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Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis

Primary Purpose

Spondyloarthropathies

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CZP 200 mg Q2W
CZP 400 mg Q4W
Placebo
Sponsored by
UCB BIOSCIENCES GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spondyloarthropathies focused on measuring Certolizumab Pegol, Cimzia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Documented diagnosis of adult-onset axial Spondyloarthritis (SpA) of at least 3 months' duration as defined by the specified Assessment of Spondyloarthritis International Society (ASAS) criteria

  • Active disease as defined by:

    • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4
    • Back pain ≥ 4 on a 0 to 10 Neurobehavioral Rating Scale (NRS) (from BASDAI item 2)
    • C-Reactive Protein (CRP) > ULN (Upper Limit of Normal) and/or current evidence (ie, within the last 3 months from Screening) for Sacroiliitis on Magnetic Resonance Imaging (MRI) as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria
  • Intolerance to or inadequate response to at least 1 Nonsteroidal Anti-Inflammatory Drug (NSAID)

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 to more than 2 previous biological agents for Axial Spondyloarthritis (SpA)
  • 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

Sites / Locations

  • 961
  • 953
  • 954
  • 971
  • 987
  • 974
  • 973
  • 966
  • 952
  • 957
  • 962
  • 959
  • 990
  • 958
  • 964
  • 969
  • 984
  • 965
  • 950
  • 985
  • 963
  • 977
  • 951
  • 970
  • 982
  • 972
  • 975
  • 978
  • 983
  • 967
  • 981
  • 968
  • 700
  • 701
  • 704
  • 705
  • 709
  • 706
  • 710
  • 702
  • 708
  • 153
  • 152
  • 151
  • 760
  • 750
  • 761
  • 756
  • 907
  • 903
  • 900
  • 910
  • 902
  • 504
  • 501
  • 500
  • 502
  • 505
  • 503
  • 200
  • 201
  • 205
  • 206
  • 204
  • 202
  • 257
  • 258
  • 255
  • 254
  • 250
  • 253
  • 260
  • 263
  • 256
  • 303
  • 305
  • 302
  • 306
  • 300
  • 352
  • 351
  • 350
  • 802
  • 801
  • 401
  • 400
  • 458
  • 452
  • 455
  • 459
  • 457
  • 450
  • 454
  • 453
  • 456
  • 462
  • 550
  • 554
  • 552
  • 553
  • 605
  • 600
  • 602
  • 601

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Placebo Comparator

Other

Other

Other

Other

Arm Label

CZP 200 mg Q2W

CZP 400 mg Q4W

Placebo

Placebo to CZP 200 mg escape on Week 16

Placebo to CZP 400 mg escape on Week 16

Placebo to CZP 200 mg on Week 24

Placebo to CZP 400 mg on Week 24

Arm Description

Subjects received 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. At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.

Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards. Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.

Matching Placebo to CZP injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16. After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg Q2W or CZP 400 mg Q4W.

Matching Placebo to CZP injections from Week 0 to Week 16. Subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16 and were treated with three loading doses of CZP 400 mg sc on Weeks 16, 18 and 20, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 22 onwards. Additionally, Placebo injections were administered as appropriate in order to maintain the study blind.

Matching Placebo to CZP injections from Week 0 to Week 16. Subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16 and were treated with three loading doses of CZP 400 mg sc on Weeks 16, 18 and 20, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 24 onwards. Additionally, Placebo injections were administered as appropriate in order to maintain the study blind.

Matching Placebo to CZP injections from Week 0 to Week 24. Three loading doses of CZP 400 mg sc were given on Weeks 24, 26 and 28, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 30 onwards. Additionally, Placebo injections were administered as appropriate in order to maintain the study blind.

Matching Placebo to CZP injections from Week 0 to Week 24. Three loading doses of CZP 400 mg sc were given on Weeks 24, 26 and 28, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 32 onwards. Additionally, Placebo injections were administered as appropriate in order to maintain the study blind.

Outcomes

Primary Outcome Measures

Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 12
The ASAS20 is 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 following domains: Patient's Global Assessment of Disease Activity Pain assessment (total spinal pain) Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI)) Inflammation (the mean of the 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 is defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit).

Secondary Outcome Measures

Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 24
The ASAS20 is 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 following domains: Patient's Global Assessment of Disease Activity Pain assessment (total spinal pain) Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI)) Inflammation (the mean of the 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 is defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit).
Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 12
The BASFI assesses physical function in comprising 10 items relating to activities during the past week. Each item ranges from 0 ("Easy") to 10 ("Impossible"). 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. A negative value in BASFI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24
The BASFI assesses physical function in comprising 10 items relating to activities during the past week. Each item ranges from 0 ("Easy") to 10 ("Impossible"). 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. A negative value in BASFI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12
The BASDAI is a validated self-reported instrument which consists of six 10 unit horizontal Numerical Rating Scales (NRSs) to measure severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration, respectively) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity. A negative value in BASDAI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24
The BASDAI is a validated self-reported instrument which consists of six 10 unit horizontal Numerical Rating Scales (NRSs) to measure severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration, respectively) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity. A negative value in BASDAI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 12
The BASMI characterizes the spinal mobility of subjects with axial Spondyloarthritis (SpA) and Ankylosing Spondylitis (AS). It 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 SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 24
The BASMI characterizes the spinal mobility of subjects with axial SpA and AS. It 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 SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Change From Baseline in the Spine Ankylosing Spondylitis Spine Magnetic Resonance Imaging (MRI) Scoring System for Disease Activity (ASspiMRI-a) in the Berlin Modification at 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. A VU is defined as the region between 2 virtual lines through the middle of each vertebra. 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. Total spine ASspiMRI-a score in the Berlin modification can range from 0 to 69 with higher scores indicating higher disease activity. A negative value in total spine ASspiMRI-a score change from Baseline indicates an improvement from Baseline. The higher the negative value the higher the reduction of inflammation.
Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at 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. A negative value in SPARCC change from Baseline indicates an improvement from Baseline. The higher the negative value the higher the reduction of inflammation.

Full Information

First Posted
March 15, 2010
Last Updated
July 4, 2018
Sponsor
UCB BIOSCIENCES GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01087762
Brief Title
Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis
Official Title
Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB BIOSCIENCES GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of two dose regimens of Certolizumab Pegol (CZP) in subjects with active axial Spondyloarthritis (axial SpA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondyloarthropathies
Keywords
Certolizumab Pegol, Cimzia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
325 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CZP 200 mg Q2W
Arm Type
Experimental
Arm Description
Subjects received 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. At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
Arm Title
CZP 400 mg Q4W
Arm Type
Experimental
Arm Description
Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards. Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching Placebo to CZP injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16. After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg Q2W or CZP 400 mg Q4W.
Arm Title
Placebo to CZP 200 mg escape on Week 16
Arm Type
Other
Arm Description
Matching Placebo to CZP injections from Week 0 to Week 16. Subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16 and were treated with three loading doses of CZP 400 mg sc on Weeks 16, 18 and 20, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 22 onwards. Additionally, Placebo injections were administered as appropriate in order to maintain the study blind.
Arm Title
Placebo to CZP 400 mg escape on Week 16
Arm Type
Other
Arm Description
Matching Placebo to CZP injections from Week 0 to Week 16. Subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16 and were treated with three loading doses of CZP 400 mg sc on Weeks 16, 18 and 20, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 24 onwards. Additionally, Placebo injections were administered as appropriate in order to maintain the study blind.
Arm Title
Placebo to CZP 200 mg on Week 24
Arm Type
Other
Arm Description
Matching Placebo to CZP injections from Week 0 to Week 24. Three loading doses of CZP 400 mg sc were given on Weeks 24, 26 and 28, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 30 onwards. Additionally, Placebo injections were administered as appropriate in order to maintain the study blind.
Arm Title
Placebo to CZP 400 mg on Week 24
Arm Type
Other
Arm Description
Matching Placebo to CZP injections from Week 0 to Week 24. Three loading doses of CZP 400 mg sc were given on Weeks 24, 26 and 28, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 32 onwards. Additionally, Placebo injections were administered as appropriate in order to maintain the study blind.
Intervention Type
Biological
Intervention Name(s)
CZP 200 mg Q2W
Other Intervention Name(s)
Cimzia, CZP, Certolizumab Pegol
Intervention Description
200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
Intervention Type
Biological
Intervention Name(s)
CZP 400 mg Q4W
Other Intervention Name(s)
Cimzia, CZP, Certolizumab Pegol
Intervention Description
400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo to CZP injection.
Primary Outcome Measure Information:
Title
Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 12
Description
The ASAS20 is 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 following domains: Patient's Global Assessment of Disease Activity Pain assessment (total spinal pain) Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI)) Inflammation (the mean of the 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 is defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit).
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 24
Description
The ASAS20 is 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 following domains: Patient's Global Assessment of Disease Activity Pain assessment (total spinal pain) Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI)) Inflammation (the mean of the 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 is defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit).
Time Frame
Week 24
Title
Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 12
Description
The BASFI assesses physical function in comprising 10 items relating to activities during the past week. Each item ranges from 0 ("Easy") to 10 ("Impossible"). 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. A negative value in BASFI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Time Frame
From Baseline to Week 12
Title
Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24
Description
The BASFI assesses physical function in comprising 10 items relating to activities during the past week. Each item ranges from 0 ("Easy") to 10 ("Impossible"). 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. A negative value in BASFI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Time Frame
From Baseline to Week 24
Title
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12
Description
The BASDAI is a validated self-reported instrument which consists of six 10 unit horizontal Numerical Rating Scales (NRSs) to measure severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration, respectively) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity. A negative value in BASDAI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Time Frame
From Baseline to Week 12
Title
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24
Description
The BASDAI is a validated self-reported instrument which consists of six 10 unit horizontal Numerical Rating Scales (NRSs) to measure severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration, respectively) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity. A negative value in BASDAI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Time Frame
From Baseline to Week 24
Title
Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 12
Description
The BASMI characterizes the spinal mobility of subjects with axial Spondyloarthritis (SpA) and Ankylosing Spondylitis (AS). It 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 SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Time Frame
From Baseline to Week 12
Title
Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 24
Description
The BASMI characterizes the spinal mobility of subjects with axial SpA and AS. It 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 SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Time Frame
From Baseline to Week 24
Title
Change From Baseline in the Spine Ankylosing Spondylitis Spine Magnetic Resonance Imaging (MRI) Scoring System for Disease Activity (ASspiMRI-a) in the Berlin Modification at Week 12
Description
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. A VU is defined as the region between 2 virtual lines through the middle of each vertebra. 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. Total spine ASspiMRI-a score in the Berlin modification can range from 0 to 69 with higher scores indicating higher disease activity. A negative value in total spine ASspiMRI-a score change from Baseline indicates an improvement from Baseline. The higher the negative value the higher the reduction of inflammation.
Time Frame
From Baseline to Week 12
Title
Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Week 12
Description
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. A negative value in SPARCC change from Baseline indicates an improvement from Baseline. The higher the negative value the higher the reduction of inflammation.
Time Frame
From Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented diagnosis of adult-onset axial Spondyloarthritis (SpA) of at least 3 months' duration as defined by the specified Assessment of Spondyloarthritis International Society (ASAS) criteria Active disease as defined by: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 Back pain ≥ 4 on a 0 to 10 Neurobehavioral Rating Scale (NRS) (from BASDAI item 2) C-Reactive Protein (CRP) > ULN (Upper Limit of Normal) and/or current evidence (ie, within the last 3 months from Screening) for Sacroiliitis on Magnetic Resonance Imaging (MRI) as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria Intolerance to or inadequate response to at least 1 Nonsteroidal Anti-Inflammatory Drug (NSAID) 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 to more than 2 previous biological agents for Axial Spondyloarthritis (SpA) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 UCB
Official's Role
Study Director
Facility Information:
Facility Name
961
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
953
City
Tuscaloosa
State/Province
Alabama
Country
United States
Facility Name
954
City
Peoria
State/Province
Arizona
Country
United States
Facility Name
971
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
987
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
974
City
La Jolla
State/Province
California
Country
United States
Facility Name
973
City
Los Angeles
State/Province
California
Country
United States
Facility Name
966
City
Palm Desert
State/Province
California
Country
United States
Facility Name
952
City
San Diego
State/Province
California
Country
United States
Facility Name
957
City
Aventura
State/Province
Florida
Country
United States
Facility Name
962
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
959
City
Orange Park
State/Province
Florida
Country
United States
Facility Name
990
City
Pinellas Park
State/Province
Florida
Country
United States
Facility Name
958
City
Vero Beach
State/Province
Florida
Country
United States
Facility Name
964
City
Hagerstown
State/Province
Maryland
Country
United States
Facility Name
969
City
Eagan
State/Province
Minnesota
Country
United States
Facility Name
984
City
Flowood
State/Province
Mississippi
Country
United States
Facility Name
965
City
Florissant
State/Province
Missouri
Country
United States
Facility Name
950
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
985
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
963
City
Asheville
State/Province
North Carolina
Country
United States
Facility Name
977
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
951
City
Middleburg Heights
State/Province
Ohio
Country
United States
Facility Name
970
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
982
City
Portland
State/Province
Oregon
Country
United States
Facility Name
972
City
Duncansville
State/Province
Pennsylvania
Country
United States
Facility Name
975
City
Dallas
State/Province
Texas
Country
United States
Facility Name
978
City
Houston
State/Province
Texas
Country
United States
Facility Name
983
City
Houston
State/Province
Texas
Country
United States
Facility Name
967
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
981
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
968
City
Seattle
State/Province
Washington
Country
United States
Facility Name
700
City
Buenos Aires
Country
Argentina
Facility Name
701
City
Buenos Aires
Country
Argentina
Facility Name
704
City
Buenos Aires
Country
Argentina
Facility Name
705
City
Cordoba
Country
Argentina
Facility Name
709
City
La Plata
Country
Argentina
Facility Name
706
City
Rosario
Country
Argentina
Facility Name
710
City
San Juan
Country
Argentina
Facility Name
702
City
San Miguel de Tucuman
Country
Argentina
Facility Name
708
City
San Miguel de Tucuman
Country
Argentina
Facility Name
153
City
Brussels
Country
Belgium
Facility Name
152
City
Gent
Country
Belgium
Facility Name
151
City
Liege
Country
Belgium
Facility Name
760
City
Campinas
Country
Brazil
Facility Name
750
City
Curitiba
Country
Brazil
Facility Name
761
City
Goiânia
Country
Brazil
Facility Name
756
City
Sao Paulo
Country
Brazil
Facility Name
907
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
903
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
900
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
910
City
Windsor
State/Province
Ontario
Country
Canada
Facility Name
902
City
Sainte Foy
State/Province
Quebec
Country
Canada
Facility Name
504
City
Brno
Country
Czechia
Facility Name
501
City
Hlucin
Country
Czechia
Facility Name
500
City
Pardubice
Country
Czechia
Facility Name
502
City
Praha 2
Country
Czechia
Facility Name
505
City
Terezin
Country
Czechia
Facility Name
503
City
Zlin
Country
Czechia
Facility Name
200
City
Boulogne-Billan Court
Country
France
Facility Name
201
City
Lille
Country
France
Facility Name
205
City
Limoges
Country
France
Facility Name
206
City
Montpellier
Country
France
Facility Name
204
City
Paris
Country
France
Facility Name
202
City
Tours
Country
France
Facility Name
257
City
Berlin
Country
Germany
Facility Name
258
City
Berlin
Country
Germany
Facility Name
255
City
Freiburg
Country
Germany
Facility Name
254
City
Hamburg
Country
Germany
Facility Name
250
City
Herne
Country
Germany
Facility Name
253
City
Leipzig
Country
Germany
Facility Name
260
City
München
Country
Germany
Facility Name
263
City
München
Country
Germany
Facility Name
256
City
Ratingen
Country
Germany
Facility Name
303
City
Budapest
Country
Hungary
Facility Name
305
City
Budapest
Country
Hungary
Facility Name
302
City
Debrecen
Country
Hungary
Facility Name
306
City
Miskolc
Country
Hungary
Facility Name
300
City
Veszprém
Country
Hungary
Facility Name
352
City
Ancona
Country
Italy
Facility Name
351
City
Firenze
Country
Italy
Facility Name
350
City
Pisa
Country
Italy
Facility Name
802
City
Cuernavaca
Country
Mexico
Facility Name
801
City
Monterrey
Country
Mexico
Facility Name
401
City
Maastricht
Country
Netherlands
Facility Name
400
City
Rotterdam
Country
Netherlands
Facility Name
458
City
Bialystok
Country
Poland
Facility Name
452
City
Dabrowka
Country
Poland
Facility Name
455
City
Elblag
Country
Poland
Facility Name
459
City
Gdanks
Country
Poland
Facility Name
457
City
Krakow
Country
Poland
Facility Name
450
City
Lublin
Country
Poland
Facility Name
454
City
Poznan
Country
Poland
Facility Name
453
City
Torun
Country
Poland
Facility Name
456
City
Warszawa
Country
Poland
Facility Name
462
City
Warszawa
Country
Poland
Facility Name
550
City
Mérida
Country
Spain
Facility Name
554
City
Santander
Country
Spain
Facility Name
552
City
Santiago de Compostela
Country
Spain
Facility Name
553
City
Sevilla
Country
Spain
Facility Name
605
City
Barnsley
Country
United Kingdom
Facility Name
600
City
Leeds
Country
United Kingdom
Facility Name
602
City
London
Country
United Kingdom
Facility Name
601
City
Salford
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24013647
Citation
Landewe R, Braun J, Deodhar A, Dougados M, Maksymowych WP, Mease PJ, Reveille JD, Rudwaleit M, van der Heijde D, Stach C, Hoepken B, Fichtner A, Coteur G, de Longueville M, Sieper J. Efficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis: 24-week results of a double-blind randomised placebo-controlled Phase 3 study. Ann Rheum Dis. 2014 Jan;73(1):39-47. doi: 10.1136/annrheumdis-2013-204231. Epub 2013 Sep 6.
Results Reference
result
PubMed Identifier
34791107
Citation
Baraliakos X, Kruse S, Auteri SE, de Peyrecave N, Nurminen T, Kumke T, Hoepken B, Braun J. Certolizumab pegol treatment in axial spondyloarthritis mitigates fat lesion development: 4-year post-hoc MRI results from a phase 3 study. Rheumatology (Oxford). 2022 Jul 6;61(7):2875-2885. doi: 10.1093/rheumatology/keab841.
Results Reference
derived
PubMed Identifier
30217232
Citation
Landewe R, Nurminen T, Davies O, Baeten D. A single determination of C-reactive protein does not suffice to declare a patient with a diagnosis of axial spondyloarthritis 'CRP-negative'. Arthritis Res Ther. 2018 Sep 14;20(1):209. doi: 10.1186/s13075-018-1707-8.
Results Reference
derived
PubMed Identifier
29670761
Citation
van der Heijde D, Braun J, Rudwaleit M, Purcaru O, Kavanaugh AF. Improvements in workplace and household productivity with certolizumab pegol treatment in axial spondyloarthritis: results to week 96 of a phase III study. RMD Open. 2018 Apr 9;4(1):e000659. doi: 10.1136/rmdopen-2018-000659. eCollection 2018.
Results Reference
derived
PubMed Identifier
28498975
Citation
van der Heijde D, Dougados M, Landewe R, Sieper J, Maksymowych WP, Rudwaleit M, Van den Bosch F, Braun J, Mease PJ, Kivitz AJ, Walsh J, Davies O, Bauer L, Hoepken B, Peterson L, Deodhar A. Sustained efficacy, safety and patient-reported outcomes of certolizumab pegol in axial spondyloarthritis: 4-year outcomes from RAPID-axSpA. Rheumatology (Oxford). 2017 Sep 1;56(9):1498-1509. doi: 10.1093/rheumatology/kex174.
Results Reference
derived
PubMed Identifier
27696727
Citation
van der Heijde D, Deodhar A, Fleischmann R, Mease PJ, Rudwaleit M, Nurminen T, Davies O. Early Disease Activity or Clinical Response as Predictors of Long-Term Outcomes With Certolizumab Pegol in Axial Spondyloarthritis or Psoriatic Arthritis. Arthritis Care Res (Hoboken). 2017 Jul;69(7):1030-1039. doi: 10.1002/acr.23092. Epub 2017 Jun 2.
Results Reference
derived
PubMed Identifier
26815944
Citation
Rudwaleit M, Rosenbaum JT, Landewe R, Marzo-Ortega H, Sieper J, van der Heijde D, Davies O, Bartz H, Hoepken B, Nurminen T, Deodhar A. Observed Incidence of Uveitis Following Certolizumab Pegol Treatment in Patients With Axial Spondyloarthritis. Arthritis Care Res (Hoboken). 2016 Jun;68(6):838-44. doi: 10.1002/acr.22848.
Results Reference
derived
PubMed Identifier
25832312
Citation
Sieper J, Kivitz A, van Tubergen A, Deodhar A, Coteur G, Woltering F, Landewe R. Impact of Certolizumab Pegol on Patient-Reported Outcomes in Patients With Axial Spondyloarthritis. Arthritis Care Res (Hoboken). 2015 Oct;67(10):1475-80. doi: 10.1002/acr.22594.
Results Reference
derived
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis

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