46. 悪性関節リウマチ
[臨床試験数:4,183,薬物数:2,538(DrugBank:401),標的遺伝子数:183,標的パスウェイ数:219]
Searched query = "Malignant rheumatoid arthritis", "Rheumatoid arthritis", "Rheumatoid arthritis with vasculitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
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 | 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 | |||
2 | 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 | |||
3 | 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 | |||
4 | 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 | ||
5 | 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 | ||
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 | 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 2B | Netherlands;United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;Bulgaria;South Africa;Germany | ||
7 | 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 2B | United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Germany;Netherlands | ||
8 | 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 2B | United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Hungary;Czech Republic;Canada;Poland;South Africa;Bulgaria;Germany;Netherlands | ||
9 | 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 | |||
10 | 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 | |||
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 | EUCTR2008-000744-13-IT (EUCTR) | 28/01/2009 | 09/01/2009 | 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 - ND | 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 - ND | Reumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: R935788 INN or Proposed INN: Fosfamatinib Disodium Product Name: R935788 INN or Proposed INN: Fosfamatinib Disodium | RIGEL PHARMACEUTICALS INC | NULL | Not Recruiting | Female: yes Male: yes | 800 | France;Bulgaria;Germany;Italy | |||
12 | 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 | ||
13 | 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 | ||
14 | 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 | ||
15 | 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 | ||
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 | EUCTR2008-000743-34-IT (EUCTR) | 11/09/2008 | 01/10/2008 | Studio di Fase II multicentrico, randomizzato, in doppio cieco, controllato verso placebo, parallel-dose di R935788 in pazienti affetti da artrite reumatoide che hanno sperimentato fallimento di almeno un biologico - ND | Studio di Fase II multicentrico, randomizzato, in doppio cieco, controllato verso placebo, parallel-dose di R935788 in pazienti affetti da artrite reumatoide che hanno sperimentato fallimento di almeno un biologico - ND | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: R935788 | RIGEL PHARMACEUTICALS INC | NULL | Not Recruiting | Female: yes Male: yes | 195 | Germany;France;Italy | |||
17 | 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 | ||
18 | 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 |
19 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 195 | Phase 2 | Germany;France;Italy | ||
20 | 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 | ||
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 |
21 | 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 |
22 | 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 |
23 | NCT00326339 (ClinicalTrials.gov) | August 2006 | 12/5/2006 | Treatment of Arthritis With Syk Kinase Inhibition (TASKI-1) | A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Dose Ranging Study to Evaluate Up to Three Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate | Rheumatoid Arthritis | Drug: R788;Drug: Placebo | Rigel Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | Both | 189 | Phase 2 | United States;Mexico |
24 | 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 | ||||
25 | 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 2B | United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Germany;Netherlands |