DDrare: Database of Drug Development for Rare Diseases

Searched query = "Familial mediterranean fever"
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 = 0.9% physiological saline; ACZ885; ACZ885, 150mg/1.0ml; CANAKINUMAB; Canakinumab; Colchicine; Colchicine sprinkle capsules; Diagnostic Test: colchicine level measurement; IL-1 Trap; INN-Tocilizumab; Ilaris; Kineret; One additional blood sample during a planned blood test; Other: Colchicine Cessation; Other: Wheat flour; Probiotic; Rilonacept; RoActemra; RoActemra® 20mg/ml Konzentrat; TOCILIZUMAB; Tocilizumab; Tocilizumab Infusion RoAcemtra (EU); Wheat

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	EUCTR2013-004291-35-NL (EUCTR)	07/10/2014	24/07/2014	Study of efficacy and safety of canakinumab in patients with Hereditary Periodic Fevers	A randomized, double-blind, placebo controlled study of canakinumab in patients with Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF), with subsequent randomized withdrawal/ dosing frequency reduction and open-label long term treatment epochs	Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF) MedDRA version: 19.0;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 19.0;Level: LLT;Classification code 10067783;Term: Tumor necrosis factor receptor-associated periodic syndrome;Classification code 10072010;Term: Hyper IgD syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Trade Name: Ilaris Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	United States;Greece;Finland;Spain;Ireland;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Belgium;Denmark;Netherlands;Germany;Japan
2	EUCTR2013-004291-35-GR (EUCTR)	22/09/2014	22/09/2014	Study of efficacy and safety of canakinumab in patients with Hereditary Periodic Fevers	A randomized, double-blind, placebo controlled study of canakinumab in patients with Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF), with subsequent randomized withdrawal/ dosing frequency reduction and open-label long term treatment epochs	Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF) MedDRA version: 17.0;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 17.0;Level: LLT;Classification code 10067783;Term: Tumor necrosis factor receptor-associated periodic syndrome;Classification code 10072010;Term: Hyper IgD syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB	Novartis Pharma Services AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	180		United States;Greece;Finland;Spain;Ireland;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Belgium;Denmark;Netherlands;Germany;Japan
3	EUCTR2013-004291-35-HU (EUCTR)	09/09/2014	25/06/2014	Study of efficacy and safety of canakinumab in patients with Hereditary Periodic Fevers	A randomized, double-blind, placebo controlled study of canakinumab in patients with Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF), with subsequent randomized withdrawal/ dosing frequency reduction and open-label long term treatment epochs	Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF) MedDRA version: 18.0;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 18.0;Level: LLT;Classification code 10067783;Term: Tumor necrosis factor receptor-associated periodic syndrome;Classification code 10072010;Term: Hyper IgD syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	United States;Greece;Spain;Ireland;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Belgium;Netherlands;Germany;Japan
4	EUCTR2013-004291-35-IE (EUCTR)	14/08/2014	10/04/2014	Study of efficacy and safety of canakinumab in patients with Hereditary Periodic Fevers	A randomized, double-blind, placebo controlled study of canakinumab in patients with Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF), with subsequent randomized withdrawal/ dosing frequency reduction and open-label long term treatment epochs	Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF) MedDRA version: 18.0;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 18.0;Level: LLT;Classification code 10067783;Term: Tumor necrosis factor receptor-associated periodic syndrome;Classification code 10072010;Term: Hyper IgD syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	United States;Greece;Spain;Ireland;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Belgium;Netherlands;Germany;Japan
5	EUCTR2013-004291-35-BE (EUCTR)	20/06/2014	27/05/2014	Study of efficacy and safety of canakinumab in patients with Hereditary Periodic Fevers	A randomized, double-blind, placebo controlled study of canakinumab in patients with Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF), with subsequent randomized withdrawal/ dosing frequency reduction and open-label long term treatment epochs	Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF) MedDRA version: 18.0;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 18.0;Level: LLT;Classification code 10067783;Term: Tumor necrosis factor receptor-associated periodic syndrome;Classification code 10072010;Term: Hyper IgD syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	United States;Greece;Spain;Ireland;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Belgium;Netherlands;Germany;Japan
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
6	EUCTR2013-004291-35-DE (EUCTR)	18/06/2014	14/04/2014	Study of efficacy and safety of canakinumab in patients with Hereditary Periodic Fevers	A randomized, double-blind, placebo controlled study of canakinumab in patients with Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF), with subsequent randomized withdrawal/ dosing frequency reduction and open-label long term treatment epochs	Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF) MedDRA version: 19.0;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 19.0;Level: LLT;Classification code 10067783;Term: Tumor necrosis factor receptor-associated periodic syndrome;Classification code 10072010;Term: Hyper IgD syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Trade Name: Ilaris Product Name: canakinumab Product Code: ACZ885, 150mg/1.0ml INN or Proposed INN: CANAKINUMAB	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	United States;Greece;Spain;Ireland;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Belgium;Netherlands;Germany;Japan
7	EUCTR2013-004291-35-IT (EUCTR)	16/05/2014	20/03/2014	Study of efficacy and safety of canakinumab in patients with Hereditary Periodic Fevers	A randomized, double-blind, placebo controlled study of canakinumab in patients with Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF), with subsequent randomized withdrawal/ dosing frequency reduction and open-label long term treatment epochs	Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF) MedDRA version: 16.1;Level: LLT;Classification code 10067783;Term: Tumor necrosis factor receptor-associated periodic syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 16.1;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;Classification code 10072010;Term: Hyper IgD syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Trade Name: Ilaris Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB	Novartis Farma SpA	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	United States;Greece;Finland;Spain;Ireland;Turkey;Israel;Russian Federation;United Kingdom;Italy;Switzerland;France;Hungary;Canada;Belgium;Denmark;Netherlands;Germany;Japan
8	EUCTR2013-004291-35-ES (EUCTR)	14/05/2014	04/04/2014	Study of efficacy and safety of canakinumab in patients with Hereditary Periodic Fevers	A randomized, double-blind, placebo controlled study of canakinumab in patients with Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF), with subsequent randomized withdrawal/ dosing frequency reduction and open-label long term treatment epochs	Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF) MedDRA version: 16.1;Level: LLT;Classification code 10067783;Term: Tumor necrosis factor receptor-associated periodic syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 16.1;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;Classification code 10072010;Term: Hyper IgD syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Trade Name: Ilaris Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB	Novartis Farmacéutica, S.A.	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	United States;Greece;Finland;Spain;Ireland;Turkey;Israel;Russian Federation;United Kingdom;Italy;Switzerland;France;Hungary;Canada;Belgium;Denmark;Netherlands;Germany;Japan
9	NCT01148797 (ClinicalTrials.gov)	December 2010	21/6/2010	Evaluate the Safety and Efficacy of Canakinumab in Pediatric Patients With Colchicine Intolerant or Colchicine Resistant Familial Mediterranean Fever (FMF)	A 6 Month Phase 2, Multi-Center, Open-label, Single Arm Study to Evaluate the Safety and Efficacy of Treatment With Canakinumab in Pediatric Patients With Colchicine Intolerant or Colchicine Resistant Familial Mediterranean Fever	Colchicine Resistant/Intolerant Familial Mediterranean Fever	Drug: Canakinumab	Novartis Pharmaceuticals	NULL	Completed	4 Years	20 Years	Both	15	Phase 2	Israel
10	NCT01088880 (ClinicalTrials.gov)	April 2010	16/3/2010	Efficacy and Safety of Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever	An Open-label, Exploratory Study to Establish the Safety and Efficacy of 3 Months Treatment With Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever	Familial Mediterranean Fever	Drug: Canakinumab	Novartis Pharmaceuticals	NULL	Completed	12 Years	75 Years	Both	10	Phase 2	Turkey
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
11	EUCTR2015-003527-57-Outside-EU/EEA (EUCTR)		14/04/2016	Efficacy and Safety of Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever	An Open-label, Exploratory Study to Establish the Safety and Efficacy of 3 Months Treatment With Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever	Familial Mediterranean Fever MedDRA version: 19.0;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Trade Name: Ilaris Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB	Novartis Pharmaceuticals	NULL	NA			Female: yes Male: yes	9		Turkey
12	EUCTR2015-003522-13-Outside-EU/EEA (EUCTR)		14/04/2016	Evaluate the Safety and Efficacy of Canakinumab in Pediatric Patients With Colchicine Intolerant or Colchicine Resistant Familial Mediterranean Fever (FMF)	A 6 Month Phase 2, Multi-Center, Open-label, Single Arm Study to Evaluate the Safety and Efficacy of Treatment With Canakinumab in Pediatric Patients With Colchicine Intolerant or Colchicine Resistant Familial Mediterranean Fever	Colchicine Resistant/Intolerant Familial Mediterranean Fever MedDRA version: 19.0;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Trade Name: Ilaris Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB	Novartis Pharmaceuticals	NULL	NA			Female: yes Male: yes	15	Phase 2	Israel
13	EUCTR2017-001678-40-Outside-EU/EEA (EUCTR)		15/05/2017	An extension study of safety of canakinumab in Japanese patients with periodic fever syndromes	An extension study of safety of canakinumab in Japanese patients with periodic fever syndromes	Three disease of periodic fever syndromes, TNF receptor Associated Periodic Syndrome (TRAPS), Hyper IgDSyndrome (HIDS)/ Mevalonate Kinase Deficiency (MKD) and Familial Mediterranean Fever (FMF MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Ilaris INN or Proposed INN: CANAKINUMAB	Novartis pharma AG	NULL	NA			Female: yes Male: yes	4	Phase 3	Japan

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

EUCTR2013-004291-35-NL
(EUCTR)

07/10/2014

24/07/2014

Study of efficacy and safety of canakinumab in patients with Hereditary Periodic Fevers

A randomized, double-blind, placebo controlled study of canakinumab in patients with Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF), with subsequent randomized withdrawal/ dosing frequency reduction and open-label long term treatment epochs

Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF)
MedDRA version: 19.0;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 19.0;Level: LLT;Classification code 10067783;Term: Tumor necrosis factor receptor-associated periodic syndrome;Classification code 10072010;Term: Hyper IgD syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Trade Name: Ilaris
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 3

United States;Greece;Finland;Spain;Ireland;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Belgium;Denmark;Netherlands;Germany;Japan

EUCTR2013-004291-35-GR
(EUCTR)

22/09/2014

Study of efficacy and safety of canakinumab in patients with Hereditary Periodic Fevers

Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF)
MedDRA version: 17.0;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 17.0;Level: LLT;Classification code 10067783;Term: Tumor necrosis factor receptor-associated periodic syndrome;Classification code 10072010;Term: Hyper IgD syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB

Novartis Pharma Services AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

180

United States;Greece;Finland;Spain;Ireland;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Belgium;Denmark;Netherlands;Germany;Japan

EUCTR2013-004291-35-HU
(EUCTR)

09/09/2014

25/06/2014

Study of efficacy and safety of canakinumab in patients with Hereditary Periodic Fevers

Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF)
MedDRA version: 18.0;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 18.0;Level: LLT;Classification code 10067783;Term: Tumor necrosis factor receptor-associated periodic syndrome;Classification code 10072010;Term: Hyper IgD syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 3

United States;Greece;Spain;Ireland;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Belgium;Netherlands;Germany;Japan

EUCTR2013-004291-35-IE
(EUCTR)

14/08/2014

10/04/2014

Study of efficacy and safety of canakinumab in patients with Hereditary Periodic Fevers

Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 3

United States;Greece;Spain;Ireland;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Belgium;Netherlands;Germany;Japan

EUCTR2013-004291-35-BE
(EUCTR)

20/06/2014

27/05/2014

Study of efficacy and safety of canakinumab in patients with Hereditary Periodic Fevers

Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 3

United States;Greece;Spain;Ireland;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Belgium;Netherlands;Germany;Japan

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

EUCTR2013-004291-35-DE
(EUCTR)

18/06/2014

14/04/2014

Study of efficacy and safety of canakinumab in patients with Hereditary Periodic Fevers

Trade Name: Ilaris
Product Name: canakinumab
Product Code: ACZ885, 150mg/1.0ml
INN or Proposed INN: CANAKINUMAB

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 3

United States;Greece;Spain;Ireland;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Belgium;Netherlands;Germany;Japan

EUCTR2013-004291-35-IT
(EUCTR)

16/05/2014

20/03/2014

Study of efficacy and safety of canakinumab in patients with Hereditary Periodic Fevers

Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF)
MedDRA version: 16.1;Level: LLT;Classification code 10067783;Term: Tumor necrosis factor receptor-associated periodic syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 16.1;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;Classification code 10072010;Term: Hyper IgD syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Trade Name: Ilaris
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB

Novartis Farma SpA

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 3

United States;Greece;Finland;Spain;Ireland;Turkey;Israel;Russian Federation;United Kingdom;Italy;Switzerland;France;Hungary;Canada;Belgium;Denmark;Netherlands;Germany;Japan

EUCTR2013-004291-35-ES
(EUCTR)

14/05/2014

04/04/2014

Study of efficacy and safety of canakinumab in patients with Hereditary Periodic Fevers

Trade Name: Ilaris
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB

Novartis Farmacéutica, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 3

United States;Greece;Finland;Spain;Ireland;Turkey;Israel;Russian Federation;United Kingdom;Italy;Switzerland;France;Hungary;Canada;Belgium;Denmark;Netherlands;Germany;Japan

NCT01148797
(ClinicalTrials.gov)

December 2010

21/6/2010

Evaluate the Safety and Efficacy of Canakinumab in Pediatric Patients With Colchicine Intolerant or Colchicine Resistant Familial Mediterranean Fever (FMF)

A 6 Month Phase 2, Multi-Center, Open-label, Single Arm Study to Evaluate the Safety and Efficacy of Treatment With Canakinumab in Pediatric Patients With Colchicine Intolerant or Colchicine Resistant Familial Mediterranean Fever

Colchicine Resistant/Intolerant Familial Mediterranean Fever

Drug: Canakinumab

Novartis Pharmaceuticals

NULL

Completed

4 Years

20 Years

Both

Phase 2

Israel

NCT01088880
(ClinicalTrials.gov)

April 2010

16/3/2010

Efficacy and Safety of Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever

An Open-label, Exploratory Study to Establish the Safety and Efficacy of 3 Months Treatment With Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever

Familial Mediterranean Fever

Drug: Canakinumab

Novartis Pharmaceuticals

NULL

Completed

12 Years

75 Years

Both

Phase 2

Turkey

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

EUCTR2015-003527-57-Outside-EU/EEA
(EUCTR)

14/04/2016

Efficacy and Safety of Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever

An Open-label, Exploratory Study to Establish the Safety and Efficacy of 3 Months Treatment With Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever

Familial Mediterranean Fever
MedDRA version: 19.0;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Trade Name: Ilaris
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB

Novartis Pharmaceuticals

NULL

Female: yes
Male: yes

Turkey

EUCTR2015-003522-13-Outside-EU/EEA
(EUCTR)

14/04/2016

Evaluate the Safety and Efficacy of Canakinumab in Pediatric Patients With Colchicine Intolerant or Colchicine Resistant Familial Mediterranean Fever (FMF)

Colchicine Resistant/Intolerant Familial Mediterranean Fever
MedDRA version: 19.0;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Trade Name: Ilaris
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB

Novartis Pharmaceuticals

NULL

Female: yes
Male: yes

Phase 2

Israel

EUCTR2017-001678-40-Outside-EU/EEA
(EUCTR)

15/05/2017

An extension study of safety of canakinumab in Japanese patients with periodic fever syndromes

Three disease of periodic fever syndromes, TNF receptor Associated Periodic Syndrome (TRAPS), Hyper IgDSyndrome (HIDS)/ Mevalonate Kinase Deficiency (MKD) and Familial Mediterranean Fever (FMF
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Ilaris
INN or Proposed INN: CANAKINUMAB

Novartis pharma AG

NULL

Female: yes
Male: yes

Phase 3

Japan