271. 強直性脊椎炎 Ankylosing spondylitis Clinical trials / Disease details


臨床試験数 : 574 薬物数 : 359 - (DrugBank : 68) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 146

  
80 trials found
No.TrialIDDate_
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PhaseCountries
1NCT05527444
(ClinicalTrials.gov)
March 15, 20226/5/2022The Clinical Efficacy and the Changes of Immune Cells Subsets With Bioagents in Ankylosing Spondylitis PatientsThe Clinical Efficacy and the Changes of Immune Cells Subsets With Bioagents in Ankylosing Spondylitis PatientsAnkylosing SpondylitisDrug: Secukinumab 150 mg/ml;Drug: Adalimumab Ab;Drug: NSAID;Drug: Thalidomide PillQilu Hospital of Shandong UniversityNULLRecruiting18 Years65 YearsAll100Phase 4China
2EUCTR2020-004284-98-GR
(EUCTR)
15/07/202105/04/2021Secukinumab open label roll-over extension protocolAn open-label, multi-center protocol for patients who have completed a previous Novartis sponsored Secukinumab study and are judged by the investigator to benefit from continued Secukinumab treatment Psoriatic Arthritis, Ankylosing Spondylitis, non-radiographic axial spondyloarthritis, Severe Chronic Plaque Psoriasis
MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;Classification code 10050576;Term: Psoriasis vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Cosentyx
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: secukinumab
Other descriptive name: SECUKINUMAB
Trade Name: Cosentyx
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
628Phase 4United States;Czechia;Greece;Spain;Guatemala;Russian Federation;Colombia;India;Egypt;Czech Republic;Mexico;Poland;Brazil;Malaysia;Belgium;Bulgaria;South Africa;Korea, Republic of
3EUCTR2020-004284-98-BG
(EUCTR)
05/02/202129/01/2021Secukinumab open label roll-over extension protocolAn open-label, multi-center protocol for patients who have completed a previous Novartis sponsored Secukinumab study and are judged by the investigator to benefit from continued Secukinumab treatment Psoriatic Arthritis, Ankylosing Spondylitis, non-radiographic axial spondyloarthritis, Severe Chronic Plaque Psoriasis
MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;Classification code 10050576;Term: Psoriasis vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Cosentyx
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: secukinumab
Other descriptive name: SECUKINUMAB
Trade Name: Cosentyx
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
628Phase 4United States;Czechia;Greece;Spain;Guatemala;Turkey;Russian Federation;Colombia;India;Egypt;Czech Republic;Mexico;Poland;Belgium;Brazil;Malaysia;Bulgaria;South Africa;Germany;Sweden;Korea, Republic of
4EUCTR2019-001177-90-SE
(EUCTR)
30/06/202017/12/2019Study to demonstrate the efficacy, safety and tolerability of an intravenous(i.v.) regimen of secukinumab compared to placebo in subjects with activeaxSpAA randomized, double-blind, placebo-controlled, parallel group, phase IIImulticenter study of intravenous secukinumab to compare efficacy at 16weeks with placebo and to assess safety and tolerability up to 52 weeks insubjects with active Ankylosing Spondylitis or non-radiographic axialSpondyloArthritis Axial Spondyloarthritis
MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
500Phase 3United States;Czechia;Philippines;Greece;Thailand;Guatemala;Turkey;Russian Federation;Colombia;Italy;India;Egypt;Poland;Belgium;Brazil;Malaysia;Bulgaria;Sweden;Korea, Republic of
5EUCTR2019-001177-90-IT
(EUCTR)
06/05/202019/05/2021Study to demonstrate the efficacy, safety and tolerability of an intravenous(i.v.) regimen of secukinumab compared to placebo in subjects with activeaxSpAA randomized, double-blind, placebo-controlled, parallel group, phase IIImulticenter study of intravenous secukinumab to compare efficacy at 16weeks with placebo and to assess safety and tolerability up to 52 weeks insubjects with active Ankylosing Spondylitis or non-radiographic axialSpondyloArthritis Axial Spondyloarthritis
MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
500Phase 3United States;Czechia;Philippines;Greece;Thailand;Guatemala;Turkey;Russian Federation;Colombia;Italy;India;Egypt;Czech Republic;Poland;Belgium;Brazil;Malaysia;Bulgaria;Sweden;Korea, Republic of
6EUCTR2019-001177-90-BG
(EUCTR)
07/04/202012/02/2020Study to demonstrate the efficacy, safety and tolerability of an intravenous(i.v.) regimen of secukinumab compared to placebo in subjects with activeaxSpAA randomized, double-blind, placebo-controlled, parallel group, phase IIImulticenter study of intravenous secukinumab to compare efficacy at 16weeks with placebo and to assess safety and tolerability up to 52 weeks insubjects with active Ankylosing Spondylitis or non-radiographic axialSpondyloArthritis Axial Spondyloarthritis
MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
500Phase 3United States;Philippines;Czechia;Greece;Thailand;Guatemala;Turkey;Russian Federation;Colombia;Italy;India;Egypt;Czech Republic;Poland;Malaysia;Belgium;Brazil;Bulgaria;Sweden;Korea, Republic of
7EUCTR2019-001177-90-CZ
(EUCTR)
20/02/202019/12/2019Study to demonstrate the efficacy, safety and tolerability of an intravenous(i.v.) regimen of secukinumab compared to placebo in subjects with activeaxSpAA randomized, double-blind, placebo-controlled, parallel group, phase IIImulticenter study of intravenous secukinumab to compare efficacy at 16weeks with placebo and to assess safety and tolerability up to 52 weeks insubjects with active Ankylosing Spondylitis or non-radiographic axialSpondyloArthritis Axial Spondyloarthritis
MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Czechia;Philippines;Greece;Thailand;Guatemala;Turkey;Russian Federation;Colombia;Italy;India;Egypt;Czech Republic;Belgium;Brazil;Malaysia;Poland;Bulgaria;Korea, Republic of;Sweden
8EUCTR2019-001177-90-GR
(EUCTR)
23/01/202013/11/2019Study to demonstrate the efficacy, safety and tolerability of an intravenous(i.v.) regimen of secukinumab compared to placebo in subjects with activeaxSpAA randomized, double-blind, placebo-controlled, parallel group, phase IIImulticenter study of intravenous secukinumab to compare efficacy at 16weeks with placebo and to assess safety and tolerability up to 52 weeks insubjects with active Ankylosing Spondylitis or non-radiographic axialSpondyloArthritis Axial Spondyloarthritis
MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Czechia;Philippines;Greece;Thailand;Guatemala;Turkey;Russian Federation;Colombia;Italy;India;Egypt;Czech Republic;Poland;Belgium;Brazil;Malaysia;Bulgaria;Sweden;Korea, Republic of
9EUCTR2019-001177-90-BE
(EUCTR)
21/01/202022/10/2019Study to demonstrate the efficacy, safety and tolerability of an intravenous(i.v.) regimen of secukinumab compared to placebo in subjects with activeaxSpAA randomized, double-blind, placebo-controlled, parallel group, phase IIImulticenter study of intravenous secukinumab to compare efficacy at 16weeks with placebo and to assess safety and tolerability up to 52 weeks insubjects with active Ankylosing Spondylitis or non-radiographic axialSpondyloArthritis Axial Spondyloarthritis
MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Thailand;Guatemala;Turkey;Russian Federation;Colombia;Italy;India;Egypt;Czech Republic;Poland;Belgium;Brazil;Malaysia;Bulgaria;Sweden;Korea, Republic of;United States;Czechia;Philippines;Greece
10NCT04156620
(ClinicalTrials.gov)
December 11, 20198/10/2019Study to Demonstrate the Efficacy, Safety and Tolerability of an Intravenous Regimen of Secukinumab Compared to Placebo in Subjects With Active axSpAA Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase III Multicenter Study of Intravenous Secukinumab to Compare Efficacy at 16 Weeks With Placebo and to Assess Safety and Tolerability up to 52 Weeks in Subjects With Active Ankylosing Spondylitis or Non-radiographic Axial SpondyloArthritisAnkylosing SpondylitisDrug: Secukinumab;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll527Phase 3United States;Belgium;Brazil;Bulgaria;Colombia;Czechia;Greece;Guatemala;India;Italy;Korea, Republic of;Malaysia;Philippines;Poland;Russian Federation;Sweden;Thailand;Turkey
11EUCTR2017-000679-10-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
12NCT03639740
(ClinicalTrials.gov)
January 15, 201917/8/2018Treat-to-target With Secukinumab in Axial SpondyloarthritisTReat-to-tArget (T2T) With seCukinumab in Axial Spondyloarthritis. IdEntification of MRI and Biochemical Biomarkers for Disease Activity, Treatment Response and Structural Damage Progression (the TRACE Study)Axial Spondyloarthritis;Ankylosing SpondylitisDrug: Secukinumab 150 milligram [Cosentyx]Professor Mikkel ØstergaardNovartis Healthcare A/SRecruiting18 Years70 YearsAll88Phase 4Denmark
13JPRN-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
14EUCTR2017-000679-10-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
15EUCTR2017-000679-10-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
16EUCTR2017-000679-10-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
17EUCTR2017-000679-10-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
18NCT03350815
(ClinicalTrials.gov)
March 13, 201831/10/2017Study Estimating the Clinical Difference Between 300 mg and 150 mg of Secukinumab Following Dose Escalation to 300 mg in Patients With Ankylosing SpondylitisA Randomized, Double-blind, Parallel-group, Multicenter Study of Secukinumab to Compare 300 mg and 150 mg at Week 52 in Patients With Ankylosing Spondylitis Who Are Randomized to Dose Escalation After Not Achieving Inactive Disease During an Initial 16 Weeks of Open-label Treatment With Secukinumab 150 mg (ASLeap)Ankylosing SpondylitisDrug: 150 mg open-label secukinumab;Drug: 150 mg double-blinded secukinumab;Drug: 300 mg double-blinded secukinumabNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll322Phase 4United States
19EUCTR2017-000679-10-FR
(EUCTR)
22/01/201822/09/2017A 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
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;Israel;Chile;Russian Federation;Colombia;France;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany
20EUCTR2017-004037-93-DK
(EUCTR)
17/01/201807/11/2017TReat-to-tArget (T2T) with seCukinumab in axial spondyloarthritis. IdEntification of MRI and biochemical biomarkers for disease activity, treatment response and structural damage progression (the TRACE study)TReat-to-tArget (T2T) with seCukinumab in axial spondyloarthritis. IdEntification of MRI and biochemical biomarkers for disease activity, treatment response and structural damage progression (the TRACE study) Axial spondyloarthritis and ankylosing spondylitis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: Cosentyx
Product Name: Cosentyx
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Afdeling for Rygkirurgi, Led- og Bindevævssygdomme ; Rigshospitalet - GlostrupNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
88Phase 4Denmark
21EUCTR2017-000679-10-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
22EUCTR2017-000679-10-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
23EUCTR2017-000679-10-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
24NCT03259074
(ClinicalTrials.gov)
November 30, 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 PharmaceuticalsNULLCompleted18 YearsN/AAll861Phase 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
25EUCTR2017-000679-10-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
26EUCTR2017-000679-10-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
27EUCTR2017-000679-10-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]
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 finished Female: yes
Male: yes
837 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;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
28NCT02896127
(ClinicalTrials.gov)
October 18, 20164/5/2016Study of Efficacy and Safety of Secukinumab in Patients With Ankylosing SpondylitisA Randomized, Double-blind, Placebo-controlled, Phase III Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes, to Compare Efficacy at 16 Weeks With Placebo and to Assess Safety and Tolerability up to 52 Weeks in Subjects With Active Ankylosing SpondylitisAnkylosing SpondyloarthritisDrug: Secukinumab;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll458Phase 3China;Czechia;Korea, Republic of;United Kingdom;Czech Republic
29EUCTR2015-005021-39-CZ
(EUCTR)
15/09/201614/07/2016Study of efficacy and safety of secukinumab in patients with Ankylosing Spondylitis.A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab in prefilled syringes, to compare efficacy at 16 weeks with placebo and to assess safety and tolerability up to 52 weeks in subjects with active Ankylosing Spondylitis. - MEASURE 5 Ankylosing Spondyloarthritis
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
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
454 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noCzech Republic;Korea, Democratic People's Republic of;China;United Kingdom
30EUCTR2015-005021-39-GB
(EUCTR)
04/08/201612/07/2016Study of efficacy and safety of secukinumab in patients with Ankylosing Spondylitis.A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab in prefilled syringes, to compare efficacy at 16 weeks with placebo and to assess safety and tolerability up to 52 weeks in subjects with active Ankylosing Spondylitis. - MEASURE 5 Ankylosing Spondyloarthritis
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
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
454 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noCzech Republic;Korea, Democratic People's Republic of;China;United Kingdom
31NCT02763046
(ClinicalTrials.gov)
May 31, 20163/5/2016Study to Examine the Clinical Efficacy and the Nonsteroidal Anti-inflammatory Drug (NSAID)-Sparing Effect of Secukinumab Over 16 Weeks in Patients With Ankylosing SpondylitisA Randomized, Double-blind, Placebo-controlled Multicenter Study of Secukinumab (AIN457) to Examine the Clinical Efficacy and the NSAID-sparing Effect of Secukinumab Over 16 Weeks in Patients With Ankylosing Spondylitis (ASTRUM)Ankylosing SpondylitisDrug: Secukinumab (AIN457) 150 mg s.c.;Drug: Placebo - Secukinumab (AIN457) 150 mg s.c.Novartis PharmaceuticalsNULLCompleted18 YearsN/AAll211Phase 4Germany
32NCT02750592
(ClinicalTrials.gov)
March 22, 20164/4/2016Study of Efficacy and Safety of Secukinumab in Japanese Patients With Active Ankylosing SpondylitisAn Open-label, Phase III, Study of Subcutaneous Secukinumab to Assess Efficacy, Safety and Tolerability at up to 52 Weeks in Japanese Patients With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: Secukinumab 150 mg provided in 1.0 mL pre-filled syringes (PFSs) for sc injection.Novartis PharmaceuticalsNULLCompleted18 YearsN/AAll30Phase 3Japan
33EUCTR2015-004575-74-DE
(EUCTR)
16/03/201618/02/2016Clinical study to examine the clinical efficacy and the NSAID-sparing effect of Secukinumab in patients with ankylosing spondylitisA randomized, double-blind, placebo-controlled multicenter study of Secukinumab (AIN457) to examine the clinical efficacy and the NSAID-sparing effect of Secukinumab over 16 weeks in patients with ankylosing spondylitis (ASTRUM) - ASTRUM 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
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Other descriptive name: SECUKINUMAB
Novartis Pharma GmbHNULLNot Recruiting Female: yes
Male: yes
190 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesGermany
34JPRN-JapicCTI-163241
01/3/2016An Open-label, Phase III, Study of Subcutaneous Secukinumab to Assess Efficacy, Safety and Tolerability at up to 52 Weeks in Japanese Patients With Active Ankylosing SpondylitisAn Open-label, Phase III, Study of Subcutaneous Secukinumab to Assess Efficacy, Safety and Tolerability at up to 52 Weeks in Japanese Patients With Active Ankylosing Spondylitis Ankylosing SpondylitisIntervention name : AIN457
Dosage And administration of the intervention : secukinumab 150mg : Baseline, 1, 2, 3, 4 week. After 4 week, administered every 4 weeks.
Control intervention name : null
Novartis Pharma K.K.NULL18BOTH30Phase 3NULL
35EUCTR2013-005575-41-GB
(EUCTR)
28/07/201527/02/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
324 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;United Kingdom;Switzerland;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany
36EUCTR2013-005575-41-BG
(EUCTR)
28/05/201518/03/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 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
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany
37NCT02159053
(ClinicalTrials.gov)
May 18, 201528/2/201416-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Ankylosing SpondylitisA Randomized, Double-blind, Placebo-controlled, Phase III Multicenter Study of Subcutaneous Secukinumab (150 mg) With and Without a Subcutaneous Loading Regimen to Assess Efficacy, Safety, and Tolerability up to 2 Years in Patients With Active Ankylosing SpondylitisSpondylitis, AnkylosingBiological: Secukinumab;Biological: PlaceboNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll350Phase 3United States;Australia;Austria;Bulgaria;Canada;Czechia;Denmark;Finland;Germany;Greece;Italy;Netherlands;Norway;Poland;Russian Federation;Slovakia;Spain;Switzerland;United Kingdom;Czech Republic;Mexico
38EUCTR2013-005575-41-ES
(EUCTR)
11/05/201503/03/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 17.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Farmacéutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
324Phase 3Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany;United States;Slovakia;Greece;Finland
39EUCTR2013-005575-41-PL
(EUCTR)
04/05/201519/03/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 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
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany
40EUCTR2013-005575-41-NO
(EUCTR)
29/04/201523/02/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 17.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
324Phase 3United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Netherlands;Germany;Norway
41EUCTR2013-005575-41-DE
(EUCTR)
27/04/201503/02/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 18.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
324Phase 3United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany
42EUCTR2013-005575-41-SK
(EUCTR)
16/04/201513/03/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 18.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
324Phase 3United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany
43EUCTR2013-005575-41-NL
(EUCTR)
13/04/201510/02/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
324Phase 3United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Germany;Netherlands
44EUCTR2013-005575-41-DK
(EUCTR)
13/04/201525/02/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
324Phase 3United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Denmark;Australia;Bulgaria;Norway;Netherlands;Germany
45EUCTR2013-005575-41-FI
(EUCTR)
08/04/201520/02/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
324Phase 3United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany
46EUCTR2013-005575-41-GR
(EUCTR)
02/04/201529/04/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 18.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
324Phase 3United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany
47EUCTR2013-005575-41-CZ
(EUCTR)
31/03/201530/01/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 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
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany
48EUCTR2013-005575-41-AT
(EUCTR)
23/03/201505/02/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 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
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany
49EUCTR2013-005575-41-IT
(EUCTR)
05/03/201511/03/201616-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 18.1;Level: LLT;Classification code 10002555;Term: Ankles swollen;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
NOVARTIS FARMA S.P.A.NULLNot RecruitingFemale: yes
Male: yes
324Phase 3Slovakia;Greece;Finland;Spain;Austria;United Kingdom;Italy;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Germany;Netherlands;Norway
50EUCTR2013-001090-24-NO
(EUCTR)
29/04/201407/03/201416-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patientsA randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 16.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
222 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Czech Republic;Mexico;Greece;Spain;Belgium;Russian Federation;Germany;Norway;United Kingdom;Sweden
51EUCTR2013-001090-24-GB
(EUCTR)
26/03/201431/12/201316-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patientsA randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
222 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom;Sweden
52EUCTR2013-001090-24-GR
(EUCTR)
25/02/201409/12/201316-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patientsA randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
222Phase 3United States;Portugal;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom
53EUCTR2013-001090-24-BE
(EUCTR)
13/02/201414/01/201416-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patientsA randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 16.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
222Phase 3United Kingdom;Sweden;United States;Portugal;Czech Republic;Mexico;Greece;Spain;Belgium;Russian Federation;Norway;Germany
54EUCTR2013-001090-24-PT
(EUCTR)
23/01/201414/11/201316-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patientsA randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
222 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom;Sweden
55EUCTR2013-001089-40-BE
(EUCTR)
23/01/201402/12/20133-year follow-up study of secukinumab treatment in patients with active Ankylosing SpondylitisAn extension study to evaluate the sustainability of clinical benefits, safety and tolerability of secukinumab in patients with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 18.1;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
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab 150 mg/1 ml Solution for injection
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab 75 mg/0.5 ml Solution for injection
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Taiwan;Turkey;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Belgium;Peru;Bulgaria;Germany;Netherlands
56NCT02008916
(ClinicalTrials.gov)
January 14, 20148/12/201316-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis PatientsA Randomized, Double-blind, Placebo-controlled Phase III Study of Secukinumab to Demonstrate the Efficacy at 16 Weeks and to Assess the Long-term Safety, Tolerability and Efficacy up to 3 Years in Subjects With Active Ankylosing SpondylitisSpondylitis, AnkylosingDrug: Secukinumab;Drug: Placebo secukinumabNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll226Phase 3United States;Belgium;Czechia;Germany;Greece;Mexico;Portugal;Russian Federation;Spain;United Kingdom;Czech Republic;Norway;Sweden
57EUCTR2013-001090-24-DE
(EUCTR)
08/01/201424/10/201316-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patientsA randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 18.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
222Phase 3Portugal;United States;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom
58EUCTR2013-001089-40-BG
(EUCTR)
07/01/201421/11/20133-year follow-up study of secukinumab treatment in patients with active Ankylosing SpondylitisAn extension study to evaluate the sustainability of clinical benefits, safety and tolerability of secukinumab in patients with active Ankylosing Spondylitis 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
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
274Phase 3United States;Taiwan;Turkey;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Belgium;Peru;Bulgaria;Germany;Netherlands
59EUCTR2013-001090-24-CZ
(EUCTR)
30/12/201308/11/201316-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patientsA randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis 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
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
222Phase 3Portugal;United States;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom
60EUCTR2013-001090-24-ES
(EUCTR)
26/12/201312/11/201316-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patientsA randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 16.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Farmacéutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
222Phase 3United States;Portugal;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom;Sweden
61EUCTR2013-001089-40-DE
(EUCTR)
20/11/201307/08/20133-year follow-up study of secukinumab treatment in patients with active Ankylosing SpondylitisAn extension study to evaluate the sustainability of clinical benefits, safety and tolerability of secukinumab in patients with active Ankylosing Spondylitis 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
Product Name: Secukinumab
Product Code: AIN457, 150 mg
INN or Proposed INN: Secukinumab
Product Name: Secukinumab
Product Code: AIN457, 75 mg
INN or Proposed INN: Secukinumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
274Phase 3United States;Taiwan;Turkey;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Belgium;Peru;Bulgaria;Germany;Netherlands
62NCT01863732
(ClinicalTrials.gov)
November 6, 201323/5/2013Extension in AS: Sustainability of Benefits, Safety and TolerabilityAn Extension Study to Evaluate the Sustainability of Clinical Benefits, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing SpondylitisSpondylitis, AnkylosingBiological: Secukinumab;Other: Placebo (Pbo)Novartis PharmaceuticalsNULLCompleted18 YearsN/AAll274Phase 3United States;Belgium;Bulgaria;Canada;France;Germany;Italy;Mexico;Netherlands;Peru;Russian Federation;Taiwan;Turkey;United Kingdom
63EUCTR2013-001089-40-NL
(EUCTR)
24/10/201326/09/20133-year follow-up study of secukinumab treatment in patients with active Ankylosing SpondylitisAn extension study to evaluate the sustainability of clinical benefits, safety and tolerability of secukinumab in patients with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 19.0;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
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Taiwan;Turkey;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Belgium;Peru;Bulgaria;Netherlands;Germany
64EUCTR2013-001089-40-GB
(EUCTR)
03/10/201316/07/20133-year follow-up study of secukinumab treatment in patients with active Ankylosing SpondylitisAn extension study to evaluate the sustainability of clinical benefits, safety and tolerability of secukinumab in patients with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 19.0;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
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Taiwan;Turkey;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Belgium;Peru;Bulgaria;Germany;Netherlands
65EUCTR2013-001089-40-IT
(EUCTR)
27/08/201302/07/20133-year follow-up study of secukinumab treatment in patients with active Ankylosing SpondylitisAn extension study to evaluate the sustainability of clinical benefits, safety and tolerability of secukinumab in patients with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 16.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Novartis Farma SpANULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Taiwan;Turkey;Russian Federation;Italy;United Kingdom;France;Mexico;Canada;Belgium;Peru;Bulgaria;Netherlands;Germany
66EUCTR2012-000046-35-DE
(EUCTR)
20/12/201219/09/2012Efficacy at 16 Weeks and Long Term Efficacy, Safety and Tolerability up to 5 years of Secukinumab (AIN457) in Patients With Active Ankylosing Spondylitis (AS)A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis - MEASURE 2 Ankylosing spondylitis
MedDRA version: 19.1;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
219Phase 3United States;Finland;Spain;Austria;Russian Federation;Switzerland;United Kingdom;Italy;Czech Republic;Canada;Singapore;Germany;Netherlands
67EUCTR2012-000046-35-ES
(EUCTR)
13/11/201226/09/2012Efficacy at 16 Weeks and Long Term Efficacy, Safety and Tolerability up to 5 years of Secukinumab (AIN457) in Patients With Active Ankylosing Spondylitis (AS)A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 15.0;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Novartis Farmacéutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
222Phase 3United States;Finland;Spain;Austria;Russian Federation;Switzerland;United Kingdom;Italy;Czech Republic;Canada;Singapore;Germany;Netherlands
68EUCTR2012-000046-35-NL
(EUCTR)
30/10/201216/08/2012Efficacy at 16 Weeks and Long Term Efficacy, Safety and Tolerability up to 5 years of Secukinumab (AIN457) in Patients With Active Ankylosing Spondylitis (AS)A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis - MEASURE 2 Ankylosing spondylitis
MedDRA version: 19.0;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
219Phase 3Italy;Czech Republic;Canada;Singapore;Netherlands;Germany;United States;Finland;Spain;Austria;Russian Federation;Switzerland;United Kingdom
69NCT01649375
(ClinicalTrials.gov)
October 18, 201220/7/201216 Week Efficacy and 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing SpondylitisA Randomized, Double-blind, Placebo-controlled Phase III Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Efficacy at 16 Weeks and to Assess Long-term Efficacy, Safety and Tolerability up to 5 Years in Patients With Active Ankylosing SpondylitisAnklyosing SpondylitisDrug: Secukinumab (75 mg);Drug: Placebo;Drug: Secukinumab (150 mg)Novartis PharmaceuticalsNULLCompleted18 YearsN/AAll219Phase 3United States;Austria;Canada;Czechia;Finland;Germany;Italy;Netherlands;Russian Federation;Singapore;Spain;Switzerland;United Kingdom;Czech Republic
70EUCTR2012-000046-35-FI
(EUCTR)
10/10/201228/08/2012Efficacy at 16 Weeks and Long Term Efficacy, Safety and Tolerability up to 5 years of Secukinumab (AIN457) in Patients With Active Ankylosing Spondylitis (AS)A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis - MEASURE 2 Ankylosing spondylitis
MedDRA version: 19.1;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
219Phase 3United States;Finland;Spain;Austria;Russian Federation;Switzerland;United Kingdom;Italy;Czech Republic;Canada;Singapore;Germany;Netherlands
71EUCTR2012-000046-35-GB
(EUCTR)
17/09/201220/07/2012Efficacy at 16 Weeks and Long Term Efficacy, Safety and Tolerability up to 5 years of Secukinumab (AIN457) in Patients With Active Ankylosing Spondylitis (AS)A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis - MEASURE 2 Ankylosing spondylitis
MedDRA version: 19.1;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
219Phase 3Spain;United States;Finland;Austria;Russian Federation;United Kingdom;Italy;Switzerland;Czech Republic;Canada;Singapore;Germany;Netherlands
72EUCTR2012-000046-35-IT
(EUCTR)
31/07/201202/08/2012A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457F
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457F
INN or Proposed INN: SECUKINUMAB
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
222Phase 3United States;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Canada;Singapore;Netherlands;Germany
73EUCTR2010-024529-18-BE
(EUCTR)
16/12/201120/10/20112-year study of secukinumab treatment in patients with active Ankylosing SpondylitisA randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active Ankylosing Spondylitis - MEASURE-1 Ankylosing spondylitis
MedDRA version: 16.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
350United States;Taiwan;Turkey;Russian Federation;Italy;United Kingdom;France;Mexico;Canada;Belgium;Peru;Bulgaria;Netherlands;Germany
74EUCTR2010-024529-18-DE
(EUCTR)
28/11/201101/08/20112-year study of secukinumab treatment in patients with active Ankylosing SpondylitisA randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active Ankylosing Spondylitis - MEASURE-1 Ankylosing spondylitis
MedDRA version: 16.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
350United States;Taiwan;Turkey;Russian Federation;Italy;United Kingdom;France;Mexico;Canada;Belgium;Peru;Bulgaria;Germany;Netherlands
75EUCTR2010-024529-18-BG
(EUCTR)
14/11/201109/11/20112-year study of secukinumab treatment in patients with active Ankylosing SpondylitisA randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active Ankylosing Spondylitis - MEASURE-1 Ankylosing spondylitis
MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
350United States;Taiwan;Turkey;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Belgium;Peru;Bulgaria;Germany;Netherlands
76NCT01358175
(ClinicalTrials.gov)
October 201119/5/201116 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing SpondylitisA Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the 16 Week Efficacy and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: Secukinumab (75 mg);Drug: Secukinumab (150 mg);Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll371Phase 3United States;Belgium;Bulgaria;Canada;France;Germany;Italy;Mexico;Netherlands;Peru;Russian Federation;Taiwan;Turkey;United Kingdom
77EUCTR2010-024529-18-GB
(EUCTR)
02/08/201118/07/20112-year study of secukinumab treatment in patients with active Ankylosing SpondylitisA randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active Ankylosing Spondylitis - MEASURE 1 Ankylosing spondylitis
MedDRA version: 16.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
350United States;Taiwan;Turkey;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Belgium;Peru;Bulgaria;Netherlands;Germany
78EUCTR2010-024529-18-IT
(EUCTR)
25/07/201129/12/20112-year study of secukinumab treatment in patients with active Ankylosing SpondylitisA randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
350Taiwan;Mexico;Canada;Belgium;Turkey;Peru;Bulgaria;Russian Federation;Germany;United Kingdom;Italy
79EUCTR2020-004284-98-CZ
(EUCTR)
05/11/2020Secukinumab open label roll-over extension protocolAn open-label, multi-center protocol for patients who have completed a previous Novartis sponsored Secukinumab study and are judged by the investigator to benefit from continued Secukinumab treatment Psoriatic Arthritis, Ankylosing Spondylitis, non-radiographic axial spondyloarthritis, Severe Chronic Plaque Psoriasis
MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;Classification code 10050576;Term: Psoriasis vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Cosentyx
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: secukinumab
Other descriptive name: SECUKINUMAB
Trade Name: Cosentyx
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma AGNULLNAFemale: yes
Male: yes
628Phase 4United States;Czechia;Greece;Spain;Guatemala;Turkey;Russian Federation;Colombia;India;Egypt;Czech Republic;Mexico;Poland;Belgium;Brazil;Malaysia;South Africa;Bulgaria;Germany;Sweden;Korea, Republic of
80EUCTR2020-004284-98-PL
(EUCTR)
15/12/2020Secukinumab open label roll-over extension protocolAn open-label, multi-center protocol for patients who have completed a previous Novartis sponsored Secukinumab study and are judged by the investigator to benefit from continued Secukinumab treatment Psoriatic Arthritis, Ankylosing Spondylitis, non-radiographic axial spondyloarthritis, Severe Chronic Plaque Psoriasis
MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;Classification code 10050576;Term: Psoriasis vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Cosentyx
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: secukinumab
Other descriptive name: SECUKINUMAB
Trade Name: Cosentyx
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma AGNULLNAFemale: yes
Male: yes
628Phase 4United States;Czechia;Greece;Spain;Guatemala;Turkey;Russian Federation;Colombia;India;Egypt;Czech Republic;Mexico;Belgium;Poland;Brazil;Malaysia;Bulgaria;South Africa;Germany;Sweden;Korea, Republic of