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Efficacy and Safety of Adalimumab in Patients With Rheumatoid Arthritis in Routine Clinical Practice

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ClinicalTrials.gov Identifier: NCT01077258
Recruitment Status : Completed
First Posted : March 1, 2010
Results First Posted : April 8, 2014
Last Update Posted : April 25, 2014
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Rheumatoid Arthritis

  Participant Flow

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
Rheumatoid Arthritis Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.

Participant Flow:   Overall Study
    Rheumatoid Arthritis
STARTED   4208 
COMPLETED   1640 
NOT COMPLETED   2568 
Lost to Follow-up                1390 
Adverse drug reaction                218 
Lack of Efficacy                663 
Clinical remission                37 
Other reasons                260 



  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.
No text entered.

Reporting Groups
  Description
Rheumatoid Arthritis Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.

Baseline Measures
   Rheumatoid Arthritis 
Overall Participants Analyzed 
[Units: Participants]
 		 4208 
Age [1] 
[Units: Years]
Mean (Standard Deviation) 		 54.6  (13.2) 
[1] Age data was available for 4147 participants
Gender [1] 
[Units: Participants]
 		 
Female   3199 
Male   958 
[1] Gender data available for 4157 participants
Region of Enrollment 
[Units: Participants]
 		 
Germany   4208 


  Outcome Measures

1.  Primary:   Change From Baseline in Disease Activity Score (DAS) 28   [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ]
  Show Outcome Measure 1

2.  Primary:   Percentage of Participants in DAS28 Remission   [ Time Frame: Months 3, 6, 9, 12, 18, and 24 ]
  Show Outcome Measure 2

3.  Secondary:   Percentage of Participants With a Significant Therapeutic Response   [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ]
  Show Outcome Measure 3

4.  Secondary:   Percentage of Participants With Low, Moderate and High Disease Activity   [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ]
  Show Outcome Measure 4

5.  Secondary:   Erythrocyte Sedimentation Rate (ESR) Over Time   [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ]
  Show Outcome Measure 5

6.  Secondary:   C-Reactive Protein (CRP) Levels Over Time   [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ]
  Show Outcome Measure 6

7.  Secondary:   Tender Joint Count (TJC) Over Time   [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ]
  Show Outcome Measure 7

8.  Secondary:   Swollen Joint Count (SJC) Over Time   [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ]
  Show Outcome Measure 8

9.  Secondary:   Hannover Functional Questionnaire (FFbH) Over Time   [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ]
  Show Outcome Measure 9

10.  Secondary:   Patients Global Assessment of Disease Activity Over Time   [ Time Frame: Baseline and Months 3, 6, 9, 12, 18 and 24 ]
  Show Outcome Measure 10

11.  Secondary:   Participants Assessment of Fatigue Over Time   [ Time Frame: Baseline and Month 3, 6, 9, 12, 18, and 24 ]
  Show Outcome Measure 11

12.  Secondary:   Participants Assessment of Pain Over Time   [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ]
  Show Outcome Measure 12

13.  Secondary:   Percentage of Participants With Impairment in Daily Activities   [ Time Frame: Baseline and Months 3, 6, 9, 18, and 24 ]
  Show Outcome Measure 13

14.  Secondary:   Number of Days Missed From Work Due to Rheumatoid Arthritis   [ Time Frame: Baseline and Months 6, 12, 18, and 24 ]
  Show Outcome Measure 14

15.  Secondary:   Percentage of Participants With In-patient Hospitalization   [ Time Frame: Month 6, 12, 18, and 24 ]
  Show Outcome Measure 15

16.  Secondary:   Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication   [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ]
  Show Outcome Measure 16


  Serious Adverse Events


  Other Adverse Events


  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
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  More Information

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: NCT01077258     History of Changes
Other Study ID Numbers: P10-448
First Submitted: February 25, 2010
First Posted: March 1, 2010
Results First Submitted: February 28, 2014
Results First Posted: April 8, 2014
Last Update Posted: April 25, 2014