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Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo (C-OPTIMISE)

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ClinicalTrials.gov Identifier: NCT02505542
Recruitment Status : Completed
First Posted : July 22, 2015
Results First Posted : April 21, 2020
Last Update Posted : December 17, 2020
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES GmbH )

Tracking Information
First Submitted Date  ICMJE July 16, 2015
First Posted Date  ICMJE July 22, 2015
Results First Submitted Date  ICMJE February 26, 2020
Results First Posted Date  ICMJE April 21, 2020
Last Update Posted Date December 17, 2020
Actual Study Start Date  ICMJE July 2015
Actual Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2020)
Percentage of Participants in Part B Who Did Not Experienced a Flare [ Time Frame: From Week 48 to Week 96 ]
A participant was considered to have experienced a flare if the participant had an Ankylosing spondylitis disease activity score (ASDAS) greater or equal to (≥) 2.1 at 2 consecutive visits or an ASDAS greater than (>) 3.5 at any visit during Part B up until Week 96. A participant qualified for Part B only if he achieved sustained remission after 48 weeks of Open-Label certolizumab pegol (CZP) treatment. Sustained remission was achieved when a participant had an ASDAS less than (<) 1.3 at Week 32 or Week 36 (if ASDAS < 1.3 at Week 32, it must have been < 2.1 at Week 36; if ASDAS < 2.1 at Week 32, it must have been < 1.3 at Week 36) and an ASDAS < 1.3 at Week 48. Missing data were handled using non-response imputation (NRI) methods.
Original Primary Outcome Measures  ICMJE
 (submitted: July 20, 2015)
Percentage of subjects in Part B who do not experience a flare [ Time Frame: From Week 48 to Week 96 ]
A flare occurs when a subject has an Ankylosing spondylitis disease activity score (ASDAS) ≥ 2.1 at 2 consecutive visits or ASDAS > 3.5 at any visit during Part B. A subject qualifies for Part B only if in sustained remission after 48 weeks of open-label Certolizumab Pegol (CZP) treatment. Sustained remission is achieved when a subject has an ASDAS < 1.3 at Week 32 or Week 36 (if ASDAS < 1.3 at Week 32, it must be < 2.1 at Week 36 [or vice versa]) and at Week 48.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2020)
  • Percentage of Participants Achieving Sustained Remission at Week 48 in Part A [ Time Frame: Week 48 ]
    Sustained remission was achieved when a participant had an ASDAS less than (<) 1.3 at Week 32 or Week 36 (if ASDAS < 1.3 at Week 32, it must have been < 2.1 at Week 36; if ASDAS < 2.1 at Week 32, it must have been < 1.3 at Week 36) and an ASDAS < 1.3 at Week 48. Missing data were handled using non-response imputation (NRI) methods.
  • Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Week 48 in Part A [ Time Frame: Week 48 ]
    The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x 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). Disease activity was measured by categorical response variables:
    • ASDAS-Inactive Disease (ASDAS-ID): ASDAS < 1.3
    • ASDAS-Moderate Disease (ASDAS-MD): ASDAS ≥ 1.3, < 2.1
    • ASDAS-High Disease activity (ASDAS-HD): ASDAS ≥ 2.1, ≤ 3.5
    • ASDAS-very High Disease activity (ASDAS-vHD): ASDAS > 3.5
    Missing data were handled using last observation carried forward (LOCF) methods.
  • Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Clinical Improvement Categories at Week 48 in Part A [ Time Frame: Week 48 ]
    The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x 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). ASDAS improvement was measured by binary response variables:
    • ASDAS-CII: ASDAS reduction (improvement) of ≥ 1.1 relative to Baseline
    • ASDAS-MI: ASDAS reduction (improvement) of ≥ 2.0 relative to Baseline
    Missing data were handled using non-response imputation (NRI) methods.
  • Time to Flare in Part B [ Time Frame: From Week 48 to Week 96 ]
    For those who met the criteria for flare (see primary efficacy variable), the time to flare was the length in days from randomization in Part B until the visit at which the criteria for flare were met. Participants who discontinued the study without meeting the criteria for flare were counted as experiencing a flare at the time of their last study visit. The time to flare was analyzed using Kaplan-Meier methods. If Kaplan-Meier Estimate was NA for all estimates then more than 75 % failed to meet the flare condition. Missing data were handled using non-response imputation (NRI) methods.
  • Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Week 96 in Part B [ Time Frame: Week 96 ]
    The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x 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). Disease activity was measured by categorical response variables:
    • ASDAS-Inactive Disease (ASDAS-ID): ASDAS < 1.3
    • ASDAS-Moderate Disease (ASDAS-MD): ASDAS ≥ 1.3, < 2.1
    • ASDAS-High Disease activity (ASDAS-HD): ASDAS ≥ 2.1, ≤ 3.5
    • ASDAS-very High Disease activity (ASDAS-vHD): ASDAS > 3.5
  • Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Clinical Improvement Categories at Week 96 in Part B [ Time Frame: Week 96 ]
    The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x 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). ASDAS improvement was measured by binary response variables:
    • ASDAS-CII: ASDAS reduction (improvement) of ≥ 1.1 relative to Baseline
    • ASDAS-MI: ASDAS reduction (improvement) of ≥ 2.0 relative to Baseline
    Missing data were handled using non-response imputation (NRI) methods.
  • Percentage of Participants With Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at Week 96 in Part B [ Time Frame: Week 96 ]
    The ASAS20 response was defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) 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 absence of deterioration in the potential remaining domain [deterioration was defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit]. Missing data were handled using non-response imputation (NRI) methods.
  • Percentage of Participants With Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at Week 96 in Part B [ Time Frame: Week 96 ]
    The ASAS40 response was defined as a relative improvement 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 (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. Missing data were handled using non-response imputation (NRI) methods.
  • Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) 5/6 Response Criteria Response at Week 96 in Part B [ Time Frame: Week 96 ]
    The ASAS 5/6 response was defined as achieving at least 20 % improvement in 5 of 6 domains, including the 4 domains defined for ASAS20 as well as spinal mobility (lateral spinal flexion) and C-reactive Protein (CRP). Missing data were handled using non-response imputation (NRI) methods.
  • Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) Partial Remission (PR) Response Criteria Response at Week 96 in Part B [ Time Frame: Week 96 ]
    The ASAS partial remission (PR) response was defined as a score of ≤ 2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS20. Missing data were handled using non-response imputation (NRI) methods.
  • Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 96 in Part B [ Time Frame: From Week 48 to Week 96 ]
    The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x 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). There is a minimum score of 0.636 for the total ASDAS score, but no defined upper score. Based on the formula even in the situation that the CRP is normal, any value below 4 is recorded as "below the limit of quantification" (BLQ) and a value of BLQ/2=2 was prespecified. This assumption is triggering the lowest possible value of 0.636. The change from Part B Baseline is calculated, a negative value indicating improvement and a positive value worsening.
  • Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 96 in Part B [ Time Frame: From Week 48 to Week 96 ]
    The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales (NRS) 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. The change from Part B Baseline is calculated, a negative value indicating improvement and a positive value worsening.
  • Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 96 in Part B [ Time Frame: From Week 48 to Week 96 ]
    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 Part B Baseline is calculated, a negative value indicating improvement and a positive value worsening.
  • Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 96 in Part B [ Time Frame: From Week 48 to Week 96 ]
    The BASMI is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 was calculated for each item based on the measurement. The mean of the sum of the 5 scores provided the total BASMI score, ranging from 0 to 10. The higher the BASMI score the more severe the patient's limitation of movement due to their axial spondyloarthritis (axSpA). The change from Part B Baseline is calculated, a negative value indicating improvement and a positive value worsening.
  • Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response Criteria Response at Week 96 in Part B [ Time Frame: Week 96 ]
    The BASDAI50 response was defined as an improvement of at least 50 % in the BASDAI score relative to Baseline. Missing data were handled using non-response imputation (NRI) methods.
  • Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Week 96 in Part B [ Time Frame: From Week 48 to Week 96 ]
    The 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 Part B Baseline is calculated, a negative value indicating improvement and a positive value worsening.
  • Change From Baseline in Spine Ankylosing Spondylitis Spine Magnetic Resonance Imaging Score for Disease Activity (ASspIMRI-a) in the Berlin Modification Score at Week 96 in Part B [ Time Frame: From Week 48 to Week 96 ]
    The Berlin modification of the ASspiMRI-a is a scoring system with a concentration on Short-Tau-Inversion Recovery (STIR) sequences without other fat saturation techniques. It quantifies changes in 23 Vertebral Units (VU) of the spine. Active inflammation was scored by grading the degree of bone marrow edema from 0 to 3 in 1 dimension on 1 or more consecutive slices that represent the highest level of inflammation in a particular VU. The change from Part B Baseline is calculated, a negative value indicating improvement and a positive value worsening.
  • Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Escape Week 12 for Participants Who Experienced a Flare in Part B [ Time Frame: Escape Week 12 ]
    The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x 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). Disease activity was measured by categorical response variables:
    • ASDAS-Inactive Disease (ASDAS-ID): ASDAS < 1.3
    • ASDAS-Moderate Disease (ASDAS-MD): ASDAS ≥ 1.3, < 2.1
    • ASDAS-High Disease activity (ASDAS-HD): ASDAS ≥ 2.1, ≤ 3.5
    • ASDAS-very High Disease activity (ASDAS-vHD): ASDAS > 3.5
  • Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Clinical Improvement Categories at Escape Week 12 for Participants Who Experienced a Flare in Part B [ Time Frame: Escape Week 12 ]
    The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x 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). ASDAS improvement was measured by binary response variables:
    • ASDAS-CII: ASDAS reduction (improvement) of ≥ 1.1 relative to Baseline
    • ASDAS-MI: ASDAS reduction (improvement) of ≥ 2.0 relative to Baseline
  • Percentage of Participants With Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at Escape Week 12 for Participants Who Experienced a Flare in Part B [ Time Frame: Escape Week 12 ]
    The ASAS20 response was defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) 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 absence of deterioration in the potential remaining domain [deterioration was defined as a relative worsening of at least 20% and an absolute worsening of at least 1 unit].
  • Percentage of Participants With Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at Escape Week 12 for Participants Who Experienced a Flare in Part B [ Time Frame: Escape Week 12 ]
    The ASAS40 response was defined as a relative improvement 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 (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.
  • Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) 5/6 Response Criteria Response at Escape Week 12 for Participants Who Experienced a Flare in Part B [ Time Frame: Escape Week 12 ]
    The ASAS 5/6 response was defined as achieving at least 20 % improvement in 5 of 6 domains, including the 4 domains defined for ASAS20 as well as spinal mobility (lateral spinal flexion) and C-reactive Protein (CRP).
  • Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) Partial Remission (PR) Response Criteria Response at Escape Week 12 for Participants Who Experienced a Flare in Part B [ Time Frame: Escape Week 12 ]
    The ASAS partial remission (PR) response was defined as a score of ≤ 2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS20.
  • Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Escape Week 12 for Participants Who Experienced a Flare in Part B [ Time Frame: From time of flare to Escape Week 12 ]
    The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x 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). There is a minimum score of 0.636 for the total ASDAS score, but no defined upper score. Based on the formula even in the situation that the CRP is normal, any value below 4 is recorded as "below the limit of quantification" (BLQ) and a value of BLQ/2=2 was prespecified. This assumption is triggering the lowest possible value of 0.636. The change from Part B Baseline is calculated, a negative value indicating improvement and a positive value worsening.
  • Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Escape Week 12 for Participants Who Experienced a Flare in Part B [ Time Frame: From time of flare to Escape Week 12 ]
    The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales (NRS) 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. The change from flare Baseline is calculated, a negative value indicating improvement and a positive value worsening.
  • Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Escape Week 12 for Participants Who Experienced a Flare in Part B [ Time Frame: From time of flare to Escape 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 flare Baseline is calculated, a negative value indicating improvement and a positive value worsening.
  • Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Escape Week 12 for Participants Who Experienced a Flare in Part B [ Time Frame: From time of flare to Escape Week 12 ]
    The BASMI is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 was calculated for each item based on the measurement. The mean of the sum of the 5 scores provided the total BASMI score, ranging from 0 to 10. The higher the BASMI score the more severe the patient's limitation of movement due to their axial spondyloarthritis (axSpA). The change from flare Baseline is calculated, a negative value indicating improvement and a positive value worsening.
  • Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Escape Week 12 for Participants Who Experienced a Flare in Part B [ Time Frame: From time of flare to Escape Week 12 ]
    The 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 flare Baseline is calculated, a negative value indicating improvement and a positive value worsening.
  • Change From Baseline in Spine Ankylosing Spondylitis Spine Magnetic Resonance Imaging Score for Activity (ASspIMRI-a) in the Berlin Modification Score at Escape Week 12 for Participants Who Experienced a Flare in Part B [ Time Frame: From time of flare to Escape Week 12 ]
    The Berlin modification of the ASspiMRI-a is a scoring system with a concentration on Short-Tau-Inversion Recovery (STIR) sequences without other fat saturation techniques. It quantifies changes in 23 Vertebral Units (VU) of the spine. Active inflammation was scored by grading the degree of bone marrow edema from 0 to 3 in 1 dimension on 1 or more consecutive slices that represent the highest level of inflammation in a particular VU. The change from flare Baseline is calculated, a negative value indicating improvement and a positive value worsening.
  • Certolizumab Pegol (CZP) Plasma Concentration During the Study [ Time Frame: From Week 0 until the Safety Follow-up Visit (10 weeks after the last dose of study medication) ]
    CZP plasma concentration was measured in micrograms per milliliter (μg/mL). Blood sample measurements that were deemed to be below the level of quantification, were set to half the lower level of quantification (LLOQ) for analysis purposes. Summary statistics were only displayed if at least two-thirds of the values were above the LLOQ and if n was greater or equal to (>=) 4. The primary purpose of the study was to evaluate treatment options for axSpA patients after being in sustained remission. Hence, one of the objectives was to evaluate the PK of these patients. The CZP plasma concentration of the patients that did not reach sustained remission were therefore not analysed, and the Pharmacokinetic Set A as described in the protocol was removed from the SAP.
  • Percentage of Participants With Positive Anti-certolizumab Pegol-antibody Levels in Plasma During the Study [ Time Frame: From Week 0 until the Safety Follow-up Visit (10 weeks after the last dose of study medication) ]
    Treatment emergent ADAb status positive was defined as either baseline ADAb negative subjects having at least one ADAb confirmed positive sample post baseline or baseline ADAb positive subjects with at least one post baseline sample with >= minimum significant ratio (MSR) increase from baseline on CZP treatment. Once determined positive, the highest titer during Part A and Part B (including Escape and Safety Follow up) was used to categorize the subject. The primary purpose of the study was to evaluate treatment options for axSpA patients after being in sustained remission. Hence, one of the objectives was to evaluate the immunogenicity of these patients. The ADAb titer of the patients that did not reach sustained remission were therefore not analysed, and the Pharmacokinetic Set A as described in the protocol was removed from the SAP.
  • Percentage of Participants With at Least One Adverse Event (AE) During Part A of the Study [ Time Frame: From Screening Period (Week -5 to Week -1) until Week 48 ]
    An AE was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
  • Percentage of Participants With at Least One Adverse Event (AE) During Part B of the Study [ Time Frame: From Week 0 until the Safety Follow-up Visit (10 weeks after the last dose of study medication) ]
    An AE was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. For subjects with flare in Part B and do escape to CZP full-dose therapy, only TEAEs with an onset date prior to the start date of escape CZP full-dose therapy were included.
  • Percentage of Participants With at Least One Adverse Event (AE) and Who Experienced a Flare During Part B of the Study [ Time Frame: From time of flare to Escape Week 12 ]
    An AE was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. For subjects with flare in Part B and do escape to CZP full-dose therapy, only TEAEs with an onset date after or on the start date of escape CZP full-dose therapy were included.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2015)
  • Percentage of subjects achieving sustained remission in Part A [ Time Frame: Week 48 ]
    Sustained remission is achieved when a subject has an ASDAS < 1.3 at Week 32 or Week 36 (if ASDAS < 1.3 at Week 32, it must be < 2.1 at Week 36 [or vice versa]) and at Week 48.
  • Percentage of subjects in Ankylosing Spondylitis Disease Activity Score (ASDAS) disease activity categories in Part A [ Time Frame: Week 48 ]
    ASDAS-Inactive Disease (ASDAS-ID): ASDAS < 1.3 ASDAS-Moderate Disease (ASDAS-MD): ASDAS ≥ 1.3, < 2.1 ASDAS-High Disease activity (ASDAS-HD): ASDAS ≥ 2.1, ≤ 3.5 ASDAS-very High Disease activity (ASDAS-vHD): ASDAS > 3.5
  • Percentage of subjects in Ankylosing Spondylitis Disease Activity Score (ASDAS) clinical improvement categories in Part A [ Time Frame: Week 48 ]
    ASDAS-CII: ASDAS reduction (improvement) of ≥ 1.1 relative to Baseline ASDAS-MI: ASDAS reduction (improvement) of ≥ 2.0 relative to Baseline
  • Time to flare in Part B [ Time Frame: From Week 48 to Week 96 ]
    For those who meet the criteria for flare (see primary efficacy variable), the time to flare is the length in days from randomization in Part B until the visit at which the criteria for flare were met. Subjects who discontinue the study without meeting the criteria for flare will be censored at the time of their last study visit. Subjects who complete the study without meeting the criteria for flare will be censored at their Week 96 visit.
  • Percentage of subjects in Ankylosing Spondylitis Disease Activity Score (ASDAS) disease activity categories in Part B [ Time Frame: Week 96 ]
    ASDAS-Inactive Disease (ASDAS-ID): ASDAS < 1.3 ASDAS-Moderate Disease (ASDAS-MD): ASDAS ≥ 1.3, < 2.1 ASDAS-High Disease activity (ASDAS-HD): ASDAS ≥ 2.1, ≤ 3.5 ASDAS-very High Disease activity (ASDAS-vHD): ASDAS > 3.5
  • Percentage of subjects in Ankylosing Spondylitis Disease Activity Score (ASDAS) clinical improvement categories in Part B [ Time Frame: Week 96 ]
    ASDAS-CII: ASDAS reduction (improvement) of ≥ 1.1 relative to Baseline ASDAS-MI: ASDAS reduction (improvement) of ≥ 2.0 relative to Baseline
  • Percentage of subjects with Axial SpondyloArthritis International Society 20 % response criteria (ASAS20) in Part B [ Time Frame: Week 96 ]
    The ASAS20 response is the improvement of at least 20 % and absolute improvement of at least 1 unit 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 absence of deterioration in the potential remaining domain.
  • Percentage of subjects with Axial SpondyloArthritis International Society 40 % response criteria (ASAS40) in Part B [ Time Frame: Week 96 ]
    The ASAS40 response is the relative improvement 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 (ASAS) 5/6 response in Part B [ Time Frame: Week 96 ]
    The ASAS 5/6 response is defined as achieving at least 20 % improvement in 5 of 6 domains, including the 4 domains defined for ASAS20 as well as spinal mobility (lateral spinal flexion) and C-reactive Protein (CRP).
  • Percentage of subjects with Axial SpondyloArthritis International Society (ASAS) partial remission (PR) response in Part B [ Time Frame: Week 96 ]
    The ASAS partial remission (PR) response is defined as a score of ≤ 2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS20.
  • Change from Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) in Part B [ Time Frame: From Week 48 to Week 96 ]
    The ASDAS score 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).
  • Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part B [ Time Frame: From Week 48 to Week 96 ]
    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 to 10, with lower scores indicating lower disease activity.
  • Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) in Part B [ Time Frame: From Week 48 to Week 96 ]
    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 in Bath Ankylosing Spondylitis Metrology Index (BASMI) in Part B [ Time Frame: From Week 48 to Week 96 ]
    The BASMI is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 is calculated for each item based on the measurement. The mean of the sum of the 5 scores provides the BASMI score. The higher the BASMI score the more severe the patient's limitation of movement due to their axial spondyloarthritis (axSpA).
  • Percentage of subjects with Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 response in Part B [ Time Frame: Week 96 ]
    The BASDAI50 response is defined as an improvement of at least 50 % in the BASDAI score relative to Baseline.
  • Change from Baseline in sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) score in Part B [ Time Frame: From Week 48 to Week 96 ]
    The 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.
  • Change from Baseline in spine Ankylosing Spondylitis spine Magnetic Resonance Imaging Score for Disease activity (ASspIMRI-a) in the Berlin modification score in Part B [ Time Frame: From Week 48 to Week 96 ]
    The Berlin modification of the ASspiMRI-a is a scoring system with a concentration on Short-Tau-Inversion Recovery (STIR) sequences without other fat saturation techniques. It quantifies changes in 23 Vertebral Units (VU) of the spine. Active inflammation is scored by grading the degree of bone marrow edema from 0 to 3 in 1 dimension on 1 or more consecutive slices that represent the highest level of inflammation in a particular VU.
  • Percentage of subjects in Ankylosing Spondylitis Disease Activity Score (ASDAS) disease activity categories for subjects who experience a flare in Part B [ Time Frame: Week 96 ]
    ASDAS-Inactive Disease (ASDAS-ID): ASDAS < 1.3 ASDAS-Moderate Disease (ASDAS-MD): ASDAS ≥ 1.3, < 2.1 ASDAS-High Disease activity (ASDAS-HD): ASDAS ≥ 2.1, ≤ 3.5 ASDAS-very High Disease activity (ASDAS-vHD): ASDAS > 3.5
  • Percentage of subjects in Ankylosing Spondylitis Disease Activity Score (ASDAS) clinical improvement categories for subjects who experience a flare in Part B [ Time Frame: Week 96 ]
    ASDAS-CII: ASDAS reduction (improvement) of ≥ 1.1 relative to Baseline ASDAS-MI: ASDAS reduction (improvement) of ≥ 2.0 relative to Baseline
  • Percentage of subjects with Axial SpondyloArthritis International Society 20 % response criteria (ASAS20) for subjects who experience a flare in Part B [ Time Frame: Week 96 ]
    The ASAS20 response is the improvement of at least 20 % and absolute improvement of at least 1 unit 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 absence of deterioration in the potential remaining domain.
  • Percentage of subjects with Axial SpondyloArthritis International Society 40 % response criteria (ASAS40) for subjects who experience a flare in Part B [ Time Frame: Week 96 ]
    The ASAS40 response is the relative improvement 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 (ASAS) 5/6 response for subjects who experience a flare in Part B [ Time Frame: Week 96 ]
    The ASAS 5/6 response is defined as achieving at least 20 % improvement in 5 of 6 domains, including the 4 domains defined for ASAS20 as well as spinal mobility (lateral spinal flexion) and C-reactive Protein (CRP).
  • Percentage of subjects with Axial SpondyloArthritis International Society (ASAS) partial remission (PR) response for subjects who experience a flare in Part B [ Time Frame: Week 96 ]
    The ASAS partial remission (PR) response is defined as a score of ≤ 2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS20.
  • Change from Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) for subjects who experience a flare in Part B [ Time Frame: From time of flare to Week 96 ]
    The ASDAS score 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).
  • Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for subjects who experience a flare in Part B [ Time Frame: From time of flare to Week 96 ]
    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 to 10, with lower scores indicating lower disease activity.
  • Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) for subjects who experience a flare in Part B [ Time Frame: From time of flare to Week 96 ]
    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 in Bath Ankylosing Spondylitis Metrology Index (BASMI) for subjects who experience a flare in Part B [ Time Frame: From time of flare to Week 96 ]
    The BASMI is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 is calculated for each item based on the measurement. The mean of the sum of the 5 scores provides the BASMI score. The higher the BASMI score the more severe the patient's limitation of movement due to their axial spondyloarthritis (axSpA).
  • Change from Baseline in sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) score for subjects who experience a flare in Part B [ Time Frame: From time of flare to Week 96 ]
    The 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.
  • Change from Baseline in spine Ankylosing Spondylitis spine Magnetic Resonance Imaging Score for activity (ASspIMRI-a) in the Berlin modification score for subjects who experience a flare in Part B [ Time Frame: From time of flare to Week 96 ]
    The Berlin modification of the ASspiMRI-a is a scoring system with a concentration on Short-Tau-Inversion Recovery (STIR) sequences without other fat saturation techniques. It quantifies changes in 23 Vertebral Units (VU) of the spine. Active inflammation is scored by grading the degree of bone marrow edema from 0 to 3 in 1 dimension on 1 or more consecutive slices that represent the highest level of inflammation in a particular VU.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo
Official Title  ICMJE A Multicenter, Open-label (Part A) Followed by a Randomized, Double-blind, Parallel-group, Placebo Controlled Study (Part B) to Evaluate Maintenance of Remission in Subjects With Active Axial Spondyloarthritis (axSpA) Receiving Either Certolizumab Pegol 200 mg Q2W or 200 mg Q4W as Compared to Placebo
Brief Summary Patients receive study drug for one year (Part A). If, after the initial run-in phase, a sustained remission is reached they will be randomly split into one of three dose groups for another year (Part B). The maintenance of the sustained remission will be analyzed.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Axial Spondyloarthrithis
  • Ankylosing Spondylitis
Intervention  ICMJE
  • 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  ICMJE
  • Open-label Certolizumab Pegol
    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 to Week 48 (Part A). Subjects in sustained remission at Week 48 are eligible for randomization into Part B.
    Intervention: Biological: Certolizumab Pegol
  • Experimental: Double-blind Certolizumab Pegol 200 mg Q2W
    Certolizumab Pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards.
    Intervention: Biological: Certolizumab Pegol
  • Experimental: Double-blind Certolizumab Pegol 200 mg Q4W

    Certolizumab Pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards.

    At visits where CZP is not received, subjects receive one injection of Placebo to maintain the study blind.

    Interventions:
    • Biological: Certolizumab Pegol
    • Other: Placebo
  • Placebo Comparator: Placebo
    One placebo injection is administered every 2 weeks from Week 48 onwards.
    Intervention: Other: Placebo
  • Placebo to CZP 200 mg Q2W escape
    Subjects randomized to Placebo who meet flare criteria receive CZP 400 mg subcutaneous (sc) every 2 weeks (Q2W) for the first 3 visits after flare has been confirmed. After that, CZP 200 mg is given every 2 weeks in open-label fashion.
    Interventions:
    • Biological: Certolizumab Pegol
    • Other: Placebo
  • CZP 200 mg Q4W to CZP 200 mg Q2W escape
    Subjects randomized to CZP 200 mg Q4W who meet flare criteria receive CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, subjects receive one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
    Interventions:
    • Biological: Certolizumab Pegol
    • Other: Placebo
  • CZP 200 mg Q2W to CZP 200 mg Q2W escape
    Subjects randomized to CZP 200 mg Q2W who meet flare criteria receive CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, subjects receive one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
    Interventions:
    • Biological: Certolizumab Pegol
    • Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 24, 2017)
736
Original Estimated Enrollment  ICMJE
 (submitted: July 20, 2015)
750
Actual Study Completion Date  ICMJE April 2019
Actual Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Documented diagnosis of adult-onset axial SpondyloArthritis (axSpA) with at least 3 months' symptom duration and meet the Assessment of SpondyloArthritis International Society (ASAS) criteria for axSpA and symptom duration of less than 5 years prior to the participation of this study
  • Active disease at Screening as defined by

    • Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥ 2.1
    • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4
    • Spinal pain > 4 on a 0 to 10 Numerical Rating Scale (NRS) (from BASDAI Item 2)
    • for modified New York (mNY) -negative subjects only: C-reactive Protein (CRP) > upper limit of normal (ULN) and/or current evidence for sacroiliitis on the Screening Magnetic Resonance Imaging (MRI)
  • Inadequate response to, or contraindication to, or intolerant to at least 2 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

Exclusion Criteria:

  • Presence of total Spinal Ankylosis ('bamboo spine')
  • Diagnosis of any other Inflammatory Arthritis
  • Prior treatment with any experimental biological agents for treatment of Axial SpondyloArthritis (SpA)
  • Exposure to more than 1 TNF-antagonist or primary failure to TNF antagonist therapy
  • History of or current chronic or recurrent infections
  • High risk of infection
  • 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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Bulgaria,   Czechia,   France,   Germany,   Hungary,   Netherlands,   Poland,   Romania,   Spain,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02505542
Other Study ID Numbers  ICMJE AS0005
2015-000339-34 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma ( UCB BIOSCIENCES GmbH )
Study Sponsor  ICMJE UCB BIOSCIENCES GmbH
Collaborators  ICMJE Parexel
Investigators  ICMJE
Study Director: UCB Cares +1 844 599 2273(UCB)
PRS Account UCB Pharma
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP