Special Investigation (Follow up Survey of the Study of Adalimumab (D2E7)for Prevention of Joint Destruction in Patients With Rheumatoid Arthritis in Japan (M06-859(NCT00870467) (HOPE 3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01163292
First received: July 14, 2010
Last updated: December 11, 2013
Last verified: December 2013
Results First Received: October 18, 2013  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Adalimumab Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
Non-Adalimumab Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)

Participant Flow:   Overall Study
    Adalimumab     Non-Adalimumab  
STARTED     106     114  
COMPLETED     65     92  
NOT COMPLETED     41     22  
Lack of Efficacy                 9                 0  
Adverse Event                 6                 0  
Initiation of biological therapy                 0                 15  
Sufficient response to adalimumab                 8                 0  
Refusal to receive adalimumab                 7                 0  
Economic reasons                 6                 0  
No further visits                 5                 7  



  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 registered

Reporting Groups
  Description
Adalimumab Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
Non-Adalimumab Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
Total Total of all reporting groups

Baseline Measures
    Adalimumab     Non-Adalimumab     Total  
Number of Participants  
[units: participants]
  106     114     220  
Age  
[units: years]
Mean ± Standard Deviation
  56.0  ± 13.0     54.7  ± 12.3     55.3  ± 12.6  
Gender  
[units: participants]
     
Female     87     92     179  
Male     19     22     41  
Body weight  
[units: kg]
Mean ± Standard Deviation
  55.46  ± 8.99     57.53  ± 11.08     56.53  ± 10.16  
Rheumatoid arthritis duration  
[units: years]
Mean ± Standard Deviation
  1.290  ± 0.428     1.316  ± 0.438     1.303  ± 0.433  
Prior Disease Modifying Anti-Rheumatic Drug (except methotrexate)  
[units: participants]
     
Yes     58     51     109  
No     48     63     111  
Concomitant Glucocorticoid Use  
[units: participants]
     
Yes     33     30     63  
No     73     84     157  
Rheumatoid Factor  
[units: participants]
     
Positive     60     71     131  
Negative     46     43     89  
Health Assessment Questionnaire Disability Index (HAQ-DI) [1]
[units: units on a scale]
Mean ± Standard Deviation
  0.29  ± 0.34     0.25  ± 0.33     0.27  ± 0.34  
Disease Activity Score [2]
[units: units on a scale]
Mean ± Standard Deviation
  2.89  ± 1.10     2.74  ± 1.11     2.81  ± 1.11  
Modified Total Sharp Score (mTSS) [3]
[units: units on a scale]
Mean ± Standard Deviation
  15.61  ± 22.19     16.47  ± 22.30     16.05  ± 22.20  
Matrix Metalloprotease (MMP-3) [4]
[units: ng/mL]
Mean ± Standard Deviation
     
Male     149.95  ± 114.81     113.70  ± 135.15     130.50  ± 125.92  
Female     86.94  ± 113.09     88.88  ± 182.09     87.94  ± 152.09  
[1] Participants assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Participants assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3).
[2] The Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient’s global assessment of disease activity, and the erythrocyte sedimentation rate (ESR). DAS 28 (ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity).
[3] Modified Total Sharp Score (mTSS) is a method of assessing radiographs, used in evaluation of inhibition of joint destruction of disease. Digitized X-rays of hands and feet were obtained, then scored in a blinded manner: for erosion (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]). Sum of scores was given as total mTSS (0 [normal] to 380 [maximal disease]).
[4] Matrix metalloprotease level in serum



  Outcome Measures
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1.  Primary:   Disease Activity Score (DAS28)   [ Time Frame: Weeks 0, 26, and 52 ]

2.  Secondary:   Matrix Metalloprotease-3 (MMP-3)   [ Time Frame: Weeks 0, 26, and 52 ]

3.  Secondary:   Modified Total Sharp Score (mTSS) Change From Week 0 to Week 52   [ Time Frame: Week 0 to Week 52 ]

4.  Secondary:   Health Assessment Questionnaire Disability Index (HAQ-DI)   [ Time Frame: Weeks 0, 26, and 52 ]

5.  Secondary:   Number of Participants With Adverse Events (AEs)   [ Time Frame: Week 0 to 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: 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: NCT01163292     History of Changes
Other Study ID Numbers: P12-069
Study First Received: July 14, 2010
Results First Received: October 18, 2013
Last Updated: December 11, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare