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
| 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 | EUCTR2010-020892-22-NL (EUCTR) | 03/08/2013 | 10/08/2011 | Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X) | A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis - OSKIRA - X | Rheumatoid Arthritis MedDRA version: 14.0;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 disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 2000 | United States;Serbia;Portugal;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;India;France;Peru;Australia;South Africa;Latvia;Netherlands;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany | |||
| 2 | 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 |
| 3 | 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 | |||
| 4 | NCT01640054 (ClinicalTrials.gov) | July 2012 | 2/7/2012 | A Long Term Study to Assess the Safety of Fostamatinib in Patients in Asia With Rheumatoid Arthritis | (OSKIRA-Asia-1X): A Long-term Study to Assess the Safety of Fostamatinib in the Treatment of Rheumatoid Arthritis in Asia | Rheumatoid Arthritis | Drug: Fostamatinib | AstraZeneca | NULL | Terminated | 18 Years | N/A | All | 115 | Phase 2 | Hong Kong;Japan;Korea, Republic of;Taiwan;Thailand;Vietnam |
| 5 | 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 | |||
| 6 | 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 | |||
| 7 | 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 |
| 8 | NCT01569074 (ClinicalTrials.gov) | April 2012 | 30/3/2012 | Evaluation of Safety and Effectiveness of Fostamatinib Compared to Placebo in Patients in Asia With Rheumatoid Arthritis | (OSKIRA-Asia-1): A Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Dose Ranging Study in Asia Evaluating Efficacy and Safety of Fostamatinib in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate Therapy | Rheumatoid Arthritis | Drug: Fostamatinib;Drug: Placebo | AstraZeneca | NULL | Terminated | 18 Years | N/A | All | 163 | Phase 2 | Hong Kong;Japan;Korea, Republic of;Taiwan;Thailand;Vietnam |
| 9 | EUCTR2010-023692-26-SK (EUCTR) | 09/09/2011 | 13/09/2011 | Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4) | (OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis - OSKIRA - 4 | Rheumatoid arthritis MedDRA version: 14.0;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 disodium Product Code: previously known as R935788 INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Germany;Netherlands | ||
| 10 | EUCTR2010-020745-27-HU (EUCTR) | 31/08/2011 | 11/07/2011 | Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist (OSKIRA - 3) | A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonist - OSKIRA - 3 | Rheumatoid Arthritis MedDRA version: 14.0;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 disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;South Africa;Germany | ||
| 11 | 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 |
| 12 | EUCTR2010-023692-26-GB (EUCTR) | 07/04/2011 | 18/11/2010 | Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4) | (OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis - OSKIRA - 4 | Rheumatoid arthritis MedDRA version: 13.1;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 disodium Product Code: previously known as R935788 INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Netherlands;Germany | ||
| 13 | NCT01336218 (ClinicalTrials.gov) | April 2011 | 14/4/2011 | Effects of Administration of Fostamatinib on Blood Concentrations of Rifampicin in Healthy Subjects. | An Open-Label, Non-Randomized, 2-Period, Single Center Study to Assess the Single Dose Pharmacokinetics of R406 in Healthy Subjects When Fostamatinib 150 mg is Administered Alone and in Combination With Rifampicin | Rheumatoid Arthritis;Healthy Volunteers | Drug: fostamatinib;Drug: rifampicin | AstraZeneca | NULL | Completed | 18 Years | 55 Years | Both | 15 | Phase 1 | United States |
| 14 | EUCTR2010-023692-26-BG (EUCTR) | 17/03/2011 | 24/02/2011 | Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4) | (OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis - OSKIRA - 4 | 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 disodium Product Code: previously known as R935788 INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 370 | Phase 2 | Netherlands;United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;Bulgaria;South Africa;Germany | ||
| 15 | 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 |
| 16 | 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 |
| 17 | NCT01311622 (ClinicalTrials.gov) | March 2011 | 21/2/2011 | Effects of Administration of Fostamatinib on Blood Concentrations of Warfarin in Healthy Subjects | An Open-Label, Single Centre Study to Assess the Pharmacokinetics and Pharmacodynamics of Warfarin When Co-Administered With Fostamatinib in Healthy Subjects | Rheumatoid Arthritis;Healthy Subjects | Drug: warfarin;Drug: fostamatinib | AstraZeneca | NULL | Completed | 18 Years | 55 Years | Both | 15 | Phase 1 | United Kingdom |
| 18 | EUCTR2010-020745-27-IT (EUCTR) | 18/02/2011 | 22/12/2010 | A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonist. D4300C00003 - OSKIRA-3 | A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonist. D4300C00003 - OSKIRA-3 | Patients with active Rheumatoid Arthritis (RA), despite treatment with methotrexate, who have had an inadequate response to a single TNF-alfa antagonist. MedDRA version: 9.1;Level: PT;Classification code 10039073 | Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib | ASTRAZENECA | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | France;Portugal;Hungary;Czech Republic;Spain;Germany;United Kingdom;Italy | ||
| 19 | EUCTR2010-020744-35-IT (EUCTR) | 18/02/2011 | 22/12/2010 | A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs. D4300C00002 - OSKIRA-2 | A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs. D4300C00002 - OSKIRA-2 | Patients with active Rheumatoid Arthritis despite current treatment with a DMARD. MedDRA version: 9.1;Level: PT;Classification code 10039073 | Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib | ASTRAZENECA | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | Portugal;Czech Republic;Spain;Lithuania;Latvia;Germany;United Kingdom;Italy | ||
| 20 | EUCTR2010-020744-35-DE (EUCTR) | 17/02/2011 | 21/07/2010 | Evaluation of Effectiveness of Two Dosing Regimens of FostamatinibCompared to Placebo in Patients With Rheumatoid Arthritis (RA) WhoAre Taking Disease Modifying Anti-rheumatic Drug (DMARD) But NotResponding. (OSKIRA - 2) | A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs - OSKIRA - 2 | 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 disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | Portugal;Serbia;United States;Spain;Ukraine;Lithuania;Israel;Italy;United Kingdom;India;Czech Republic;Canada;Romania;South Africa;Latvia;Germany | ||
| 21 | EUCTR2010-020892-22-DE (EUCTR) | 17/02/2011 | 21/07/2010 | Evaluation of Long-term Safety and Effectiveness of Fostamatinib in theTreatment of Rheumatoid Arthritis (RA) (OSKIRA-X) | A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X | 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 disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 2000 | Serbia;Portugal;United States;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;Australia;South Africa;Netherlands;Latvia;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany | |||
| 22 | EUCTR2010-020745-27-DE (EUCTR) | 17/02/2011 | 21/07/2010 | Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist (OSKIRA - 3) | A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonist - OSKIRA - 3 | 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 disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;South Africa;Germany | ||
| 23 | EUCTR2010-023692-26-CZ (EUCTR) | 16/02/2011 | 22/12/2010 | Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4) | (OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis - OSKIRA - 4 | 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 disodium Product Code: previously known as R935788 INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Germany;Netherlands | ||
| 24 | EUCTR2010-020743-12-DE (EUCTR) | 15/02/2011 | 21/07/2010 | Evaluation of Effectiveness of Two Dosing Regimens of FostamatinibCompared to Placebo in Patients With Rheumatoid Arthritis (RA) WhoAre Taking Methotrexate But Not Responding. (OSKIRA - 1) | A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate - OSKIRA - 1 | Rheumatoid arthritis MedDRA version: 13.1;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 disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Ukraine;Chile;Russian Federation;United Kingdom;India;France;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Peru;Australia;Bulgaria;Germany | ||
| 25 | EUCTR2010-020892-22-IT (EUCTR) | 08/02/2011 | 22/12/2010 | A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA-X | A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA-X | Patients with active Rheumatoid Arthritis (RA) who have participated in a qualifying study. MedDRA version: 9.1;Level: PT;Classification code 10039073 | Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib | ASTRAZENECA | NULL | Not Recruiting | Female: yes Male: yes | 2000 | Portugal;Czech Republic;Estonia;Hungary;Spain;Lithuania;Bulgaria;Latvia;Germany;United Kingdom;Italy | |||
| 26 | EUCTR2010-023692-26-HU (EUCTR) | 04/02/2011 | 08/02/2011 | Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4) | (OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis - OSKIRA - 4 | Rheumatoid arthritis MedDRA version: 16.0;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 disodium Product Code: previously known as R935788 INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Hungary;Czech Republic;Canada;Poland;South Africa;Bulgaria;Germany;Netherlands | ||
| 27 | NCT02092961 (ClinicalTrials.gov) | February 2011 | 19/3/2014 | Randomised Double-Blind, Placebo-Controlled, Parallel Group Study in Patients With Active Rheumatoid Arthritis:Magnetic Resonance Imaging Sub-Study | A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared With Placebo or Adalimumab Monotherapy in Patients With Active Rheumatoid Arthritis: Magnetic Resonance Imaging Sub-Study | Rheumatoid Arthritis | Drug: Fostamatinib;Drug: Adalimumab;Drug: Placebo of Fostamatinib;Drug: Placebo of Adalimumab | AstraZeneca | NULL | Terminated | 18 Years | N/A | All | 198 | Phase 2 | United States;Bulgaria;Canada;Czech Republic;Germany;Hungary;Netherlands;Poland;Russian Federation;South Africa;United Kingdom |
| 28 | EUCTR2010-020892-22-BG (EUCTR) | 13/01/2011 | 09/11/2010 | Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X) | A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X | 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 disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 2000 | Serbia;Portugal;United States;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;Australia;South Africa;Netherlands;Latvia;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany | |||
| 29 | EUCTR2010-020743-12-PL (EUCTR) | 11/01/2011 | 01/10/2010 | Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Not Responding. (OSKIRA - 1) | A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate - OSKIRA - 1 | 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 disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Ukraine;Russian Federation;Chile;United Kingdom;India;France;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Peru;Australia;Bulgaria;Germany | ||
| 30 | NCT01242514 (ClinicalTrials.gov) | January 2011 | 10/11/2010 | Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) | (OSKIRA-X): A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Fostamatinib | AstraZeneca | NULL | Terminated | 18 Years | N/A | All | 1917 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;Chile;Colombia;Czech Republic;Estonia;France;Germany;Hungary;India;Israel;Italy;Latvia;Lithuania;Mexico;Peru;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom;Netherlands;Turkey |
| 31 | NCT01264770 (ClinicalTrials.gov) | January 2011 | 17/12/2010 | Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) | (OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared With Adalimumab Monotherapy in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Fostamatinib and placebo injections;Drug: Adalimumab and placebo of fostamatinib;Drug: Placebo of fostamatinib, fostamatinib, and placebo injections | AstraZeneca | NULL | Terminated | 18 Years | N/A | All | 644 | Phase 2 | United States;Bulgaria;Canada;Czech Republic;Germany;Hungary;Netherlands;Poland;Russian Federation;Slovakia;South Africa;Ukraine;United Kingdom |
| 32 | EUCTR2010-020892-22-PT (EUCTR) | 17/12/2010 | 17/09/2010 | A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X | A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 2000 | Portugal;Estonia;Spain;Lithuania;United Kingdom;Italy;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands | |||
| 33 | EUCTR2010-020744-35-PT (EUCTR) | 17/12/2010 | 16/09/2010 | A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs - OSKIRA - 2 | A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs - OSKIRA - 2 | Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | Portugal;Czech Republic;Spain;Lithuania;Latvia;Germany;Italy;United Kingdom | ||
| 34 | EUCTR2010-020745-27-PT (EUCTR) | 17/12/2010 | 16/09/2010 | A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonist - OSKIRA - 3 | A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonist - OSKIRA - 3 | Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | France;Portugal;Hungary;Czech Republic;Spain;Germany;Italy;United Kingdom | ||
| 35 | EUCTR2010-020745-27-FR (EUCTR) | 14/12/2010 | 05/10/2010 | A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonist - OSKIRA - 3 | A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonist - OSKIRA - 3 | Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;France;Hungary;Czech Republic;Spain;Belgium;Germany;Italy;United Kingdom | ||
| 36 | EUCTR2010-020743-12-FR (EUCTR) | 14/12/2010 | 05/10/2010 | A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate - OSKIRA - 1 | A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate - OSKIRA - 1 | Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | France;Estonia;Hungary;Slovakia;Poland;Belgium;Bulgaria;Germany;United Kingdom | ||
| 37 | EUCTR2010-020745-27-ES (EUCTR) | 13/12/2010 | 30/09/2010 | A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonistEstudio en fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar dos pautas posológicas de fostamatinib disódico en pacientes con artritis reumatoide que tienen una respuesta insuficiente a un antagonista del TNF-alfa - OSKIRA - 3 | A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonistEstudio en fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar dos pautas posológicas de fostamatinib disódico en pacientes con artritis reumatoide que tienen una respuesta insuficiente a un antagonista del TNF-alfa - OSKIRA - 3 | Rheumatoid ArthritisArtritis reumatoide MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | France;Portugal;Hungary;Czech Republic;Belgium;Spain;Germany;Italy;United Kingdom | ||
| 38 | EUCTR2010-020892-22-ES (EUCTR) | 13/12/2010 | 05/10/2010 | A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid ArthritisEstudio de extensión a largo plazo para evaluar la seguridad y la eficacia de fostamatinib disódico (FosD) en el tratamiento de la artritisreumatoide - OSKIRA - X | A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid ArthritisEstudio de extensión a largo plazo para evaluar la seguridad y la eficacia de fostamatinib disódico (FosD) en el tratamiento de la artritisreumatoide - OSKIRA - X | Rheumatoid ArthritisArtritis reumatoide MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 2000 | Portugal;Czech Republic;Estonia;Hungary;Spain;Lithuania;Bulgaria;Netherlands;Latvia;Germany;Italy;United Kingdom | |||
| 39 | EUCTR2010-020744-35-ES (EUCTR) | 13/12/2010 | 23/09/2010 | A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDsEstudio en fase III, multicéntrico, aleatorizado, dobleciego, controlado con placebo y de grupos paralelos para evaluar dos pautas posológicas defostamatinib disódico en pacientes con artritis reumatoide que tienen una respuesta insuficientea los FARME - OSKIRA - 2 | A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDsEstudio en fase III, multicéntrico, aleatorizado, dobleciego, controlado con placebo y de grupos paralelos para evaluar dos pautas posológicas defostamatinib disódico en pacientes con artritis reumatoide que tienen una respuesta insuficientea los FARME - OSKIRA - 2 | Rheumatoid ArthritisArtritis reumatoide MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | Portugal;Czech Republic;Spain;Lithuania;Latvia;Germany;Italy;United Kingdom | ||
| 40 | EUCTR2010-020892-22-BE (EUCTR) | 23/11/2010 | 01/07/2010 | Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X) | A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X | Rheumatoid Arthritis MedDRA version: 16.0;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 disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 2000 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;India;France;Peru;Australia;South Africa;Netherlands;Latvia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany | ||
| 41 | EUCTR2010-020745-27-BE (EUCTR) | 23/11/2010 | 01/07/2010 | Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist (OSKIRA - 3) | A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonist - OSKIRA - 3 | Rheumatoid Arthritis MedDRA version: 13.1;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 disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;South Africa;Germany | ||
| 42 | EUCTR2010-020743-12-BE (EUCTR) | 23/11/2010 | 07/07/2010 | A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate - OSKIRA - 1 | A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate - OSKIRA - 1 | Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | France;Estonia;Hungary;Slovakia;Poland;Belgium;Bulgaria;Germany;United Kingdom | ||
| 43 | EUCTR2010-020743-12-BG (EUCTR) | 10/11/2010 | 09/11/2010 | A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate - OSKIRA - 1 | A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate - OSKIRA - 1 | Rheumatoid arthritis MedDRA version: 15.1;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 disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Ukraine;Russian Federation;Chile;United Kingdom;India;France;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Peru;Bulgaria;Germany | ||
| 44 | NCT01245790 (ClinicalTrials.gov) | November 2010 | 19/11/2010 | A Study of Fostamatinib in Subjects With Impaired Kidney Function | An Open-label, Phase I Study to Assess the Pharmacokinetics of R406 in Subjects With Renal Impairment Compared to Healthy Subjects Following Administration of a Single Dose of Fostamatinib 150 mg | Rheumatoid Arthritis;Renal Impairment | Drug: fostamatinib | AstraZeneca | NULL | Completed | 18 Years | N/A | Both | 24 | Phase 1 | United States |
| 45 | EUCTR2010-020743-12-GB (EUCTR) | 26/10/2010 | 05/07/2010 | A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate - OSKIRA - 1 | A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate - OSKIRA - 1 | Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | France;Estonia;Hungary;Slovakia;Poland;Belgium;Bulgaria;Germany;United Kingdom | ||
| 46 | EUCTR2010-020745-27-GB (EUCTR) | 26/10/2010 | 05/07/2010 | Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist (OSKIRA - 3) | A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonist - OSKIRA - 3 | Rheumatoid Arthritis MedDRA version: 13.1;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 disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | France;Portugal;United States;Spain;Israel;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;South Africa;Germany | ||
| 47 | EUCTR2010-020892-22-GB (EUCTR) | 26/10/2010 | 05/07/2010 | Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X) | A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X | 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 disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 2000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Portugal;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;Australia;South Africa;Netherlands;Latvia;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany | ||
| 48 | EUCTR2010-020744-35-GB (EUCTR) | 26/10/2010 | 05/07/2010 | Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. (OSKIRA - 2) | A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs - OSKIRA - 2 | Rheumatoid Arthritis MedDRA version: 13.1;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 disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Portugal;Serbia;Spain;Ukraine;Lithuania;Israel;United Kingdom;Italy;India;Czech Republic;Canada;Romania;South Africa;Germany;Latvia | ||
| 49 | EUCTR2010-020892-22-LV (EUCTR) | 22/10/2010 | 13/08/2010 | Evaluation of Long-term Safety and Effectiveness of Fostamatinib in theTreatment of Rheumatoid Arthritis (RA) (OSKIRA-X) | A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis - OSKIRA - X | 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 disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 2000 | United States;Portugal;Serbia;Estonia;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;India;France;Australia;Peru;South Africa;Latvia;Netherlands;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany | |||
| 50 | EUCTR2010-020744-35-LV (EUCTR) | 22/10/2010 | 13/08/2010 | Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. (OSKIRA - 2) | A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs - OSKIRA - 2 | 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 disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Portugal;Serbia;Spain;Ukraine;Lithuania;Israel;United Kingdom;Italy;Czech Republic;Canada;Romania;South Africa;Latvia;Germany | ||
| 51 | EUCTR2010-020892-22-HU (EUCTR) | 15/10/2010 | 11/08/2010 | A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X | A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X | Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 2000 | Portugal;Czech Republic;Estonia;Hungary;Spain;Lithuania;Bulgaria;Latvia;Germany;Italy;United Kingdom | |||
| 52 | EUCTR2010-020743-12-HU (EUCTR) | 14/10/2010 | 11/08/2010 | A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate - OSKIRA - 1 | A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate - OSKIRA - 1 | Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | France;Estonia;Hungary;Poland;Bulgaria;Germany;United Kingdom | ||
| 53 | EUCTR2010-020745-27-CZ (EUCTR) | 11/10/2010 | 30/08/2010 | Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist (OSKIRA - 3) | A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonist - OSKIRA - 3 | Rheumatoid Arthritis MedDRA version: 13.1;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 disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;South Africa;Germany | ||
| 54 | EUCTR2010-020892-22-SK (EUCTR) | 11/10/2010 | 05/08/2010 | Evaluation of Long-term Safety and Effectiveness of Fostamatinib in theTreatment of Rheumatoid Arthritis (RA) (OSKIRA-X) | A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis - OSKIRA - X | Rheumatoid Arthritis MedDRA version: 14.0;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 disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 2000 | United States;Serbia;Portugal;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;India;France;Peru;Australia;South Africa;Netherlands;Latvia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany | |||
| 55 | EUCTR2010-020744-35-LT (EUCTR) | 11/10/2010 | 18/08/2010 | Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. (OSKIRA - 2) | A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs - OSKIRA - 2 | 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 disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Portugal;Serbia;Spain;Ukraine;Lithuania;Israel;United Kingdom;Italy;India;Czech Republic;Canada;Romania;South Africa;Germany;Latvia | ||
| 56 | EUCTR2010-020892-22-LT (EUCTR) | 11/10/2010 | 18/08/2010 | Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X) | A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis - OSKIRA - X | Rheumatoid Arthritis MedDRA version: 14.0;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 disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 2000 | United States;Serbia;Portugal;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;India;France;Peru;Australia;South Africa;Netherlands;Latvia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany | |||
| 57 | EUCTR2010-020743-12-SK (EUCTR) | 11/10/2010 | 05/08/2010 | Evaluation of Effectiveness of Two Dosing Regimens of FostamatinibCompared to Placebo in Patients With Rheumatoid Arthritis (RA) WhoAre Taking Methotrexate But Not Responding. (OSKIRA - 1) | A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate - OSKIRA - 1 | Rheumatoid arthritis MedDRA version: 14.0;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 disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Ukraine;Russian Federation;Chile;United Kingdom;India;France;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Peru;Australia;Bulgaria;Germany | ||
| 58 | EUCTR2010-020892-22-CZ (EUCTR) | 11/10/2010 | 30/08/2010 | Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X) | A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X | Rheumatoid Arthritis MedDRA version: 16.0;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 disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 2000 | Serbia;Portugal;United States;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;Australia;South Africa;Netherlands;Latvia;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany | |||
| 59 | EUCTR2010-020744-35-CZ (EUCTR) | 11/10/2010 | 30/08/2010 | Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. (OSKIRA - 2) | A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs - OSKIRA - 2 | Rheumatoid Arthritis MedDRA version: 13.1;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 disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Portugal;Serbia;Spain;Ukraine;Lithuania;Israel;United Kingdom;Italy;India;Czech Republic;Canada;Romania;South Africa;Germany;Latvia | ||
| 60 | EUCTR2010-020892-22-EE (EUCTR) | 27/09/2010 | 16/08/2010 | Evaluation of Long-term Safety and Effectiveness of Fostamatinib in theTreatment of Rheumatoid Arthritis (RA) (OSKIRA-X) | A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis - OSKIRA - X | Rheumatoid Arthritis MedDRA version: 13.1;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 disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 2000 | United States;Serbia;Portugal;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;India;France;Peru;Australia;South Africa;Netherlands;Latvia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany | |||
| 61 | EUCTR2010-020743-12-EE (EUCTR) | 24/09/2010 | 16/08/2010 | Evaluation of Effectiveness of Two Dosing Regimens of FostamatinibCompared to Placebo in Patients With Rheumatoid Arthritis (RA) WhoAre Taking Methotrexate But Not Responding. (OSKIRA - 1) | A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate - OSKIRA - 1 | Rheumatoid arthritis MedDRA version: 13.1;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 disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | Astra Zeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Ukraine;Russian Federation;Chile;United Kingdom;India;France;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Peru;Bulgaria;Germany | ||
| 62 | NCT01197755 (ClinicalTrials.gov) | September 2010 | 8/9/2010 | Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist | (OSKIRA-3): A Phase III, Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients With Inadequate Response to a TNF-alpha Antagonist | Rheumatoid Arthritis | Drug: fostamatinib;Drug: placebo | AstraZeneca | NULL | Completed | 18 Years | N/A | All | 323 | Phase 3 | United States;Argentina;Belgium;Brazil;Canada;Czech Republic;France;Germany;Hungary;Israel;Italy;Mexico;Portugal;South Africa;Spain;United Kingdom;Australia |
| 63 | NCT01197534 (ClinicalTrials.gov) | September 2010 | 8/9/2010 | Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. | (OSKIRA-2): A Phase III, Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients With an Inadequate Response to DMARDs | Rheumatoid Arthritis | Drug: fostamatinib;Drug: placebo, fostamatinib | AstraZeneca | NULL | Completed | 18 Years | N/A | All | 913 | Phase 3 | United States;Canada;Czech Republic;Germany;India;Israel;Italy;Latvia;Lithuania;Portugal;Romania;Serbia;South Africa;Spain;Ukraine;United Kingdom |
| 64 | NCT01197521 (ClinicalTrials.gov) | September 2010 | 8/9/2010 | Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Not Responding. | (OSKIRA-1): A Phase III, Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate | Rheumatoid Arthritis | Drug: fostamatinib;Drug: placebo, fostamatinib | AstraZeneca | NULL | Completed | 18 Years | N/A | All | 923 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Chile;Estonia;France;Hungary;India;Mexico;Peru;Poland;Slovakia;Ukraine;United Kingdom;Germany;Russian Federation |
| 65 | EUCTR2008-000744-13-BG (EUCTR) | 19/03/2009 | 26/01/2009 | Long Term Follow On Safety Study of Fostamatinib in Patients Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study | An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study | 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: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788 Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788 Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788 Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788 | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 800 | France;United States;Mexico;Belgium;Poland;Romania;Peru;Bulgaria;Germany;Colombia;Italy | |||
| 66 | EUCTR2008-000744-13-FR (EUCTR) | 10/02/2009 | 21/10/2008 | An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study | An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788 Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788 Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788 Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788 | Rigel Pharmaceuticals, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Germany;Bulgaria;France;Italy | |||
| 67 | EUCTR2008-000744-13-BE (EUCTR) | 09/12/2008 | 08/10/2008 | An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study | An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788 Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788 Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788 Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788 | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 2 | France;Belgium;Bulgaria;Germany;Italy | ||
| 68 | EUCTR2008-000742-30-HU (EUCTR) | 18/10/2008 | 24/04/2008 | A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate | A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788 Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788 | Rigel Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 2 | Hungary;Bulgaria;Poland | ||
| 69 | EUCTR2008-000742-30-BG (EUCTR) | 15/10/2008 | 14/08/2008 | A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate | A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788 Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788 | Rigel Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 2 | Hungary;Bulgaria;Poland | ||
| 70 | EUCTR2008-000742-30-PL (EUCTR) | 17/09/2008 | 30/09/2008 | A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate | A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788 Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788 | Rigel Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 2 | Hungary;Bulgaria;Poland | ||
| 71 | EUCTR2008-000743-34-DE (EUCTR) | 10/09/2008 | 10/06/2008 | A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients with Rheumatoid Arthritis Who Have Failed at Least One Biologic | A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients with Rheumatoid Arthritis Who Have Failed at Least One Biologic | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788 | Rigel Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | Germany;France;Italy | ||
| 72 | NCT00805467 (ClinicalTrials.gov) | August 2008 | 5/12/2008 | Open-Label, Multicenter Extension Study for Patients Completing Treatment Phase of a Rigel-Sponsored R935788 Studies | An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients With Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study | Rheumatoid Arthritis | Drug: Fostamatinib Disodium (R935788) | AstraZeneca | NULL | Terminated | 18 Years | N/A | All | 624 | Phase 2 | United States;Belgium;Bulgaria;Colombia;France;Germany;Italy;Mexico;Peru;Poland;Romania |
| 73 | EUCTR2008-000743-34-FR (EUCTR) | 21/07/2008 | 17/04/2008 | A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients with Rheumatoid Arthritis Who Have Failed at Least One Biologic | A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients with Rheumatoid Arthritis Who Have Failed at Least One Biologic | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788 | Rigel Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | France;Belgium;Germany;Italy | ||
| 74 | EUCTR2008-000743-34-BE (EUCTR) | 18/06/2008 | 09/04/2008 | A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients with Rheumatoid Arthritis Who Have Failed at Least One Biologic | A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients with Rheumatoid Arthritis Who Have Failed at Least One Biologic | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788 | Rigel Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | France;Belgium;Germany;Italy | ||
| 75 | NCT00665925 (ClinicalTrials.gov) | May 2008 | 22/4/2008 | Efficacy and Safety Study of R935788 Tablets to Treat Rheumatoid Arthritis | A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate | Rheumatoid Arthritis | Drug: Fostamatinib disodium (R935788);Drug: Placebo | Rigel Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 457 | Phase 2 | United States;Bulgaria;Colombia;Mexico;Poland;Romania;Israel |
| 76 | NCT00665626 (ClinicalTrials.gov) | May 2008 | 22/4/2008 | Efficacy and Safety Study of R935788 Tablets to Treat Rheumatoid Arthritis (Taski-3) | A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients With Rheumatoid Arthritis Who Have Failed at Least One Biologic | Rheumatoid Arthritis | Drug: Fostamatinib disodium (R935788);Drug: Placebo | Rigel Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 219 | Phase 2 | United States;Belgium;Colombia;France;Germany;Italy;Peru;Brazil |
| 77 | EUCTR2008-000744-13-DE (EUCTR) | 07/10/2008 | An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study | An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788 Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788 | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 800 | France;Belgium;Bulgaria;Germany;Italy | ||||
| 78 | JPRN-JapicCTI-121843 | 28/05/2012 | OSKIRA-Asia-1 | A Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Dose Ranging Study in Asia Evaluating Efficacy and Safety of Fostamatinib in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate Therapy | Rheumatoid Arthritis | Intervention name : Fostamatinib Dosage And administration of the intervention : 100mg twice daily for 12 weeks Intervention name : Fostamatinib Dosage And administration of the intervention : 75mg twice daily for 12 weeks Intervention name : Fostamatinib Dosage And administration of the intervention : 50mg twice daily for 12 weeks Intervention name : Fostamatinib Dosage And administration of the intervention : 100mg twice daily for 4 weeks, followed by150mg once daily up to Week 12 Control intervention name : Placebo Dosage And administration of the control intervention : twice daily for 12 weeks | AstraZeneca | NULL | 18 | BOTH | Phase 2 | NULL | ||||
| 79 | EUCTR2010-023692-26-DE (EUCTR) | 07/12/2010 | Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared with Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4) | (OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis - OSKIRA - 4 | 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 disodium Product Code: previously known as R935788 INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 370 | Phase 2 | United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Germany;Netherlands | |||
| 80 | JPRN-JapicCTI-121990 | 22/10/2012 | OSKIRA-Asia-1X | A Long-term Study to Assess the Safety of Fostamatinib in the Treatment of Rheumatoid Arthritis in Asia | Rheumatoid Arthritis | Intervention name : Fostamatinib Dosage And administration of the intervention : 100mg once daily | AstraZeneca | NULL | 18 | BOTH | Phase 2 | NULL |