Hyrimoz ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
271強直性脊椎炎9

271. 強直性脊椎炎


臨床試験数 : 563 薬物数 : 372 - (DrugBank : 72) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 145
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)
05/03/201919/12/2018A 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 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 AGNULLNot RecruitingFemale: yes
Male: yes
837Phase 3United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Chile;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
2EUCTR2017-000679-10-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 AGNULLNot RecruitingFemale: yes
Male: yes
837Phase 3United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Chile;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
3EUCTR2017-000679-10-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 3Portugal;United States;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Chile;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-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]
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 AGNULLNot RecruitingFemale: yes
Male: yes
837Phase 3United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan
5EUCTR2017-000679-10-NL
(EUCTR)
07/06/201818/12/2017A 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 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 AGNULLNot RecruitingFemale: yes
Male: yes
837Phase 3United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Chile;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
6EUCTR2017-000679-10-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]
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 AGNULLNot RecruitingFemale: 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
7EUCTR2017-000679-10-FI
(EUCTR)
18/12/201705/10/2017A 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 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 AGNULLNot RecruitingFemale: yes
Male: yes
837Phase 3United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Chile;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
8EUCTR2017-000679-10-DE
(EUCTR)
18/12/201724/08/2017A 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 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 AGNULLNot RecruitingFemale: yes
Male: yes
837Phase 3United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Chile;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
9EUCTR2017-000679-10-DK
(EUCTR)
23/11/201725/10/2017A 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 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 AGNULLNot RecruitingFemale: yes
Male: yes
837Phase 3United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Chile;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