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Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier:
NCT01087762
First received: March 15, 2010
Last updated: November 17, 2016
Last verified: November 2016
Results First Received: November 6, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   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 for the interim period, and 315 for the final analysis (10 subjects dropped out before receiving a CZP dose), which is an Intention-to-Treat (ITT) dataset.

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.

Reporting Groups
  Description
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.

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).

All CZP 200 mg

All subjects who received CZP at the specified dose (200 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.

Placebo : Matching Placebo to CZP injection.

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

All CZP 400 mg

All subjects who received CZP at the specified dose (400 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.

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 for 2 periods

Period 1:   Double Blind Period (Weeks 0-24)
    Placebo   CZP 200 mg Q2W   CZP 400 mg Q4W   All CZP 200 mg   All CZP 400 mg
STARTED   107 [1]   111 [1]   107 [1]   0   0 
COMPLETED   95   105   98   0   0 
NOT COMPLETED   12   6   9   0   0 
Lack of Efficacy                2                0                3                0                0 
Protocol Violation                6                0                1                0                0 
Lost to Follow-up                1                2                1                0                0 
Withdrawal by Subject                1                2                1                0                0 
SAE, non-fatal                2                2                3                0                0 
[1] Completed 24-weeks Double-blind Period

Period 2:   Open-Label Period (Weeks 48-204)
    Placebo   CZP 200 mg Q2W   CZP 400 mg Q4W   All CZP 200 mg   All CZP 400 mg
STARTED   0   0   0   158   157 
COMPLETED   0   0   0   99   100 
NOT COMPLETED   0   0   0   59   57 
Lack of Efficacy                0                0                0                4                14 
Protocol Violation                0                0                0                1                1 
Lost to Follow-up                0                0                0                5                2 
Withdrawal by Subject                0                0                0                22                15 
Unspecified                0                0                0                2                4 
SAE, non-fatal                0                0                0                7                4 
AE, non-serious non-fatal                0                0                0                16                13 
SAE, non-fatal + AE, non-serious/fatal                0                0                0                2                4 



  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
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.

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).

Total Title No text entered.

Baseline Measures
   Placebo   CZP 200 mg Q2W   CZP 400 mg Q4W   Total Title 
Overall Participants Analyzed 
[Units: Participants]
 107   111   107   325 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      102  95.3%      110  99.1%      105  98.1%      317  97.5% 
>=65 years      5   4.7%      1   0.9%      2   1.9%      8   2.5% 
Age 
[Units: Years]
Mean (Standard Deviation)
       
Mean age   39.9  (12.4)   39.1  (11.9)   39.8  (39.9)   39.6  (11.9) 
Gender 
[Units: Participants]
Count of Participants
       
Female      42  39.3%      44  39.6%      39  36.4%      125  38.5% 
Male      65  60.7%      67  60.4%      68  63.6%      200  61.5% 
Weight 
[Units: Kilogram (kg)]
Mean (Standard Deviation)
 82.142  (18.147)   79.305  (18.599)   83.893  (18.855)   81.757  (18.576) 
Height 
[Units: Centimeter (cm)]
Mean (Standard Deviation)
 170.704  (9.692)   171.769  (10.171)   172.753  (9.607)   171.739  (9.834) 


  Outcome Measures
  Show All Outcome Measures

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
  Hide Limitations and Caveats

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
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  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
Organization: Cares
phone: +1887822 ext 9493


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: UCB Pharma ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier: NCT01087762     History of Changes
Other Study ID Numbers: AS001
2009-011719-19 ( EudraCT Number )
Study First Received: March 15, 2010
Results First Received: November 6, 2013
Last Updated: November 17, 2016