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Study Complete
Sponsor ID
CC-10004-AS-001

Study of Apremilast to treat subjects with active Ankylosing SpondylitisPOSTURE

Sponsor ID
CC-10004-AS-001
Clinicaltrials.gov ID
NCT01583374
EUCTIS ID
N/A
EudraCT ID
2011-001555-37
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
N/A
Type
Interventional
Masking
Triple (Participant, Care Provider, Investigator)
Enrollment
490
Additional Study Details

Protocol Summary

Primary Outcome Measures
Not Available
Secondary Outcome Measures
Not Available

Locations

Location
Status
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Location
Universitatsklinikum Erlangen
Erlangen, Germany, 91054
Status
Completed
Location
Universitatsklinikum Heidelberg
Heidelberg, Germany, 69120
Status
Completed
Location
Corporacio Sanitaria Parc Tauli de Sabadell
Sabadell, Spain, 08208
Status
Completed
Location
Complejo Hospitalario Universitario de Santiago de Compostela Travesía de la Choupana s/n
Santiago de Compostela, Spain, 15706
Status
Completed
Location
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Status
Completed
Location
Burnette & Silverfield, MDS PLC
Tampa, Florida, United States, 33614
Status
Completed
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Study Info
Age
18+ years
Condition
  • Ankylosing Spondylitis
    • Sex
    All
    Trial Dates
    May 2012 - Feb 2014
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Must have a documented diagnosis of ankylosing spondylitis as defined by low back pain and stiffness, which improves with exercise, but is not relieved by rest for more than 3 months prior to screening. At the completion of screening procedures, a documented diagnosis of definite active AS, as defined by the modified New York criteria (1984) whereby both criteria, at least 1 radiographic criterion and at least 1 clinical criterion, must be met - 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