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 |
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.
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
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