DDrare: Database of Drug Development for Rare Diseases

107. 若年性特発性関節炎［全身型若年性特発性関節炎（~2018.3）］
［臨床試験数：151，薬物数：75（DrugBank：13），標的遺伝子数：16，標的パスウェイ数：90］

Searched query = "Juvenile idiopathic arthritis", "Systemic juvenile idiopathic arthritis", "Systemic-onset juvenile idiopathic arthritis", "JIA", "SJIA"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = ACTEMRA; ACZ885; ACZ885 150 mg (Canakinumab); ACZ885 Drug Substance; ACZ885G; ANAKINRA; APD421; Abatacept; Actemra; Actemra, MRA; Anakinra; Anakinra / kineret; BARICITINIB; Baricitinib; CANAKINUMAB; CCP-690-550-10; CP; CP-690,550-10; CSs; Canakinumab; Corticosteroids; EMAPALUMAB; Emapalumab; Fully human anti-interferon gamma monoclonal antibody; Heparin; IL-6 receptor inhibitor, recombinant humanized monoclonal antibody; ILARIS; ITF2357; Ilaris; In double-blind phase: treatment with tofacitinib; In open-label phase: treatment with tofacitinib; Interferon Gamma; KINERET*SC 7SIR 100MG 0,67ML; Kineret; Kineret® or anakinra; LY3009104; Ly3009104; MRA; MRA (Actemra); MRA (tocilizumab); MRA(Tocilizumab); MRA, Actemra; MTX; Methotrexate; NI-0501; NSAIDs; Non-steroidal anti-inflammatory drugs (NSAIDs); Null; Olumiant; Pneumo23; REGN88; RIL-1RA; RO4877533 (TCZ); Recombinant antihumanized anti-human monoclonal antibody directed against the IL-6R; Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class; Rilonacept; Rilonacept (IL-1 Trap); Ro 487-7533/F10-04; RoActemra; Roactemra; SAR153191; SAR153191 (REGN88); SARILUMAB; Sarilumab; Sarilumab SAR153191 (REGN88); TOCILIZUMAB; TOCILIZUMAB SC; TOFACITINIB CITRATE; Tocilizumab; Tocilizumab Roche; Tocilizumab SC; Tocilizumab [RoActemra/Actemra]; Tofacitinib; Tofacitinib citrate; Tofacitinibe citrate

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2017-002018-29-PL (EUCTR)	28/10/2020	09/08/2020	Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA Population	EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (sJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS	Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib citrate Product Code: CP -690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: Tofacitinibe citrate Product Code: CCP-690-550-10 INN or Proposed INN: tofacitinib Other descriptive name: APD421	Pfizer Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100	Phase 3	United States;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;United Kingdom;Italy;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Germany;China
2	NCT03000439 (ClinicalTrials.gov)	May 10, 2018	9/11/2016	A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA	EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS	Arthritis Juvenile Idiopathic	Drug: In open-label phase: treatment with tofacitinib;Drug: In double-blind phase: treatment with tofacitinib or placebo in 1:1 ratio	Pfizer	NULL	Recruiting	2 Years	17 Years	All	100	Phase 3	United States;Argentina;Brazil;Canada;Chile;China;Israel;Mexico;Russian Federation;South Africa;Turkey;Ukraine

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2017-002018-29-PL
(EUCTR)

28/10/2020

09/08/2020

Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA Population

EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (sJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS

Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Tofacitinib citrate
Product Code: CP -690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: Tofacitinibe citrate
Product Code: CCP-690-550-10
INN or Proposed INN: tofacitinib
Other descriptive name: APD421

Pfizer Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Phase 3

United States;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;United Kingdom;Italy;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Germany;China

NCT03000439
(ClinicalTrials.gov)

May 10, 2018

9/11/2016

A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA

EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS

Arthritis Juvenile Idiopathic

Drug: In open-label phase: treatment with tofacitinib;Drug: In double-blind phase: treatment with tofacitinib or placebo in 1:1 ratio

Pfizer

NULL

Recruiting

2 Years

17 Years

All

100

Phase 3

United States;Argentina;Brazil;Canada;Chile;China;Israel;Mexico;Russian Federation;South Africa;Turkey;Ukraine