Fostamatinib 100 mg (DrugBank: Fostamatinib)
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 | 8 |
| 49 | 全身性エリテマトーデス | 0 |
| 61 | 自己免疫性溶血性貧血 | 0 |
| 66 | IgA腎症 | 2 |
| 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 | NCT01725230 (ClinicalTrials.gov) | November 2012 | 7/11/2012 | Assess the Pharmacokinetics of Rosuvastatin and Simvastatin When Administered Alone or in Combination With Fostamatinib | An Open-label, Non-randomized, 2-Period, Fixed Sequence, Single-center Study to Assess the Pharmacokinetics of Rosuvastatin and Simvastatin in Healthy Subjects When Administered Alone and in Combination With Fostamatinib 100 mg Twice Daily | Rheumatoid Arthritis | Drug: Fostamatinib;Drug: Rosuvastatin;Drug: Simvastatin | AstraZeneca | NULL | Completed | 18 Years | 55 Years | Both | 42 | Phase 1 | United States |
| 2 | EUCTR2011-006070-73-DE (EUCTR) | 28/08/2012 | 24/02/2012 | Evaluation of the Effect of Fostamatinib Dosed at 100mg twice a Day on Blood Pressure when Walking, Moving Around and Living Normal Daily Life in Patients with Rheumatoid Arthritis | A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fostamatinib 100 mg Twice Daily on 24-hour Ambulatory Blood Pressure in Patients with Rheumatoid Arthritis - Oskira ABPM | Rheumatoid arthritis MedDRA version: 15.0;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: Fostamatinib 50 mg blue film-coated tablet Product Code: R935788 INN or Proposed INN: Fostamatinib disodium Other descriptive name: R788 sodium hexahydrate, RIG2-01, RIG-G | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 130 | United States;Czech Republic;Mexico;Argentina;Brazil;Poland;Ukraine;Peru;Bulgaria;South Africa;Germany | |||
| 3 | EUCTR2011-006070-73-BG (EUCTR) | 22/05/2012 | 07/05/2012 | Evaluation of the Effect of Fostamatinib Dosed at 100mg twice a Day on Blood Pressure when Walking, Moving Around and Living Normal Daily Life in Patients with Rheumatoid Arthritis | A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fostamatinib 100 mg Twice Daily on 24-hour Ambulatory Blood Pressure in Patients with Rheumatoid Arthritis - Oskira ABPM | Rheumatoid arthritis MedDRA version: 14.1;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: Fostamatinib 50 mg blue film-coated tablet Product Code: R935788 INN or Proposed INN: Fostamatinib disodium Other descriptive name: R788 sodium hexahydrate, RIG2-01, RIG-G | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 130 | United States;Czech Republic;Mexico;Argentina;Brazil;Poland;Ukraine;Peru;South Africa;Bulgaria;Germany | |||
| 4 | EUCTR2011-006070-73-CZ (EUCTR) | 16/05/2012 | 29/02/2012 | Evaluation of the Effect of Fostamatinib Dosed at 100mg twice a Day on Blood Pressure when Walking, Moving Around and Living Normal Daily Life in Patients with Rheumatoid Arthritis | A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fostamatinib 100 mg Twice Daily on 24-hour Ambulatory Blood Pressure in Patients with Rheumatoid Arthritis - Oskira ABPM | Rheumatoid arthritis MedDRA version: 14.1;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: Fostamatinib 50 mg blue film-coated tablet Product Code: R935788 INN or Proposed INN: Fostamatinib disodium Other descriptive name: R788 sodium hexahydrate, RIG2-01, RIG-G | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 130 | United States;Czech Republic;Mexico;Argentina;Brazil;Poland;Ukraine;Peru;Bulgaria;South Africa;Germany | |||
| 5 | NCT01563978 (ClinicalTrials.gov) | April 2012 | 23/3/2012 | Study of the Effect of Fostamatinib Twice Daily on Blood Pressure in Patients With Rheumatoid Arthritis | OSKIRA-ABPM: A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fostamatinib 100 mg Twice Daily on 24-hour Ambulatory Blood Pressure in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: fostamatinib;Drug: placebo | AstraZeneca | NULL | Completed | 18 Years | N/A | All | 266 | Phase 2 | United States;Bulgaria;Czech Republic;Germany;Poland;South Africa;Ukraine;Argentina;Mexico;Peru |
| 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 | NCT01355354 (ClinicalTrials.gov) | June 2011 | 17/5/2011 | Effects of Administration of Fostamatinib on Blood Concentrations of Digoxin in Healthy Subjects | An Open-Label, Non-Randomised, 2-Period, Single Centre Study to Assess the Pharmacokinetics of Digoxin in Healthy Subjects When Administered Alone and in Combination With Fostamatinib 100 mg Twice Daily | Healthy Volunteers;Rheumatoid Arthritis | Drug: Digoxin;Drug: Fostamatinib | AstraZeneca | NULL | Completed | 18 Years | 45 Years | Both | 21 | Phase 1 | United Kingdom |
| 7 | NCT01276262 (ClinicalTrials.gov) | March 2011 | 12/1/2011 | Effects of Administration of Fostamatinib on Blood Concentrations of an Oral Contraceptive in Healthy Female Subjects | A Single-blind, Placebo-controlled, 2-period, Fixed Sequence Study to Determine the Effects of Coadministration of Fostamatinib 100 mg Twice Daily on the Pharmacokinetics of an Oral Contraceptive in Healthy Female Subjects | Scientific Terminology Rheumatoid Arthritis, Healthy Female Volunteers, Pharmacokinetics, Oral Contraceptive, Drug-drug Interaction;Laymen Terminology Level of Oral Contraceptive in Blood, Oral Contraceptive, Rheumatoid Arthritis, Drug -Drug Interaction | Drug: fostamatinib;Drug: Microgynon® 30 (Oral contraceptive);Drug: Placebo | AstraZeneca | NULL | Completed | 18 Years | 45 Years | Female | 22 | Phase 1 | United Kingdom |
| 8 | NCT01309854 (ClinicalTrials.gov) | March 2011 | 21/2/2011 | Effects of Administration of Fostamatinib on Blood Concentrations of Pioglitazone in Healthy Subjects | An Open-Label, Single Center Study to Assess the Pharmacokinetics of Pioglitazone in Healthy Subjects When Administered Alone and in Combination With Fostamatinib 100 mg Twice Daily | Rheumatoid Arthritis;Healthy Volunteers;Pharmacokinetics;Pioglitazone;Drug-drug Interaction;Amount of Pioglitazone in Blood | Drug: fostamatinib;Drug: pioglitazone | AstraZeneca | NULL | Completed | 18 Years | 55 Years | Both | 15 | Phase 1 | United States |
| 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 | NCT02112838 (ClinicalTrials.gov) | October 2014 | 10/4/2014 | Safety and Efficacy Study of Fostamatinib to Treat Immunoglobin A (IgA) Nephropathy | A Phase 2, Multi-Center, Randomised, Double-Blind, Ascending-Dose, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of Fostamatinib in the Treatment of IgA Nephropathy | IGA Nephropathy | Drug: Fostamatinib 150 mg;Drug: Fostamatinib 100 mg;Drug: Placebo | Rigel Pharmaceuticals | NULL | Completed | 18 Years | 70 Years | All | 76 | Phase 2 | United States;Austria;Germany;Hong Kong;Taiwan;United Kingdom;Singapore;Switzerland |
| 2 | EUCTR2014-000331-16-AT (EUCTR) | 25/08/2014 | 22/07/2014 | N/A | A Phase 2, Multi-Center, Randomised, Double-Blind, Ascending-Dose, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of Fostamatinib in the Treatment of IgA Nephropathy - N/A | IgA nephropathy (IgAN);Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: Fostamatinib 100 mg tablet Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: FOSTAMATINIB DISODIUM Product Name: Fostamatinib 150 mg tablet Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: FOSTAMATINIB DISODIUM | Rigel Pharmaceuticals Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | United States;Hong Kong;Taiwan;Singapore;Austria;United Kingdom;Switzerland |