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A Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects With Enthesitis Related Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01166282
First received: July 19, 2010
Last updated: June 24, 2016
Last verified: June 2016
Results First Received: May 12, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Enthesitis Related Arthritis (ERA)
Interventions: Biological: adalimumab
Biological: placebo for 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
The study included a 30-day screening period.

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
Double-blind Placebo EOW Placebo for adalimumab every other week (eow) for 12 weeks.
Double-blind Adalimumab EOW Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
Open-label Adalimumab EOW Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for up to 192 weeks.

Participant Flow for 2 periods

Period 1:   Double-blind Period
    Double-blind Placebo EOW     Double-blind Adalimumab EOW     Open-label Adalimumab EOW  
STARTED     15     31     0  
COMPLETED     15     31     0  
NOT COMPLETED     0     0     0  

Period 2:   Open-label Period
    Double-blind Placebo EOW     Double-blind Adalimumab EOW     Open-label Adalimumab EOW  
STARTED     0     0     46  
COMPLETED     0     0     29  
NOT COMPLETED     0     0     17  
Adverse Event                 0                 0                 6  
Withdrawal by Subject                 0                 0                 4  
Lack of Efficacy                 0                 0                 2  
Remission                 0                 0                 4  
Irregular Compliance                 0                 0                 1  



  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.
Intent-to-treat (ITT) population: All randomized participants who received at least 1 dose of study drug.

Reporting Groups
  Description
Double-blind Placebo EOW Placebo for adalimumab every other week (eow) for 12 weeks.
Double-blind Adalimumab EOW Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
Total Total of all reporting groups

Baseline Measures
    Double-blind Placebo EOW     Double-blind Adalimumab EOW     Total  
Number of Participants  
[units: participants]
  15     31     46  
Age  
[units: years]
Mean (Standard Deviation)
  11.9  (2.85)     13.4  (2.86)     12.9  (2.92)  
Gender  
[units: participants]
     
Female     6     9     15  
Male     9     22     31  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Change in Number of Active Joints With Arthritis From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

2.  Secondary:   Number of Sites of Enthesitis: Change From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

3.  Secondary:   Tender Joint Count (TJC72): Change From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

4.  Secondary:   Swollen Joint Count (SJC68): Change From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

5.  Secondary:   Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 30% Response (ACR Pedi30)   [ Time Frame: Baseline and Week 12 ]

6.  Secondary:   Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 50% Response (ACR Pedi50)   [ Time Frame: Baseline and Week 12 ]

7.  Secondary:   Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 70% Response (ACR Pedi70)   [ Time Frame: Baseline and Week 12 ]

8.  Secondary:   Number of Participants With Adverse Events (AEs)   [ Time Frame: Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks) ]


  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 Information
Organization: AbbVie
phone: 800-633-9110


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01166282     History of Changes
Other Study ID Numbers: M11-328
2009-017938-46 ( EudraCT Number )
Study First Received: July 19, 2010
Results First Received: May 12, 2016
Last Updated: June 24, 2016
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Canada: Health Canada
Mexico: Ministry of Health
Poland: The Central Register of Clinical Trials
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Switzerland: Swissmedic
Sweden: Medical Products Agency
Italy: The Italian Medicines Agency
Germany: Paul-Ehrlich-Institut
Ireland: Irish Medicines Board
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)