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Special Investigation in Patients With Psoriasis Vulgaris and Psoriatic Arthritis (All Patients Investigation)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01155570
First received: June 30, 2010
Last updated: September 30, 2013
Last verified: September 2013
Results First Received: July 23, 2013  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Psoriasis

  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
Ninety-four participants entered this study from study NCT00647400 (M04-702), a Phase III extension study of Humira (adalimumab) in Japan.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 752 participants registered, 4 participants did not have case report forms retrieved (2 whose registration was duplicated and 2 who did not receive Humira). Of the remaining 748 participants, 14 were excluded from analysis (7 changed hospital after registration, 7 didn't visit clinic after the first Humira administration).

Reporting Groups
  Description
Humira Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.

Participant Flow:   Overall Study
    Humira  
STARTED     734 [1]
Efficacy Analysis Population     708 [2]
COMPLETED     592  
NOT COMPLETED     142  
Adverse Event                 39  
Lack of Efficacy                 46  
Participant's Economic Reasons                 17  
No Hospital Visits                 7  
Adverse Event + Lack of Efficacy                 2  
Adverse Event + Other Reasons                 7  
Participant's Economic Reasons + Other                 1  
Other Reasons                 23  
[1] Safety Analysis Population
[2] 5 received Humira off-label, 21 did not receive Humira after the first administration



  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.
Safety Analysis Population

Reporting Groups
  Description
Humira Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.

Baseline Measures
    Humira  
Number of Participants  
[units: participants]
  734  
Age  
[units: years]
Mean ± Standard Deviation
  50.7  ± 13.4  
Gender  
[units: participants]
 
Female     176  
Male     558  
Physician's Global Assessment (PGA) [1]
[units: units on a scale]
Mean ± Standard Deviation
  2.7  ± 5.7  
Psoriasis Area and Severity Index (PASI) [2]
[units: units on a scale]
Mean ± Standard Deviation
  15.7  ± 12.2  
Dermatology Life Quality Index (DLQI) [3]
[units: units on a scale]
Mean ± Standard Deviation
  8.43  ± 6.77  
Pain Visual Analog Scale (VAS) [4]
[units: units on a scale]
Mean ± Standard Deviation
  49.5  ± 30.7  
Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) [5]
[units: units on a scale]
Mean ± Standard Deviation
  4.4  ± 1.7  
Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) [6]
[units: units on a scale]
Mean ± Standard Deviation
  3.5  ± 1.3  
[1] The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories: 0 (Clear); 1 (Minimal); 2 (Mild); 3 (Moderate); 4 (Severe); 5 (Very Severe). PGA was assessed at baseline in 644 participants.
[2] Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions, and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI was assessed at baseline in 625 participants.
[3] Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each question are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. DLQI was assessed at baseline in 280 participants.
[4] Participants assessed their pain due to psoriatic arthritis in the last week, on a a single-line Visual Analogue Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be). VAS was assessed at baseline in 153 participants.
[5] DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0.49 to 9.07. A DAS28-4 score less than 2.6 indicates clinical remission, DAS28-4 2.6 to 3.2 indicates low disease activity, DAS28-4 3.2 to less than 5.1 indicates moderate disease activity, and DAS28-4 of 5.1 or greater indicates high disease activity. DAS28-4 (ESR) was assessed at baseline in 94 participants with psoriatic arthritis.
[6] DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0.49 to 9.07. A DAS28-4 score less than 2.6 indicates clinical remission, DAS28-4 2.6 to 3.2 indicates low disease activity, DAS28-4 3.2 to less than 5.1 indicates moderate disease activity, and DAS28-4 of 5.1 or greater indicates high disease activity. DAS28-4 (CRP) was assessed at baseline in 131 participants with psoriatic arthritis.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs), Deaths, and Discontinuations Due to AEs   [ Time Frame: From study registration through Week 24 ]

2.  Primary:   Physician's Global Assessment at Week 4   [ Time Frame: Week 4 ]

3.  Primary:   Physician's Global Assessment At Week 8   [ Time Frame: Week 8 ]

4.  Primary:   Physician's Global Assessment at Week 16   [ Time Frame: Week 16 ]

5.  Primary:   Physician's Global Assessment at Week 24   [ Time Frame: Week 24 ]

6.  Primary:   Psoriasis Area and Severity Index (PASI) at Week 16   [ Time Frame: Week 16 ]

7.  Primary:   Psoriasis Area and Severity Index (PASI) at Week 24   [ Time Frame: Week 24 ]

8.  Primary:   Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16   [ Time Frame: Baseline and Week 16 ]

9.  Primary:   Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 24   [ Time Frame: Baseline and Week 24 ]

10.  Primary:   Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16   [ Time Frame: Baseline and Week 16 ]

11.  Primary:   Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI90) Response at Week 24   [ Time Frame: Baseline and Week 24 ]

12.  Primary:   Dermatology Life Quality Index at Week 16   [ Time Frame: Week 16 ]

13.  Primary:   Dermatology Life Quality Index at Week 24   [ Time Frame: Week 24 ]

14.  Primary:   Pain Visual Analog Scale (VAS) at Week 4   [ Time Frame: Week 4 ]

15.  Primary:   Pain Visual Analog Scale (VAS) at Week 16   [ Time Frame: Week 16 ]

16.  Primary:   Pain Visual Analog Scale (VAS) at Week 24   [ Time Frame: Week 24 ]

17.  Primary:   Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 4   [ Time Frame: Week 4 ]

18.  Primary:   Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 16   [ Time Frame: Week 16 ]

19.  Primary:   Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 24   [ Time Frame: Week 24 ]

20.  Primary:   Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 4   [ Time Frame: Week 4 ]

21.  Primary:   Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 16   [ Time Frame: Week 16 ]

22.  Primary:   Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 24   [ Time Frame: Week 24 ]

23.  Secondary:   Physician’s Overall Response Rating At Week 24   [ Time Frame: Baseline and Week 24 ]


  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: NCT01155570     History of Changes
Other Study ID Numbers: P12-077
Study First Received: June 30, 2010
Results First Received: July 23, 2013
Last Updated: September 30, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare