Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis (axSpA) Without X-Ray Evidence of Ankylosing Spondylitis (AS) and Objective Signs of Inflammation (C-AXSPAND)

NCT02552212 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	UCB BIOSCIENCES GmbH
Phase	Phase 3
Status	COMPLETED
Enrolment	317
Start date	2015-09
Completion	2020-05

Conditions

• Axial Spondyloarthritis
• Nonradiographic Axial Spondyloarthritis
• Nr-axSpA

Interventions

• Certolizumab Pegol
• Placebo

Primary outcomes

• Percentage of Subjects With Ankylosing Spondylitis Disease Activity Score Major Improvement (ASDAS-MI) Response Criteria Response at Week 52 — Week 52
  This variable was considered as primary in all countries except for Canada (and any other country where applicable or where requested by Regulatory Authorities) where it was considered as secondary variable. ASDAS-MI was achieved when there was a reduction (improvement) \>= 2.0 in the ASDAS relative to Baseline, or when the lowest possible ASDAS score (0.6) was reached. The ASDAS was calculated as the sum of the following components: 0.121 × Back pain (BASDAI Q2 result) 0.058 × Duration of morning stiffness (BASDAI Q6 result) 0.110 × Patient's Global Assessment of Disease Activity (PGADA) 0.073 × Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm \[ln\] of the (CRP \[mg/L\] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units, where 0 is "not active" and 10 is "very active").
• Percentage of Subjects With Axial SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 12 — Week 12
  This variable was considered as primary for Canada (and any other country where applicable or where requested by Regulatory Authorities) and as secondary variable in all other countries. The ASAS40 response was defined as relative improvements of at least 40 % and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS), where 0 is "not active" and 10 is "very active" in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain.
• Certolizumab Pegol Plasma Concentration at Baseline — Baseline (Week 0)
  Certolizumab pegol plasma concentration was measured at Baseline in micrograms per millilitre (µg/mL).
• Certolizumab Pegol Plasma Concentration at Week 1 — Week 1
  Certolizumab pegol plasma concentration was measured at Week 1, in µg/mL.
• Certolizumab Pegol Plasma Concentration at Week 2 — Week 2
  Certolizumab pegol plasma concentration was measured at Week 2, in µg/mL.
• Certolizumab Pegol Plasma Concentration at Week 4 — Week 4
  Certolizumab pegol plasma concentration was measured at Week 4, in µg/mL.

Countries

United States, Australia, Bulgaria, Canada, Czechia, Hungary, Poland, Russia, Taiwan