Trial Outcomes & Findings for Trial of Early Aggressive Drug Therapy in Juvenile Idiopathic Arthritis (NCT NCT00443430)

NCT ID: NCT00443430

Last Updated: 2013-05-31

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 85 participants
• Primary outcome timeframe: 6 months after initiation of study intervention
• Results posted on: 2013-05-31

Participant Flow

85 children with poly JIA within 12 months of onset recruited from pediatric rheumatology clinics at 15 sites

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.

Participant milestones

Measure	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
Overall Study STARTED	43	42
Overall Study COMPLETED	39	38
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Measure	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
Overall Study Lack of Efficacy	3	3
Overall Study Adverse Event	1	1

Baseline Characteristics

Trial of Early Aggressive Drug Therapy in Juvenile Idiopathic Arthritis

Baseline characteristics by cohort

Measure	Methotrexate Arm n=43 Participants Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone	Methotrexate-Prednisolone-Etanercept Arm n=42 Participants 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 n=85 Participants Total of all reporting groups
Age, Categorical <=18 years	43 Participants n=5 Participants	42 Participants n=7 Participants	85 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	11.1 years STANDARD_DEVIATION 4.1 • n=5 Participants	9.9 years STANDARD_DEVIATION 4.6 • n=7 Participants	10.5 years STANDARD_DEVIATION 4.3 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	29 Participants n=7 Participants	63 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	13 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment United States	43 participants n=5 Participants	42 participants n=7 Participants	85 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months after initiation of study intervention

Population: all participants receiving study medications

Outcome measures

Measure	Methotrexate Arm n=43 Participants Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone	Methotrexate-Prednisolone-Etanercept Arm n=42 Participants 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
Proportion of Participants Who Attain Inactive Disease by 6 Months	10 participants	17 participants

SECONDARY outcome

Timeframe: Over 12 months maximum study participation per subject

Population: all participants that received study medications

Outcome measures

Measure	Methotrexate Arm n=43 Participants Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone	Methotrexate-Prednisolone-Etanercept Arm n=42 Participants 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
Safety Profiles, Including the Number of Treatment-emergent, Serious, or Unexpected Adverse Events and Other Important Medical Events	1 events	2 events

SECONDARY outcome

Timeframe: 12 months or end of study

Population: all participants receiving study medications

6 months of clinical inactive disease

Outcome measures

Measure	Methotrexate Arm n=43 Participants Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone	Methotrexate-Prednisolone-Etanercept Arm n=42 Participants 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
Clinical Remission on Medication	3 participants	9 participants

Adverse Events

Methotrexate Arm

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Methotrexate-Prednisolone-Etanercept Arm

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Methotrexate Arm n=43 participants at risk Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone	Methotrexate-Prednisolone-Etanercept Arm n=42 participants at risk 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
Infections and infestations pneumonia	0.00% 0/43	2.4% 1/42 • Number of events 1
Psychiatric disorders psychosis	2.3% 1/43 • Number of events 1	0.00% 0/42
Infections and infestations septic hip	0.00% 0/43	2.4% 1/42 • Number of events 1

Other adverse events

Measure	Methotrexate Arm n=43 participants at risk Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone	Methotrexate-Prednisolone-Etanercept Arm n=42 participants at risk 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
Hepatobiliary disorders liver function test elevation	0.00% 0/43	7.1% 3/42 • Number of events 3

Additional Information

Carol Wallace, MD Principal Investigator

University of Washington and Seattle Children's Hospital

Phone: 206-987-2057

Email: cwallace@u.washington.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place