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. (see Contacts and Locations)
Verified July 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01808118
First received: March 7, 2013
Last updated: July 21, 2014
Last verified: July 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: 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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 108 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: July 21, 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
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on October 01, 2014