Trial Outcomes & Findings for Surveillance of Humira in Korean JIA Patients (NCT NCT02141984)

Results Overview

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either related, possible, probably not, not related, or unassessable. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above.

Recruitment status

COMPLETED

Target enrollment

28 participants

Primary outcome timeframe

Adverse Events (AEs) were collected from informed consent to within 70 days following the last scheduled administration of Humira (up to 22 weeks)

Results posted on

2017-06-23

Participant Flow

A total of 600 participants were expected to enroll in the study; however, due to low prevalence of JIA and ERA, only 28 participants were enrolled.

Participant milestones

Participant milestones
Measure	Patients With Polyarticular JIA or ERA Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA)
Overall Study STARTED	28
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients With Polyarticular JIA or ERA Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA)
Overall Study Lack of Efficacy	2

Baseline Characteristics

Surveillance of Humira in Korean JIA Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Polyarticular JIA or ERA n=28 Participants Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA)
Age, Continuous	17.68 years STANDARD_DEVIATION 5.69 • n=99 Participants
Sex: Female, Male Female	14 Participants n=99 Participants
Sex: Female, Male Male	14 Participants n=99 Participants

PRIMARY outcome

Timeframe: Adverse Events (AEs) were collected from informed consent to within 70 days following the last scheduled administration of Humira (up to 22 weeks)

Population: Safety analysis set: All participants who received at least one administration of Humira during the study (after informed consent or first administration of Humira) and for 70 days following the last scheduled administration of Humira.

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either related, possible, probably not, not related, or unassessable. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above.

Outcome measures

Outcome measures
Measure	Patients With Polyarticular JIA or ERA n=28 Participants Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA)
Number of Participants With Adverse Events Any AE	6 participants
Number of Participants With Adverse Events Unexpected AE	1 participants
Number of Participants With Adverse Events Any SAE	1 participants

SECONDARY outcome

Timeframe: From the first administration (Day 1) to approximately 12 weeks (±4 weeks)

Population: Effectiveness analysis set: All participants who have been administered Humira for not less than 12 (± 4) weeks or more and for whom effectiveness evaluation parameters have been recorded including active joint count as well as Physician global assessment and Parent's global assessment at baseline and 12 weeks.

Active Joint Count will be assessed and collected by participating investigators in routine medical practice. Sixty-eight joints were assessed by physical examination. Active joints are defined as joints with positive results for tenderness, swelling, pain on passive motion, or limitation of passive motion. Higher scores represent higher disease activity.

Outcome measures

Outcome measures
Measure	Patients With Polyarticular JIA or ERA n=19 Participants Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA)
Changes in Active Joint Count From Baseline and 12 Weeks Post-Treatment	-6.05 active joint Standard Deviation 6.65

SECONDARY outcome

Timeframe: From the first administration (Day 1) to approximately 12 weeks (±4 weeks)

Population: Effectiveness analysis set: All participants who have been administered Humira for not less than 12 (± 4) weeks or more and for whom effectiveness evaluation parameters have been recorded including active joint count as well as Physician global assessment and Parent's global assessment at baseline and 12 weeks.

The Physician's global assessment of the disease assessment was evaluated as 'Improved,' 'Not changed,' 'Aggravated,' or 'Not assessable.'

Outcome measures

Outcome measures
Measure	Patients With Polyarticular JIA or ERA n=19 Participants Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA)
Physician's Global Assessment of the Disease Improved	18 participants
Physician's Global Assessment of the Disease Not changed	1 participants
Physician's Global Assessment of the Disease Aggravated	0 participants
Physician's Global Assessment of the Disease Not assessable	0 participants

SECONDARY outcome

Timeframe: From the first administration (Day 1) to approximately 12 weeks (±4 weeks)

Population: Effectiveness analysis set: All participants who have been administered Humira for not less than 12 (± 4) weeks or more and for whom effectiveness evaluation parameters have been recorded including active joint count as well as Physician global assessment and Parent's global assessment at baseline and 12 weeks.

Parent's global assessment for effectiveness was evaluated as 'Improved,' 'Not changed,' 'Aggravated,' or 'Not assessable.'

Outcome measures

Outcome measures
Measure	Patients With Polyarticular JIA or ERA n=19 Participants Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA)
Parent's Global Assessment for Effectiveness Improved	19 Participants
Parent's Global Assessment for Effectiveness Not changed	0 Participants
Parent's Global Assessment for Effectiveness Aggravated	0 Participants
Parent's Global Assessment for Effectiveness Not assessable	0 Participants

Adverse Events

Patients With Polyarticular JIA or ERA

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Patients With Polyarticular JIA or ERA n=28 participants at risk Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA)
Skin and subcutaneous tissue disorders Erythema	3.6% 1/28 • Adverse Events (AEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 22 weeks); SAEs were collected from the time informed consent was obtained (22 weeks).

Other adverse events

Other adverse events
Measure	Patients With Polyarticular JIA or ERA n=28 participants at risk Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA)
Infections and infestations Influenza	10.7% 3/28 • Adverse Events (AEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 22 weeks); SAEs were collected from the time informed consent was obtained (22 weeks).
Musculoskeletal and connective tissue disorders Back pain	3.6% 1/28 • Adverse Events (AEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 22 weeks); SAEs were collected from the time informed consent was obtained (22 weeks).
Musculoskeletal and connective tissue disorders Joint Swelling	3.6% 1/28 • Adverse Events (AEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 22 weeks); SAEs were collected from the time informed consent was obtained (22 weeks).
Skin and subcutaneous tissue disorders Urticaria	3.6% 1/28 • Adverse Events (AEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 22 weeks); SAEs were collected from the time informed consent was obtained (22 weeks).
General disorders Pyrexia	3.6% 1/28 • Adverse Events (AEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 22 weeks); SAEs were collected from the time informed consent was obtained (22 weeks).

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Results disclosure agreements

Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
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Restriction type: OTHER