Trial record 1 of 4 for:    certolizumab pegol and axial spondyloarthritis
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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 Pharma ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier:
NCT01087762
First received: March 15, 2010
Last updated: September 19, 2014
Last verified: September 2014
Results First Received: November 6, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Spondyloarthropathies
Interventions: Biological: CZP 200 mg Q2W
Biological: CZP 400 mg Q4W
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

This is a multicenter study with 128 sites in North America, Latin America, Western Europe, and Central/Eastern Europe.

325 subjects are included in Randomized Set (RS) shown in Participant Flow, which is an Intention-to-Treat (ITT) dataset. At Week 16, 56 placebo-escape subjects were re-randomized to one CZP arm.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Patients with positive Tuberculosis (Tb) tests within Screening Period, but no signs and symptoms of active Tb had to be treated with prophylactic Tb treatment for at least 4 weeks prior to first study drug administration.

Data provided here are Interim Results for the 24-weeks double-blind, placebo-controlled Period.


Reporting Groups
  Description
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.

Placebo : Matching Placebo to CZP injection.

CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).

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.

Placebo : Matching Placebo to CZP injection.

CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).

Placebo Throughout the Double-Blind Period

Matching Placebo to Certolizumab Pegol (CZP) injections throughout the whole double-blind Period from Week 0 to Week 24.

Placebo : Matching Placebo to CZP injection.

Placebo to CZP 200 mg Escape on Week 16

Matching Placebo to Certolizumab Pegol (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.

Placebo : Matching Placebo to CZP injection.

CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).

Placebo to CZP 400 mg Escape on Week 16

Matching Placebo to Certolizumab Pegol (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.

Placebo : Matching Placebo to CZP injection.

CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).


Participant Flow:   Overall Study
    CZP 200 mg Q2W     CZP 400 mg Q4W     Placebo Throughout the Double-Blind Period     Placebo to CZP 200 mg Escape on Week 16     Placebo to CZP 400 mg Escape on Week 16  
STARTED     111     107     51     27     29  
COMPLETED     105 [1]   98 [1]   41 [1]   26 [1]   28 [1]
NOT COMPLETED     6     9     10     1     1  
Adverse Event                 2                 3                 2                 0                 0  
Lack of Efficacy                 0                 3                 1                 0                 1  
Protocol Violation                 0                 1                 5                 1                 0  
Lost to Follow-up                 2                 1                 1                 0                 0  
Withdrawal by Subject                 2                 1                 1                 0                 0  
[1] Completed 24-weeks Double-blind Period



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline Characteristics refer to the Randomized Set (RS), which is an Intention-to-Treat (ITT) dataset.

Reporting Groups
  Description
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.

Placebo : Matching Placebo to CZP injection.

CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).

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.

Placebo : Matching Placebo to CZP injection.

CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).

Placebo

Matching Placebo to Certolizumab Pegol (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 every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).

Placebo : Matching Placebo to CZP injection.

Total Total of all reporting groups

Baseline Measures
    CZP 200 mg Q2W     CZP 400 mg Q4W     Placebo     Total  
Number of Participants  
[units: participants]
  111     107     107     325  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     110     105     102     317  
>=65 years     1     2     5     8  
Age  
[units: years]
Mean ± Standard Deviation
  39.1  ± 11.9     39.8  ± 11.3     39.9  ± 12.4     39.6  ± 11.9  
Gender  
[units: participants]
       
Female     44     39     42     125  
Male     67     68     65     200  
Study-Specific Measure  
[units: kilogram¬†(kg)]
Mean ± Standard Deviation
  79.305  ± 18.599     83.893  ± 18.855     82.142  ± 18.147     81.757  ± 18.576  
Study-Specific Measure  
[units: centimeter¬†(cm)]
Mean ± Standard Deviation
  171.769  ± 10.171     172.753  ± 9.607     170.704  ± 9.692     171.739  ± 9.834  



  Outcome Measures
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1.  Primary:   Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 12   [ Time Frame: Week 12 ]

2.  Secondary:   Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 24   [ Time Frame: Week 24 ]

3.  Secondary:   Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 12   [ Time Frame: From Baseline to Week 12 ]

4.  Secondary:   Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24   [ Time Frame: From Baseline to Week 24 ]

5.  Secondary:   Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12   [ Time Frame: From Baseline to Week 12 ]

6.  Secondary:   Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24   [ Time Frame: From Baseline to Week 24 ]

7.  Secondary:   Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 12   [ Time Frame: From Baseline to Week 12 ]

8.  Secondary:   Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 24   [ Time Frame: From Baseline to Week 24 ]

9.  Secondary:   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 ]

10.  Secondary:   Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Week 12   [ Time Frame: From Baseline to Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
phone: +1 877 822 9493 (UCB)


Publications of Results:

Responsible Party: UCB Pharma ( 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: September 19, 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