Study of Apremilast to Treat Subjects With Active Ankylosing Spondylitis (POSTURE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01583374
First received: April 20, 2012
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

Apremilast is a new, orally available, small molecule drug that specifically inhibits phosphodiesterase 4 (PDE4), an enzyme that modulates inflammatory cytokines. This clinical study tests whether apremilast can improve the signs and symptoms of ankylosing spondylitis.


Condition Intervention Phase
Ankylosing Spondyloarthritis
Drug: Apremilast tablet 20 mg
Drug: Apremilast tablet 30 mg BID
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Active Ankylosing Spondylitis

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Assessment in Ankylosing Spondylitis (ASAS 20) [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
    ASAS 20 at Wk 16


Secondary Outcome Measures:
  • Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
    Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)

  • Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
    Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index(BASDAI)

  • Assessment in Ankylosing Spondylitis (ASAS 20) [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
    Assessment in Ankylosing Spondylitis (ASAS 20)

  • Change from baseline in the Physical Component Summary score (PCS) of Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
    Change from baseline in the Physical Component Summary score (PCS) of Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36)

  • Change from baseline in Bath Ankylosing Spondylitis Metrology Index-linear (BASMI-lin) [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
    Change from baseline in Bath Ankylosing Spondylitis Metrology Index-linear (BASMI-lin)


Estimated Enrollment: 456
Study Start Date: May 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Apremilast 20 mg
Apremilast 20 mg will be taken orally twice a day (BID)
Drug: Apremilast tablet 20 mg
PDE4-specific inhibitor
Experimental: Apremilast 30 mg
Apremilast 30 mg will be taken orally twice a day (BID)
Drug: Apremilast tablet 30 mg BID
PDE4-specific inhibitor
Placebo Comparator: Placebo
Placebo
Drug: Placebo
PDE4-specific inhibitor

Detailed Description:

Patients will be assigned two different treatments based on chance (randomized) to placebo or apremilast (20 or 30 mg tablet). The duration of the study is approximately 5 years. The double blind period (when patients nor the physician knows whether placebo or apremilast is taken) is 24 weeks. At Week 16, subjects who do not have either a ≥ 20% improvement or a ≥ 1 unit improvement from baseline in at least two of the four SpondyloArthritis international Society (ASAS) domains will enter the "early escape" from their current treatment in a double-blinded manner. However, such subjects will be permitted to continue in the study. At Week 24, subjects may enter a long-term extension phase for up to an additional 4.5 years (236 weeks). At "second escape" (at Week 24), apremilast 20 mg BID treated subjects will be transitioned to receive double-blinded apremilast 30 mg BID; apremilast 30 mg BID will remain on double-blinded apremilast 30 mg BID because they may continue to improve with a longer duration of treatment. After Week 24 and during the early portion of the long-term extension through Week 52, all subjects will continue on either double-blinded apremilast 20 mg BID or 30 mg BID treatment. After all subjects have completed Week 52 or have terminated early from the study and the 52-week data base is locked, open-label apremilast 20 mg BID or 30 mg BID treatment will be provided.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented diagnosis of Definite Ankylosing Spondylitis [(AS); arthritis of the spine]
  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is ≥ 4
  • Total back pain is ≥ 4
  • On stable dose of AS medication (or lack of medication) prior to randomization and through week 24

Exclusion Criteria:

  • Prior treatment with a Tumor Necrosis Factor (TNF) blocker and any biologic treatment for AS
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01583374

  Show 98 Study Locations
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Lilia Pineda, MD Celgene Corporation
  More Information

Additional Information:
No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01583374     History of Changes
Other Study ID Numbers: CC-10004-AS-001, 2011-001555-37
Study First Received: April 20, 2012
Last Updated: October 30, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Bulgaria: Bulgarian Drug Agency
Czech Republic: State Institute for Drug Control
Estonia: The State Agency of Medicine
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Netherlands: Medicines Evaluation Board (MEB)
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
Slovakia: State Institute for Drug Control
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Celgene Corporation:
spondylitis
spondyloarthritis
Spondyloarthropathy
Oral preparation

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Spondylarthritis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Ankylosis
Joint Diseases
Arthritis
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 14, 2014