Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis



Status:Completed
Conditions:Neurology, Orthopedic
Therapuetic Areas:Neurology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:8/3/2018
Start Date:March 2010
End Date:August 2015

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Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis

The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to
evaluate the efficacy and safety of two dose regimens of Certolizumab Pegol (CZP) in subjects
with active axial Spondyloarthritis (axial SpA).


Inclusion Criteria:

- Documented diagnosis of adult-onset axial Spondyloarthritis (SpA) of at least 3
months' duration as defined by the specified Assessment of Spondyloarthritis
International Society (ASAS) criteria

- Active disease as defined by:

- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4

- Back pain ≥ 4 on a 0 to 10 Neurobehavioral Rating Scale (NRS) (from BASDAI item
2)

- C-Reactive Protein (CRP) > ULN (Upper Limit of Normal) and/or current evidence
(ie, within the last 3 months from Screening) for Sacroiliitis on Magnetic
Resonance Imaging (MRI) as defined by Assessment of Spondyloarthritis
International Society (ASAS) criteria

- Intolerance to or inadequate response to at least 1 Nonsteroidal Anti-Inflammatory
Drug (NSAID)

Exclusion Criteria:

- Presence of total Spinal Ankylosis ("bamboo spine")

- Diagnosis of any other Inflammatory Arthritis

- Prior treatment with any experimental biological agents for treatment of Axial
Spondyloarthritis (SpA)

- Exposure to more than 1 TNF-antagonist or to more than 2 previous biological agents
for Axial Spondyloarthritis (SpA)

- History of or current chronic or recurrent infections

- High risk of infection

- Recent live vaccination

- Concurrent malignancy or a history of malignancy

- Class III or IV congestive heart failure - New York Heart Association (NYHA)

- Demyelinating disease of the central nervous system

- Female subjects who are breastfeeding, pregnant or plan to become pregnant during the
study or within 3 months following the last dose of the investigational product

- Subjects with any other condition which, in the investigator's judgment, would make
the subject unsuitable for inclusion in the study
We found this trial at
32
sites
99
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La Jolla, CA
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Asheville, NC
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Aventura, FL
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Birmingham, AL
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Brooklyn, NY
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Buenos Aires,
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Cleveland, OH
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Dallas, TX
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Duncansville, Pennsylvania 16635
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Eagan, MN
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Florissant, MO
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Flowood, MS
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Fort Lauderdale, FL
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Hagerstown, MD
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Houston, TX
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Los Angeles, CA
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Middleburg Heights, OH
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Oklahoma City, OK
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Orange Park, FL
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Palm Desert, CA
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Peoria, AZ
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Pinellas Park, FL
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Portland, OR
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Saint Louis, MO
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San Antonio, TX
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San Diego, CA
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Scottsdale, AZ
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Seattle, WA
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Tucson, AZ
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Tuscaloosa, AL
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Vero Beach, FL
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