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

UCB

Status and phase: Completed; Phase 3

Conditions: Axial Spondyloarthritis; Nonradiographic Axial Spondyloarthritis; Nr-axSpA

Treatments: Biological: Certolizumab Pegol; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02552212

2015-001894-41 (EudraCT Number)

AS0006

Details and patient eligibility

About

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.

Enrollment: 317 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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317 participants in 2 patient groups, including a placebo group

Certolizumab Pegol 200 mg Q2W

Experimental group

Description:

Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.

Treatment:

Biological: Certolizumab Pegol

Placebo

Placebo Comparator group

Description:

Matching placebo to Certolizumab Pegol (CZP) injections are administered every 2 weeks from Week 0 onwards.

Treatment:

Other: Placebo