Study Comparing the Efficacy and Safety of Continuing Versus Withdrawing Adalimumab Therapy in Maintaining Remission in Subjects With Non-Radiographic Axial Spondyloarthritis - Full Text View

Purpose

This is a Multicenter, randomized, double-blind study in subjects with moderate to severe non-radiographic Axial Spondyloarthritis.

There is a 28-week open-label period followed by a 40-week double-blind, placebo-controlled period for subjects who meet the randomization criteria. Subjects who flare during the double-blind period will have an opportunity to receive at least 12-weeks of rescue therapy.

Condition	Intervention	Phase
Axial Spondyloarthritis	Biological: adalimumab Biological: Placebo	Phase 4

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, Randomized, Double-Blind, Study Comparing the Efficacy and Safety of Continuing Versus Withdrawing Adalimumab Therapy in Maintaining Remission in Subjects With Non-Radiographic Axial Spondyloarthritis

Resource links provided by NLM:

Genetics Home Reference related topics: ankylosing spondylitis

MedlinePlus related topics: Ankylosing Spondylitis Joint Disorders Spine Injuries and Disorders

Drug Information available for: Adalimumab

U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:

The proportion of participants who do not experience a flare during period 2 by Week 68 of the study where a flare is defined as having any 2 consecutive study visits with ASDAS ≥ 2.1 [ Time Frame: Up to Week 68 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Ankylosing Spondylitis Disease Activity Score (ASDAS) Inactive Disease (ASDAS < 1.3) [ Time Frame: Up to Week 68 ] [ Designated as safety issue: No ]
ASDAS Major Improvement (a change from baseline ≤ -2.00) [ Time Frame: Up to Week 68 ] [ Designated as safety issue: No ]
ASDAS Clinically Important Improvement (a change from baseline ≤ -1.10) [ Time Frame: Up to Week 68 ] [ Designated as safety issue: No ]
Assessment of Spondyloarthritis International Society (ASAS20) [ Time Frame: Up to Week 68 ] [ Designated as safety issue: No ]
ASAS20 response: improvement of ≥ 20% and absolute improvement of ≥ 1 unit (on a scale of 0 to 10) from Baseline in ≥ 3 of the following 4 domains, with no deterioration in the remaining domain (defined as a worsening of ≥ 20% and a net worsening≥ 1 unit).
- Patient's Global Assessment (PTGA) - Represented by the PTGA-disease activity Numerical Rating Scale (NRS) score (0 to 10)
- Pain - Represented by the patient's assessment of total back pain NRS score (0 to 10)
- Function - Represented by the Bath Ankylosing Spondylitis Functional Index (BASFI) NRS score (0 to 10)
- Inflammation - Represented by the mean of the 2 morning stiffness related BASDAI NRS scores (mean of items 5 and 6 of the BASDAI [0 to 10])
Assessment of Spondyloarthritis International Society (ASAS40) [ Time Frame: Up to Week 68 ] [ Designated as safety issue: No ]
ASAS40 response: improvement of ≥ 40% and absolute improvement of ≥ 2 units (on a scale of 0 to 10) from Baseline in ≥ 3 of the 4 domains above in ASAS20 with no deterioration in the potential remaining domain
Assessment of Spondyloarthritis International Society (ASAS 5/6) [ Time Frame: Up to Week 68 ] [ Designated as safety issue: No ]
ASAS5/6 response: 20% improvement from Baseline in 5 out of the following 6 domains: BASFI, patient's assessment of total back pain, PTGA-disease activity, inflammation (mean of items 5 and 6 of the BASDAI]) lateral lumbar flexion from Bath Ankylosing Spondylitis Metrology Index (BASMI), and high sensitivity C-reactive Protein (hs-CRP)
ASAS Partial Remission [ Time Frame: Up to Week 68 ] [ Designated as safety issue: No ]
ASAS partial remission: absolute score of < 2 units for each of the 4 domains identified above in ASAS20
Bath AS Disease Activity Index 50 (BASDAI50) [ Time Frame: Up to Week 68 ] [ Designated as safety issue: No ]

Estimated Enrollment:	740
Study Start Date:	May 2013
Estimated Study Completion Date:	May 2017
Estimated Primary Completion Date:	May 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Open-label (OL) Adalimumab 40 mg every other week (eow), Weeks 0-28. If subjects flare during the double-blind period, subjects will have an opportunity to receive at least 12 weeks of adalimumab 40 mg eow.	Biological: adalimumab 40 mg every other week Other Name: Humira ABT-D2E7
Placebo Comparator: Placebo Placebo every other week (eow), Weeks 28-68. Placebo will be discontinued in subjects who meet the criteria for flare.	Biological: Placebo every other week
Experimental: Double-Blind Adalimumab 40 mg every other week (eow), Weeks 28-68.	Biological: adalimumab 40 mg every other week Other Name: Humira ABT-D2E7

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 antiinflammatories (NSAIDs)
Subject with axial SpA fulfilling the Assessment of Spondyloarthritis International Society (ASAS) axial SpA classification criteria
Subject with evidence of active inflammation in the sacroiliac (SI) joints or spine on MRI, or elevated hs-CRP
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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01808118

Contacts

Contact: Paige M Gjelsten	847-937-9090	paige.m.gjelsten@abbvie.com
Contact: Tami Dillberg	847-937-6332	tami.dillberg@abbvie.com

Locations

United States, Connecticut
Site Reference ID/Investigator# 90933	Recruiting
Danbury, Connecticut, United States, 06810
Principal Investigator: Site Reference ID/Investigator# 90933
United States, New Jersey
Site Reference ID/Investigator# 86554	Recruiting
Clifton, New Jersey, United States, 07012
Principal Investigator: Site Reference ID/Investigator# 86554
United States, Pennsylvania
Site Reference ID/Investigator# 74957	Recruiting
Duncansville, Pennsylvania, United States, 16635
Principal Investigator: Site Reference ID/Investigator# 74957
Canada
Site Reference ID/Investigator# 75836	Recruiting
Montreal, Canada, H2L 1S6
Principal Investigator: Site Reference ID/Investigator# 75836

Sponsors and Collaborators

AbbVie

Investigators

Study Director:

Jaclyn K Anderson, DO

AbbVie

More Information

Additional Information:

Humira Prescribing Information This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	AbbVie
ClinicalTrials.gov Identifier:	NCT01808118 History of Changes
Other Study ID Numbers:	M13-375, 2012-000646-35
Study First Received:	March 7, 2013
Last Updated:	May 17, 2013
Health Authority:	Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Slovakia: State Institute for Drug Control European Union: European Medicines Agency Switzerland: Swissmedic United Kingdom: Medicines and Healthcare Products Regulatory Agency Canada: Health Canada Mexico: Secretaria de Salud Denmark: Danish Medicines Agency Sweden: Medical Products Agency Italy: The Italian Medicines Agency Germany: Paul-Ehrlich-Institut Norway: Norwegian Medicines Agency Ireland: Irish Medicines Board Finland: Finnish Medicines Agency New Zealand: Health and Disability Ethics Committees New Zealand: Medsafe Czech Republic: State Institute for Drug Control United States: Food and Drug Administration Belgium: Federal Agency for Medicinal Products and Health Products Australia: National Health and Medical Research Council Brazil: National Health Surveillance Agency Spain: Agencia Española de Medicamentos y Productos Sanitarios Brazil: National Committee of Ethics in Research Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Mexico: Federal Commission for Protection Against Health Risks France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Russia: Ministry of Health of the Russian Federation

Keywords provided by AbbVie:

Anti-Inflammatory Agents
Spinal Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Spondylarthropathy

Spondyloarthritis
Antirheumatic Agents
Adalimumab
Spondylitis
Ankylosing Spondyloarthritis

Additional relevant MeSH terms:

Bone Diseases, Infectious
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis

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

ClinicalTrials.gov processed this record on June 18, 2013