↑ 薬物リストへ　← 戻る

Gp2017 (adalimumab biosimilar)    (DrugBank: Adalimumab)

16 diseases
告示番号疾患名（ページ内リンク）臨床試験数
19ライソゾーム病0
37膿疱性乾癬（汎発型）0
40高安動脈炎0
41巨細胞性動脈炎0
46悪性関節リウマチ0
56ベーチェット病0
84サルコイドーシス0
96クローン病0
97潰瘍性大腸炎0
151ラスムッセン脳炎0
160先天性魚鱗癬0
164眼皮膚白皮症0
222一次性ネフローゼ症候群0
226間質性膀胱炎（ハンナ型）0
269化膿性無菌性関節炎・壊疽性膿皮症・アクネ症候群0
271強直性脊椎炎14

19. ライソゾーム病　［臨床試験数：784，薬物数：673（DrugBank：101），標的遺伝子数：68，標的パスウェイ数：184］
Searched query = "Lysosomal storage disease", "Lysosomal disease", "Gaucher disease", "Niemann-Pick disease", "Niemann-Pick type C", "GM1-gangliosidosis", "GM1-gangliosidoses", "GM2-gangliosidosis", "GM2-gangliosidoses", "Tay-Sachs disease", "Sandhoff disease", "Krabbe disease", "Metachromatic leukodystrophy", "Multiple-sulfatase deficiency", "Farber disease", "Mucopolysaccharidosis type I", "Mucopolysaccharidosis I", "MPS I", "Hurler syndrome", "Scheie syndrome", "Mucopolysaccharidosis type II", "Mucopolysaccharidosis II", "MPS II", "Hunter syndrome", "Mucopolysaccharidosis type III", "Mucopolysaccharidosis III", "MPS III", "Sanfilippo syndrome", "Mucopolysaccharidosis type IV", "Mucopolysaccharidosis IV", "MPS IV", "MPS IVA", "Morquio syndrome", "Morquio A syndrome", "Mucopolysaccharidosis type VI", "Mucopolysaccharidosis VI", "MPS VI", "Maroteaux-Lamy syndrome", "Mucopolysaccharidosis type VII", "Mucopolysaccharidosis VII", "MPS VII", "Sly syndrome", "Mucopolysaccharidosis type IX", "Mucopolysaccharidosis IX", "MPS IX", "Hyaluronidase deficiency", "Sialidosis", "Galactosialidosis", "Mucolipidosis II", "Mucolipidosis type II", "I-cell disease", "Mucolipidosis III", "Mucolipidosis type III", "Alpha-Mannosidosis", "Alpha-Mannosidase Deficiency", "Beta-Mannosidosis", "Beta-Mannosidase Deficiency", "Fucosidosis", "Aspartylglucosaminuria", "Schindler disease", "Kanzaki disease", "Pompe disease", "Acid lipase deficiency", "Wolman disease", "Cholesterol ester storage disease", "Danon disease", "Free sialic acid storage disease", "Salla disease", "Ceroid lipofuscinosis", "Fabry disease", "Cystinosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: . Trials are sorted by Date_enrollment from most recent to oldest in the table.
0 / 784 trial found

37. 膿疱性乾癬（汎発型）　［臨床試験数：58，薬物数：50（DrugBank：18），標的遺伝子数：17，標的パスウェイ数：96］
Searched query = "Generalised pustular psoriasis", "Pustular psoriasis", "Herpetic impetigo", "Generalization of acrodermatitis continua", "Generalization of dermatitis continua of the extremities"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: . Trials are sorted by Date_enrollment from most recent to oldest in the table.
0 / 58 trial found

40. 高安動脈炎　［臨床試験数：22，薬物数：46（DrugBank：20），標的遺伝子数：22，標的パスウェイ数：111］
Searched query = "Takayasu arteritis", "Aortitis syndrome", "Pulseless disease"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: . Trials are sorted by Date_enrollment from most recent to oldest in the table.
0 / 22 trial found

41. 巨細胞性動脈炎　［臨床試験数：108，薬物数：111（DrugBank：32），標的遺伝子数：33，標的パスウェイ数：121］
Searched query = "Giant cell arteritis", "Temporal arteritis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: . Trials are sorted by Date_enrollment from most recent to oldest in the table.
0 / 108 trial found

46. 悪性関節リウマチ　［臨床試験数：4,183，薬物数：2,538（DrugBank：401），標的遺伝子数：183，標的パスウェイ数：219］
Searched query = "Malignant rheumatoid arthritis", "Rheumatoid arthritis", "Rheumatoid arthritis with vasculitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: . Trials are sorted by Date_enrollment from most recent to oldest in the table.
0 / 4,183 trial found

56. ベーチェット病　［臨床試験数：68，薬物数：87（DrugBank：31），標的遺伝子数：36，標的パスウェイ数：113］
Searched query = "Behcet disease", "Behçet disease"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: . Trials are sorted by Date_enrollment from most recent to oldest in the table.
0 / 68 trial found

84. サルコイドーシス　［臨床試験数：143，薬物数：221（DrugBank：79），標的遺伝子数：82，標的パスウェイ数：165］
Searched query = "Sarcoidosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: . Trials are sorted by Date_enrollment from most recent to oldest in the table.
0 / 143 trial found

96. クローン病　［臨床試験数：2,209，薬物数：1,276（DrugBank：240），標的遺伝子数：166，標的パスウェイ数：210］
Searched query = "Crohn disease", "Terminal ileitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: . Trials are sorted by Date_enrollment from most recent to oldest in the table.
0 / 2,209 trial found

97. 潰瘍性大腸炎　［臨床試験数：2,269，薬物数：1,331（DrugBank：241），標的遺伝子数：114，標的パスウェイ数：181］
Searched query = "Ulcerative colitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: . Trials are sorted by Date_enrollment from most recent to oldest in the table.
0 / 2,269 trial found

151. ラスムッセン脳炎　［臨床試験数：2，薬物数：4（DrugBank：2），標的遺伝子数：6，標的パスウェイ数：84］
Searched query = "Rasmussen encephalitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: . Trials are sorted by Date_enrollment from most recent to oldest in the table.
0 / 2 trial found

160. 先天性魚鱗癬　［臨床試験数：32，薬物数：62（DrugBank：18），標的遺伝子数：15，標的パスウェイ数：107］
Searched query = "Congenital ichthyosis", "Keratinopathic ichthyosis", "Epidermolytic ichthyosis", "Harlequin ichthyosis", "Congenital Ichthyosiform Erythroderma", "Foliate ichthyosis", "Ichthyosis syndrome", "Netherton syndrome", "Sjogren-Larsson syndrome", "Sjögren-Larsson syndrome", "Keratitis-ichtyosis-deafness syndrome", "Dorfman-Chanarin syndrome", "Neutral lipid storage disease", "NLSD", "Multiple sulfatase deficiency", "Austin disease", "Recessive X-linked ichthyosis", "RXLI", "X-linked recessive ichthyosis", "Ichthyosis, brittle hair, impaired intelligence, decreased fertility and short stature", "IBID", "Trichothiodystrophy", "Follicular ichthyosis", "Congenital hemidysplasia, ichthyosiform erythroderma or nevus, and limb defects syndrome", "CHILD syndrome", "Conradi-Hunermann-Happle syndrome", "Conradi-Hünermann-Happle syndrome", "CHHS"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: . Trials are sorted by Date_enrollment from most recent to oldest in the table.
0 / 32 trial found

164. 眼皮膚白皮症　［臨床試験数：15，薬物数：57（DrugBank：34），標的遺伝子数：34，標的パスウェイ数：136］
Searched query = "Oculocutaneous albinism", "Hermansky-Pudlak syndrome", "Chediak-Higashi syndrome", "Griscelli syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: . Trials are sorted by Date_enrollment from most recent to oldest in the table.
0 / 15 trial found

222. 一次性ネフローゼ症候群　［臨床試験数：234，薬物数：241（DrugBank：78），標的遺伝子数：59，標的パスウェイ数：185］
Searched query = "Primary nephrotic syndrome", "Minimal change nephrotic syndrome", "MCNS", "Membranous nephropathy", "Focal segmental glomerulosclerosis", "FSGS", "Membranoproliferative glomerulonephritis", "MPGN"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: . Trials are sorted by Date_enrollment from most recent to oldest in the table.
0 / 234 trial found

226. 間質性膀胱炎（ハンナ型）　［臨床試験数：133，薬物数：151（DrugBank：46），標的遺伝子数：48，標的パスウェイ数：137］
Searched query = "Interstitial cystitis with Hunners ulcer", "Interstitial cystitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: . Trials are sorted by Date_enrollment from most recent to oldest in the table.
0 / 133 trial found

269. 化膿性無菌性関節炎・壊疽性膿皮症・アクネ症候群　［臨床試験数：20，薬物数：26（DrugBank：10），標的遺伝子数：12，標的パスウェイ数：90］
Searched query = "Pyogenic arthritis", "Pyoderma gangrenosum", "Acne syndrome", "PAPA syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: . Trials are sorted by Date_enrollment from most recent to oldest in the table.
0 / 20 trial found

271. 強直性脊椎炎　［臨床試験数：531，薬物数：343（DrugBank：66），標的遺伝子数：41，標的パスウェイ数：141］
Searched query = "Ankylosing spondylitis", "Spondylarthritis ankylopoietica"
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.
14 / 531 trials found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2017-000679-10-GR
(EUCTR)		05/03/201919/12/2018Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Trade Name: COSENTYX
INN or Proposed INN: secukinumab
Other descriptive name: SECUKINUMAB
Trade Name: Hyrimoz
Product Name: adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB		Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		837Phase 3Portugal;United States;Philippines;Taiwan;Slovakia;Greece;Spain;Israel;Chile;Russian Federation;Colombia;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan
2JPRN-JapicCTI-184106
07/11/201811/09/2018Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar) (SURPASS)A Randomized, Partially-blinded Study of Secukinumab to Demonstrate Reduction of Radiographic Progression Versus GP2017 (Adalimumab Biosimilar) at 104 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing Spondylitis Ankylosing SpondylitisIntervention name : Secukinumab
INN of the intervention : Secukinumab
Dosage And administration of the intervention : Secukinumab 150mg or 300mg will be administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100
Control intervention name : GP2017 (adalimumab biosimilar)
INN of the control intervention : Adalimumab
Dosage And administration of the control intervention : GP2017 (adalimumab biosimilar) 40 mg will be administered at Baseline followed by dosing every 2 weeks until Week 102		Novartis Pharma K.K.NULLcomplete18BOTH15Phase 3Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa
3EUCTR2017-000679-10-SK
(EUCTR)		24/10/201802/10/2017Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Trade Name: COSENTYX
INN or Proposed INN: secukinumab
Other descriptive name: SECUKINUMAB
Trade Name: Hyrimoz
Product Name: adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB		Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		837Phase 3Portugal;United States;Philippines;Taiwan;Slovakia;Greece;Spain;Israel;Chile;Russian Federation;Colombia;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan
4EUCTR2017-000679-10-PT
(EUCTR)		16/07/201815/01/2018Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Trade Name: COSENTYX
INN or Proposed INN: secukinumab
Other descriptive name: SECUKINUMAB
Trade Name: Hyrimoz
Product Name: adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB		Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		837Phase 3United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Chile;Israel;Colombia;France;Australia;Denmark;Peru;Netherlands;Korea, Republic of;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan
5EUCTR2017-000679-10-PL
(EUCTR)		19/06/201828/03/2018Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes		837Phase 3Portugal;United States;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Chile;Israel;Colombia;France;Australia;Denmark;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
6EUCTR2017-000679-10-NL
(EUCTR)		07/06/201818/12/2017Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Trade Name: COSENTYX
INN or Proposed INN: secukinumab
Other descriptive name: SECUKINUMAB
Product Name: adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB		Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		837Phase 3Portugal;United States;Philippines;Taiwan;Slovakia;Spain;Russian Federation;Chile;Israel;Colombia;France;Australia;Denmark;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany
7EUCTR2017-000679-10-FR
(EUCTR)		22/01/201822/09/2017Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes		837Phase 3Portugal;United States;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Chile;Israel;Colombia;France;Australia;Denmark;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany
8EUCTR2017-000679-10-CZ
(EUCTR)		10/01/201825/09/2017Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes		837Phase 3Portugal;United States;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Chile;Israel;Colombia;France;Australia;Denmark;Peru;Netherlands;Korea, Republic of;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan
9EUCTR2017-000679-10-FI
(EUCTR)		18/12/201705/10/2017Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes		837Phase 3Portugal;United States;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Chile;Israel;Colombia;France;Australia;Denmark;Peru;Netherlands;Korea, Republic of;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan
10EUCTR2017-000679-10-DE
(EUCTR)		18/12/201724/08/2017Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Trade Name: COSENTYX
INN or Proposed INN: secukinumab
Other descriptive name: SECUKINUMAB
Trade Name: Hyrimoz
Product Name: adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB		Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		837Phase 3United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Israel;Chile;Russian Federation;Colombia;France;Denmark;Australia;Peru;Netherlands;Korea, Republic of;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
11EUCTR2017-000679-10-DK
(EUCTR)		23/11/201725/10/2017Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes		837Phase 3Portugal;United States;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Chile;Israel;Colombia;France;Australia;Denmark;Peru;Netherlands;Korea, Republic of;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan
12EUCTR2017-000679-10-ES
(EUCTR)		23/11/201718/09/2017Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Trade Name: COSENTYX
INN or Proposed INN: secukinumab
Other descriptive name: SECUKINUMAB
Product Name: adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB		Novartis Farmacéutica, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		837Phase 3Portugal;United States;Philippines;Taiwan;Slovakia;Spain;Russian Federation;Chile;Israel;Colombia;France;Australia;Denmark;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany
13EUCTR2017-000679-10-GB
(EUCTR)		16/11/201708/08/2017Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes		837Phase 3Portugal;United States;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Chile;Israel;Colombia;France;Australia;Denmark;Peru;Netherlands;Korea, Republic of;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan
14NCT03259074
(ClinicalTrials.gov)		July 4, 201721/8/2017Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)A Randomized, Partially-blinded Study of Secukinumab to Demonstrate Reduction of Radiographic Progression Versus GP2017 (Adalimumab Biosimilar) at 104 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing SpondylitisAnkylosing SpondylitisBiological: Secukinumab;Biological: GP2017 (adalimumab biosimilar)Novartis PharmaceuticalsNULLActive, not recruiting18 YearsN/AAll860Phase 3United States;Argentina;Australia;Belgium;Canada;Chile;Colombia;Czechia;Denmark;Finland;France;Germany;Greece;Israel;Japan;Korea, Republic of;Mexico;Netherlands;Peru;Philippines;Poland;Portugal;Romania;Russian Federation;Slovakia;Spain;Taiwan;Turkey;United Kingdom;Monaco

先頭へ