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Trial record 1 of 8 for:    certolizumab pegol and psoriatic arthritis
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Certolizumab Pegol in Subjects With Adult Onset Active and Progressive Psoriatic Arthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01087788
First Posted: March 16, 2010
Last Update Posted: March 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES GmbH )
Results First Submitted: October 25, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, 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 (PBO) 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 
Received CZP 200 mg Q2W at 16 Weeks   30 [1]   0 [2]   0 [2] 
Received CZP 400 mg Q4W at 16 Weeks   29 [3]   0 [2]   0 [2] 
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 
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 
Patient (P) does not want to attend                1                0                0 
Protocol violation (decision of monitor)                0                1                0 
Exclusion criteria were not met                0                1                0 
P cannot comply with scheduled visits                0                0                1 
[1] 30 subjects left the Placebo group and were re-randomized to CZP 200 mg Q2W on Week 16.
[2] not applicable for this arm
[3] 29 subjects left the Placebo group and were re-randomized to CZP 400 mg Q4W on Week 16.

Period 2:   24-weeks Dose-blind Period
    Placebo   CZP 200 mg Q2W   CZP 400 mg Q4W
STARTED   120   128   120 
Received CZP 200 mg Q2W at 24 Weeks   60 [1]   0 [2]   0 [2] 
Received CZP 400 mg Q2W at 24 Weeks   60 [3]   0 [2]   0 [2] 
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 
AE, serious fatal                0                1                0 
AE, serious non-fatal                2                1                2 
AE, non-serious non-fatal                2                1                1 
Sponsor decision following missed visits                1                0                0 
Patient moved                0                0                1 
[1] Sum of subjects re-randomized to CZP 200mg Q2W at week 16 (30 subjects) and at week 24 (30 subjects)
[2] not applicable for this arm
[3] Sum of subjects re-randomized to CZP 400mg Q2W at week 16 (29 subjects) and at week 24 (31 subjects)

Period 3:   Open-Label Period (OL-P)
    Placebo   CZP 200 mg Q2W   CZP 400 mg Q4W
STARTED   111 [1]   121 [1]   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 
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 
Sponsor request                1                0                0 
Principal investigator decision                0                1                2 
No participation in study extension                0                0                1 
Personal reasons                0                0                1 
[1] 2 subj. completed the Dose-Blind Period, then withdrew from the study rather than entering the OL-P.



  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]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      129  94.9%      126  91.3%      128  94.8%      383  93.6% 
>=65 years      7   5.1%      12   8.7%      7   5.2%      26   6.4% 
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]
Count of Participants
       
Female      79  58.1%      74  53.6%      73  54.1%      226  55.3% 
Male      57  41.9%      64  46.4%      62  45.9%      183  44.7% 


  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 )
First Submitted: March 15, 2010
First Posted: March 16, 2010
Results First Submitted: October 25, 2013
Results First Posted: February 25, 2014
Last Update Posted: March 1, 2017