spondylitis Metrology Index (BASMI) and C reactive protein (acute phase reactant) at screening, baseline and weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, 24 and 28 [ Time Frame: Up to 28 weeks post first infusion ] [ Designated as safety issue: No ]
Physician's global assessment of disease activity at screening, baseline and weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, 24 and 28 [ Time Frame: Up to 28 weeks post first infusion ] [ Designated as safety issue: No ]
MRI at baseline and weeks 6 and 28 [ Time Frame: Up to 28 weeks post first infusion ] [ Designated as safety issue: No ]
Quality of Life Questionnaires at baseline and weeks 4, 12 and 28: SF-36 Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) [ Time Frame: Up to 28 weeks post first infusion ] [ Designated as safety issue: No ]
44-joint count at screening, baseline and weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, 24 and 28 [ Time Frame: Up to 28 weeks post first infusion ] [ Designated as safety issue: No ]
Maastricht Ankylosing Spondylitis Enthesis Score (MASES) at screening, baseline and weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, 24 and 28 [ Time Frame: Up to 28 weeks post first infusion ] [ Designated as safety issue: No ]
Leeds enthesis index (LEI) at screening, baseline and weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, 24 and 28 [ Time Frame: Up to 28 weeks post first infusion ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	January 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: AIN457
2: Placebo Comparator	Drug: Placebo

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with moderate to severe ankylosing spondylitis
Other protocol defined inclusion criteria may apply

Exclusion Criteria:

Male or female patients who plan to conceive during the time course of the study and for 6 months following the second dose.
Participation in any clinical trial within 4 weeks prior to initial dosing or longer.
Previous use of immunosuppressive agents such as cyclosporine without the necessary wash-out period
History of severe allergy to food or drugs
Positive tuberculin test
Total ankylosis of the spine (end stage disease)
Patients with psoriatic arthritis
Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809159

Contacts

Contact: Novartis

+4141 61 324 1111

Locations

Germany
Novartis Investigative Site
Herne, Germany
Novartis Investigative Site
Berlin, Germany
Netherlands
Novartis Investigative Site
Leiden, Netherlands
Novartis Investigative Site
Amsterdam, Netherlands
United Kingdom
Novartis Investigative Site
Leeds, United Kingdom

Sponsors and Collaborators

Novartis

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CAIN457A2209
Study First Received:	December 16, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00809159
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; Germany: Federal Institute for Drugs and Medical Devices; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Novartis:

Ankylosing spondylitis
IgG1K monoclonal antibody
Interleukin -17A neutralizing

Study placed in the following topic categories:

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

Arthritis
Spondylitis, Ankylosing
Spondylarthritis
Spondylitis
Immunoglobulins
Spondylarthropathies
Ankylosis

Additional relevant MeSH terms:

Infection
Bone Diseases, Infectious

ClinicalTrials.gov processed this record on January 14, 2009