Methotrexate injection
( DrugBank: Methotrexate / KEGG DRUG: Methotrexate )
2 diseases
96. クローン病
臨床試験数 : 2,442 / 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
Showing 1 to 10 of 18 trials
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2018-003594-95-NL (EUCTR) | 30/04/201920190430 | 30/04/201920190430 | Addition of methotrexate to regain clinical response in IBD patients on anti-TNF therapy | Methotrexate to suppress immunogenicity to anti-tumor necrosis factor therapy in IBD patients with loss of response Methotrexateto suppress immunogenicity to anti-tumor necrosis factor therapy in IBD patients with lo ... | Inflammatory bowel disease: Crohn's disease and Ulcerative colitis MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] Inflammatory bowel disease: Crohn's disease and Ulcerative colitis MedDRA version: 20.0;Level: PT;Cl ... | Trade Name: methotrexate injection INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: methotrexate injection INN or Proposed INN: Methotrexate Other descriptive name: METHOTREX ... | Amsterdam UMC location AMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 4 | Netherlands | ||
| 2 | EUCTR2016-000522-18-BE (EUCTR) | 02/05/201820180502 | 08/01/201820180108 | Risk stratified randomized controlled trial in paediatric Crohn’s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively – a treatment strategy Risk stratified randomized controlled trial in paediatric Crohn’s Disease: Methotrexateversus azathi ... | Risk stratified randomized controlled trial in paediatric Crohn’s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively – a treatment strategy - REDUCE-RISKincd-PIBD-TRIAL Risk stratified randomized controlled trial in paediatric Crohn’s Disease: Methotrexateversus azathi ... | Pediatric Crohn’s disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: humira INN or Proposed INN: ADALIMUMAB Product Name: Imurel INN or Proposed INN: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Methotrexate Product Name: methotrexate Product Name: humira INN or Proposed INN: ADALIMUMAB Product Name: Imurel INN or Proposed INN: azathiop ... | PIBDNet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 312 | Phase 4 | France;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 3 | EUCTR2016-000522-18-CZ (EUCTR) | 24/04/201820180424 | 25/04/201820180425 | Risk stratified randomized controlled trial in paediatric Crohn´s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy Risk stratified randomized controlled trial in paediatric Crohn´s Disease: Methotrexateversus azathi ... | Risk stratified randomized controlled trial in paediatric Crohn´s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy - REDUCE-RISK in CD-PIBD-TRIAL Risk stratified randomized controlled trial in paediatric Crohn´s Disease: Methotrexateversus azathi ... | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Azathioprin INN or Proposed INN: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Humira 40 mg injekcní roztok v predplnené injekcní stríkacce Product Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate Product Name: methotrexate INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE Product Name: Azathioprin INN or Proposed INN: azathioprine Other descriptive name: AZATHIOPRINE Trade ... | PIBDNet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 312 | Phase 4 | France;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 4 | EUCTR2016-000522-18-GB (EUCTR) | 28/03/201820180328 | 05/12/201720171205 | Risk-stratified randomised controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy. Risk-stratified randomised controlled trial in paediatric Crohn's Disease: Methotrexateversus azathi ... | Risk Stratified randomised controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy - REDUCE-RISKinCD-PIBD -TRIAL Risk Stratified randomised controlled trial in paediatric Crohn's Disease: Methotrexateversus azathi ... | Paediatric Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] Paediatric Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's ... | Trade Name: Humira 40mg/0.4ml pre-filled syringe Product Name: Humira 40mg/0.4ml pre-filled syringe INN or Proposed INN: ADALIMUMAB Other descriptive name: SUB20016 Product Name: Azathioprine INN or Proposed INN: Azathioprine Other descriptive name: Azathioprine INN or Proposed INN: Azathioprine Product Name: Methotrexate INN or Proposed INN: Methotrexate INN or Proposed INN: Methotrexate Product Name: Mercaptopurine INN or Proposed INN: Mercaptopurine Other descriptive name: 6-Mercaptopurine Trade Name: Humira 40mg/0.4ml pre-filled syringe Product Name: Humira 40mg/0.4ml pre-filled syringe IN ... | PIBD net | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 312 | Phase 4 | France;Czech Republic;Canada;Poland;Belgium;Spain;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 5 | EUCTR2016-000522-18-NL (EUCTR) | 28/12/201720171228 | 03/07/201720170703 | Risk stratified randomized controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy. Risk stratified randomized controlled trial in paediatric Crohn's Disease: Methotrexateversus azathi ... | Risk stratified randomized controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy. - REDUCE-RISKincd-PIBD-TRIAL Risk stratified randomized controlled trial in paediatric Crohn's Disease: Methotrexateversus azathi ... | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira Product Name: humira INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprine Product Name: imuran INN or Proposed INN: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: methotrexate Product Name: methotrexate Product Code: L01BA INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE Trade Name: Humira Product Name: humira INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprine Product ... | PIBDNet | NULL | Not Recruiting | Female: yes Male: yes | 312 | Phase 4 | France;Czechia;Czech Republic;Hungary;Canada;Poland;Belgium;Israel;Germany;Netherlands;United Kingdom;Italy France;Czechia;Czech Republic;Hungary;Canada;Poland;Belgium;Israel;Germany;Netherlands;United Kingdo ... | ||
| 6 | EUCTR2016-000522-18-IT (EUCTR) | 24/02/201720170224 | 08/06/202120210608 | Comparison of the effectiveness of treatment with an immunosuppressant medication over another or with respect to a biological drug in the maintenance of remission in children suffering from Crohn's Disease. Comparison of the effectiveness of treatment with an immunosuppressant medication over another or wi ... | Risk-stratified randomized controlled trial in paediatric Crohn¿s Disease: Methotrexate versus Azathioprine or Adalimumab for mantaining remission in patients at low or at high risk for aggressive disease course, respectively ¿ a treatment strategy - REDUCE-RISKincd-PBID-TRIAL Risk-stratified randomized controlled trial in paediatric Crohn¿s Disease: Methotrexateversus Azathi ... | Crohn Disease MedDRA version: 20.0;Level: LLT;Classification code 10042759;Term: Symptoms involving digestive system;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] Crohn Disease MedDRA version: 20.0;Level: LLT;Classification code 10042759;Term: Symptoms involving ... | Trade Name: METHOTREXATE - 20 MG/0.8 ML SOLUZIONE INIETTABILE 4 SIRINGHE PRERIEMPITE MONOUSO DA 1.25 ML Product Name: Methotrexate Product Code: N.A Trade Name: HUMIRA - 40MG/0.8ML SOLUZ. INIETTABILE- USO SOTTOCUTANEO-FLACONCINO(VETRO) 0.8ML 2 ASTUCCI:1 FLACONCINO+1SIRINGA+1AGO+1ADATT.STERILE-2TAMPONI IMBEVUTI ALCOOL Product Name: Humira Product Code: N.A Trade Name: AZATIOPRINA ASPEN - 50 COMPRESSE Product Name: Azatioprina Product Code: N.A Trade Name: PURINETHOL - 50 MG COMPRESSE25 COMPRESSE Product Name: Purinethol Trade Name: METHOTREXATE- 20 MG/0.8 ML SOLUZIONE INIETTABILE 4 SIRINGHE PRERIEMPITE MONOUSO DA 1.25 ... | UMBERTO I - POLICLINICO DI ROMA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 312 | Phase 4 | France;Czechia;Czech Republic;Hungary;Poland;Belgium;Netherlands;Germany;United Kingdom;Italy | ||
| 7 | EUCTR2016-000522-18-DE (EUCTR) | 05/01/201720170105 | 01/08/201620160801 | Risk stratified randomized controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively a treatment strategy Risk stratified randomized controlled trial in paediatric Crohn's Disease: Methotrexateversus azathi ... | Risk stratified randomized controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively a treatment strategy - REDUCE-RISK in CD-PIBD-TRIAL Risk stratified randomized controlled trial in paediatric Crohn's Disease: Methotrexateversus azathi ... | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Humira INN or Proposed INN: ADALIMUMAB Product Name: Azathioprin INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Product Name: Methotrexat INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE Product Name: Humira INN or Proposed INN: ADALIMUMAB Product Name: Azathioprin INN or Proposed INN: Aza ... | PIBD-Net | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 312 | Phase 3 | France;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 8 | EUCTR2013-005013-13-PL (EUCTR) | 25/06/201420140625 | 31/03/201420140331 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Me ... | A 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 A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Saf ... | 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] Subjects with Moderate to Severe Rheumatoid Arthritis despite MethotrexateTherapy. The intended use ... | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Produc ... | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Bosnia and Herzegovina;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;Latvia;United Kingdom;Korea, Republic of Bosnia and Herzegovina;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;La ... | |||
| 9 | EUCTR2013-005013-13-BG (EUCTR) | 28/04/201420140428 | 23/04/201420140423 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Me ... | A 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 A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Saf ... | 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] Subjects with Moderate to Severe Rheumatoid Arthritis despite MethotrexateTherapy. The intended use ... | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Produc ... | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 3 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Rep ... | ||
| 10 | EUCTR2013-005013-13-LT (EUCTR) | 08/04/201420140408 | 13/02/201420140213 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Me ... | A 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 A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Saf ... | 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] Subjects with Moderate to Severe Rheumatoid Arthritis despite MethotrexateTherapy. The intended use ... | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Produc ... | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Rep ... |
97. 潰瘍性大腸炎
臨床試験数 : 2,630 / 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
Showing 1 to 9 of 9 trials
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2018-003594-95-NL (EUCTR) | 30/04/201920190430 | 30/04/201920190430 | Addition of methotrexate to regain clinical response in IBD patients on anti-TNF therapy | Methotrexate to suppress immunogenicity to anti-tumor necrosis factor therapy in IBD patients with loss of response Methotrexateto suppress immunogenicity to anti-tumor necrosis factor therapy in IBD patients with lo ... | Inflammatory bowel disease: Crohn's disease and Ulcerative colitis MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] Inflammatory bowel disease: Crohn's disease and Ulcerative colitis MedDRA version: 20.0;Level: PT;Cl ... | Trade Name: methotrexate injection INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: methotrexate injection INN or Proposed INN: Methotrexate Other descriptive name: METHOTREX ... | Amsterdam UMC location AMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 4 | Netherlands | ||
| 2 | EUCTR2013-005013-13-PL (EUCTR) | 25/06/201420140625 | 31/03/201420140331 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Me ... | A 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 A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Saf ... | 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] Subjects with Moderate to Severe Rheumatoid Arthritis despite MethotrexateTherapy. The intended use ... | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Produc ... | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Bosnia and Herzegovina;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;Latvia;United Kingdom;Korea, Republic of Bosnia and Herzegovina;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;La ... | |||
| 3 | EUCTR2013-005013-13-BG (EUCTR) | 28/04/201420140428 | 23/04/201420140423 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Me ... | A 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 A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Saf ... | 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] Subjects with Moderate to Severe Rheumatoid Arthritis despite MethotrexateTherapy. The intended use ... | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Produc ... | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 3 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Rep ... | ||
| 4 | EUCTR2013-005013-13-LT (EUCTR) | 08/04/201420140408 | 13/02/201420140213 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Me ... | A 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 A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Saf ... | 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] Subjects with Moderate to Severe Rheumatoid Arthritis despite MethotrexateTherapy. The intended use ... | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Produc ... | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Rep ... | |||
| 5 | EUCTR2013-005013-13-CZ (EUCTR) | 03/04/201420140403 | 13/02/201420140213 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Me ... | A 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 A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Saf ... | 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] Subjects with Moderate to Severe Rheumatoid Arthritis despite MethotrexateTherapy. The intended use ... | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Produc ... | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Rep ... | |||
| 6 | EUCTR2006-003607-40-FI (EUCTR) | 23/04/200920090423 | 26/02/200920090226 | METEOR: A CONTROLLED, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METH-OTREXATE VS PLACEBO IN THE REMISSION OF STEROID-DEPENDENT ULCERATIVE COLITIS - METEOR METEOR: A CONTROLLED, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METH-OTREXATE VS PLACEB ... | METEOR: A CONTROLLED, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METH-OTREXATE VS PLACEBO IN THE REMISSION OF STEROID-DEPENDENT ULCERATIVE COLITIS - METEOR METEOR: A CONTROLLED, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METH-OTREXATE VS PLACEB ... | Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative coli ... | Trade Name: Trexan inj 25 mg/ml INN or Proposed INN: Methotrexate | GETAID, Jean Minjoz Hospital | NULL | Not Recruiting | Female: yes Male: yes | 110 | Finland;Belgium;Austria;Netherlands | |||
| 7 | EUCTR2006-003607-40-BE (EUCTR) | 09/12/200820081209 | 27/10/200820081027 | A CONTROLLED, RANDOMISED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATE VS PLACEBO IN CORTICOSTEROID-DEPENDENT ULCERATIVE COLITIS - METEOR A CONTROLLED, RANDOMISED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATEVS PLACEBO IN CORTI ... | A CONTROLLED, RANDOMISED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATE VS PLACEBO IN CORTICOSTEROID-DEPENDENT ULCERATIVE COLITIS - METEOR A CONTROLLED, RANDOMISED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATEVS PLACEBO IN CORTI ... | Steroid-dependent ulcerative colitis | Trade Name: methotrexate bellon Product Name: methotrexate bellon 25mg/ml INN or Proposed INN: methotrexate bellon 25mg/ml Trade Name: methotrexatebellon Product Name: methotrexatebellon 25mg/ml INN or Proposed INN: methotrex ... | Besancon University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | Finland;Belgium;Austria;Netherlands | |||
| 8 | EUCTR2006-003607-40-AT (EUCTR) | 26/11/200820081126 | 10/11/200820081110 | A CONTROLLED, RANDOMISED,DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATE VS PLACEBO IN STEROID-REFRACTORY ULCERATIVE COLITIS - METEOR A CONTROLLED, RANDOMISED,DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATEVS PLACEBO IN STEROI ... | A CONTROLLED, RANDOMISED,DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATE VS PLACEBO IN STEROID-REFRACTORY ULCERATIVE COLITIS - METEOR A CONTROLLED, RANDOMISED,DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATEVS PLACEBO IN STEROI ... | Steroid-dependent ulcerative colitis | Trade Name: methotrexate bellon Product Name: methotrexate bellon 25mg/ml INN or Proposed INN: methotrexate bellon 25mg/ml Trade Name: methotrexatebellon Product Name: methotrexatebellon 25mg/ml INN or Proposed INN: methotrex ... | Besancon University Hospitaö | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Finland;Netherlands;Austria | ||||
| 9 | EUCTR2006-003607-40-NL (EUCTR) | 13/11/200820081113 | 13/08/200820080813 | A CONTROLLED, RANDOMISED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATE VS PLACEBO IN STEROID-REFRACTORY ULCERATIVE COLITIS - METEOR A CONTROLLED, RANDOMISED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATEVS PLACEBO IN STERO ... | A CONTROLLED, RANDOMISED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATE VS PLACEBO IN STEROID-REFRACTORY ULCERATIVE COLITIS - METEOR A CONTROLLED, RANDOMISED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATEVS PLACEBO IN STERO ... | Steroid-dependent ulcerative colitis | Trade Name: methotrexate bellon Product Name: methotrexate bellon 25mg/ml INN or Proposed INN: methotrexate bellon 25mg/ml Trade Name: methotrexatebellon Product Name: methotrexatebellon 25mg/ml INN or Proposed INN: methotrex ... | Besancon University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 110 | Finland;Netherlands;Austria |