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Trial of Early Aggressive Drug Therapy in Juvenile Idiopathic Arthritis

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ClinicalTrials.gov Identifier: NCT00443430
Recruitment Status : Completed
First Posted : March 6, 2007
Results First Posted : May 31, 2013
Last Update Posted : May 31, 2013
Sponsor:
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Amgen
Information provided by (Responsible Party):
Carol Wallace, Seattle Children's Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: Juvenile Chronic Polyarthritis
Juvenile Idiopathic Arthritis
Juvenile Rheumatoid Arthritis
Interventions: Drug: methotrexate
Drug: methotrexate - etanercept - prednisolone arm

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
85 children with poly JIA within 12 months of onset recruited from pediatric rheumatology clinics at 15 sites

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible patients were permitted to have received up to 2 intra-articular corticosteroid injections before or up to 2 weeks after baseline; and oral prednisolone for up to 4 weeks, but must have been off corticosteroids for at least 1 week prior to enrollment. Patients with past or current JIA-associated uveitis were excluded.

Reporting Groups
  Description
Methotrexate Arm Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
Methotrexate-Prednisolone-Etanercept Arm Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks

Participant Flow:   Overall Study
    Methotrexate Arm   Methotrexate-Prednisolone-Etanercept Arm
STARTED   43   42 
COMPLETED   39   38 
NOT COMPLETED   4   4 
Lack of Efficacy                3                3 
Adverse Event                1                1 



  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.
2 patients were ineligible

Reporting Groups
  Description
Methotrexate Arm Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
Methotrexate-Prednisolone-Etanercept Arm Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks
Total Total of all reporting groups

Baseline Measures
   Methotrexate Arm   Methotrexate-Prednisolone-Etanercept Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 43   42   85 
Age 
[Units: Participants]
     
<=18 years   43   42   85 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 11.1  (4.1)   9.9  (4.6)   10.5  (4.3) 
Gender 
[Units: Participants]
     
Female   34   29   63 
Male   9   13   22 
Region of Enrollment 
[Units: Participants]
     
United States   43   42   85 


  Outcome Measures

1.  Primary:   Proportion of Participants Who Attain Inactive Disease by 6 Months   [ Time Frame: 6 months after initiation of study intervention ]

2.  Secondary:   Safety Profiles, Including the Number of Treatment-emergent, Serious, or Unexpected Adverse Events and Other Important Medical Events   [ Time Frame: Over 12 months maximum study participation per subject ]

3.  Secondary:   Clinical Remission on Medication   [ Time Frame: 12 months or end of study ]


  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
small number of participants with recent onset poly JIA


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Carol Wallace, MD Principal Investigator
Organization: University of Washington and Seattle Children's Hospital
phone: 206-987-2057
e-mail: cwallace@u.washington.edu


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

Responsible Party: Carol Wallace, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT00443430     History of Changes
Other Study ID Numbers: R01AR049762 ( U.S. NIH Grant/Contract )
5R01AR049762-02 ( U.S. NIH Grant/Contract )
First Submitted: March 2, 2007
First Posted: March 6, 2007
Results First Submitted: March 13, 2013
Results First Posted: May 31, 2013
Last Update Posted: May 31, 2013