L04AB04 ( DrugBank: - )


4 diseases
告示番号疾患名(ページ内リンク)臨床試験数
46悪性関節リウマチ18
107若年性特発性関節炎5
160先天性魚鱗癬1
271強直性脊椎炎2

46. 悪性関節リウマチ


臨床試験数 : 4,356 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-001970-41-DK
(EUCTR)
21/12/201715/09/2017 Dose reduction and withdrawal of biological therapy in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis: Protocol for a 18 months multi-centre trial Dose reduction and discontinuation of biological therapy in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis: Protocol for a 18 months randomised, open label, parallel-group, multi-centre trial - The BIODOPT trial (BIOlogical Dose OPTimisation) Rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis
MedDRA version: 21.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859
MedDRA version: 21.0;Classification code 10062719;Term: Seronegative rheumatoid arthritis;Classification code 10037160;Term: Psoriatic arthritis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 100000004859
MedDRA version: 21.1;Classification code 10041672;Term: Spondylitis ankylosing;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;Classification code 10045966;Term: Unspecified inflammatory spondylopathy;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Orencia
Product Name: Abatacept
Product Code: L04AA24
INN or Proposed INN: ABATACEPT
Trade Name: Orencia
Product Name: Abatacept
Product Code: L04AA24
INN or Proposed INN: ABATACEPT
Trade Name: Humira
Product Name: Adalimumab
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: L04AB05
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Enbrel
Product Name: Etanercept
Product Code: L04AB01
INN or Proposed INN: ETANERCEPT
MD, PhD Salome KristensenNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesDenmark
2EUCTR2015-003433-10-GB
(EUCTR)
05/07/201630/03/2016 ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis GP17-302 A randomized, double-blind, parallel-group, multicenter study to demonstrate similar efficacy and to compare safety and immunogenicity of GP2017 and Humira® in patients with moderate to severe active rheumatoid arthritis - ADMYRA trial rheumatoid arthritis
MedDRA version: 19.1;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: Adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Hexal, AGNULLNot Recruiting Female: yes
Male: yes
308 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of
3EUCTR2015-003433-10-RO
(EUCTR)
09/06/201622/06/2016ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid ArthritisGP17-302A randomized, double-blind, parallel-group, multicenterstudy to demonstrate similar efficacy and to comparesafety and immunogenicity of GP2017 and Humira® inpatients with moderate to severe active rheumatoid arthritis - ADMYRA trial rheumatoid arthritis
MedDRA version: 19.0;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: Adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Hexal, AGNULLNot RecruitingFemale: yes
Male: yes
308Phase 3United States;Serbia;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of
4EUCTR2015-003433-10-CZ
(EUCTR)
08/06/201630/03/2016ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid ArthritisGP17-302A randomized, double-blind, parallel-group, multicenterstudy to demonstrate similar efficacy and to comparesafety and immunogenicity of GP2017 and Humira® inpatients with moderate to severe active rheumatoid arthritis - ADMYRA trial rheumatoid arthritis
MedDRA version: 19.1;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: Adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Hexal, AGNULLNot RecruitingFemale: yes
Male: yes
308Phase 3Serbia;United States;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of
5EUCTR2015-003433-10-HU
(EUCTR)
26/05/201614/04/2016ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid ArthritisGP17-302A randomized, double-blind, parallel-group, multicenterstudy to demonstrate similar efficacy and to comparesafety and immunogenicity of GP2017 and Humira® inpatients with moderate to severe active rheumatoid arthritis - ADMYRA trial rheumatoid arthritis
MedDRA version: 19.0;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: Adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Hexal, AGNULLNot RecruitingFemale: yes
Male: yes
308Phase 3Serbia;United States;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of
6EUCTR2015-003433-10-DE
(EUCTR)
25/05/201607/04/2016ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid ArthritisGP17-302A randomized, double-blind, parallel-group, multicenterstudy to demonstrate similar efficacy and to comparesafety and immunogenicity of GP2017 and Humira® inpatients with moderate to severe active rheumatoid arthritis - ADMYRA trial rheumatoid arthritis
MedDRA version: 19.0;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: Adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Hexal, AGNULLNot RecruitingFemale: yes
Male: yes
308Phase 3Serbia;United States;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of
7EUCTR2015-003433-10-ES
(EUCTR)
09/05/201622/07/2016ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid ArthritisGP17-302A randomized, double-blind, parallel-group, multicenterstudy to demonstrate similar efficacy and to comparesafety and immunogenicity of GP2017 and Humira® inpatients with moderate to severe active rheumatoid arthritis - ADMYRA trial rheumatoid arthritis
MedDRA version: 19.0;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: Adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Hexal, AGNULLNot RecruitingFemale: yes
Male: yes
308Phase 3Serbia;United States;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of
8EUCTR2014-000358-13-DE
(EUCTR)
14/01/201631/07/2015A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritisA PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A Moderately to severely active Rheumatoid Arthritis
MedDRA version: 20.0;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: Tofacitinib citrate
Product Code: CP-690, 550 - 10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe
Product Name: Adalimumab
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate sodium 2.5mg tablets
Product Name: Methotrexate sodium 2.5mg tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE SODIUM
Trade Name: Zostavax®
Product Name: Zostavax
Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
1080Phase 3;Phase 4United States;Serbia;Philippines;Estonia;Taiwan;Spain;Thailand;Israel;Chile;Russian Federation;Australia;Peru;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
9EUCTR2014-000358-13-HR
(EUCTR)
08/06/201510/11/2015A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A Moderately to severely active Rheumatoid Arthritis
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: Tofacitinib citrate
Product Code: CP-690, 550 - 10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe
Product Name: Adalimumab
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate sodium 2.5mg tablets
Product Name: Methotrexate sodium 2.5mg tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE SODIUM
Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
1080Phase 3;Phase 4United States;Serbia;Philippines;Estonia;Taiwan;Spain;Thailand;Israel;Chile;Russian Federation;Australia;Peru;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
10EUCTR2014-000358-13-ES
(EUCTR)
13/01/201522/09/2014A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritisA PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A Moderately to severely active Rheumatoid Arthritis
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: Tofacitinib citrate
Product Code: CP-690, 550 - 10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe
Product Name: Adalimumab
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate sodium 2.5mg tablets
Product Name: Methotrexate sodium 2.5mg tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE SODIUM
Product Name: Tofacitinib citrate
Product Code: CP-690, 550 - 10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe
Product Name: Adalimumab
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate sodium 2.5mg tablets
Product Name: Methotrexate sodium 2.5mg tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE SODIUM
Product Name: Tofacitinib citrate
Product Code: CP-690, 550 - 10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe
Product Name: Adalimumab
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate sodium 2.5mg tablets
Product Name: Methotrexate sodium 2.5mg tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE SODIUM
Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
1080Phase 3;Phase 4Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
11EUCTR2014-000358-13-CZ
(EUCTR)
04/12/201404/08/2014A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritisA PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A Moderately to severely active Rheumatoid Arthritis
MedDRA version: 19.1;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: Tofacitinib citrate
Product Code: CP-690, 550 - 10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe
Product Name: Adalimumab
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate sodium 2.5mg tablets
Product Name: Methotrexate sodium 2.5mg tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE SODIUM
Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
1080Phase 3;Phase 4Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
12EUCTR2014-000358-13-PL
(EUCTR)
03/12/201424/09/2014A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritisA PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A Moderately to severely active Rheumatoid Arthritis
MedDRA version: 19.1;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: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe
Product Name: Adalimumab
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate sodium 2.5mg tablets
Product Name: Methotrexate sodium 2.5mg tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE SODIUM
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
1080Phase 3;Phase 4Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
13EUCTR2014-000358-13-EE
(EUCTR)
13/11/201407/08/2014A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritisA PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A Moderately to severely active Rheumatoid Arthritis
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: Tofacitinib citrate
Product Code: CP-690, 550 - 10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe
Product Name: Adalimumab
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate sodium 2.5mg tablets
Product Name: Methotrexate sodium 2.5mg tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE SODIUM
Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
1080Phase 3;Phase 4Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
14EUCTR2014-000358-13-GB
(EUCTR)
12/11/201412/09/2014A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritisA PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A Moderately to severely active Rheumatoid Arthritis
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] - Immune System Diseases [C20]
Product Name: Tofacitinib citrate
Product Code: CP-690, 550 - 10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe
Product Name: Adalimumab
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate sodium 2.5mg tablets
Product Name: Methotrexate sodium 2.5mg tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE SODIUM
Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
1080Phase 3;Phase 4Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
15EUCTR2014-000358-13-RO
(EUCTR)
10/11/201410/03/2015A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritisA PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A Moderately to severely active Rheumatoid Arthritis
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: Tofacitinib citrate
Product Code: CP-690, 550 - 10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe
Product Name: Adalimumab
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate sodium 2.5mg tablets
Product Name: Methotrexate sodium 2.5mg tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE SODIUM
Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
1080Phase 3;Phase 4United States;Serbia;Philippines;Estonia;Taiwan;Spain;Thailand;Israel;Chile;Russian Federation;Australia;Peru;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
16EUCTR2014-000358-13-BG
(EUCTR)
06/11/201428/10/2014A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritisA PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A Moderately to severely active Rheumatoid Arthritis
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: Tofacitinib citrate
Product Code: CP-690, 550 - 10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe
Product Name: Adalimumab
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate sodium 2.5mg tablets
Product Name: Methotrexate sodium 2.5mg tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE SODIUM
Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
1080Phase 3;Phase 4Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
17EUCTR2014-000358-13-LT
(EUCTR)
03/10/201411/09/2014A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritisA PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A Moderately to severely active Rheumatoid Arthritis
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] - Immune System Diseases [C20]
Product Name: Tofacitinib citrate
Product Code: CP-690, 550 - 10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe
Product Name: Adalimumab
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate sodium 2.5mg tablets
Product Name: Methotrexate sodium 2.5mg tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE SODIUM
Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
1080Phase 3;Phase 4Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Germany
18EUCTR2014-000358-13-LV
(EUCTR)
26/09/201411/09/2014A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritisA PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A Moderately to severely active Rheumatoid Arthritis
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] - Immune System Diseases [C20]
Product Name: Tofacitinib citrate
Product Code: CP-690, 550 - 10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe
Product Name: Adalimumab
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate sodium 2.5mg tablets
Product Name: Methotrexate sodium 2.5mg tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE SODIUM
Pfizer Inc. 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
1080Phase 3;Phase 4Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany

107. 若年性特発性関節炎


臨床試験数 : 447 薬物数 : 297 - (DrugBank : 57) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 146
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-000681-10-IT
(EUCTR)
23/12/202024/05/2021An 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 - TALZ Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: Taltz (80 mg solution for injection in pre-filled syringe)
Product Name: Ixekizumab
Product Code: [TALTZ]
INN or Proposed INN: ixekizumab
Trade Name: Humira
Product Name: Humira
Product Code: [L04AB04]
INN or Proposed INN: Adalimumab
ELI LILLY & COMPANY, LILLY CORPORATE CENTERNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3France;Czech Republic;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy
2EUCTR2019-000119-10-DE
(EUCTR)
20/01/202025/06/2019A study of Baricitinib in children and young adults with JIA associated eye inflammationAn Open-label, Active-Controlled, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody Positive Uveitis - JUVE-BRIGHT Juvenile Idiopathic Arthritis Associated Uveitis or Anterior Antinuclear Antibody-Positive Uveitis
MedDRA version: 20.0;Level: PT;Classification code 10046851;Term: Uveitis;System Organ Class: 10015919 - Eye disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 3France;Spain;Germany;United Kingdom;Italy
3EUCTR2019-000119-10-IT
(EUCTR)
08/10/201917/06/2021A study of Baricitinib in children and young adults with JIA associated eye inflammationAn Open-label, Active-Controlled, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody Positive Uveitis - JUVE-BRIGHT Juvenile Idiopathic Arthritis Associated Uveitis or Anterior Antinuclear Antibody-Positive Uveitis
MedDRA version: 20.0;Level: PT;Classification code 10046851;Term: Uveitis;System Organ Class: 10015919 - Eye disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: [LY3009104]
INN or Proposed INN: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: [LY3009104]
INN or Proposed INN: BARICITINIB
Trade Name: SUB180983
Product Name: Olumiant
Product Code: [LY3009104]
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: [LY3009104]
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Humira
Product Name: Humira
Product Code: [Humira]
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
Product Code: [L04AB04]
INN or Proposed INN: ADALIMUMAB
ELI LILLY & COMPANY, LILLY CORPORATE CENTERNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 3France;European Union;Germany;United Kingdom;Italy
4EUCTR2019-000119-10-FR
(EUCTR)
14/08/201929/05/2019A study of Baricitinib in children and young adults with JIA associated eye inflammationAn Open-label, Active-Controlled, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody Positive Uveitis - JUVE-BRIGHT Juvenile Idiopathic Arthritis Associated Uveitis or Anterior Antinuclear Antibody-Positive Uveitis
MedDRA version: 20.0;Level: PT;Classification code 10046851;Term: Uveitis;System Organ Class: 10015919 - Eye disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 3France;Germany;United Kingdom
5EUCTR2019-000119-10-GB
(EUCTR)
06/08/201917/04/2019A study of Baricitinib in children and young adults with JIA associated eye inflammationAn Open-label, Active-Controlled, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody Positive Uveitis - JUVE-BRIGHT Juvenile Idiopathic Arthritis Associated Uveitis or Anterior Antinuclear Antibody-Positive Uveitis
MedDRA version: 20.0;Level: PT;Classification code 10046851;Term: Uveitis;System Organ Class: 10015919 - Eye disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 3France;Germany;United Kingdom

160. 先天性魚鱗癬


臨床試験数 : 42 薬物数 : 71 - (DrugBank : 21) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 112
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2013-002205-54-FR
(EUCTR)
17/09/201319/06/2015N/AN/A - ANTI-TNF-SN
MedDRA version: 18.0;Level: PT;Classification code 10062909;Term: Netherton's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France

271. 強直性脊椎炎


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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-000681-10-IT
(EUCTR)
23/12/202024/05/2021An 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 - TALZ Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: Taltz (80 mg solution for injection in pre-filled syringe)
Product Name: Ixekizumab
Product Code: [TALTZ]
INN or Proposed INN: ixekizumab
Trade Name: Humira
Product Name: Humira
Product Code: [L04AB04]
INN or Proposed INN: Adalimumab
ELI LILLY & COMPANY, LILLY CORPORATE CENTERNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3France;Czech Republic;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy
2EUCTR2017-001970-41-DK
(EUCTR)
21/12/201715/09/2017 Dose reduction and withdrawal of biological therapy in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis: Protocol for a 18 months multi-centre trial Dose reduction and discontinuation of biological therapy in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis: Protocol for a 18 months randomised, open label, parallel-group, multi-centre trial - The BIODOPT trial (BIOlogical Dose OPTimisation) Rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis
MedDRA version: 21.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859
MedDRA version: 21.0;Classification code 10062719;Term: Seronegative rheumatoid arthritis;Classification code 10037160;Term: Psoriatic arthritis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 100000004859
MedDRA version: 21.1;Classification code 10041672;Term: Spondylitis ankylosing;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;Classification code 10045966;Term: Unspecified inflammatory spondylopathy;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Orencia
Product Name: Abatacept
Product Code: L04AA24
INN or Proposed INN: ABATACEPT
Trade Name: Orencia
Product Name: Abatacept
Product Code: L04AA24
INN or Proposed INN: ABATACEPT
Trade Name: Humira
Product Name: Adalimumab
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: L04AB05
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Enbrel
Product Name: Etanercept
Product Code: L04AB01
INN or Proposed INN: ETANERCEPT
MD, PhD Salome KristensenNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesDenmark