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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
Enrollment 85

Recruitment Details 85 children with poly JIA within 12 months of onset recruited from pediatric rheumatology clinics at 15 sites
Pre-assignment Details 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.
Arm/Group Title Methotrexate Arm Methotrexate-Prednisolone-Etanercept Arm
Hide Arm/Group Description Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone 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
Period Title: Overall Study
Started 43 42
Completed 39 38
Not Completed 4 4
Reason Not Completed
Lack of Efficacy             3             3
Adverse Event             1             1
Arm/Group Title Methotrexate Arm Methotrexate-Prednisolone-Etanercept Arm Total
Hide Arm/Group Description Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone 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 of all reporting groups
Overall Number of Baseline Participants 43 42 85
Hide Baseline Analysis Population Description
2 patients were ineligible
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 42 participants 85 participants
<=18 years
43
 100.0%
42
 100.0%
85
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 42 participants 85 participants
11.1  (4.1) 9.9  (4.6) 10.5  (4.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 42 participants 85 participants
Female
34
  79.1%
29
  69.0%
63
  74.1%
Male
9
  20.9%
13
  31.0%
22
  25.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 43 participants 42 participants 85 participants
43 42 85
1.Primary Outcome
Title Proportion of Participants Who Attain Inactive Disease by 6 Months
Hide Description [Not Specified]
Time Frame 6 months after initiation of study intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
all participants receiving study medications
Arm/Group Title Methotrexate Arm Methotrexate-Prednisolone-Etanercept Arm
Hide Arm/Group Description:
Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
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
Overall Number of Participants Analyzed 43 42
Measure Type: Number
Unit of Measure: participants
10 17
2.Secondary Outcome
Title Safety Profiles, Including the Number of Treatment-emergent, Serious, or Unexpected Adverse Events and Other Important Medical Events
Hide Description [Not Specified]
Time Frame Over 12 months maximum study participation per subject
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
all participants that received study medications
Arm/Group Title Methotrexate Arm Methotrexate-Prednisolone-Etanercept Arm
Hide Arm/Group Description:
Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
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
Overall Number of Participants Analyzed 43 42
Measure Type: Number
Unit of Measure: events
1 2
3.Secondary Outcome
Title Clinical Remission on Medication
Hide Description 6 months of clinical inactive disease
Time Frame 12 months or end of study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
all participants receiving study medications
Arm/Group Title Methotrexate Arm Methotrexate-Prednisolone-Etanercept Arm
Hide Arm/Group Description:
Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
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
Overall Number of Participants Analyzed 43 42
Measure Type: Number
Unit of Measure: participants
3 9
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Methotrexate Arm Methotrexate-Prednisolone-Etanercept Arm
Hide Arm/Group Description Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone 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
All-Cause Mortality
Methotrexate Arm Methotrexate-Prednisolone-Etanercept Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Methotrexate Arm Methotrexate-Prednisolone-Etanercept Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/43 (2.33%)      2/42 (4.76%)    
Infections and infestations     
pneumonia  1 [1]  0/43 (0.00%)  0 1/42 (2.38%)  1
septic hip  3 [2]  0/43 (0.00%)  0 1/42 (2.38%)  1
Psychiatric disorders     
psychosis  2 [3]  1/43 (2.33%)  1 0/42 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, pneumonia
2
Term from vocabulary, psychosis
3
Term from vocabulary, septic hop
[1]
This participant withdrew from the study, the event resolved without sequelae
[2]
after discontinuation of open label therapy for 2 months, patient was found to have infection of the hip, this resolved. No organism was recovered.
[3]
Participant on open label medications had acute psyhotic event that resolved with tapering of prednisolone. Patient continued in the study.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Methotrexate Arm Methotrexate-Prednisolone-Etanercept Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/43 (0.00%)      3/42 (7.14%)    
Hepatobiliary disorders     
liver function test elevation  1 [1]  0/43 (0.00%)  0 3/42 (7.14%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, abnormal transaminas
[1]
elevation of LFT grade 3
small number of participants with recent onset poly JIA
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
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