Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo

Completed · Phase 3 · Has a placebo group

Conditions studied: Axial Spondyloarthrithis, Ankylosing Spondylitis

In brief

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.

Key facts

Study ID

NCT02505542

Run by

UCB BIOSCIENCES GmbH

People needed

736

Starts

2015-07-01

Expected to finish

2019-04-01

Last updated by the study team

2020-12-17

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• As0005 2316 — Mesa, Arizona, United States
• As0005 2314 — Phoenix, Arizona, United States
• As0005 2317 — Sun City, Arizona, United States
• As0005 2307 — Palm Desert, California, United States
• As0005 2310 — San Francisco, California, United States
• As0005 2305 — Upland, California, United States
• As0005 2308 — Denver, Colorado, United States
• As0005 2302 — Brandon, Florida, United States
• As0005 2321 — Hagerstown, Maryland, United States
• As0005 2312 — Minot, North Dakota, United States
• As0005 2323 — Oklahoma City, Oklahoma, United States
• As0005 2311 — Duncansville, Pennsylvania, United States
• As0005 2315 — Jackson, Tennessee, United States
• As0005 2303 — Austin, Texas, United States
• As0005 2318 — Dallas, Texas, United States
• As0005 1006 — Genk, Belgium
• As0005 1001 — Ghent, Belgium
• As0005 1004 — Merksem, Belgium
• As0005 1003 — Mons, Belgium
• As0005 1109 — Pleven, Bulgaria
• As0005 1103 — Plovdiv, Bulgaria
• As0005 1106 — Plovdiv, Bulgaria
• As0005 1111 — Rousse, Bulgaria
• As0005 1110 — Sevlievo, Bulgaria
• As0005 2313 — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.