271. 強直性脊椎炎
[臨床試験数:531,薬物数:343(DrugBank:66),標的遺伝子数:41,標的パスウェイ数:141

Searched query = "Ankylosing spondylitis", "Spondylarthritis ankylopoietica"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
68 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04527380
(ClinicalTrials.gov)
January 7, 202124/8/2020A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic ArthritisMulticenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab With Adalimumab Reference Arm, in Children With Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic ArthritisJuvenile Psoriatic Arthritis;Enthesitis Related ArthritisDrug: Ixekizumab;Drug: AdalimumabEli Lilly and CompanyNULLNot yet recruiting2 Years17 YearsAll100Phase 3Argentina;Belgium;Czechia;Denmark;France;Germany;Italy;Mexico;Netherlands;Spain;Switzerland;United Kingdom
2EUCTR2018-000681-10-GB
(EUCTR)
24/11/202011/09/2020An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis
MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Taltz (80 mg solution for injection in pre-filled syringe)
INN or Proposed INN: IXEKIZUMAB
Other descriptive name: LY2439821
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3France;Spain;Belgium;Denmark;Netherlands;Germany;Switzerland;Italy;United Kingdom
3EUCTR2018-000681-10-DE
(EUCTR)
23/11/202007/08/2020An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Taltz (80 mg solution for injection in pre-filled syringe)
INN or Proposed INN: IXEKIZUMAB
Other descriptive name: LY2439821
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3France;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy
4EUCTR2018-000681-10-BE
(EUCTR)
22/10/202022/10/2020An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Taltz (80 mg solution for injection in pre-filled syringe)
INN or Proposed INN: IXEKIZUMAB
Other descriptive name: LY2439821
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3France;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy
5NCT04018599
(ClinicalTrials.gov)
July 15, 201911/7/2019Comparison of PK and Tolerability of MSB11022 Administered by AI or PFSA Phase I, Randomized, Open-label, Parallel-group Study to Determine the Pharmacokinetics, Safety, and Tolerability of MSB11022 (Proposed Adalimumab Biosimilar) Following a Single Subcutaneous Injection by an Auto-injector or by a Pre-filled Syringe in Healthy SubjectsRheumatoid Arthritis;Polyarticular Juvenile Idiopathic Arthritis;Psoriatic Arthritis;Ankylosing Spondylitis;Crohn Disease;Ulcerative Colitis;Plaque Psoriasis;Pediatric Plaque Psoriasis;Pediatric Crohns Disease;Hidradenitis Suppurativa;Non-infectious UveitisDrug: 40 mg MSB11022Fresenius Kabi SwissBioSim GmbHPRA Health SciencesCompleted18 Years55 YearsAll216Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2017-000679-10-GR
(EUCTR)
05/03/201919/12/2018Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
INN or Proposed INN: secukinumab
Other descriptive name: SECUKINUMAB
Trade Name: Hyrimoz
Product Name: adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
837Phase 3Portugal;United States;Philippines;Taiwan;Slovakia;Greece;Spain;Israel;Chile;Russian Federation;Colombia;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan
7JPRN-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
8EUCTR2017-000679-10-SK
(EUCTR)
24/10/201802/10/2017Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
INN or Proposed INN: secukinumab
Other descriptive name: SECUKINUMAB
Trade Name: Hyrimoz
Product Name: adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
837Phase 3Portugal;United States;Philippines;Taiwan;Slovakia;Greece;Spain;Israel;Chile;Russian Federation;Colombia;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan
9EUCTR2017-000679-10-PT
(EUCTR)
16/07/201815/01/2018Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
INN or Proposed INN: secukinumab
Other descriptive name: SECUKINUMAB
Trade Name: Hyrimoz
Product Name: adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
837Phase 3United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Chile;Israel;Colombia;France;Australia;Denmark;Peru;Netherlands;Korea, Republic of;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan
10EUCTR2017-000679-10-PL
(EUCTR)
19/06/201828/03/2018Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
837Phase 3Portugal;United States;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Chile;Israel;Colombia;France;Australia;Denmark;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2017-000679-10-NL
(EUCTR)
07/06/201818/12/2017Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
INN or Proposed INN: secukinumab
Other descriptive name: SECUKINUMAB
Product Name: adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
837Phase 3Portugal;United States;Philippines;Taiwan;Slovakia;Spain;Russian Federation;Chile;Israel;Colombia;France;Australia;Denmark;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany
12EUCTR2017-000679-10-FR
(EUCTR)
22/01/201822/09/2017Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
837Phase 3Portugal;United States;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Chile;Israel;Colombia;France;Australia;Denmark;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany
13EUCTR2017-000679-10-CZ
(EUCTR)
10/01/201825/09/2017Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
837Phase 3Portugal;United States;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Chile;Israel;Colombia;France;Australia;Denmark;Peru;Netherlands;Korea, Republic of;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan
14EUCTR2017-000679-10-FI
(EUCTR)
18/12/201705/10/2017Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
837Phase 3Portugal;United States;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Chile;Israel;Colombia;France;Australia;Denmark;Peru;Netherlands;Korea, Republic of;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan
15EUCTR2017-000679-10-DE
(EUCTR)
18/12/201724/08/2017Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
INN or Proposed INN: secukinumab
Other descriptive name: SECUKINUMAB
Trade Name: Hyrimoz
Product Name: adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
837Phase 3United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Israel;Chile;Russian Federation;Colombia;France;Denmark;Australia;Peru;Netherlands;Korea, Republic of;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2017-000679-10-DK
(EUCTR)
23/11/201725/10/2017Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
837Phase 3Portugal;United States;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Chile;Israel;Colombia;France;Australia;Denmark;Peru;Netherlands;Korea, Republic of;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan
17EUCTR2017-000679-10-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
18EUCTR2017-000679-10-GB
(EUCTR)
16/11/201708/08/2017Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
837Phase 3Portugal;United States;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Chile;Israel;Colombia;France;Australia;Denmark;Peru;Netherlands;Korea, Republic of;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan
19NCT03259074
(ClinicalTrials.gov)
July 4, 201721/8/2017Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)A Randomized, Partially-blinded Study of Secukinumab to Demonstrate Reduction of Radiographic Progression Versus GP2017 (Adalimumab Biosimilar) at 104 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing SpondylitisAnkylosing SpondylitisBiological: Secukinumab;Biological: GP2017 (adalimumab biosimilar)Novartis PharmaceuticalsNULLActive, not recruiting18 YearsN/AAll860Phase 3United States;Argentina;Australia;Belgium;Canada;Chile;Colombia;Czechia;Denmark;Finland;France;Germany;Greece;Israel;Japan;Korea, Republic of;Mexico;Netherlands;Peru;Philippines;Poland;Portugal;Romania;Russian Federation;Slovakia;Spain;Taiwan;Turkey;United Kingdom;Monaco
20NCT02893254
(ClinicalTrials.gov)
September 22, 201629/8/2016Efficacy and Safety of IBI303 in Adult Patients With Active Ankylosing SpondylitisA Multicenter, Randomized, Double-blind, Parallel-controlled Phase 3 Study Evaluating the Efficacy and Safety of Recombinant Human Monoclonal Antibody Against Human Tumor Necrosis Factor-a (IBI303) Compared to Adalimumab in Patients With Active Ankylosing SpondylitisASDrug: IBI303;Drug: AdalimumabInnovent Biologics (Suzhou) Co. Ltd.NULLCompleted18 Years65 YearsAll438Phase 3NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT02750800
(ClinicalTrials.gov)
April 7, 201613/4/2016Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE)Post-marketing Observational Study to Evaluate the Effect of HUMIRA (Adalimumab) Treatment With AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary in a Real-life Setting: VALUERheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Psoriasis;Crohn's Disease;Ulcerative ColitisBiological: Adalimumab;Behavioral: AbbVie Care 2.0AbbVieNULLCompleted18 Years99 YearsAll427Hungary
22EUCTR2015-002284-42-FI
(EUCTR)
18/09/201528/08/2015The rationale for this study is to gain insight in the extent and impact of immunogenicityof TNF inhibitors in the European daily clinical practice. Furthermore, an European widedatabase will give insight in factors influencing immunogenicity and treatment outcomein terms of disease activitINTENT: immunogenicity in patients failing response on anti-TNF-Immunogenicity and pharmacokinetics in patients failing torespond to TNF inhibitors (phase 1);-Clinical effectiveness of subsequent TNF inhibitor treatment andpredictive value of pharmacokinetics and immunogenicity (phase2) - INTENT rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis.;Therapeutic area: Not possible to specifyTrade Name: Enbrel
Product Name: etanercept
Trade Name: Humira
Product Name: adalimumab
Trade Name: Cimzia
Product Name: certolizumab pegol
Trade Name: Simponi
Product Name: golimumab
Trade Name: Remicade
Product Name: infliximab
READENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1650Phase 1Finland
23EUCTR2014-004887-39-PL
(EUCTR)
08/08/201507/07/2015A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid ArthritisAn Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis Subjects with Rheumatoid Arthritis. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), Axial spondyloarthritis without radiographic evidence of AS, psoriasis (Ps), psoriatic arthritis (PsA), and ulcerative colitis (UC).
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: SB5
INN or Proposed INN: ADALIMUMAB
Product Code: SB5
INN or Proposed INN: ADALIMUMAB
Samsung Bioepis Co., LtdNULLNot RecruitingFemale: yes
Male: yes
Poland
24NCT02492217
(ClinicalTrials.gov)
May 20153/7/2015Biomarkers Identification of Anti-tumor Necrosis Factor (TNF) a Agent's Efficacy in Ankylosing Spondylitis PatientsBiomarkers Identification of Anti-TNF a Agent's Efficacy in Ankylosing Spondylitis Patients Using a Transcriptome Analysis and Mass SpectrometryAnkylosing SpondylitisDrug: AdalimumabUniversidade Nova de LisboaNULLCompleted18 Years75 YearsAll69Phase 4Portugal
25NCT02333383
(ClinicalTrials.gov)
December 31, 20146/1/2015Observe the Frequency of Extra-Axial Symptoms in Korean Ankylosing Spondylitis (AS) PatientsA Prospective, Mono-Country, Multi-Center Study to Observe the Frequency of Extra-Axial Symptoms in Korean Ankylosing Spondylitis Patients on Adalimumab TherapyAnkylosing SpondylitisDrug: AdalimumabAbbVieNULLCompleted19 Years100 YearsAll201Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT01870284
(ClinicalTrials.gov)
July 20143/6/2013Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients With Active Ankylosing SpondylitisSpondylitis, AnkylosingDrug: Ixekizumab;Drug: Placebo;Drug: AdalimumabEli Lilly and CompanyNULLWithdrawn18 YearsN/ABoth0Phase 3United States;Argentina;Belgium;Canada;Czech Republic;France;Germany;Hungary;Mexico;Netherlands;Poland;Russian Federation;Spain;Ukraine;United Kingdom
27EUCTR2013-005013-13-PL
(EUCTR)
25/06/201431/03/2014A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira®
Product Name: Humira®
INN or Proposed INN: ADALIMUMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
490Bosnia and Herzegovina;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;Latvia;United Kingdom;Korea, Republic of
28EUCTR2013-005013-13-BG
(EUCTR)
28/04/201423/04/2014A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira®
Product Name: Humira®
INN or Proposed INN: ADALIMUMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
490Phase 3Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina
29EUCTR2013-005013-13-LT
(EUCTR)
08/04/201413/02/2014A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira®
Product Name: Humira®
INN or Proposed INN: ADALIMUMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
490Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina
30EUCTR2013-005013-13-CZ
(EUCTR)
03/04/201413/02/2014A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira®
Product Name: Humira®
INN or Proposed INN: ADALIMUMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
490Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2011-002325-22-ES
(EUCTR)
28/10/201308/08/2013Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients with Active Ankylosing Spondylitis - SPIRIT-A1 Spondylitis, Ankylosing
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: Ixekizumab
Product Code: LY2439821
INN or Proposed INN: Ixekizumab
Other descriptive name: Monoclonal Antibody (MAb)
Trade Name: Adalimumab
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Eli Lilly & CompanyNULLNot RecruitingFemale: yes
Male: yes
408United States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany
32EUCTR2011-002325-22-BE
(EUCTR)
28/10/201309/08/2013Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients with Active Ankylosing Spondylitis - SPIRIT-A1 Spondylitis, Ankylosing
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: Ixekizumab
Product Code: LY2439821
INN or Proposed INN: Ixekizumab
Other descriptive name: Monoclonal Antibody (MAb)
Trade Name: Adalimumab
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Eli Lilly & CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
408United States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;South Africa;Netherlands;Germany
33EUCTR2011-002325-22-DE
(EUCTR)
25/10/201309/08/2013Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients with Active Ankylosing Spondylitis - SPIRIT-A1 Spondylitis, Ankylosing
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: Ixekizumab
Product Code: LY2439821
INN or Proposed INN: Ixekizumab
Other descriptive name: Monoclonal Antibody (MAb)
Trade Name: Adalimumab
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Eli Lilly & CompanyNULLNot RecruitingFemale: yes
Male: yes
408United States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany
34EUCTR2011-002325-22-HU
(EUCTR)
26/09/201317/07/2013Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients with Active Ankylosing Spondylitis - SPIRIT-A1 Spondylitis, Ankylosing
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: Ixekizumab
Product Code: LY2439821
INN or Proposed INN: Ixekizumab
Other descriptive name: Monoclonal Antibody (MAb)
Trade Name: Adalimumab
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Eli Lilly & CompanyNULLNot RecruitingFemale: yes
Male: yes
408United States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany
35NCT02132234
(ClinicalTrials.gov)
June 201328/4/2014Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing SpondylitisEffects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing SpondylitisRheumatoid Arthritis;Psoriatic Arthritis;Ankylosing Spondylitis;HypertensionDrug: Etanercept;Drug: Adalimumab;Drug: Certolizumab;Drug: InfliximabJagiellonian UniversityDepartmet of Rheumatology, J Dietl Hospital, Krakow, PolandRecruiting18 YearsN/ABoth100Phase 4Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT01895764
(ClinicalTrials.gov)
March 201324/4/2013Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)Ankylosing SpondylitisDrug: Adalimumab;Drug: MethotrexateUniversity Hospital, ToursNULLCompleted18 YearsN/ABoth110Phase 4France
37NCT01768858
(ClinicalTrials.gov)
February 5, 201314/1/2013Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical PracticeAssessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical PracticeRheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Crohn´s Disease;Ulcerative Colitis;Plaque PsoriasisDrug: AdalimumabAbbVieRaffeiner GmbHCompleted18 Years99 YearsAll96Austria
38NCT01610947
(ClinicalTrials.gov)
May 14, 201224/5/2012Effect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease ActivityEffect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease Activity: a Randomized Controlled TrialSpondyloarthritisDrug: Adalimumab, Etanercept, Golimumab or infliximabUniversity Hospital, MontpellierNULLCompleted18 YearsN/AAll398N/AFrance
39NCT01174186
(ClinicalTrials.gov)
October 201016/7/2010Intestinal Inflammation in Ankylosing Spondylitis and the Effects of Adalimumab on Mucosal HealingIntestinal Inflammation in Ankylosing Spondylitis Assessed by Fecal Calprotectin, Capsular Endoscopy and Colonoscopy and the Effects of Adalimumab on Mucosal HealingSpondyloarthritis;EnterocolitisDrug: AdalimumabRegionshospitalet SilkeborgAbbott;Given Imaging Ltd.;Central Denmark RegionCompleted18 Years45 YearsAll30Phase 4Denmark
40EUCTR2009-018085-35-DK
(EUCTR)
21/05/201005/05/2010Intestinal inflammation in ankylosing spondylitis assessed by stoll samples and endoscopy and the effects of adalimumab on inflammationIntestinal Inflammation in Ankylosing Spondylitis assessed by Fecal Calprotectin, Capsular Endoscopy and Colonoscopy and the effects of Adalimumab on mucosal healing - INTASAH Ankylosing spondylitis Inflammatory bowel disease
MedDRA version: 14.0;Level: PT;Classification code 10061371;Term: Spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.0;Level: LLT;Classification code 10041672;Term: Spondylitis ankylosing;Classification code 10048398;Term: Spondylitis ankylosing aggravated;Classification code 10041671;Term: Spondylitis ankylopoietica;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10041673;Term: Spondylitis NOS;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Regionalhospital SilkeborgNULLNot RecruitingFemale: yes
Male: yes
Phase 4Denmark
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT01060098
(ClinicalTrials.gov)
April 201029/1/2010T Cells and TNF (Tumor Necrosis Factor): The Impact of TNF BlockadeT Cells and TNF: The Impact of TNF Blockade on Effector T Cell Populations in Rheumatoid Arthritis and Other Conditions Treated With Anti-TNFalpha AgentsRheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic ArthritisDrug: anti-TNF therapy (etanercept or adalimumab)Imperial College LondonNULLCompleted18 Years80 YearsAll48United Kingdom
42NCT01114880
(ClinicalTrials.gov)
January 20105/2/2010Efficacy and Safety of Adalimumab in Adult Chinese Subjects With Active Ankylosing SpondylitisA Phase 3, Randomized, Double-Blind, Placebo Controlled, Multicenter, Efficacy and Safety Study of Adalimumab in Adult Chinese Subjects With Active Ankylosing SpondylitisAnkylosing SpondylitisBiological: adalimumab;Other: placeboAbbottNULLCompleted18 Years65 YearsAll344Phase 3China
43EUCTR2008-006885-27-NL
(EUCTR)
21/04/200905/11/2008EFFICACY AND SAFETY OF ADALIMUMAB (HUMIRA®) IN PATIENTS WITH PERIPHERAL SPONDYLOARTHRITIS WITHOUT ANKYLOSING SPONDYLITIS OR PSORIATIC ARTHRITISEFFICACY AND SAFETY OF ADALIMUMAB (HUMIRA®) IN PATIENTS WITH PERIPHERAL SPONDYLOARTHRITIS WITHOUT ANKYLOSING SPONDYLITIS OR PSORIATIC ARTHRITIS PERIPHERAL SPONDYLOARTHRITIS WITHOUT ANKYLOSING SPONDYLITIS OR PSORIATIC ARTHRITIS
MedDRA version: 9.1;Level: LLT;Classification code 10051265;Term: Spondyloarthropathy
Trade Name: Humira
Product Name: adalimumab
INN or Proposed INN: adalimumab
Other descriptive name: ADALIMUMAB
Clinical Immunology and RheumatologyNULLNot RecruitingFemale: yes
Male: yes
Netherlands
44NCT02489760
(ClinicalTrials.gov)
July 200827/6/2015Etanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch StudyEtanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch StudyAnkylosing SpondylitisBiological: Adalimumab;Biological: EtanerceptChung Shan Medical UniversityNULLActive, not recruiting18 Years70 YearsBoth30Phase 4Taiwan
45EUCTR2007-003358-27-DE
(EUCTR)
02/05/200821/11/2007Phase III, multi-center, randomized, double blind, placebo-controlled study for treatment of juvenile ankylosing spondylitis with Adalimumab - Humira StudyPhase III, multi-center, randomized, double blind, placebo-controlled study for treatment of juvenile ankylosing spondylitis with Adalimumab - Humira Study Juvenile ankylosing spondylitis
MedDRA version: 10;Level: LLT;Classification code 10002556;Term:
Trade Name: Humira®
INN or Proposed INN: adalimumab
Center of Pediatrics and Neonatology, Asklepios Clinic Sankt AugustinNULLNot RecruitingFemale: yes
Male: yes
Phase 3Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46JPRN-JapicCTI-080580
01/4/2008A Multi-Center, Open-Labeled Study of Adalimumab in Japanese Subjects with Active Ankylosing SpondylitisA Multi-Center, Open-Labeled Study of Adalimumab in Japanese Subjects with Active Ankylosing Spondylitis Ankylosing SpondylitisIntervention name : adalimumab
INN of the intervention : adalimumab
Dosage And administration of the intervention : Every other week,Subcutaneous, 40mg
Control intervention name : null
Abbott Japan Co., Ltd.Eisai Co., Ltd.15BOTH30Phase 3NULL
47NCT01072058
(ClinicalTrials.gov)
February 200818/2/2010Heart Function in Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF BlockerProspective Evaluation of Heart Function by Echocardiographic Study, Pro-brain Natriuretic Peptide Type B and Troponin T in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF BlockerArthritis, Rheumatoid;Spondylitis, AnkylosingDrug: TNF blockers (infliximab, adalimumab, etanercept)University of Sao PauloNULLActive, not recruiting18 Years70 YearsBoth100Phase 4Brazil
48NCT00667355
(ClinicalTrials.gov)
February 200824/4/2008A Study of Adalimumab in Japanese Subjects With Active Ankylosing SpondylitisA Multi-Center, Open-Label Efficacy, Safety, and Pharmacokinetic Study of Adalimumab in Japanese Subjects With Active Ankylosing SpondylitisAnkylosing SpondylitisBiological: adalimumabAbbottEisai Co., Ltd.Completed15 YearsN/AAll41Phase 3Japan
49EUCTR2005-004826-21-BE
(EUCTR)
01/06/200720/01/2006Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODYReview of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODY Active Ankylosing SpondylitisProduct Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1200Greece;Finland;Spain;Belgium;Ireland;Austria;Denmark;Germany;Norway;Italy;Sweden;United Kingdom
50EUCTR2005-004826-21-GR
(EUCTR)
28/06/200613/07/2006Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODYReview of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODY Active Ankylosing SpondylitisProduct Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1200Finland;United Kingdom;Germany;Denmark;Norway;Spain;Ireland;Italy;Greece;Austria;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2005-004826-21-AT
(EUCTR)
28/03/200603/03/2006Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODYReview of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODY Active Ankylosing SpondylitisTrade Name: Humira
Product Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1200Finland;United Kingdom;Germany;Denmark;Norway;Spain;Ireland;Italy;Greece;Austria;Sweden
52EUCTR2005-004826-21-GB
(EUCTR)
06/03/200612/12/2005Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODYReview of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODY Active Ankylosing SpondylitisProduct Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1200Greece;Finland;Spain;Ireland;Austria;Denmark;Germany;Norway;Italy;United Kingdom;Sweden
53EUCTR2005-004826-21-IE
(EUCTR)
03/03/200611/01/2006Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODYReview of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODY Active Ankylosing SpondylitisTrade Name: Humira
Product Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1200Finland;United Kingdom;Germany;Denmark;Norway;Spain;Ireland;Italy;Greece;Austria;Sweden
54EUCTR2005-004826-21-IT
(EUCTR)
28/02/200623/06/2006Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors RHAPSODY - RHAPSODYReview of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors RHAPSODY - RHAPSODY Active Ankylosing Spondylitis
MedDRA version: 6.1;Level: PT;Classification code 10002556
INN or Proposed INN: AdalimumabABBOTTNULLNot RecruitingFemale: yes
Male: yes
1200Finland;United Kingdom;Germany;Denmark;Norway;Spain;Ireland;Italy;Greece;Austria;Sweden
55EUCTR2005-004826-21-DK
(EUCTR)
20/02/200605/01/2006Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODYReview of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODY Active Ankylosing SpondylitisTrade Name: Humira
Product Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1200Phase 3Greece;Finland;Belgium;Spain;Ireland;Austria;Denmark;Germany;Norway;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2005-004826-21-ES
(EUCTR)
17/02/200619/01/2006Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. Revisión de la seguridad y eficacia con adalimumab en pacientes con espondilitis anquilosante activa. Estudio abierto para evaluar la respuesta a adalimumab en pacientes que no han respondido al tratamiento convencional o a los inhibidores del TNF alfa. - RHAPSODYReview of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. Revisión de la seguridad y eficacia con adalimumab en pacientes con espondilitis anquilosante activa. Estudio abierto para evaluar la respuesta a adalimumab en pacientes que no han respondido al tratamiento convencional o a los inhibidores del TNF alfa. - RHAPSODY Active Ankylosing Spondylitis Espondilitis anquilosante activaTrade Name: Humira
Product Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1200Greece;Finland;Spain;Ireland;Austria;Denmark;Germany;Norway;Italy;United Kingdom;Sweden
57EUCTR2005-004826-21-SE
(EUCTR)
01/02/200623/12/2005Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODYReview of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODY Active Ankylosing SpondylitisProduct Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1200Finland;United Kingdom;Germany;Denmark;Norway;Spain;Ireland;Italy;Greece;Austria;Sweden
58NCT00478660
(ClinicalTrials.gov)
February 200623/5/2007An Open-Label Study to Evaluate the Response to Adalimumab in Patients With Active Ankylosing Spondylitis Who Have Failed Standard Therapy or TNF-Alpha Inhibitors (RHAPSODY)Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis - An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-Alpha Inhibitors (RHAPSODY)Ankylosing SpondylitisDrug: adalimumab (Humira)AbbottNULLCompleted18 YearsN/ABoth1250Phase 3Austria;Belgium;Denmark;Finland;France;Germany;Greece;Ireland;Italy;Netherlands;Norway;Spain;Sweden;Switzerland;United Kingdom
59EUCTR2005-004826-21-DE
(EUCTR)
30/01/200607/12/2005Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODYReview of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODY Active Ankylosing SpondylitisProduct Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1200Finland;United Kingdom;Germany;Denmark;Norway;Spain;Ireland;Italy;Greece;Austria;Sweden
60EUCTR2005-004826-21-NO
(EUCTR)
26/01/200605/12/2005Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODYReview of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODY Active Ankylosing SpondylitisProduct Name: Humira
INN or Proposed INN: Adalimumab
Abbott LaboratoriesNULLNot RecruitingFemale: yes
Male: yes
1200Finland;United Kingdom;Germany;Denmark;Norway;Spain;Ireland;Italy;Greece;Austria;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2005-004826-21-FI
(EUCTR)
20/01/200628/11/2005Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODYReview of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODY Active Ankylosing SpondylitisProduct Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1200Greece;Finland;Belgium;Spain;Ireland;Austria;Denmark;Germany;Norway;Italy;United Kingdom;Sweden
62NCT00235105
(ClinicalTrials.gov)
March 20056/10/2005D2E7-Early ASAdalimumab in Early Axial Spondyloarthritis (Without Radiological Sacroiliitis): Placebo Controlled Phase Over 3 Months Followed by a 9 Months Open Extension PhaseAnkylosing SpondylitisDrug: Adalimumab 40 mg sc every other weekCharite University, Berlin, GermanyAbbottActive, not recruiting18 YearsN/ABoth46Phase 2;Phase 3Germany
63NCT00133315
(ClinicalTrials.gov)
September 200422/8/2005TNFalfa Blocking Treatment of SpondylarthropathiesTNFalfa Blocking Treatment of Spondylarthropathies - A Danish Multicenter Study of New Methods for Better Monitoring and Prognostifying Patients With SpondylarthropathiesSpondylarthropathies;Ankylosing Spondylitis;Psoriatic ArthritisDrug: Infliximab;Drug: Etanercept;Drug: AdalimumabHvidovre University HospitalNULLCompleted18 YearsN/ABoth50Phase 4Denmark
64NCT00085644
(ClinicalTrials.gov)
January 200410/6/2004Human Anti-tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing SpondylitisA Phase 3 Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing SpondylitisAnkylosing SpondylitisBiological: adalimumab (D2E7);Biological: placeboAbbottNULLCompleted18 YearsN/AAll315Phase 3United States
65NCT00195819
(ClinicalTrials.gov)
December 200316/9/2005Safety and Efficacy of Adalimumab in Patients With Active Ankylosing SpondylitisA Phase 3, Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing SpondylitisAnkylosing SpondylitisBiological: adalimumab (D2E7);Biological: placeboAbbottNULLCompleted18 YearsN/AAll82Phase 3Canada;United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2014-004532-18-Outside-EU/EEA
(EUCTR)
12/11/2014A Multi-Center, Open-Label Efficacy, Safety, and Pharmacokinetic Study of Adalimumab in Japanese Subjects With Active Ankylosing SpondylitisA Multi-Center, Open-Label Efficacy, Safety, and Pharmacokinetic Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis 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] - Immune System Diseases [C20]
Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbottNULLNAFemale: yes
Male: yes
41Japan
67EUCTR2018-000681-10-FR
(EUCTR)
06/08/2020An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis
MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Taltz (80 mg solution for injection in pre-filled syringe)
INN or Proposed INN: IXEKIZUMAB
Other descriptive name: LY2439821
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNAFemale: yes
Male: yes
100Phase 3France;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy
68EUCTR2018-000681-10-DK
(EUCTR)
31/08/2020An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis
MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Taltz (80 mg solution for injection in pre-filled syringe)
INN or Proposed INN: IXEKIZUMAB
Other descriptive name: LY2439821
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNAFemale: yes
Male: yes
100Phase 3France;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Switzerland