46. 悪性関節リウマチ Malignant rheumatoid arthritis Clinical trials / Disease details


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

  
13 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
1EUCTR2015-002634-41-DE
(EUCTR)
25/02/201610/11/2015 Long-term study of BI695501 in patients with active rheumatoid arthritisLong-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab 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 Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Boehringer Ingelheim International GmbHNULLNot Recruiting Female: yes
Male: yes
400 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of
2EUCTR2015-002634-41-BG
(EUCTR)
24/02/201621/12/2015Long-term study of BI695501 in patients with active rheumatoid arthritisLong-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab 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 Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of
3NCT02640612
(ClinicalTrials.gov)
January 22, 201618/12/2015Long-term Assessment of Safety and Efficacy of BI 695501 in Patients With Rheumatoid ArthritisLong-term Assessment of Safety, Efficacy, Pharmacokinetics and Immunogenicity of BI 695501 in Patients With Rheumatoid Arthritis (RA): an Open-label Extension Trial for Patients Who Have Completed Trial 1297.2 and Are Eligible for Long-term Treatment With AdalimumabArthritis, RheumatoidDrug: BI 695501Boehringer IngelheimNULLCompleted18 Years80 YearsAll430Phase 3United States;Bulgaria;Chile;Estonia;Germany;Hungary;Korea, Republic of;Malaysia;Poland;Russian Federation;Serbia;Spain;Thailand;Ukraine
4EUCTR2015-002634-41-PL
(EUCTR)
20/01/201616/12/2015Long-term study of BI695501 in patients with active rheumatoid arthritisLong-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab 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 Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Poland;Malaysia;Bulgaria;Germany;Korea, Republic of
5EUCTR2015-002634-41-HU
(EUCTR)
07/01/201616/10/2015Long-term study of BI695501 in patients with active rheumatoid arthritisLong-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab 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 Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of
6NCT02636907
(ClinicalTrials.gov)
January 6, 201618/12/2015Assessment of the Handling Experience With the BI 695501 Autoinjector in Patients With Rheumatoid Arthritis Followed by an Extension Phase Using BI 695501 Prefilled SyringeAssessment of Real-life Patient Handling Experience of BI 695501 Administered Subcutaneously With an Autoinjector in Patients With Rheumatoid Arthritis: an Open-label, Interventional Clinical Trial Followed by an Extension Phase of BI 695501 Administered With a Prefilled SyringeArthritis, RheumatoidDrug: BI 695501 Autoinjector;Drug: BI 695501 Prefilled syringeBoehringer IngelheimNULLCompleted18 Years80 YearsAll77Phase 2United States;Poland;Ukraine
7EUCTR2015-002634-41-ES
(EUCTR)
17/12/201530/10/2015Long-term study of BI695501 in patients with active rheumatoid arthritisLong-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab 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 Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of
8NCT02137226
(ClinicalTrials.gov)
January 26, 201512/5/2014BI 695501 Compared to Adalimumab in Patients With Active Rheumatoid ArthritisEfficacy, Safety and Immunogenicity of BI 695501 Versus Adalimumab in Patients With Active Rheumatoid Arthritis: a Randomized, Double-blind,Parallel Arm, Multiple Dose, Active Comparator TrialArthritis, RheumatoidDrug: BI 695501;Drug: US-licensed Humira®Boehringer IngelheimNULLCompleted18 Years80 YearsAll645Phase 3United States;Bulgaria;Chile;Estonia;Germany;Hungary;Korea, Republic of;Malaysia;New Zealand;Poland;Russian Federation;Serbia;Spain;Thailand;Ukraine;Argentina;Colombia;Mexico;Philippines;South Africa
9EUCTR2012-002945-40-DE
(EUCTR)
22/09/201401/04/2014BI695501 compared to adalimumab in patients with active rheumatoid arthritisEfficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator 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 Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
650Phase 3United States;Serbia;Estonia;Thailand;Spain;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;South Africa;Germany;New Zealand;Korea, Republic of
10EUCTR2012-002945-40-BG
(EUCTR)
21/08/201405/08/2014BI695501 compared to adalimumab in patients with active rheumatoid arthritisEfficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator 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 Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
650Phase 3Serbia;United States;Estonia;Spain;Thailand;Ukraine;Russian Federation;Chile;Hungary;Poland;Malaysia;Bulgaria;South Africa;Germany;New Zealand;Korea, Republic of
11EUCTR2012-002945-40-ES
(EUCTR)
07/07/201429/04/2014BI695501 compared to adalimumab in patients with active rheumatoid arthritisEfficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial Rheumatoid arthritis
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 Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Serbia;Philippines;Estonia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Colombia;France;Hungary;Mexico;Argentina;Poland;Malaysia;Belgium;South Africa;Bulgaria;Germany;New Zealand;Korea, Republic of
12EUCTR2012-002945-40-HU
(EUCTR)
27/05/201404/04/2014BI695501 compared to adalimumab in patients with active rheumatoid arthritisEfficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial 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 Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
650Phase 3United States;Serbia;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Hungary;Mexico;Argentina;Malaysia;Poland;South Africa;Bulgaria;Germany;New Zealand;Korea, Republic of
13EUCTR2012-002945-40-EE
(EUCTR)
09/05/201410/04/2014BI695501 compared to adalimumab in patients with active rheumatoid arthritisEfficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial 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 Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
650Phase 3United States;Serbia;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;New Zealand;Korea, Republic of