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Trial record 1 of 5 for:    certolizumab pegol and psoriatic arthritis
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Certolizumab Pegol in Subjects With Adult Onset Active and Progressive Psoriatic Arthritis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier:
NCT01087788
First received: March 15, 2010
Last updated: November 6, 2014
Last verified: November 2014
Results First Received: October 25, 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: Arthritis, Psoriatic
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 116 sites in North America, Latin America, Western Europe, and Central/Eastern Europe.

409 subjects are included in Randomized Set (RS) shown in the Participant Flow, 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.

Provided data are Interim Results up to Week 48:

  • Week 0-24: double-blind, placebo-controlled
  • Week 24-48: dose-blind.

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 and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.

After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).

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.

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.


Participant Flow for 2 periods

Period 1:   24-weeks Double-blind Period
    Placebo     CZP 200 mg Q2W     CZP 400 mg Q4W  
STARTED     136     138     135  
COMPLETED     120     128     120  
NOT COMPLETED     16     10     15  
Adverse Event                 2                 4                 7  
Lack of Efficacy                 2                 0                 1  
Protocol Violation                 0                 1                 0  
Lost to Follow-up                 4                 1                 1  
Withdrawal by Subject                 7                 2                 5  
Other reason                 1                 2                 1  

Period 2:   24-weeks Dose-blind Period
    Placebo     CZP 200 mg Q2W     CZP 400 mg Q4W  
STARTED     120     128     120  
COMPLETED     113     123     114  
NOT COMPLETED     7     5     6  
Adverse Event                 4                 3                 3  
Lack of Efficacy                 0                 2                 1  
Lost to Follow-up                 1                 0                 1  
Withdrawal by Subject                 1                 0                 0  
Other Reason                 1                 0                 1  



  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.
409 subjects are included in Randomized Set (RS) shown in Baseline Characteristics, 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 and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.

After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).

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.

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.

Total Total of all reporting groups

Baseline Measures
    Placebo     CZP 200 mg Q2W     CZP 400 mg Q4W     Total  
Number of Participants  
[units: participants]
  136     138     135     409  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     129     126     128     383  
>=65 years     7     12     7     26  
Age  
[units: years]
Mean ± Standard Deviation
  47.3  ± 11.1     48.2  ± 12.3     47.1  ± 10.8     47.6  ± 11.4  
Gender  
[units: participants]
       
Female     79     74     73     226  
Male     57     64     62     183  
Region of Enrollment  
[units: participants]
       
United States     28     27     29     84  
Spain     3     2     1     6  
Ireland     0     0     1     1  
United Kingdom     3     1     2     6  
Italy     3     2     3     8  
Czech Republic     21     24     22     67  
Hungary     9     9     10     28  
Mexico     1     2     1     4  
Canada     4     4     6     14  
Argentina     16     17     17     50  
Poland     33     36     32     101  
Belgium     1     0     0     1  
Brazil     2     2     2     6  
Germany     12     12     9     33  
Weight  
[units: kilogram¬†(kg)]
Mean ± Standard Deviation
  82.63  ± 19.94     85.80  ± 17.65     84.83  ± 18.68     84.43  ± 18.77  
Height  
[units: centimeter¬†(cm)]
Mean ± Standard Deviation
  168.18  ± 10.24     167.91  ± 9.98     169.56  ± 8.48     168.54  ± 9.61  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   American College of Rheumatology 20 (ACR20) Response at Week 12   [ Time Frame: Week 12 ]

2.  Primary:   Change From Baseline in Modified Total Sharp Score (mTSS) in Modification for Psoriatic Arthritis at Week 24   [ Time Frame: From Baseline to Week 24 ]

3.  Secondary:   American College of Rheumatology 20 (ACR20) Response at Week 24   [ Time Frame: Week 24 ]

4.  Secondary:   Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 24   [ Time Frame: From Baseline to Week 24 ]

5.  Secondary:   Psoriasis Area Severity Index (PASI75) Response at Week 24 in the Subgroup of Subjects With Psoriasis (PSO) Involving at Least 3 % Body Surface Area (BSA) at Baseline   [ Time Frame: Week 24 ]

6.  Secondary:   Change From Baseline in Modified Total Sharp Score (mTSS) at Week 48   [ Time Frame: From Baseline to Week 48 ]


  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:
Publications automatically indexed to this study:

Responsible Party: UCB Pharma ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier: NCT01087788     History of Changes
Other Study ID Numbers: PsA001, 2009-011720-59
Study First Received: March 15, 2010
Results First Received: October 25, 2013
Last Updated: November 6, 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: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Hungary: Research Ethics Medical Committee
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