Study in Rheumatoid Arthritis for Subjects Who Completed Preceding Study M13-390 With Adalimumab

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01752855
First received: December 17, 2012
Last updated: October 22, 2014
Last verified: October 2014
Results First Received: October 22, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Intervention: Biological: New formulation adalimumab

  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
New Formulation for 48 Weeks New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
Current Formulation for 24 Weeks, New Formulation for 24 Weeks Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week

Participant Flow:   Overall Study
    New Formulation for 48 Weeks     Current Formulation for 24 Weeks, New Formulation for 24 Weeks  
STARTED     44     44  
COMPLETED     43     40  
NOT COMPLETED     1     4  
Adverse Event                 1                 0  
Withdrew Consent                 0                 2  
Lack of Efficacy                 0                 2  



  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.
All participants who received at least 1 dose of study drug

Reporting Groups
  Description
New Formulation for 48 Weeks New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
Current Formulation for 24 Weeks, New Formulation for 24 Weeks Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
Total Total of all reporting groups

Baseline Measures
    New Formulation for 48 Weeks     Current Formulation for 24 Weeks, New Formulation for 24 Weeks     Total  
Number of Participants  
[units: participants]
  44     44     88  
Age  
[units: years]
Mean ± Standard Deviation
  55.7  ± 10.8     52.0  ± 12.0     53.9  ± 11.5  
Gender  
[units: participants]
     
Female     37     37     74  
Male     7     7     14  



  Outcome Measures
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1.  Primary:   Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 36 and 48   [ Time Frame: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48 ]

2.  Primary:   Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 36 and 48   [ Time Frame: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48 ]

3.  Primary:   Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 36 and 48   [ Time Frame: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48 ]

4.  Primary:   Mean Change From Baseline in Health Assessment Questionnaire (HAQ-DI) at Weeks 36 and 48   [ Time Frame: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48 ]

5.  Secondary:   Percentage of Participants Positive for Anti-adalimumab Antibody   [ Time Frame: Week 24 through Week 48 ]


  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


No publications provided


Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01752855     History of Changes
Other Study ID Numbers: M13-692, 2012-003881-42
Study First Received: December 17, 2012
Results First Received: October 22, 2014
Last Updated: October 22, 2014
Health Authority: United States: Food and Drug Administration