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

This study is currently recruiting participants.
Verified April 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01808118
First received: March 7, 2013
Last updated: April 8, 2014
Last verified: April 2014
  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:


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: April 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 TB screening assessment
  • Ability to administer subcutaneous injections
  • General good health otherwise

Exclusion Criteria:

  • Prior anti-Tumor Necrosis Factor (TNF) therapy; biologic therapy with a potential therapeutic impact on SpA or treated with an investigational drug of chemical or biologic nature within 30 days or 5 half-lives of baseline.
  • Fulfillment of the radiographic criterion of the 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: Laura DeVivo 847-938-5833 laura.devivo@abbvie.com

  Show 93 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Jaclyn K Anderson, DO AbbVie
  More Information

Additional Information:
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: April 8, 2014
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
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
Russia: Ministry of Health of the Russian Federation
France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by AbbVie:
Spinal Diseases
Anti-Inflammatory Agents
Musculoskeletal Diseases
Joint Diseases
Arthritis
Spondylarthropathy
Spondyloarthritis
Antirheumatic Agents
Adalimumab
Spondylitis
Ankylosing Spondyloarthritis

Additional relevant MeSH terms:
Spinal Diseases
Spondylarthritis
Spondylitis
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Bone Diseases, Infectious
Infection
Adalimumab
Antirheumatic Agents
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014