Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Arthritis, Neurology, Neurology |
| Therapuetic Areas: | Neurology, Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 3/31/2019 |
| Start Date: | July 2015 |
| End Date: | April 2019 |
A Multicenter, Open-label (Part A) Followed by a Randomized, Double-blind, Parallel-group, Placebo Controlled Study (Part B) to Evaluate Maintenance of Remission in Subjects With Active Axial Spondyloarthritis (axSpA) Receiving Either Certolizumab Pegol 200 mg Q2W or 200 mg Q4W as Compared to Placebo
Patients receive study drug for one year (Part A). If, after the initial run-in phase, a
sustained remission is reached they will be randomly split into one of three dose groups for
another year (Part B). The maintenance of the sustained remission will be analyzed.
sustained remission is reached they will be randomly split into one of three dose groups for
another year (Part B). The maintenance of the sustained remission will be analyzed.
Inclusion Criteria:
- Documented diagnosis of adult-onset axial SpondyloArthritis (axSpA) with at least 3
months' symptom duration and meet the Assessment of SpondyloArthritis International
Society (ASAS) criteria for axSpA and symptom duration of less than 5 years prior to
the participation of this study
- Active disease at Screening as defined by
- Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥ 2.1
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4
- Spinal pain > 4 on a 0 to 10 Numerical Rating Scale (NRS) (from BASDAI Item 2)
- for modified New York (mNY) -negative subjects only: C-reactive Protein (CRP) >
upper limit of normal (ULN) and/or current evidence for sacroiliitis on the
Screening Magnetic Resonance Imaging (MRI)
- Inadequate response to, or contraindication to, or intolerant to at least 2
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
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 primary failure to TNF antagonist therapy
- 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
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