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

• ClinicalTrials.gov Identifier: NCT02552212
• Recruitment Status: Completed
• First Posted: September 17, 2015
• Results First Posted: August 17, 2020
• Last Update Posted: August 18, 2022
• Sponsor: UCB BIOSCIENCES GmbH
• Information provided by (Responsible Party): UCB Pharma ( UCB BIOSCIENCES GmbH )

Tracking Information

• First Submitted Date: September 15, 2015
• First Posted Date: September 17, 2015
• Results First Submitted Date: April 27, 2019
• Results First Posted Date: August 17, 2020
• Last Update Posted Date: August 18, 2022
• Actual Study Start Date: September 2015
• Actual Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 31, 2020)

• Percentage of Subjects With Ankylosing Spondylitis Disease Activity Score Major Improvement (ASDAS-MI) Response Criteria Response at Week 52 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline (Week 0) ]
  Certolizumab pegol plasma concentration was measured at Baseline in micrograms per millilitre (µg/mL).
• Certolizumab Pegol Plasma Concentration at Week 1 [ Time Frame: Week 1 ]
  Certolizumab pegol plasma concentration was measured at Week 1, in µg/mL.
• Certolizumab Pegol Plasma Concentration at Week 2 [ Time Frame: Week 2 ]
  Certolizumab pegol plasma concentration was measured at Week 2, in µg/mL.
• Certolizumab Pegol Plasma Concentration at Week 4 [ Time Frame: Week 4 ]
  Certolizumab pegol plasma concentration was measured at Week 4, in µg/mL.
• Certolizumab Pegol Plasma Concentration at Week 12 [ Time Frame: Week 12 ]
  Certolizumab pegol plasma concentration was measured at Week 12, in µg/mL.
• Certolizumab Pegol Plasma Concentration at Week 24 [ Time Frame: Week 24 ]
  Certolizumab pegol plasma concentration was measured at Week 24, in µg/mL.
• Certolizumab Pegol Plasma Concentration at Week 36 [ Time Frame: Week 36 ]
  Certolizumab pegol plasma concentration was measured at Week 36, in µg/mL.
• Certolizumab Pegol Plasma Concentration at Week 52 [ Time Frame: Week 52 ]
  Certolizumab pegol plasma concentration was measured at Week 52, in µg/mL.
• Certolizumab Pegol Plasma Concentration at Follow-Up (FU) Visit [ Time Frame: Follow-up Visit (up to Week 60) ]
  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.

Original Primary Outcome Measures (submitted: September 15, 2015)

Percentage of subjects meeting the Ankylosing Spondylitis Disease Activity Score major improvement (ASDAS-MI) response criteria at Week 52 [ Time Frame: Week 52 ]

ASDAS-MI is achieved when there is a reduction (improvement) ≥ 2.0 in the ASDAS relative to Baseline. The ASDAS is 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 × PtGADA 0.073 × Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm of the CRP [mg/L] + 1) Back pain, PtGADA, duration of morning stiffness, peripheral pain/swelling and fatigue are all assessed on a numerical scale (0 to 10 units).

Current Secondary Outcome Measures (submitted: May 3, 2021)

• Percentage of Subjects With Axial SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 52 [ Time Frame: Week 52 ]
  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.
• Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: From Baseline to Week 12 ]
  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.
• Change From Baseline to Week 52 in the Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: From Baseline to Week 52 ]
  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.
• Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: From Baseline to Week 12 ]
  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.
• Change From Baseline to Week 52 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: From Baseline to Week 52 ]
  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.
• Change From Baseline to Week 12 in Sacroiliac Spondyloarthritis Research Consortium of Canada (SI-SPARCC) Score [ Time Frame: From Baseline to Week 12 ]
  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.
• Number of Subjects Without Relevant Changes to Background Medication From Baseline to Week 52 [ Time Frame: From Baseline to Week 52 ]
  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.
• Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 52 [ Time Frame: From Baseline to Week 52 ]
  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.
• Change From Baseline in ASQoL at Week 1 [ Time Frame: From Baseline to Week 1 ]
  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.
• Change From Baseline in ASQoL at Week 2 [ Time Frame: From Baseline to Week 2 ]
  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.
• Change From Baseline in ASQoL at Week 4 [ Time Frame: From Baseline to Week 4 ]
  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.
• Change From Baseline in ASQoL at Week 12 [ Time Frame: From Baseline to Week 12 ]
  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.
• Change From Baseline in ASQoL at Week 24 [ Time Frame: From Baseline to Week 24 ]
  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.
• Change From Baseline in ASQoL at Week 36 [ Time Frame: From Baseline to Week 36 ]
  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.
• Change From Baseline in ASQoL at Week 48 [ Time Frame: From Baseline to Week 48 ]
  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.
• Change From Baseline in Nocturnal Spinal Pain Numerical Rating Scale (NRS) at Week 52 [ Time Frame: From Baseline to Week 52 ]
  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.
• Number of Subjects With Anterior Uveitis (AU) or New AU Flares Through Week 52 [ Time Frame: Throughout the study conduct (up to Week 52) ]
  The number of subjects with AU or new AU flares during the study treatment period.
• 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) ]
  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.
• 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) ]
  A serious adverse event (SAE) is any untoward medical occurrence that at any dose:

  • Results in death
  • Is life-threatening
  • Requires in patient hospitalization or prolongation of existing hospitalization
  • Is a congenital anomaly or birth defect
  • Is an infection that requires treatment parenteral antibiotics
  • Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above.
• 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) ]
  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.

Original Secondary Outcome Measures (submitted: September 15, 2015)

• Percentage of subjects with Axial SpondyloArthritis International Society 40 % response criteria (ASAS40) at Week 12 [ Time Frame: Week 12 ]
  The ASAS40 response is 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) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PtGADA), 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.
• Percentage of subjects with Axial SpondyloArthritis International Society 40 % response criteria (ASAS40) at Week 52 [ Time Frame: Week 52 ]
  The ASAS40 response is 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) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PtGADA), 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.
• Change from Baseline to Week 12 in the Bath ankylosing spondylitis functional index (BASFI) [ Time Frame: From Baseline to Week 12 ]
  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 to 10, with lower scores indicating better physical function.
• Change from Baseline to Week 52 in the Bath ankylosing spondylitis functional index (BASFI) [ Time Frame: From Baseline to Week 52 ]
  The Bath ankylosing spondylitis functional index (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 to 10, with lower scores indicating better physical function.
• Change from Baseline to Week 12 in the Bath ankylosing spondylitis disease activity index (BASDAI) [ Time Frame: From Baseline to Week 12 ]
  The Bath ankylosing spondylitis disease activity index (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 to 10, with lower scores indicating lower disease activity.
• Change from Baseline to Week 52 in the Bath ankylosing spondylitis disease activity index (BASDAI) [ Time Frame: From Baseline to Week 52 ]
  The Bath ankylosing spondylitis disease activity index (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 to 10, with lower scores indicating lower disease activity.
• Change from Baseline to Week 12 in sacroiliac Spondyloarthritis Research Consortium of Canada (SI-SPARCC) score [ Time Frame: From Baseline to Week 12 ]
  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.
• Percentage of subjects without relevant changes to background medication from Baseline to Week 52 [ Time Frame: From Baseline to Week 52 ]
  The number of subjects who do not have relevant changes to background medications during the study treatment period.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS
• Official 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Axial Spondyloarthritis
• Nonradiographic Axial Spondyloarthritis
• Nr-axSpA

Intervention

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

  • Cimzia
  • CDP870
• Other: Placebo
  • Active Substance: Placebo
  • Pharmaceutical Form: Prefilled syringe
  • Concentration: 0.9 % saline
  • Route of Administration: Subcutaneous injection

Study Arms

• 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.
  Intervention: Biological: Certolizumab Pegol
• Placebo Comparator: Placebo
  Matching placebo to Certolizumab Pegol (CZP) injections are administered every 2 weeks from Week 0 onwards.
  Intervention: Other: Placebo

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 5, 2017): 317
• Original Estimated Enrollment (submitted: September 15, 2015): 300
• Actual Study Completion Date: May 2020
• Actual Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Bulgaria, Canada, Czechia, Hungary, Poland, Russian Federation, Taiwan, United States
• Removed Location Countries: Czech Republic

Administrative Information

• NCT Number: NCT02552212
• Other Study ID Numbers: AS0006; 2015-001894-41 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: UCB Pharma ( UCB BIOSCIENCES GmbH )
• Original Responsible Party: Same as current
• Current Study Sponsor: UCB BIOSCIENCES GmbH
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: UCB Cares; 1-844-599-2273 (UCB)

• PRS Account: UCB Pharma
• Verification Date: August 2022