Trial · NCT00534495

Safety and Effectiveness of Rilonacept for Treating Systemic Juvenile Idiopathic Arthritis in Children and Young Adults

NCT00534495, Phase 2, Completed, Montefiore Medical Center; results first posted 2015-12-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Effectiveness of Rilonacept for Treating Systemic Juvenile Idiopathic Arthritis in Children and Young Adults. Trials, record NCT00534495. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00534495

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Effectiveness of Rilonacept for Treating Systemic Juvenile Idiopathic Arthritis in Children and Young Adults
NCT number: NCT00534495
Status: Completed
Phases: Phase 2
Enrollment: 71 participants, actual
Lead sponsor: Montefiore Medical Center
Conditions: Juvenile Idiopathic Arthritis
Interventions: Rilonacept
First posted: 2007-09-26
Last updated: 2015-12-11
Results first posted: 2015-12-11

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Time to Response to Treatment, as Determined by a Modified JIA ACR30 Requiring no Fever, Coupled With a Requirement for Corticosteroid Taper in Participants Who Are Taking Corticosteroids	At Week 12
Primary	Number of Serious Adverse Events,Adverse Events, Infections, Development of MAS	At Weeks 0- 24
Secondary	Number of Participants With Response as Determined by JIA ACR50 and JIA ACR70	At Week 4 and week 12
Secondary	Pediatric Quality of Life Inventory	At Weeks 4, 12 and 24	Visual Analog Score (0-100 mm) 0 very well , 100 very poor
Secondary	Physical Function as Determined by Childhood Health Assessment Questionnaire ( CHAQ)	At Weeks 12 and 24	Childhood Health Assesment Questionairre dissability index (C-HAQ)-DI, Disability Index Calculation: The index is calculated by adding the scores for each of the categories and dividing by the number of categories answered. This gives a score in the 0 to 3.0 range. lower is better
Secondary	Number of Participants With Presence of Systemic Features ( Fever, Rash)	At Weeks 4, 12 and 24

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Time to Response to Treatment, as Determined by a Modified JIA ACR30 Requiring no Fever, Coupled With a Requirement for Corticosteroid Taper in Participants Who Are Taking Corticosteroids	At Week 12		weeks	MEDIAN
SECONDARY	Number of Participants With Response as Determined by JIA ACR50 and JIA ACR70	At Week 4 and week 12	Participants in the study at week 4 (rilonacept 35 and placebo 33).Participants in the study at week 12 ( Rilonacept 33 and placebo 29).	participants	NUMBER
SECONDARY	Pediatric Quality of Life Inventory	At Weeks 4, 12 and 24	At Week 4 ,36 Rilonacept and 34 Placebo patient. At week 12, Rilonacept 33 patients and Placebo 29.At baseline Rilonacept 36 and Placebo 35 participants.	units on a scale	MEDIAN
SECONDARY	Physical Function as Determined by Childhood Health Assessment Questionnaire ( CHAQ)	At Weeks 12 and 24	36 Rilonacept and 35 placebo at baseline , 36 Rilonacept and 34 placebo at week 4, 33 Rilonacept and 29 placebo at week 12, and 57 combined at week 24.	units on a scale	MEDIAN
SECONDARY	Number of Participants With Presence of Systemic Features ( Fever, Rash)	At Weeks 4, 12 and 24	At week 4 ,Rilonacept 36 and Placebo 34 participants , at week 12 , Rilonacept 33 and 29 Placebo participants , and at week 24 combined group with 57 participants, at baseline Rilonacept 36 and Placebo 35 participants.	participants	NUMBER
PRIMARY	Number of Serious Adverse Events,Adverse Events, Infections, Development of MAS	At Weeks 0- 24		events	NUMBER

Source ClinicalTrials.gov

Results by group70

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Time to Response to Treatment, as Determined by a Modified JIA ACR30 Requiring no Fever, Coupled With a Requirement for Corticosteroid Taper in Participants Who Are Taking Corticosteroids	Rilonacept		4	Inter-Quartile Range 2 to 10	weeks
Time to Response to Treatment, as Determined by a Modified JIA ACR30 Requiring no Fever, Coupled With a Requirement for Corticosteroid Taper in Participants Who Are Taking Corticosteroids	Placebo		8	Inter-Quartile Range 6 to NA	weeks
Number of Participants With Response as Determined by JIA ACR50 and JIA ACR70	Rilonacept	week 4 ,ACR 50	21		participants
Number of Participants With Response as Determined by JIA ACR50 and JIA ACR70	Placebo	week 4 ,ACR 50	10		participants
Number of Participants With Response as Determined by JIA ACR50 and JIA ACR70	Rilonacept	week 12, ACR 50	26		participants
Number of Participants With Response as Determined by JIA ACR50 and JIA ACR70	Placebo	week 12, ACR 50	13		participants
Number of Participants With Response as Determined by JIA ACR50 and JIA ACR70	Rilonacept	week 4 ,ACR 70	21		participants
Number of Participants With Response as Determined by JIA ACR50 and JIA ACR70	Placebo	week 4 ,ACR 70	10		participants
Number of Participants With Response as Determined by JIA ACR50 and JIA ACR70	Rilonacept	week 12,ACR 70	28		participants
Number of Participants With Response as Determined by JIA ACR50 and JIA ACR70	Placebo	week 12,ACR 70	19		participants

1 to 10 of 70Source ClinicalTrials.gov

See all 70 results by group

Participant flow27

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Double Blind Placebo Phase Week 0-4	STARTED	Rilonacept	36
Double Blind Placebo Phase Week 0-4	STARTED	Placebo	35
Double Blind Placebo Phase Week 0-4	STARTED	Long Term Extension All Participants	0
Double Blind Placebo Phase Week 0-4	COMPLETED	Rilonacept	36
Double Blind Placebo Phase Week 0-4	COMPLETED	Placebo	34
Double Blind Placebo Phase Week 0-4	COMPLETED	Long Term Extension All Participants	0
Double Blind Placebo Phase Week 0-4	NOT COMPLETED	Rilonacept	0
Double Blind Placebo Phase Week 0-4	NOT COMPLETED	Placebo	1
Double Blind Placebo Phase Week 0-4	NOT COMPLETED	Long Term Extension All Participants	0
All Active Treatment Phase Week 4-24	STARTED	Rilonacept	36

1 to 10 of 27Source ClinicalTrials.gov

See all 27 participant flow

Adverse events190

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal pain ,upper	Gastrointestinal disorders	Rilonacept Week (0-4)	1	36
other	Abdominal pain ,upper	Gastrointestinal disorders	Placebo Week (0-4)	2	35
other	Abdominal pain ,upper	Gastrointestinal disorders	Rilonacept Week (4-24)	3	35
other	Abdominal pain ,upper	Gastrointestinal disorders	Placebo Week (4-24)	1	33
other	Abdominal pain ,upper	Gastrointestinal disorders	Long Term Extension 24 Weeks to 21 Months	0	40
other	Arthralgia	Musculoskeletal and connective tissue disorders	Rilonacept Week (0-4)	0	36
other	Arthralgia	Musculoskeletal and connective tissue disorders	Placebo Week (0-4)	1	35
other	Arthralgia	Musculoskeletal and connective tissue disorders	Rilonacept Week (4-24)	2	35
other	Arthralgia	Musculoskeletal and connective tissue disorders	Placebo Week (4-24)	6	33
other	Arthralgia	Musculoskeletal and connective tissue disorders	Long Term Extension 24 Weeks to 21 Months	1	40

1 to 10 of 190Source ClinicalTrials.gov

See all 190 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Rilonacept Week (0-4)
Total, all-cause mortality	Placebo Week (0-4)
Total, all-cause mortality	Rilonacept Week (4-24)
Total, all-cause mortality	Placebo Week (4-24)
Total, all-cause mortality	Long Term Extension 24 Weeks to 21 Months
Total, other adverse events	Rilonacept Week (0-4)	9	36
Total, other adverse events	Placebo Week (0-4)	19	35
Total, other adverse events	Rilonacept Week (4-24)	27	35
Total, other adverse events	Placebo Week (4-24)	28	33
Total, other adverse events	Long Term Extension 24 Weeks to 21 Months	28	40

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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