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

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00809159

First received: December 16, 2008

Last updated: June 17, 2011

Last verified: June 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	December 16, 2008
Last Updated Date	June 17, 2011
Start Date ^ICMJE	March 2009
Primary Completion Date	May 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 22, 2010)	Part 1: 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). Part 2: Change in BASDAI response at 6 weeks [ Time Frame: Interim analysis at 6 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: December 16, 2008)	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 ]
Change History	Complete list of historical versions of study NCT00809159 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 22, 2010)	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 ] Quality of Life Questionnaires (SF-36 and ASQoL) at baseline and weeks 4, 12 and 28: [ 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) and 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 ]
Original Secondary Outcome Measures ^ICMJE (submitted: December 16, 2008)	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 ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy of AIN457 in Adults (18-65 Years) With Moderate to Severe Ankylosing Spondylitis
Official Title ^ICMJE	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
Brief Summary	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 administered three weeks apart In Part 1 patients will be administered either AIN457 10 mg/kg or placebo. In Part 2, patients will be administered either 10 mg/kg, 1.0 mg/kg or 0.1 mg/kg AIN457. Thirty patients will be enrolled in Part 1 and an additional 30 patients into Part 2 (i.e. no patients will be enrolled into both Parts 1 and 2).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Ankylosing Spondylitis
Intervention ^ICMJE	Drug: AIN457 Drug: ARIN457
Study Arm (s)	Experimental: Arm 1 Part 1 Exp 1 Intervention: Drug: AIN457 Placebo Comparator: Arm 2 Part 1 P Intervention: Drug: AIN457 Experimental: Arm 3 Part 2 Exp 1 Intervention: Drug: AIN457 Experimental: Arm 4 Part 2 Exp 2 Intervention: Drug: ARIN457 Experimental: Arm 5 Part 2 Exp 3 Intervention: Drug: AIN457
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	60
Completion Date	Not Provided
Primary Completion Date	May 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Germany, Netherlands, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00809159
Other Study ID Numbers ^ICMJE	CAIN457A2209
Has Data Monitoring Committee	No
Responsible Party	External Affairs, Novartis
Study Sponsor ^ICMJE	Novartis Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Novartis
Verification Date	June 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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