- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02552212
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
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Expanded Access
Contacts and Locations
Study Locations
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Camperdown, Australia
- As0006 208
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Coffs Harbour, Australia
- As0006 210
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Footscray, Australia
- As0006 204
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Malvern East, Australia
- As0006 201
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Maroochydore, Australia
- As0006 209
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South Hobart, Australia
- As0006 205
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Victoria Park, Australia
- As0006 202
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Plovdiv, Bulgaria
- As0006 302
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Plovdiv, Bulgaria
- As0006 305
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Ruse, Bulgaria
- As0006 304
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Sevlievo, Bulgaria
- As0006 306
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Sofia, Bulgaria
- As0006 300
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Sofia, Bulgaria
- As0006 307
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Sofia, Bulgaria
- As0006 309
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Varna, Bulgaria
- As0006 308
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Edmonton, Canada
- As0006 152
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Victoria, Canada
- As0006 150
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Hlučín, Czechia
- As0006 326
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Hustopeče, Czechia
- As0006 324
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Olomouc, Czechia
- As0006 327
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Ostrava, Czechia
- As0006 320
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Pardubice, Czechia
- As0006 322
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Praha, Czechia
- As0006 323
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Praha, Czechia
- As0006 329
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Praha, Czechia
- As0006 330
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Praha 2, Czechia
- As0006 328
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Příbor, Czechia
- As0006 333
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Rychnov Nad Kněžnou, Czechia
- As0006 332
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Zlín, Czechia
- As0006 331
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Balatonfüred, Hungary
- As0006 365
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Budapest, Hungary
- As0006 362
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Budapest, Hungary
- As0006 363
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Szekesfehervar, Hungary
- As0006 361
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Bydgoszcz, Poland
- As0006 406
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Elbląg, Poland
- As0006 400
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Kraków, Poland
- As0006 401
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Kraków, Poland
- As0006 402
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Lublin, Poland
- As0006 411
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Poznań, Poland
- As0006 403
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Poznań, Poland
- As0006 404
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Toruń, Poland
- As0006 405
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Warszawa, Poland
- As0006 407
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Warszawa, Poland
- As0006 408
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Warszawa, Poland
- As0006 409
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Warszawa, Poland
- As0006 410
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Wrocław, Poland
- As0006 413
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Wrocław, Poland
- As0006 414
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Chelyabinsk, Russian Federation
- As0006 461
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Ivanovo, Russian Federation
- As0006 453
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Kazan, Russian Federation
- As0006 450
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Kazan, Russian Federation
- As0006 451
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Kemerovo, Russian Federation
- As0006 458
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Moscow, Russian Federation
- As0006 455
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Moscow, Russian Federation
- As0006 466
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Orenburg, Russian Federation
- As0006 462
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Ryazan', Russian Federation
- As0006 452
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Saint Petersburg, Russian Federation
- As0006 459
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Saint Petersburg, Russian Federation
- As0006 463
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Saint Petersburg, Russian Federation
- As0006 464
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Saint Petersburg, Russian Federation
- As0006 467
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Samara, Russian Federation
- As0006 465
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Saratov, Russian Federation
- As0006 454
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Smolensk, Russian Federation
- As0006 460
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Tolyatti, Russian Federation
- As0006 456
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Yaroslavl, Russian Federation
- As0006 457
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Hualien City, Taiwan
- As0006 232
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Taichung City, Taiwan
- As0006 230
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Taichung City, Taiwan
- As0006 233
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Taipei, Taiwan
- As0006 231
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Alabama
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Birmingham, Alabama, United States
- As0006 125
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Arizona
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Scottsdale, Arizona, United States
- As0006 120
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Tucson, Arizona, United States
- As0006 115
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California
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Beverly Hills, California, United States
- As0006 155
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Palm Desert, California, United States
- As0006 101
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San Francisco, California, United States
- As0006 143
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Connecticut
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New Haven, Connecticut, United States
- As0006 160
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Florida
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Daytona Beach, Florida, United States
- As0006 117
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DeBary, Florida, United States
- As0006 116
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Fort Lauderdale, Florida, United States
- As0006 124
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New Port Richey, Florida, United States
- As0006 133
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Plantation, Florida, United States
- As0006 138
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Tampa, Florida, United States
- As0006 134
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Vero Beach, Florida, United States
- As0006 106
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Georgia
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Atlanta, Georgia, United States
- As0006 148
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Idaho
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Idaho Falls, Idaho, United States
- As0006 137
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Maryland
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Cumberland, Maryland, United States
- As0006 102
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Cumberland, Maryland, United States
- As0006 141
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Wheaton, Maryland, United States
- As0006 111
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Massachusetts
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Boston, Massachusetts, United States
- As0006 127
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Worcester, Massachusetts, United States
- As0006 147
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Minnesota
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Eagan, Minnesota, United States
- As0006 110
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Rochester, Minnesota, United States
- As0006 123
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Missouri
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Saint Louis, Missouri, United States
- As0006 103
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New York
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Brooklyn, New York, United States
- As0006 114
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North Carolina
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Charlotte, North Carolina, United States
- As0006 118
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Oklahoma
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Oklahoma City, Oklahoma, United States
- As0006 149
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Oregon
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Portland, Oregon, United States
- As0006 105
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Pennsylvania
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Duncansville, Pennsylvania, United States
- As0006 108
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Philadelphia, Pennsylvania, United States
- As0006 144
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Wyomissing, Pennsylvania, United States
- As0006 129
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South Carolina
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Orangeburg, South Carolina, United States
- As0006 156
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Utah
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Salt Lake City, Utah, United States
- As0006 107
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Washington
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Seattle, Washington, United States
- As0006 104
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Wisconsin
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Manitowoc, Wisconsin, United States
- As0006 158
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Onalaska, Wisconsin, United States
- As0006 113
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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Other Names:
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Placebo Comparator: Placebo
Matching placebo to Certolizumab Pegol (CZP) injections are administered every 2 weeks from Week 0 onwards.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Subjects With Ankylosing Spondylitis Disease Activity Score Major Improvement (ASDAS-MI) Response Criteria Response at Week 52
Time Frame: Week 52
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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
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Percentage of Subjects With Axial SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 12
Time Frame: Week 12
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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
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Certolizumab Pegol Plasma Concentration at Baseline
Time Frame: Baseline (Week 0)
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Certolizumab pegol plasma concentration was measured at Baseline in micrograms per millilitre (µg/mL).
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Baseline (Week 0)
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Certolizumab Pegol Plasma Concentration at Week 1
Time Frame: Week 1
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Certolizumab pegol plasma concentration was measured at Week 1, in µg/mL.
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Week 1
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Certolizumab Pegol Plasma Concentration at Week 2
Time Frame: Week 2
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Certolizumab pegol plasma concentration was measured at Week 2, in µg/mL.
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Week 2
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Certolizumab Pegol Plasma Concentration at Week 4
Time Frame: Week 4
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Certolizumab pegol plasma concentration was measured at Week 4, in µg/mL.
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Week 4
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Certolizumab Pegol Plasma Concentration at Week 12
Time Frame: Week 12
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Certolizumab pegol plasma concentration was measured at Week 12, in µg/mL.
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Week 12
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Certolizumab Pegol Plasma Concentration at Week 24
Time Frame: Week 24
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Certolizumab pegol plasma concentration was measured at Week 24, in µg/mL.
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Week 24
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Certolizumab Pegol Plasma Concentration at Week 36
Time Frame: Week 36
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Certolizumab pegol plasma concentration was measured at Week 36, in µg/mL.
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Week 36
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Certolizumab Pegol Plasma Concentration at Week 52
Time Frame: Week 52
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Certolizumab pegol plasma concentration was measured at Week 52, in µg/mL.
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Week 52
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Certolizumab Pegol Plasma Concentration at Follow-Up (FU) Visit
Time Frame: Follow-up Visit (up to Week 60)
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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)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Subjects With Axial SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 52
Time Frame: Week 52
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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.
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Week 52
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Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Functional Index (BASFI)
Time Frame: From Baseline to Week 12
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The BASFI is a validated disease-specific instrument for assessing physical function.
The BASFI comprises 10 items relating to the past week.
The BASFI is the mean of the 10 scores such that the total score ranges from 0 (Easy) to 10 (Impossible), with lower scores indicating better physical function.
The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
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From Baseline to Week 12
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Change From Baseline to Week 52 in the Bath Ankylosing Spondylitis Functional Index (BASFI)
Time Frame: From Baseline to Week 52
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The BASFI is a validated disease-specific instrument for assessing physical function.
The BASFI comprises 10 items relating to the past week.
The BASFI is the mean of the 10 scores such that the total score ranges from 0 (Easy) to 10 (Impossible), with lower scores indicating better physical function.
The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
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From Baseline to Week 52
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Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time Frame: From Baseline to Week 12
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The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective.
It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week.
The final BASDAI scores ranges from 0 (not active) to 10 (very active), with lower scores indicating lower disease activity.
The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
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From Baseline to Week 12
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Change From Baseline to Week 52 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time Frame: From Baseline to Week 52
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The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective.
It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week.
The final BASDAI scores ranges from 0 (not active) to 10 (very active), with lower scores indicating lower disease activity.
The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
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From Baseline to Week 52
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Change From Baseline to Week 12 in Sacroiliac Spondyloarthritis Research Consortium of Canada (SI-SPARCC) Score
Time Frame: From Baseline to Week 12
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The Spondyloarthritis Research Consortium of Canada (SPARCC) scoring method for lesions found on the Magnetic Resonance Imaging (MRI) is based on an abnormal increased signal on the Short-Tau-Inversion Recovery (STIR) sequence, representing bone marrow edema.
Total Sacroiliac (SI) joint SPARCC score can range from 0 to 72 with higher scores indicating higher joint inflammation.
The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
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From Baseline to Week 12
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Number of Subjects Without Relevant Changes to Background Medication From Baseline to Week 52
Time Frame: From Baseline to Week 52
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The number of subjects who did not have relevant changes to background medications during the study treatment period. A subject is without relevant changes to background medication if they do not have: the addition of a new disease-modifying antirheumatic drug (DMARD) or the change from one DMAR to another; the addition of an nonsteroidal anti-inflammatory drug (NSAID) or the change from one NSAID to another; an increased dose of chronic corticosteroids; the addition of a new chronic analgesic medication or increased dose in chronic analgesic medication; and they complete double-blind study treatment to Week 52. |
From Baseline to Week 52
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Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 52
Time Frame: From Baseline to Week 52
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The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL.
The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
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From Baseline to Week 52
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Change From Baseline in ASQoL at Week 1
Time Frame: From Baseline to Week 1
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The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL.
The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
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From Baseline to Week 1
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Change From Baseline in ASQoL at Week 2
Time Frame: From Baseline to Week 2
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The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL.
The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
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From Baseline to Week 2
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Change From Baseline in ASQoL at Week 4
Time Frame: From Baseline to Week 4
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The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL.
The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
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From Baseline to Week 4
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Change From Baseline in ASQoL at Week 12
Time Frame: From Baseline to Week 12
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The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL.
The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
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From Baseline to Week 12
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Change From Baseline in ASQoL at Week 24
Time Frame: From Baseline to Week 24
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The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL.
The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
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From Baseline to Week 24
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Change From Baseline in ASQoL at Week 36
Time Frame: From Baseline to Week 36
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The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL.
The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
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From Baseline to Week 36
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Change From Baseline in ASQoL at Week 48
Time Frame: From Baseline to Week 48
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The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL.
The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
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From Baseline to Week 48
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Change From Baseline in Nocturnal Spinal Pain Numerical Rating Scale (NRS) at Week 52
Time Frame: From Baseline to Week 52
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The nocturnal spinal pain experienced by subjects due to AS was measured by following question 'How much pain of your spine due to spondylitis do you have at night?'.
The NRS ranged from 0 to 10, where 0 represented 'no pain' and 10 represented 'most severe pain'.
The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
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From Baseline to Week 52
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Number of Subjects With Anterior Uveitis (AU) or New AU Flares Through Week 52
Time Frame: Throughout the study conduct (up to Week 52)
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The number of subjects with AU or new AU flares during the study treatment period.
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Throughout the study conduct (up to Week 52)
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Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) During the Study
Time Frame: From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156)
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An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
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From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156)
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Percentage of Subjects With Serious Adverse Events (SAEs) During the Study
Time Frame: From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156)
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A serious adverse event (SAE) is any untoward medical occurrence that at any dose:
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From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156)
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Percentage of Subjects With Adverse Events Leading to Withdrawal From Investigational Medicinal Product (IMP) During the Study
Time Frame: From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156)
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An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
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From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: UCB Cares, 1-844-599-2273 (UCB)
Publications and helpful links
General 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AS0006
- 2015-001894-41 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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