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Observational Study to Explore the Effectiveness of Adalimumab Treatment in Conjunction With Utilization of a Patient Support Program (PSP) (PASSION)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01383421
First received: June 26, 2011
Last updated: April 10, 2017
Last verified: April 2017
Results First Received: April 10, 2017  
Study Type: Observational
Study Design: Observational Model: Other;   Time Perspective: Other
Condition: Rheumatoid Arthritis

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Participants With RA Receiving Adalimumab

Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.

All participants were offered to participate in the PSP while treated by ADA for their RA.


Participant Flow:   Overall Study
    Participants With RA Receiving Adalimumab
STARTED   1025 [1] 
COMPLETED   679 
NOT COMPLETED   346 
[1] ITT population: all enrolled participants who received at least 1 dose of study drug.



  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.
ITT population: all enrolled participants who received at least 1 dose of study drug.

Reporting Groups
  Description
Participants With RA Receiving Adalimumab

Participants with RA who initiated adalimumab based on current clinical practice criteria (without taking participation in the study into account), with the first dose corresponding to the Enrollment/Baseline visit.

All participants were offered to participate in the PSP while treated by ADA for their RA.


Baseline Measures
   Participants With RA Receiving Adalimumab 
Overall Participants Analyzed 
[Units: Participants]
 1025 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.3  (13.33) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      790  77.1% 
Male      235  22.9% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Achieving a Minimal Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 78   [ Time Frame: Baseline, Week 78 ]

2.  Secondary:   Percentage of Participants Achieving a MCID in the HAQ-DI at Week 12   [ Time Frame: Baseline, Week 12 ]

3.  Secondary:   Percentage of Participants Achieving a MCID in the HAQ-DI at Week 24   [ Time Frame: Baseline, Week 24 ]

4.  Secondary:   Percentage of Participants Achieving a MCID in the HAQ-DI at Week 36   [ Time Frame: Baseline, Week 36 ]

5.  Secondary:   Percentage of Participants Achieving a MCID in the HAQ-DI at Week 52   [ Time Frame: Baseline, Week 52 ]

6.  Secondary:   Percentage of Participants Achieving a MCID in the HAQ-DI at Week 64   [ Time Frame: Baseline, Week 64 ]

7.  Other Pre-specified:   Mean Change From Baseline in With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) at Weeks 24, 52, and 78   [ Time Frame: Baseline and Weeks 24, 52, 78 ]

8.  Other Pre-specified:   Mean Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 24, 52, and 78   [ Time Frame: Baseline, Weeks 24, 52, and 78 ]

9.  Other Pre-specified:   Mean Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 24, 52, and 78   [ Time Frame: Baseline, Weeks 24, 52, and 78 ]

10.  Other Pre-specified:   Percentage of Participants Achieving American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Week 78   [ Time Frame: Week 78 ]

11.  Other Pre-specified:   Percentage of Participants With a Good or Moderate European League Against Rheumatism (EULAR) Response (Using DAS28[ESR] at Week 78   [ Time Frame: Week 78 ]

12.  Other Pre-specified:   Percentage of Participants With a Good or Moderate EULAR Response (Using DAS28[CRP] at Week 78   [ Time Frame: Week 78 ]

13.  Other Pre-specified:   Mean Change From Baseline in Work Productivity and Activity Impairment (WPAI) at Week 24   [ Time Frame: Baseline, Week 24 ]

14.  Other Pre-specified:   Mean Change From Baseline in WPAI at Week 52   [ Time Frame: Baseline, Week 52 ]

15.  Other Pre-specified:   Mean Change From Baseline in WPAI at Week 78   [ Time Frame: Baseline, Week 78 ]

16.  Other Pre-specified:   Mean Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores at Week 24   [ Time Frame: Baseline, Week 24 ]

17.  Other Pre-specified:   Mean Change From Baseline in TSQM Scores at Week 52   [ Time Frame: Baseline, Week 52 ]

18.  Other Pre-specified:   Mean Change From Baseline in TSQM Scores at Week 78   [ Time Frame: Baseline, Week 78 ]

19.  Other Pre-specified:   Mean Change From Baseline in Compliance Questionnaire Rheumatology (CQR) at Weeks 24, 52, and 78   [ Time Frame: Baseline, Week 24, 52, and 78 ]

20.  Other Pre-specified:   Percentage of Participants Who Demonstrated Improvement From Baseline or Who Remained at Level 4 From Baseline on the Patient Activation Measure (PAM-13) at Week 78   [ Time Frame: Baseline, Week 78 ]

21.  Other Pre-specified:   Percentage of Participants Who Started and Remained at Level 4 From Baseline to Week 78 on the PAM-13   [ Time Frame: Baseline, Week 78 ]

22.  Other Pre-specified:   Percentage of Participants Who Started at Level 3 (or Above) at Baseline and Remained at Level 3 or Improved to Level 4 on the PAM-13 at Week 78   [ Time Frame: Baseline, Week 78 ]

23.  Other Pre-specified:   Change From Baseline Means in the Beliefs About Medicines Questionnaire (BMQ) at Week 78   [ Time Frame: Baseline, Week 78 ]

24.  Other Pre-specified:   PSP Satisfaction Questionnaire Responses at Week 12   [ Time Frame: Week 12 ]

25.  Other Pre-specified:   PSP Satisfaction Questionnaire Responses at Week 24   [ Time Frame: Week 24 ]

26.  Other Pre-specified:   PSP Satisfaction Questionnaire Responses at Week 52   [ Time Frame: Week 52 ]

27.  Other Pre-specified:   PSP Satisfaction Questionnaire Responses at Week 78   [ Time Frame: Week 78 ]


  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
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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 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.


Results Point of Contact:  
Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor Abbott)
phone: 800-633-9110



Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01383421     History of Changes
Other Study ID Numbers: P12-072
Study First Received: June 26, 2011
Results First Received: April 10, 2017
Last Updated: April 10, 2017