Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS
C-AXSPAND
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
2 other identifiers
interventional
317
9 countries
105
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2015
Longer than P75 for phase_3
105 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 15, 2015
CompletedFirst Posted
Study publicly available on registry
September 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedResults Posted
Study results publicly available
August 17, 2020
CompletedAugust 18, 2022
August 1, 2022
2.7 years
September 15, 2015
April 27, 2019
August 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (11)
Percentage of Subjects With Ankylosing Spondylitis Disease Activity Score Major Improvement (ASDAS-MI) Response Criteria Response at 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").
Week 52
Percentage of Subjects With Axial SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at 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.
Week 12
Certolizumab Pegol Plasma Concentration at Baseline
Certolizumab pegol plasma concentration was measured at Baseline in micrograms per millilitre (µg/mL).
Baseline (Week 0)
Certolizumab Pegol Plasma Concentration at Week 1
Certolizumab pegol plasma concentration was measured at Week 1, in µg/mL.
Week 1
Certolizumab Pegol Plasma Concentration at Week 2
Certolizumab pegol plasma concentration was measured at Week 2, in µg/mL.
Week 2
Certolizumab Pegol Plasma Concentration at Week 4
Certolizumab pegol plasma concentration was measured at Week 4, in µg/mL.
Week 4
Certolizumab Pegol Plasma Concentration at Week 12
Certolizumab pegol plasma concentration was measured at Week 12, in µg/mL.
Week 12
Certolizumab Pegol Plasma Concentration at Week 24
Certolizumab pegol plasma concentration was measured at Week 24, in µg/mL.
Week 24
Certolizumab Pegol Plasma Concentration at Week 36
Certolizumab pegol plasma concentration was measured at Week 36, in µg/mL.
Week 36
Certolizumab Pegol Plasma Concentration at Week 52
Certolizumab pegol plasma concentration was measured at Week 52, in µg/mL.
Week 52
Certolizumab Pegol Plasma Concentration at Follow-Up (FU) Visit
Certolizumab pegol plasma concentration was measured at the Follow-Up Visit, in µg/mL. Follow-Up Visit was defined as 8 weeks after Week 52 or Withdrawal (WD) visit for subjects not participating in the Safety Follow-Up Extension (SFE) Period.
Follow-up Visit (up to Week 60)
Secondary Outcomes (20)
Percentage of Subjects With Axial SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 52
Week 52
Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Functional Index (BASFI)
From Baseline to Week 12
Change From Baseline to Week 52 in the Bath Ankylosing Spondylitis Functional Index (BASFI)
From Baseline to Week 52
Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
From Baseline to Week 12
Change From Baseline to Week 52 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
From Baseline to Week 52
- +15 more secondary outcomes
Study Arms (2)
Certolizumab Pegol 200 mg Q2W
EXPERIMENTALCertolizumab 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.
Placebo
PLACEBO COMPARATORMatching placebo to Certolizumab Pegol (CZP) injections are administered every 2 weeks from Week 0 onwards.
Interventions
* Active Substance: Certolizumab Pegol * Pharmaceutical Form: Prefilled syringe * Concentration: 200 mg / ml * Route of Administration: Subcutaneous injection
* Active Substance: Placebo * Pharmaceutical Form: Prefilled syringe * Concentration: 0.9 % saline * Route of Administration: Subcutaneous injection
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (105)
As0006 125
Birmingham, Alabama, United States
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 118
Charlotte, North Carolina, United States
As0006 149
Oklahoma City, Oklahoma, United States
As0006 105
Portland, Oregon, United States
As0006 108
Duncansville, Pennsylvania, United States
As0006 144
Philadelphia, Pennsylvania, United States
As0006 129
Wyomissing, Pennsylvania, United States
As0006 156
Orangeburg, South Carolina, United States
As0006 107
Salt Lake City, Utah, United States
As0006 104
Seattle, Washington, United States
As0006 158
Manitowoc, Wisconsin, United States
As0006 113
Onalaska, Wisconsin, United States
As0006 208
Camperdown, Australia
As0006 210
Coffs Harbour, Australia
As0006 204
Footscray, Australia
As0006 201
Malvern East, Australia
As0006 209
Maroochydore, Australia
As0006 205
South Hobart, Australia
As0006 202
Victoria Park, Australia
As0006 302
Plovdiv, Bulgaria
As0006 305
Plovdiv, Bulgaria
As0006 304
Rousse, Bulgaria
As0006 306
Sevlievo, Bulgaria
As0006 300
Sofia, Bulgaria
As0006 307
Sofia, Bulgaria
As0006 309
Sofia, Bulgaria
As0006 308
Varna, Bulgaria
As0006 152
Edmonton, Canada
As0006 150
Victoria, Canada
As0006 326
Hlučín, Czechia
As0006 324
Hustopeče, Czechia
As0006 327
Olomouc, Czechia
As0006 320
Ostrava, Czechia
As0006 322
Pardubice, Czechia
As0006 323
Prague, Czechia
As0006 328
Prague, Czechia
As0006 329
Prague, Czechia
As0006 330
Prague, Czechia
As0006 333
Příbor, Czechia
As0006 332
Rychnov nad Kněžnou, Czechia
As0006 331
Zlín, Czechia
As0006 365
Balatonfüred, Hungary
As0006 362
Budapest, Hungary
As0006 363
Budapest, Hungary
As0006 361
Székesfehérvár, Hungary
As0006 406
Bydgoszcz, Poland
As0006 400
Elblag, Poland
As0006 401
Krakow, Poland
As0006 402
Krakow, Poland
As0006 411
Lublin, Poland
As0006 403
Poznan, Poland
As0006 404
Poznan, Poland
As0006 405
Torun, Poland
As0006 407
Warsaw, Poland
As0006 408
Warsaw, Poland
As0006 409
Warsaw, Poland
As0006 410
Warsaw, Poland
As0006 413
Wroclaw, Poland
As0006 414
Wroclaw, Poland
As0006 461
Chelyabinsk, Russia
As0006 453
Ivanovo, Russia
As0006 450
Kazan', Russia
As0006 451
Kazan', Russia
As0006 458
Kemerovo, Russia
As0006 455
Moscow, Russia
As0006 466
Moscow, Russia
As0006 462
Orenburg, Russia
As0006 452
Ryazan, Russia
As0006 459
Saint Petersburg, Russia
As0006 463
Saint Petersburg, Russia
As0006 464
Saint Petersburg, Russia
As0006 467
Saint Petersburg, Russia
As0006 465
Samara, Russia
As0006 454
Saratov, Russia
As0006 460
Smolensk, Russia
As0006 456
Tolyatti, Russia
As0006 457
Yaroslavl, Russia
As0006 232
Hualien City, Taiwan
As0006 230
Taichung, Taiwan
As0006 233
Taichung, Taiwan
As0006 231
Taipei, Taiwan
Related Publications (4)
van der Heijde D, Gensler LS, Maksymowych WP, Landewe R, Rudwaleit M, Bauer L, Kumke T, Kim M, Auteri SE, Hoepken B, Deodhar A. Long-term safety and clinical outcomes of certolizumab pegol treatment in patients with active non-radiographic axial spondyloarthritis: 3-year results from the phase 3 C-axSpAnd study. RMD Open. 2022 Mar;8(1):e002138. doi: 10.1136/rmdopen-2021-002138.
PMID: 35296532RESULTRobinson PC, Maksymowych WP, Gensler LS, Hall S, Rudwaleit M, Hoepken B, Bauer L, Kumke T, Kim M, de Peyrecave N, Deodhar A. Certolizumab Pegol Efficacy in Patients With Non-Radiographic Axial Spondyloarthritis Stratified by Baseline MRI and C-Reactive Protein Status: An Analysis From the C-axSpAnd Study. ACR Open Rheumatol. 2022 Sep;4(9):794-801. doi: 10.1002/acr2.11469. Epub 2022 Jun 22.
PMID: 35733363RESULTMaksymowych WP, Kumke T, Auteri SE, Hoepken B, Bauer L, Rudwaleit M. Predictors of long-term clinical response in patients with non-radiographic axial spondyloarthritis receiving certolizumab pegol. Arthritis Res Ther. 2021 Oct 29;23(1):274. doi: 10.1186/s13075-021-02650-4.
PMID: 34715908DERIVEDDeodhar A, Gensler LS, Kay J, Maksymowych WP, Haroon N, Landewe R, Rudwaleit M, Hall S, Bauer L, Hoepken B, de Peyrecave N, Kilgallen B, van der Heijde D. A Fifty-Two-Week, Randomized, Placebo-Controlled Trial of Certolizumab Pegol in Nonradiographic Axial Spondyloarthritis. Arthritis Rheumatol. 2019 Jul;71(7):1101-1111. doi: 10.1002/art.40866. Epub 2019 May 28.
PMID: 30848558DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
1-844-599-2273 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
September 15, 2015
First Posted
September 17, 2015
Study Start
September 1, 2015
Primary Completion
May 1, 2018
Study Completion
May 1, 2020
Last Updated
August 18, 2022
Results First Posted
August 17, 2020
Record last verified: 2022-08