A Post-Marketing Observational Study to Evaluate the Effectiveness of Adalimumab in Patients With Moderately to Severely Active Rheumatoid Arthritis in China

This study has been terminated.
(This study was prematurely terminated due to low enrollment)
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01464021
First received: October 31, 2011
Last updated: February 3, 2014
Last verified: February 2014
Results First Received: December 11, 2013  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Arthritis
Rheumatoid

  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
No text entered.

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
Adalimumab Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.

Participant Flow:   Overall Study
    Adalimumab  
STARTED     26  
COMPLETED     0  
NOT COMPLETED     26  
Withdrawal by Subject                 13  
Lost to Follow-up                 1  
Lack of Efficacy                 1  
various                 11  



  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.
No text entered.

Reporting Groups
  Description
Adalimumab Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.

Baseline Measures
    Adalimumab  
Number of Participants  
[units: participants]
  26  
Age  
[units: years]
Mean ± Standard Deviation
  45.0  ± 11.17  
Gender  
[units: participants]
 
Female     21  
Male     5  
Race/Ethnicity, Customized  
[units: participants]
 
Asian     26  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With at Least a Moderate European League Against Rheumatism (EULAR) Response   [ Time Frame: Week 12 ]

2.  Secondary:   Percent Change From Baseline in Disease Activity Score (DAS)28 Erythrocyte Sedimentation Rate (ESR)   [ Time Frame: Weeks 4, 8, 12, 26 ]

3.  Secondary:   Percent Change From Baseline in Tender and Swollen Joint Counts   [ Time Frame: Weeks 4, 8, 12, 26 ]

4.  Secondary:   Percent Change From Baseline in C-reactive Protein   [ Time Frame: Weeks 4, 8, 12, 26 ]

5.  Secondary:   Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)   [ Time Frame: Weeks 4, 8, 12, 26 ]

6.  Secondary:   Percent Change From Baseline in Patient’s Global Assessment of Disease Activity   [ Time Frame: Weeks 4, 8, 12, 26 ]

7.  Secondary:   Percent Change From Baseline in Patient’s Assessment of Pain   [ Time Frame: Weeks 4, 8, 12, 26 ]

8.  Secondary:   Percent Change From Baseline in Physician’s Global Assessment of RA Disease Activity   [ Time Frame: Weeks 4, 8, 12, 26 ]

9.  Secondary:   Percent Change From Baseline in Health Assessment Questionnaire – Disability Index (HAQ-DI)   [ Time Frame: Weeks 4, 8, 12, 26 ]


  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
The study was terminated early due to low enrollment and high drop-out rate. Only serious adverse events and events leading to discontinuation were collected.  


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


No publications provided


Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01464021     History of Changes
Other Study ID Numbers: P13-194
Study First Received: October 31, 2011
Results First Received: December 11, 2013
Last Updated: February 3, 2014
Health Authority: China: Ethics Committee