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Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc. ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier:
NCT01087762
First received: March 15, 2010
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

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).


Condition Intervention Phase
Spondyloarthropathies
Biological: CZP 200 mg Q2W
Biological: CZP 400 mg Q4W
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

    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 [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: From Baseline to Week 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: From Baseline to Week 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: From Baseline to Week 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: No ]
    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.


Enrollment: 325
Study Start Date: March 2010
Estimated Study Completion Date: October 2015
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CZP 200 mg Q2W

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.

Biological: CZP 200 mg Q2W
200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
Other Names:
  • Cimzia
  • CZP
  • Certolizumab Pegol
Other: Placebo
Matching Placebo to CZP injection.
Experimental: CZP 400 mg Q4W

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.

Biological: CZP 400 mg Q4W
400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
Other Names:
  • Cimzia
  • CZP
  • Certolizumab Pegol
Other: Placebo
Matching Placebo to CZP injection.
Placebo Comparator: Placebo

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.

Other: Placebo
Matching Placebo to CZP injection.
Placebo to CZP 200 mg escape on Week 16
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.
Biological: CZP 200 mg Q2W
200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
Other Names:
  • Cimzia
  • CZP
  • Certolizumab Pegol
Other: Placebo
Matching Placebo to CZP injection.
Placebo to CZP 400 mg escape on Week 16
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.
Biological: CZP 400 mg Q4W
400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
Other Names:
  • Cimzia
  • CZP
  • Certolizumab Pegol
Other: Placebo
Matching Placebo to CZP injection.
Placebo to CZP 200 mg on Week 24
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.
Biological: CZP 200 mg Q2W
200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
Other Names:
  • Cimzia
  • CZP
  • Certolizumab Pegol
Other: Placebo
Matching Placebo to CZP injection.
Placebo to CZP 400 mg on Week 24
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.
Biological: CZP 400 mg Q4W
400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
Other Names:
  • Cimzia
  • CZP
  • Certolizumab Pegol
Other: Placebo
Matching Placebo to CZP injection.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01087762

  Hide Study Locations
Locations
United States, Alabama
961
Birmingham, Alabama, United States
953
Tuscaloosa, Alabama, United States
United States, Arizona
954
Peoria, Arizona, United States
971
Scottsdale, Arizona, United States
987
Tucson, Arizona, United States
United States, California
974
La Jolla, California, United States
973
Los Angeles, California, United States
966
Palm Desert, California, United States
952
San Diego, California, United States
United States, Florida
957
Aventura, Florida, United States
962
Fort Lauderdale, Florida, United States
959
Orange Park, Florida, United States
990
Pinellas Park, Florida, United States
958
Vero Beach, Florida, United States
United States, Maryland
964
Hagerstown, Maryland, United States
United States, Minnesota
969
Eagan, Minnesota, United States
United States, Mississippi
984
Flowood, Mississippi, United States
United States, Missouri
965
Florissant, Missouri, United States
950
St. Louis, Missouri, United States
United States, New York
985
Brooklyn, New York, United States
United States, North Carolina
963
Asheville, North Carolina, United States
United States, Ohio
977
Cleveland, Ohio, United States
951
Middleburg Heights, Ohio, United States
United States, Oklahoma
970
Oklahoma City, Oklahoma, United States
United States, Oregon
982
Portland, Oregon, United States
United States, Pennsylvania
972
Duncansville, Pennsylvania, United States
United States, Texas
975
Dallas, Texas, United States
978
Houston, Texas, United States
983
Houston, Texas, United States
967
San Antonio, Texas, United States
United States, Utah
981
Salt Lake City, Utah, United States
United States, Washington
968
Seattle, Washington, United States
Argentina
700
Buenos Aires, Argentina
701
Buenos Aires, Argentina
704
Buenos Aires, Argentina
705
Cordoba, Argentina
709
La Plata, Argentina
706
Rosario, Argentina
710
San Juan, Argentina
702
San Miguel de Tucuman, Argentina
708
San Miguel de Tucuman, Argentina
Belgium
153
Brussels, Belgium
152
Gent, Belgium
151
Liege, Belgium
Brazil
760
Campinas, Brazil
750
Curitiba, Brazil
761
Goiânia, Brazil
756
Sao Paulo, Brazil
Canada, British Columbia
907
Victoria, British Columbia, Canada
Canada, Manitoba
903
Winnipeg, Manitoba, Canada
Canada, Newfoundland and Labrador
900
St. John's, Newfoundland and Labrador, Canada
Canada, Ontario
910
Windsor, Ontario, Canada
Canada, Quebec
902
Sainte Foy, Quebec, Canada
Czech Republic
504
Brno, Czech Republic
501
Hlucin, Czech Republic
500
Pardubice, Czech Republic
502
Praha 2, Czech Republic
505
Terezin, Czech Republic
503
Zlin, Czech Republic
France
200
Boulogne-Billan Court, France
201
Lille, France
205
Limoges, France
206
Montpellier, France
204
Paris, France
202
Tours, France
Germany
257
Berlin, Germany
258
Berlin, Germany
255
Freiburg, Germany
254
Hamburg, Germany
250
Herne, Germany
253
Leipzig, Germany
260
München, Germany
263
München, Germany
256
Ratingen, Germany
Hungary
303
Budapest, Hungary
305
Budapest, Hungary
302
Debrecen, Hungary
306
Miskolc, Hungary
300
Veszprém, Hungary
Italy
352
Ancona, Italy
351
Firenze, Italy
350
Pisa, Italy
Mexico
802
Cuernavaca, Mexico
801
Monterrey, Mexico
Netherlands
401
Maastricht, Netherlands
400
Rotterdam, Netherlands
Poland
458
Bialystok, Poland
452
Dabrowka, Poland
455
Elblag, Poland
459
Gdanks, Poland
457
Krakow, Poland
450
Lublin, Poland
454
Poznan, Poland
453
Torun, Poland
456
Warszawa, Poland
462
Warszawa, Poland
Spain
550
Mérida, Spain
554
Santander, Spain
552
Santiago de Compostela, Spain
553
Sevilla, Spain
United Kingdom
605
Barnsley, United Kingdom
600
Leeds, United Kingdom
602
London, United Kingdom
601
Salford, United Kingdom
Sponsors and Collaborators
UCB BIOSCIENCES GmbH
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 UCB
  More Information

Additional Information:
Publications:
Responsible Party: UCB, Inc. ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier: NCT01087762     History of Changes
Other Study ID Numbers: AS001, 2009-011719-19
Study First Received: March 15, 2010
Results First Received: November 6, 2013
Last Updated: January 17, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Paul-Ehrlich-Institut
Hungary: National Institute of Pharmacy
Ireland: Irish Medicines Board
Italy: Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: The Central Register of Clinical Trials
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Brazil: National Health Surveillance Agency
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Mexico: Federal Commission for Sanitary Risks Protection

Keywords provided by UCB, Inc.:
Certolizumab Pegol
Cimzia

Additional relevant MeSH terms:
Spondylarthritis
Spondylarthropathies
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Bone Diseases, Infectious
Infection
Immunoglobulin Fab Fragments
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014