Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis

Completed · Phase 3 · Has a placebo group

Conditions studied: Spondyloarthropathies

In brief

The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of two dose regimens of Certolizumab Pegol (CZP) in subjects with active axial Spondyloarthritis (axial SpA).

Key facts

Study ID

NCT01087762

Run by

UCB BIOSCIENCES GmbH

People needed

325

Starts

2010-03-01

Expected to finish

2015-08-01

Last updated by the study team

2018-08-01

Who can join

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

You may qualify if…

• Documented diagnosis of adult-onset axial Spondyloarthritis (SpA) of at least 3 months' duration as defined by the specified Assessment of Spondyloarthritis International Society (ASAS) criteria
• Active disease as defined by:
• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4
• Back pain ≥ 4 on a 0 to 10 Neurobehavioral Rating Scale (NRS) (from BASDAI item 2)
• C-Reactive Protein (CRP) > ULN (Upper Limit of Normal) and/or current evidence (ie, within the last 3 months from Screening) for Sacroiliitis on Magnetic Resonance Imaging (MRI) as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria
• Intolerance to or inadequate response to at least 1 Nonsteroidal Anti-Inflammatory Drug (NSAID)

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 to more than 2 previous biological agents for Axial Spondyloarthritis (SpA)
• 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

• 953 — Tuscaloosa, Alabama, United States
• 954 — Peoria, Arizona, United States
• 971 — Scottsdale, Arizona, United States
• 987 — Tucson, Arizona, United States
• 974 — La Jolla, California, United States
• 973 — Los Angeles, California, United States
• 966 — Palm Desert, California, United States
• 952 — San Diego, California, United States
• 957 — Aventura, Florida, United States
• 962 — Fort Lauderdale, Florida, United States
• 959 — Orange Park, Florida, United States
• 990 — Pinellas Park, Florida, United States
• 958 — Vero Beach, Florida, United States
• 964 — Hagerstown, Maryland, United States
• 969 — Eagan, Minnesota, United States
• 984 — Flowood, Mississippi, United States
• 965 — Florissant, Missouri, United States
• 950 — St Louis, Missouri, United States
• 985 — Brooklyn, New York, United States
• 963 — Asheville, North Carolina, United States
• 977 — Cleveland, Ohio, United States
• 951 — Middleburg Heights, Ohio, United States
• 970 — Oklahoma City, Oklahoma, United States
• 982 — Portland, Oregon, United States
• 961 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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