Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS



Status:Active, not recruiting
Conditions:Arthritis, Arthritis, Neurology, Neurology, Orthopedic
Therapuetic Areas:Neurology, Rheumatology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:September 2015
End Date:April 2020

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Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis (axSpA) Without X-Ray Evidence of Ankylosing Spondylitis (AS) and Objective Signs of Inflammation

Patients with active Axial Spondyloarthritis without x-ray evidence of Ankylosing Spondylitis
and with signs of inflammation will be randomly assigned to receive certolizumab pegol (CZP)
200 mg every two weeks or placebo. The primary objective is to demonstrate the efficacy of
CZP in these patients.


Inclusion Criteria:

- At least 18 years old at the start of Screening Visit

- A documented diagnosis of adult-onset axial SpondyloArthritis (axSpA) and meet the
Assessment of SpondyloArthritis International Society (ASAS) criteria for axSpA

- Subjects must have had back pain for at least 12 months before Screening

- No sacroiliitis defined by Modified New York (mNY) criteria on sacroiliac (SI) x-rays

- Active disease at Screening as defined by

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

- Spinal pain >= 4 on a 0 to 10 Numerical Rating Scale (NRS)

- Inadequate response to, have a contraindication to, or have been intolerant to at
least 2 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

Exclusion Criteria:

- Diagnosis of AS or any other Inflammatory Arthritis

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

- Exposure to more than 1 tumor necrosis factor (TNF)-antagonist or primary failure to
TNF antagonist therapy

- History of or current chronic or recurrent infections

- Subjects with known Tuberculosis (TB) infection, at high risk of acquiring TB
infection, or latent Tuberculosis (LTB)

- 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
38
sites
Charlotte, North Carolina
2101
mi
from 91732
Charlotte, NC
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Atlanta, Georgia
1919
mi
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Atlanta, GA
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Beverly Hills, California
22
mi
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Beverly Hills, CA
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Birmingham, Alabama
1785
mi
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Birmingham, AL
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Birmingham, Alabama
1785
mi
from 91732
Birmingham, AL
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Boston, Massachusetts
2578
mi
from 91732
Boston, MA
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Brooklyn, New York
2186
mi
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Brooklyn, NY
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Camperdown,
?
mi
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Camperdown,
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Cumberland, Maryland
2185
mi
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Cumberland, MD
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Cumberland, Maryland
2185
mi
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Cumberland, MD
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Daytona Beach, Florida
2189
mi
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Daytona Beach, FL
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DeBary, Florida
2180
mi
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DeBary, FL
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Duncansville, Pennsylvania 16635
2201
mi
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Duncansville, PA
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Eagan, Minnesota
1510
mi
from 91732
Eagan, MN
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Fort Lauderdale, Florida
2315
mi
from 91732
Fort Lauderdale, FL
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Idaho Falls, Idaho
725
mi
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Idaho Falls, ID
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Manitowoc, Wisconsin
1756
mi
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Manitowoc, WI
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New Haven, Connecticut
2486
mi
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New Haven, CT
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New Port Richey, Florida
2114
mi
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New Port Richey, FL
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Oklahoma City, Oklahoma
1165
mi
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Oklahoma City, OK
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Onalaska, Wisconsin 54650
1580
mi
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Onalaska, WI
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Orangeburg, South Carolina
2122
mi
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Orangeburg, SC
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Palm Desert, California
97
mi
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Palm Desert, CA
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Philadelphia, Pennsylvania
2375
mi
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Philadelphia, PA
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Plantation, Florida
2310
mi
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Plantation, FL
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Portland, Oregon
828
mi
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Portland, OR
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Rochester, Minnesota
1524
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Rochester, MN
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Saint Louis, Missouri
1573
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Saint Louis, MO
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Salt Lake City, Utah
570
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Salt Lake City, UT
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San Francisco, California
355
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San Francisco, CA
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Scottsdale, Arizona
351
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Scottsdale, AZ
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Seattle, Washington
961
mi
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Seattle, WA
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Tampa, Florida
2136
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Tampa, FL
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Tucson, Arizona
429
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Tucson, AZ
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Vero Beach, Florida
2261
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Vero Beach, FL
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Wheaton, Maryland
2279
mi
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Wheaton, MD
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Worcester, Massachusetts
2540
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Worcester, MA
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Wyomissing, Pennsylvania
?
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Wyomissing, PA
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