A Comparison of Two Assessment Tools in Predicting Treatment Success of Cimzia in Rheumatoid Arthritis Subjects (PREDICT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01255761
First received: December 6, 2010
Last updated: March 10, 2014
Last verified: March 2014
Results First Received: October 7, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Intervention: Biological: Certolizumab Pegol (CZP)

  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

Enrollment began in November 2010. Overall study completion occurred in December 2012.

The Participant Flow consists of the Randomized Set (RS). The RS consists of all subjects randomized into the study.

The Baseline Characteristics consists of the Safety Set (SS). SS consists of all subjects that received at least 1 dose of study medication.


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

The Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.

FAS-NRI: For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).


Reporting Groups
  Description
RAPID3 to Assess Response to Cimzia

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI to Assess Response to Cimzia

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)


Participant Flow:   Overall Study
    RAPID3 to Assess Response to Cimzia     CDAI to Assess Response to Cimzia  
STARTED     369     367  
COMPLETED     187     192  
NOT COMPLETED     182     175  
Adverse Event                 29                 43  
Lack of Efficacy                 86                 74  
Protocol Violation                 9                 5  
Lost to Follow-up                 10                 8  
Withdrawal by Subject                 11                 27  
Other Reasons                 37                 18  



  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.
The Baseline Characteristics consists of the Safety Set (SS). SS consists of all subjects that received at least 1 dose of study medication.

Reporting Groups
  Description
RAPID3 to Assess Response to Cimzia

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

CDAI to Assess Response to Cimzia

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.

Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Total Total of all reporting groups

Baseline Measures
    RAPID3 to Assess Response to Cimzia     CDAI to Assess Response to Cimzia     Total  
Number of Participants  
[units: participants]
  369     367     736  
Age  
[units: participants]
     
<=18 years     0     1     1  
Between 18 and 65 years     295     276     571  
>=65 years     74     90     164  
Age  
[units: years]
Mean ± Standard Deviation
  54.1  ± 12.5     55.7  ± 12.8     54.9  ± 12.7  
Gender  
[units: participants]
     
Female     280     293     573  
Male     89     74     163  
Region of Enrollment  
[units: participants]
     
United States     369     367     736  
Weight  
[units: Kilogram]
Mean ± Standard Deviation
  84.08  ± 21.35     80.17  ± 19.23     82.13  ± 20.40  
Height  
[units: Centimeters]
Mean ± Standard Deviation
  164.94  ± 9.91     164.00  ± 9.25     164.47  ± 9.59  
Body Mass Index (BMI)  
[units: kg/┬ám^2]
Mean ± Standard Deviation
  30.87  ± 7.23     29.82  ± 6.90     30.34  ± 7.08  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Response at Week 12 as Assessed by Randomized Tool [Clinical Disease Activity Index (CDAI) or Routine Assessment of Patient Index Data 3 (RAPID3)]   [ Time Frame: Baseline (Week 0) to Week 12 ]

2.  Primary:   Responders at Week 12 (as Assessed by Randomized Tool Clinical Disease Activity Index [CDAI] or Routine Assessment of Patient Index Data [RAPID3]) Achieving Low Disease Activity (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]≤3.2) at Week 52   [ Time Frame: Baseline (Week 0) to Week 52 ]

3.  Secondary:   Percentage of All Subjects Who Are Both Responders at Week 12 and With Non-low Disease Activity (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] > 3.2) at Week 52   [ Time Frame: Baseline (Week 0) to Week 52 ]

4.  Secondary:   Responders at Week 12 Achieving Remission (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] < 2.6) at Week 52   [ Time Frame: Baseline (Week 0) to Week 52 ]

5.  Secondary:   Percentage of All Subjects Who Are Both Responders at Week 12 and With Non-remission (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] > 2.6) at Week 52   [ Time Frame: Baseline (Week 0) to Week 52 ]

6.  Secondary:   Change From Baseline in the Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] Assessed at Week 12   [ Time Frame: Baseline (Week 0) to Week 12 ]

7.  Secondary:   Change From Baseline in Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] Assessed at Week 52   [ Time Frame: Baseline (Week 0) to Week 52 ]

8.  Secondary:   Change From Baseline in Clinical Disease Activity Index (CDAI) Assessed at Week 12   [ Time Frame: Baseline (Week 0) to Week 12 ]

9.  Secondary:   Change From Baseline in Clinical Disease Activity Index (CDAI) Assessed at Week 52   [ Time Frame: Baseline (Week 0) to Week 52 ]

10.  Secondary:   Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Assessed at Week 12   [ Time Frame: Baseline (Week 0) to Week 12 ]

11.  Secondary:   Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Assessed at Week 52   [ Time Frame: Baseline (Week 0) to Week 52 ]

12.  Secondary:   Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Low Disease Activity (DAS28[ESR] ≤ 3.2) at Week 12   [ Time Frame: Week 12 ]

13.  Secondary:   Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Low Disease Activity (DAS28[ESR] ≤ 3.2) at Week 52   [ Time Frame: Week 52 ]

14.  Secondary:   Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS [ESR] < 2.6) at Week 12   [ Time Frame: Week 12 ]

15.  Secondary:   Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Week 52   [ Time Frame: Week 52 ]

16.  Secondary:   Percentage of Subjects With CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI ≤ 10) at Week 12   [ Time Frame: Week 12 ]

17.  Secondary:   Percentage of Subjects With CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI ≤ 10) at Week 52   [ Time Frame: Week 52 ]

18.  Secondary:   Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤ 2.8) at Week 12   [ Time Frame: Week 12 ]

19.  Secondary:   Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤ 2.8) at Week 52   [ Time Frame: Week 52 ]

20.  Secondary:   Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 ≤ 6.0) at Week 12   [ Time Frame: Week 12 ]

21.  Secondary:   Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 ≤ 6.0) at Week 52   [ Time Frame: Week 52 ]

22.  Secondary:   Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 ≤ 3.0) at Week 12   [ Time Frame: Week 12 ]

23.  Secondary:   Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 ≤ 3.0) at Week 52   [ Time Frame: Week 52 ]

24.  Secondary:   Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12   [ Time Frame: Week 12 ]

25.  Secondary:   Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12   [ Time Frame: Week 12 ]

26.  Secondary:   Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12   [ Time Frame: Week 12 ]

27.  Secondary:   Number of Days With No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12   [ Time Frame: Week 12 ]

28.  Secondary:   Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12   [ Time Frame: Week 12 ]

29.  Secondary:   Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12   [ Time Frame: Week 12 ]

30.  Secondary:   Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12   [ Time Frame: Week 12 ]

31.  Secondary:   Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12   [ Time Frame: Week 12 ]

32.  Secondary:   Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52   [ Time Frame: Week 52 ]

33.  Secondary:   Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52   [ Time Frame: Week 52 ]

34.  Secondary:   Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52   [ Time Frame: Week 52 ]

35.  Secondary:   Number of Days With No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52   [ Time Frame: Week 52 ]

36.  Secondary:   Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52   [ Time Frame: Week 52 ]

37.  Secondary:   Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52   [ Time Frame: Week 52 ]

38.  Secondary:   Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52   [ Time Frame: Week 52 ]

39.  Secondary:   Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52   [ Time Frame: Week 52 ]


  Serious Adverse Events


  Other Adverse Events


  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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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.  


Results Point of Contact:  
Name/Title: (UCB) Study Director
Organization: UCB Clinical Trial Call Center
phone: +1 887 822 9493


No publications provided


Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT01255761     History of Changes
Other Study ID Numbers: RA0064
Study First Received: December 6, 2010
Results First Received: October 7, 2013
Last Updated: March 10, 2014
Health Authority: United States: Food and Drug Administration