Standard therapy (DrugBank: -)
2 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 49 | 全身性エリテマトーデス | 18 |
| 97 | 潰瘍性大腸炎 | 16 |
| 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 | EUCTR2018-004645-16-NL (EUCTR) | 29/01/2020 | 29/10/2019 | A study of belimumab in children with lupus | A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants with Systemic Lupus Erythematosus (SLE) - Ph 2,Benlysta, PLUTO-SC, PK-PD study in pediatric patients with SLE | Lupus - SLE MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Benlysta Product Name: Belimumab Product Code: GSK1550188 INN or Proposed INN: BELIMUMAB Other descriptive name: LymphoStat-B®, monoclonal anti-BLyS, LSB, BENLYSTA® | GlaxoSmithKline Research & Development Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | United States;Mexico;Argentina;Spain;Germany;Netherlands;Japan | ||
| 2 | EUCTR2018-004645-16-DE (EUCTR) | 27/12/2019 | 18/09/2019 | A study of belimumab in children with lupus | A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants with Systemic Lupus Erythematosus (SLE) - Ph 2,Benlysta, PLUTO-SC, PK-PD study in pediatric patients with SLE | Lupus - SLE MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Benlysta Product Name: Belimumab Product Code: GSK1550188 INN or Proposed INN: BELIMUMAB Other descriptive name: LymphoStat-B®, monoclonal anti-BLyS, LSB, BENLYSTA® | GlaxoSmithKline Research & Development Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | United States;Mexico;Argentina;Spain;Netherlands;Germany;Japan | ||
| 3 | EUCTR2018-004645-16-ES (EUCTR) | 16/12/2019 | 11/11/2019 | A study of belimumab in children with lupus | A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants with Systemic Lupus Erythematosus (SLE) - Ph 2,Benlysta, PLUTO-SC, PK-PD study in pediatric patients with SLE | Lupus - SLE MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | GlaxoSmithKline, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | United States;Mexico;Argentina;Spain;Netherlands;Germany;Japan | |||
| 4 | NCT04179032 (ClinicalTrials.gov) | November 28, 2019 | 25/11/2019 | Study of Subcutaneous (SC) Belimumab in Pediatric Participants With Systemic Lupus Erythematosus (SLE) | A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Combination Product: Belimumab | GlaxoSmithKline | NULL | Recruiting | 5 Years | 17 Years | All | 30 | Phase 2 | United States;Argentina;Germany;Japan;Mexico;Netherlands;Spain |
| 5 | NCT04082416 (ClinicalTrials.gov) | October 10, 2019 | 1/9/2019 | Study of Recombinant Human B Lymphocyte(RC18) Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE) | A Phase III, Placebo-Controlled ,Multi-Center, Randomized, Double-Blind, Dose-exploring Trial of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Systemic Lupus Erythematosus (SLE). | Systemic Lupus Erythematosus | Biological: Placebo plus standard therapy;Biological: RC18 160 mg plus standard therapy | RemeGen | NULL | Recruiting | 18 Years | 65 Years | All | 318 | Phase 3 | China |
| 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 |
| 6 | NCT03312907 (ClinicalTrials.gov) | March 1, 2018 | 13/10/2017 | A Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) - BLISS-BELIEVE | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Belimumab;Drug: Rituximab;Drug: Rituximab-placebo;Drug: Standard therapy (Including Immunosuppressants);Drug: Standard therapy (Excluding Immunosuppressants);Drug: Steroid Taper | GlaxoSmithKline | NULL | Active, not recruiting | 18 Years | N/A | All | 292 | Phase 3 | United States;Argentina;Brazil;Canada;France;Germany;Korea, Republic of;Mexico;Netherlands;Russian Federation;Spain |
| 7 | NCT02885610 (ClinicalTrials.gov) | December 2015 | 26/8/2016 | Study of RC18 Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE) | A Phase IIb , Placebo-Controlled ,Multi-Center, Randomized, Double-Blind, Dose-explorating Trial of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Systemic Lupus Erythematosus (SLE). | Systemic Lupus Erythematosus | Biological: Placebo plus standard therapy;Biological: RC18 80 mg plus standard therapy;Biological: RC18 160 mg plus standard therapy;Biological: RC18 240 mg plus standard therapy | RemeGen | NULL | Completed | 18 Years | 65 Years | All | 249 | Phase 2 | China |
| 8 | NCT01632241 (ClinicalTrials.gov) | February 19, 2013 | 28/6/2012 | Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE) | A Phase 3/4, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Adult Subjects of Black Race With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Biological: Placebo plus standard therapy;Biological: Belimumab 10 mg/kg plus standard therapy;Drug: Standard therapy | Human Genome Sciences Inc., a GSK Company | GlaxoSmithKline | Completed | 18 Years | N/A | All | 503 | Phase 4 | United States;Brazil;Colombia;France;South Africa;United Kingdom |
| 9 | EUCTR2011-000368-88-IT (EUCTR) | 04/02/2013 | 11/12/2012 | A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patient 5 to 17 years of age. | A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE). - Belimumab in pediatric patients with SLE | Systemic lupus erythematosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta (belimumab) INN or Proposed INN: BELIMUMAB | GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD. | NULL | Not Recruiting | Female: yes Male: yes | 100 | United States;Mexico;Canada;Argentina;Spain;Brazil;Peru;Netherlands;United Kingdom;Italy | |||
| 10 | EUCTR2011-000368-88-NL (EUCTR) | 03/12/2012 | 02/07/2012 | A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age | A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE) - Belimumab in pediatric patients with SLE | Systemic Lupus Erythematosus MedDRA version: 17.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: BENLYSTA™ (belimumab) Product Name: Benlysta (belimumab) Product Code: GSK1550188 INN or Proposed INN: belimumab | GlaxoSmithKline Research & Development Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | United States;Mexico;Canada;Argentina;Poland;Brazil;Spain;Peru;Russian Federation;Netherlands;Italy;United Kingdom | |||
| 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 |
| 11 | NCT01705977 (ClinicalTrials.gov) | November 27, 2012 | 10/10/2012 | Belimumab Assessment of Safety in SLE | A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab | Systemic Lupus Erythematosus | Biological: Placebo plus standard therapy;Biological: Belimumab 10 mg/kg plus standard therapy;Other: Standard therapy | Human Genome Sciences Inc., a GSK Company | GlaxoSmithKline | Active, not recruiting | 18 Years | N/A | All | 4019 | Phase 4 | United States;Argentina;Australia;Brazil;Bulgaria;Canada;Chile;Colombia;Croatia;Czechia;Estonia;Hong Kong;Hungary;Indonesia;Italy;Korea, Republic of;Lithuania;Malaysia;Mexico;New Zealand;Peru;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Switzerland;Taiwan;Thailand;Ukraine;Czech Republic;Norway |
| 12 | NCT01649765 (ClinicalTrials.gov) | September 7, 2012 | 23/7/2012 | Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy | A Multi-center, Randomized, Placebo-Controlled Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: belimumab 10mg/kg;Other: placebo | GlaxoSmithKline | Human Genome Sciences Inc., a GSK Company | Active, not recruiting | 5 Years | 17 Years | All | 93 | Phase 2 | United States;Argentina;Canada;Japan;Mexico;Peru;Poland;Russian Federation;Spain;United Kingdom;Brazil;Italy;Netherlands |
| 13 | EUCTR2011-000368-88-ES (EUCTR) | 27/07/2012 | 21/05/2012 | A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age. | A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE). - Belimumab in pediatric patients with SLE | Systemic Lupus Erythematosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: BENLYSTA? (belimumab) Product Name: Benlysta (belimumab) Product Code: GSK1550188 INN or Proposed INN: belimumab | GlaxoSmithKline, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Germany;Netherlands;Italy;Brazil;Russian Federation;United Kingdom;Canada;Peru;Argentina;Mexico;Spain;United States;Poland | |||
| 14 | EUCTR2011-000368-88-GB (EUCTR) | 13/06/2012 | 18/04/2012 | A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age | A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE) - Belimumab in pediatric patients with SLE | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: BENLYSTA™ (belimumab) Product Name: Benlysta (belimumab) Product Code: GSK1550188 INN or Proposed INN: belimumab | GlaxoSmithKline Research & Development Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United States;Mexico;Canada;Argentina;Spain;Poland;Brazil;Peru;Russian Federation;Netherlands;Italy;United Kingdom | ||
| 15 | NCT01484496 (ClinicalTrials.gov) | November 16, 2011 | 28/11/2011 | A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Biological: Placebo;Biological: Belimumab 200 mg SC;Drug: Standard therapy | Human Genome Sciences Inc., a GSK Company | GlaxoSmithKline | Completed | 18 Years | N/A | All | 839 | Phase 3 | United States;Argentina;Austria;Belgium;Brazil;Bulgaria;Chile;Colombia;Croatia;Czechia;Denmark;France;Germany;Hungary;Italy;Japan;Malaysia;Mexico;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Spain;Sweden;Taiwan;Thailand;Ukraine;United Kingdom;Czech Republic |
| 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 |
| 16 | NCT00479622 (ClinicalTrials.gov) | August 2007 | 25/5/2007 | Study of TRU-015 in Subjects With Membranous Nephropathy Secondary to Systemic Lupus Erythematosus | A Randomized, Two-Arm, Parallel Group Study of the Safety, Pharmacokinetics, and Pharmacodynamics of TRU-015 Added to Standard Therapy in Subjects With Membranous Nephropathy Secondary to Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: TRU-015 | Wyeth is now a wholly owned subsidiary of Pfizer | Emergent Product Development Seattle LLC | Terminated | 18 Years | 70 Years | Both | 20 | Phase 1 | United States |
| 17 | EUCTR2011-000368-88-Outside-EU/EEA (EUCTR) | 17/02/2014 | A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age | A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE) - Belimumab in pediatric patients with SLE | Systemic Lupus Erythematosus MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: BENLYSTA™ (belimumab) Product Name: Benlysta (belimumab) Product Code: GSK1550188 INN or Proposed INN: belimumab | GlaxoSmithKline Research & Development Ltd | NULL | NA | Female: yes Male: yes | 100 | Argentina;Brazil;Netherlands;Mexico;Peru;Poland;Russian Federation;Germany;Canada;Italy;Spain;United Kingdom;United States | ||||
| 18 | EUCTR2011-000368-88-PL (EUCTR) | 04/06/2012 | A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age | A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with SLE - Belimumab in pediatric patients with SLE | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: BENLYSTA™ (belimumab) Product Name: Benlysta (belimumab) Product Code: GSK1550188 INN or Proposed INN: belimumab | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Mexico;Canada;Argentina;Brazil;Spain;Poland;Peru;Russian Federation;Netherlands;Italy;United Kingdom |
| 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 | EUCTR2013-000366-11-RO (EUCTR) | 25/03/2015 | 11/03/2015 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Serbia;Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | |||
| 2 | EUCTR2013-000366-11-SK (EUCTR) | 19/06/2014 | 21/05/2014 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Denmark;Bulgaria;Latvia;Sweden | ||
| 3 | EUCTR2013-000366-11-BG (EUCTR) | 23/04/2014 | 06/03/2014 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 4 | EUCTR2013-000366-11-LV (EUCTR) | 14/03/2014 | 07/02/2014 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 5 | EUCTR2013-000366-11-LT (EUCTR) | 10/03/2014 | 22/01/2014 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 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 |
| 6 | EUCTR2013-000366-11-HU (EUCTR) | 24/02/2014 | 28/11/2013 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 7 | EUCTR2013-000366-11-PL (EUCTR) | 12/12/2013 | 05/09/2013 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Latvia;Sweden | ||
| 8 | EUCTR2013-000366-11-ES (EUCTR) | 07/10/2013 | 12/07/2013 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Belarus;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Latvia;Sweden | |||
| 9 | EUCTR2013-000366-11-CZ (EUCTR) | 12/09/2013 | 05/06/2013 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 10 | EUCTR2013-000366-11-BE (EUCTR) | 02/09/2013 | 11/07/2013 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 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 |
| 11 | EUCTR2013-000366-11-GB (EUCTR) | 30/08/2013 | 09/07/2013 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | |||
| 12 | EUCTR2013-000366-11-FI (EUCTR) | 20/08/2013 | 05/07/2013 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 13 | EUCTR2013-000366-11-IE (EUCTR) | 17/07/2013 | 16/05/2013 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 14 | EUCTR2013-000366-11-DK (EUCTR) | 10/07/2013 | 10/07/2013 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 15 | EUCTR2013-000366-11-SE (EUCTR) | 28/06/2013 | 13/05/2013 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 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 |
| 16 | NCT00705484 (ClinicalTrials.gov) | June 1, 2007 | 23/6/2008 | European Safety Registry in Ulcerative Colitis (P04808) | Ulcerative Colitis European Registry: A Prospective, Observational, Non-interventional, Post-Marketing Safety Surveillance Program | Ulcerative Colitis | Biological: infliximab;Drug: Standard Therapy | Merck Sharp & Dohme Corp. | Centocor, Inc. | Completed | 18 Years | N/A | All | 2239 | Austria;Belgium;Czech Republic;Denmark;France;Germany;Greece;Ireland;Italy;Netherlands;Spain;Sweden;United Kingdom;United States |