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

Completed · Phase 3 · Has a placebo group

Conditions studied: Axial Spondyloarthritis, Nonradiographic Axial Spondyloarthritis, Nr-axSpA

In brief

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.

Key facts

Study ID

NCT02552212

Run by

UCB BIOSCIENCES GmbH

People needed

317

Starts

2015-09-01

Expected to finish

2020-05-01

Last updated by the study team

2022-08-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• As0006 120 — Scottsdale, Arizona, United States
• As0006 115 — Tucson, Arizona, United States
• As0006 155 — Beverly Hills, California, United States
• As0006 101 — Palm Desert, California, United States
• As0006 143 — San Francisco, California, United States
• As0006 160 — New Haven, Connecticut, United States
• As0006 117 — Daytona Beach, Florida, United States
• As0006 116 — DeBary, Florida, United States
• As0006 124 — Fort Lauderdale, Florida, United States
• As0006 133 — New Port Richey, Florida, United States
• As0006 138 — Plantation, Florida, United States
• As0006 134 — Tampa, Florida, United States
• As0006 106 — Vero Beach, Florida, United States
• As0006 148 — Atlanta, Georgia, United States
• As0006 137 — Idaho Falls, Idaho, United States
• As0006 102 — Cumberland, Maryland, United States
• As0006 141 — Cumberland, Maryland, United States
• As0006 111 — Wheaton, Maryland, United States
• As0006 127 — Boston, Massachusetts, United States
• As0006 147 — Worcester, Massachusetts, United States
• As0006 110 — Eagan, Minnesota, United States
• As0006 123 — Rochester, Minnesota, United States
• As0006 103 — St Louis, Missouri, United States
• As0006 114 — Brooklyn, New York, United States
• As0006 125 — Birmingham, Alabama, 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.