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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02552212




Registration number
NCT02552212
Ethics application status
Date submitted
15/09/2015
Date registered
17/09/2015
Date last updated
18/08/2022

Titles & IDs
Public title
Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS
Scientific title
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
Secondary ID [1] 0 0
2015-001894-41
Secondary ID [2] 0 0
AS0006
Universal Trial Number (UTN)
Trial acronym
C-AXSPAND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Axial Spondyloarthritis 0 0
Nonradiographic Axial Spondyloarthritis 0 0
Nr-axSpA 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Other - Certolizumab Pegol
Other interventions - Placebo

Experimental: Certolizumab Pegol 200 mg Q2W - 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.

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


Treatment: Other: Certolizumab Pegol
* Active Substance: Certolizumab Pegol
* Pharmaceutical Form: Prefilled syringe
* Concentration: 200 mg / ml
* Route of Administration: Subcutaneous injection

Other interventions: Placebo
* Active Substance: Placebo
* Pharmaceutical Form: Prefilled syringe
* Concentration: 0.9 % saline
* Route of Administration: Subcutaneous injection
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Subjects With Ankylosing Spondylitis Disease Activity Score Major Improvement (ASDAS-MI) Response Criteria Response at Week 52
Timepoint [1] 0 0
Week 52
Primary outcome [2] 0 0
Percentage of Subjects With Axial SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 12
Timepoint [2] 0 0
Week 12
Primary outcome [3] 0 0
Certolizumab Pegol Plasma Concentration at Baseline
Timepoint [3] 0 0
Baseline (Week 0)
Primary outcome [4] 0 0
Certolizumab Pegol Plasma Concentration at Week 1
Timepoint [4] 0 0
Week 1
Primary outcome [5] 0 0
Certolizumab Pegol Plasma Concentration at Week 2
Timepoint [5] 0 0
Week 2
Primary outcome [6] 0 0
Certolizumab Pegol Plasma Concentration at Week 4
Timepoint [6] 0 0
Week 4
Primary outcome [7] 0 0
Certolizumab Pegol Plasma Concentration at Week 12
Timepoint [7] 0 0
Week 12
Primary outcome [8] 0 0
Certolizumab Pegol Plasma Concentration at Week 24
Timepoint [8] 0 0
Week 24
Primary outcome [9] 0 0
Certolizumab Pegol Plasma Concentration at Week 36
Timepoint [9] 0 0
Week 36
Primary outcome [10] 0 0
Certolizumab Pegol Plasma Concentration at Week 52
Timepoint [10] 0 0
Week 52
Primary outcome [11] 0 0
Certolizumab Pegol Plasma Concentration at Follow-Up (FU) Visit
Timepoint [11] 0 0
Follow-up Visit (up to Week 60)
Secondary outcome [1] 0 0
Percentage of Subjects With Axial SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 52
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Functional Index (BASFI)
Timepoint [2] 0 0
From Baseline to Week 12
Secondary outcome [3] 0 0
Change From Baseline to Week 52 in the Bath Ankylosing Spondylitis Functional Index (BASFI)
Timepoint [3] 0 0
From Baseline to Week 52
Secondary outcome [4] 0 0
Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Timepoint [4] 0 0
From Baseline to Week 12
Secondary outcome [5] 0 0
Change From Baseline to Week 52 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Timepoint [5] 0 0
From Baseline to Week 52
Secondary outcome [6] 0 0
Change From Baseline to Week 12 in Sacroiliac Spondyloarthritis Research Consortium of Canada (SI-SPARCC) Score
Timepoint [6] 0 0
From Baseline to Week 12
Secondary outcome [7] 0 0
Number of Subjects Without Relevant Changes to Background Medication From Baseline to Week 52
Timepoint [7] 0 0
From Baseline to Week 52
Secondary outcome [8] 0 0
Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 52
Timepoint [8] 0 0
From Baseline to Week 52
Secondary outcome [9] 0 0
Change From Baseline in ASQoL at Week 1
Timepoint [9] 0 0
From Baseline to Week 1
Secondary outcome [10] 0 0
Change From Baseline in ASQoL at Week 2
Timepoint [10] 0 0
From Baseline to Week 2
Secondary outcome [11] 0 0
Change From Baseline in ASQoL at Week 4
Timepoint [11] 0 0
From Baseline to Week 4
Secondary outcome [12] 0 0
Change From Baseline in ASQoL at Week 12
Timepoint [12] 0 0
From Baseline to Week 12
Secondary outcome [13] 0 0
Change From Baseline in ASQoL at Week 24
Timepoint [13] 0 0
From Baseline to Week 24
Secondary outcome [14] 0 0
Change From Baseline in ASQoL at Week 36
Timepoint [14] 0 0
From Baseline to Week 36
Secondary outcome [15] 0 0
Change From Baseline in ASQoL at Week 48
Timepoint [15] 0 0
From Baseline to Week 48
Secondary outcome [16] 0 0
Change From Baseline in Nocturnal Spinal Pain Numerical Rating Scale (NRS) at Week 52
Timepoint [16] 0 0
From Baseline to Week 52
Secondary outcome [17] 0 0
Number of Subjects With Anterior Uveitis (AU) or New AU Flares Through Week 52
Timepoint [17] 0 0
Throughout the study conduct (up to Week 52)
Secondary outcome [18] 0 0
Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) During the Study
Timepoint [18] 0 0
From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156)
Secondary outcome [19] 0 0
Percentage of Subjects With Serious Adverse Events (SAEs) During the Study
Timepoint [19] 0 0
From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156)
Secondary outcome [20] 0 0
Percentage of Subjects With Adverse Events Leading to Withdrawal From Investigational Medicinal Product (IMP) During the Study
Timepoint [20] 0 0
From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156)

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2020
Sample size
Target
Accrual to date
Final
317
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
As0006 208 - Camperdown
Recruitment hospital [2] 0 0
As0006 210 - Coffs Harbour
Recruitment hospital [3] 0 0
As0006 204 - Footscray
Recruitment hospital [4] 0 0
As0006 201 - Malvern East
Recruitment hospital [5] 0 0
As0006 209 - Maroochydore
Recruitment hospital [6] 0 0
As0006 205 - South Hobart
Recruitment hospital [7] 0 0
As0006 202 - Victoria Park
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Coffs Harbour
Recruitment postcode(s) [3] 0 0
- Footscray
Recruitment postcode(s) [4] 0 0
- Malvern East
Recruitment postcode(s) [5] 0 0
- Maroochydore
Recruitment postcode(s) [6] 0 0
- South Hobart
Recruitment postcode(s) [7] 0 0
- Victoria Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Oklahoma
Country [15] 0 0
United States of America
State/province [15] 0 0
Oregon
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Utah
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
United States of America
State/province [20] 0 0
Wisconsin
Country [21] 0 0
Bulgaria
State/province [21] 0 0
Plovdiv
Country [22] 0 0
Bulgaria
State/province [22] 0 0
Ruse
Country [23] 0 0
Bulgaria
State/province [23] 0 0
Sevlievo
Country [24] 0 0
Bulgaria
State/province [24] 0 0
Sofia
Country [25] 0 0
Bulgaria
State/province [25] 0 0
Varna
Country [26] 0 0
Canada
State/province [26] 0 0
Edmonton
Country [27] 0 0
Canada
State/province [27] 0 0
Victoria
Country [28] 0 0
Czechia
State/province [28] 0 0
Hlucín
Country [29] 0 0
Czechia
State/province [29] 0 0
Hustopece
Country [30] 0 0
Czechia
State/province [30] 0 0
Olomouc
Country [31] 0 0
Czechia
State/province [31] 0 0
Ostrava
Country [32] 0 0
Czechia
State/province [32] 0 0
Pardubice
Country [33] 0 0
Czechia
State/province [33] 0 0
Praha 2
Country [34] 0 0
Czechia
State/province [34] 0 0
Praha
Country [35] 0 0
Czechia
State/province [35] 0 0
Príbor
Country [36] 0 0
Czechia
State/province [36] 0 0
Rychnov Nad Knežnou
Country [37] 0 0
Czechia
State/province [37] 0 0
Zlín
Country [38] 0 0
Hungary
State/province [38] 0 0
Balatonfüred
Country [39] 0 0
Hungary
State/province [39] 0 0
Budapest
Country [40] 0 0
Hungary
State/province [40] 0 0
Szekesfehervar
Country [41] 0 0
Poland
State/province [41] 0 0
Bydgoszcz
Country [42] 0 0
Poland
State/province [42] 0 0
Elblag
Country [43] 0 0
Poland
State/province [43] 0 0
Kraków
Country [44] 0 0
Poland
State/province [44] 0 0
Lublin
Country [45] 0 0
Poland
State/province [45] 0 0
Poznan
Country [46] 0 0
Poland
State/province [46] 0 0
Torun
Country [47] 0 0
Poland
State/province [47] 0 0
Warszawa
Country [48] 0 0
Poland
State/province [48] 0 0
Wroclaw
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Chelyabinsk
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Ivanovo
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Kazan
Country [52] 0 0
Russian Federation
State/province [52] 0 0
Kemerovo
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Moscow
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Orenburg
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Ryazan'
Country [56] 0 0
Russian Federation
State/province [56] 0 0
Saint Petersburg
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Samara
Country [58] 0 0
Russian Federation
State/province [58] 0 0
Saratov
Country [59] 0 0
Russian Federation
State/province [59] 0 0
Smolensk
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Tolyatti
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Yaroslavl
Country [62] 0 0
Taiwan
State/province [62] 0 0
Hualien City
Country [63] 0 0
Taiwan
State/province [63] 0 0
Taichung City
Country [64] 0 0
Taiwan
State/province [64] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
UCB BIOSCIENCES GmbH
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT02552212
Trial related presentations / publications
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.
Robinson 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.
Maksymowych 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.
Deodhar 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.
Public notes

Contacts
Principal investigator
Name 0 0
UCB Cares
Address 0 0
1-844-599-2273 (UCB)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02552212