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Certolizumab Pegol in Subjects With Adult Onset Active and Progressive Psoriatic Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier:
NCT01087788
First received: March 15, 2010
Last updated: August 23, 2016
Last verified: August 2016
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
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study started to enroll patients in March 2010 and concluded in August 2015.

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

The study included a 24-week Double-Blind, a 24-week Dose-Blind, and an Open-Label Treatment Period.

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


Participant Flow for 3 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 
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 
AE, serious fatal                0                1                1 
AE, serious non-fatal                0                2                3 
AE, non-serious non-fatal                2                1                2 
AE, unknown type                0                0                1 

Period 2:   24-weeks Double-blind Period
    Placebo   CZP 200 mg Q2W   CZP 400 mg Q4W
STARTED   120   128   120 
COMPLETED   113   123   114 
NOT COMPLETED   7   5   6 
Lack of Efficacy                0                2                1 
Lost to Follow-up                1                0                1 
Withdrawal by Subject                1                0                0 
other                1                0                1 
AE, serious fatal                0                1                0 
AE, serious non-fatal                2                1                2 
AE, non-serious non-fatal                2                1                1 

Period 3:   Open-Label Period
    Placebo   CZP 200 mg Q2W   CZP 400 mg Q4W
STARTED   111   121   114 
COMPLETED   81   97   86 
NOT COMPLETED   30   24   28 
Lack of Efficacy                4                2                3 
Protocol Violation                2                1                0 
Lost to Follow-up                0                4                2 
Withdrawal by Subject                13                8                10 
other                1                1                4 
AE, serious fatal                2                0                1 
AE, serious non-fatal                1                3                4 
AE, non-serious non-fatal                6                4                4 
SAE, non-fatal+AE, non-serious non-fatal                0                1                0 
AE, non-serious unknown                1                0                0 



  Baseline Characteristics
  Hide Baseline Characteristics

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 Title No text entered.

Baseline Measures
   Placebo   CZP 200 mg Q2W   CZP 400 mg Q4W   Total Title 
Overall Participants Analyzed 
[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)
       
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 


  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
  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
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
Organization: Cares
phone: +1877 822 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: NCT01087788     History of Changes
Other Study ID Numbers: PsA001
2009-011720-59 ( EudraCT Number )
Study First Received: March 15, 2010
Results First Received: October 25, 2013
Last Updated: August 23, 2016
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