OFATUMUMAB ( DrugBank: Ofatumumab )
3 diseases
告示番号 | 疾患名(ページ内リンク) | 臨床試験数 |
---|---|---|
13 | 多発性硬化症/視神経脊髄炎 | 126 |
35 | 天疱瘡 | 7 |
46 | 悪性関節リウマチ | 28 |
13. 多発性硬化症/視神経脊髄炎
臨床試験数 : 3,342 / 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241
Showing 1 to 10 of 126 diseases
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 | NCT05266469 (ClinicalTrials.gov) | May 1, 2022 | 23/2/2022 | Exploring the Profiles of RMS Patients on Ofatumumab or Ocrelizumab in a Real-World Setting in the Gulf Exploring the Profiles of RMS Patients on Ofatumumabor Ocrelizumab in a Real-World Setting in the Gu ... | Exploring the Characteristics and Profiles of Relapsing Multiple Sclerosis Patients Initiated on Ofatumumab or Ocrelizumab in a Real-World Setting in the Gulf Region Exploring the Characteristics and Profiles of Relapsing Multiple Sclerosis Patients Initiated on Ofa ... | Relapsing Multiple Sclerosis | Other: Ofatumumab;Other: Ocrelizumab | Novartis Pharmaceuticals | NULL | Not yet recruiting | 18 Years | 100 Years | All | 240 | NULL | |
2 | NCT05090033 (ClinicalTrials.gov) | April 30, 2022 | 22/9/2021 | Characterizing the Use of Ofatumumab in a Real World Setting | Secondary Use of Data Study Characterizing Kesimpta (Ofatumumab) Onboarding and Utilization in RMS Patients Using MSGo, With a Non-interventional Primary Use of Data Sub-study Comparing Patient Reported Outcomes Relative to Clinical Outcomes (EAFToS) Secondary Use of Data Study Characterizing Kesimpta (Ofatumumab) Onboarding and Utilization in RMS P ... | Relapsing Multiple Sclerosis | Other: ofatumumab | Novartis Pharmaceuticals | NULL | Not yet recruiting | 18 Years | N/A | All | 3500 | NULL | |
3 | NCT05285904 (ClinicalTrials.gov) | March 30, 2022 | 8/3/2022 | Kesimpta® (Ofatumumab) in Swiss Multiple Sclerosis Patients - an Observational Study | Kesimpta® (Ofatumumab) in Swiss Multiple Sclerosis Patients - an Observational Study (KOSMOS) | Multiple Sclerosis | Other: Ofatumumab | Novartis Pharmaceuticals | NULL | Not yet recruiting | 18 Years | 99 Years | All | 149 | NULL | |
4 | NCT05090371 (ClinicalTrials.gov) | March 2, 2022 | 12/10/2021 | A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation A Multicenter Study of Continued Current Therapy vs Transition to OfatumumabAfter Neurofilament (NfL ... | A Randomized, Open Label, Multi-center, Active-comparator Study to Assess Efficacy, Safety & Tolerability of Ofatumumab 20mg sc Monthly Versus Continued Current Therapy in Relapsing-remitting Multiple Sclerosis After Elevation of Serum Neurofilament Light Levels (SOSTOS) A Randomized, Open Label, Multi-center, Active-comparator Study to Assess Efficacy, Safety & Tolerab ... | Relapsing-Remitting Multiple Sclerosis | Drug: Ofatumumab;Drug: Disease modifying treatment (DMT) | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 50 Years | All | 150 | Phase 4 | United States |
5 | NCT05171972 (ClinicalTrials.gov) | January 29, 2022 | 10/12/2021 | Reduced Oligodendrocyte-specific Cytotoxicity and Ofatumumab Treatment | Assessing Reduced Oligodendrocyte-specific Cytotoxicity of Peripheral Blood Leukocytes in Patients With Multiple Sclerosis Following Treatment With Ofatumumab Assessing Reduced Oligodendrocyte-specific Cytotoxicity of Peripheral Blood Leukocytes in Patients W ... | Relapsing Remitting Multiple Sclerosis | Drug: Ofatumumab | University of Southern California | Novartis Pharmaceuticals | Recruiting | 18 Years | 65 Years | All | 40 | United States | |
6 | NCT05084638 (ClinicalTrials.gov) | January 25, 2022 | 7/10/2021 | Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls. Study to Assess the Effect of Ofatumumabin Treatment Naïve, Very Early RRMS Patients Benchmarked Aga ... | AGNOS: An 18-month, Open-label, Multi-Center Study to Assess the Effect of Ofatumumab 20mg SC Monthly in Treatment Naïve, Very Early Relapsing Remitting Multiple Sclerosis Patients Benchmarked Against Healthy Controls on Select Outcomes. AGNOS: An 18-month, Open-label, Multi-Center Study to Assess the Effect of Ofatumumab20mg SC Monthly ... | Relapse Remitting Multiple Sclerosis | Drug: Ofatumumab | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 35 Years | All | 168 | Phase 4 | United States |
7 | EUCTR2020-002700-39-HR (EUCTR) | 29/11/2021 | 06/12/2021 | Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis. Efficacy and safety of ofatumumaband siponimod compared to fingolimod in pediatric patients with mul ... | A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ... | Multiple Sclerosis in pediatric patients MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] Multiple Sclerosis in pediatric patients MedDRA version: 20.1;Level: PT;Classification code 10028245 ... | Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Siponimod Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade ... | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Serbia;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany United States;Serbia;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation; ... | ||
8 | NCT04926818 (ClinicalTrials.gov) | October 5, 2021 | 14/6/2021 | Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis Efficacy and Safety of Ofatumumaband Siponimod Compared to Fingolimod in Pediatric Patients With Mul ... | A 2-year Randomized, 3-arm, Double-blind, Non-inferiority Study Comparing the Efficacy and Safety of Ofatumumab and Siponimod Versus Fingolimod in Pediatric Patients With Multiple Sclerosis Followed by an Open-label Extension A 2-year Randomized, 3-arm, Double-blind, Non-inferiority Study Comparing the Efficacy and Safety of ... | Multiple Sclerosis (MS) | Drug: Fingolimod;Drug: Ofatumumab;Drug: Siponimod;Other: Fingolimod placebo;Other: Siponimod placebo;Other: Ofatumumab placebo Drug: Fingolimod;Drug: Ofatumumab;Drug: Siponimod;Other: Fingolimod placebo;Other: Siponimod placebo ... | Novartis Pharmaceuticals | NULL | Recruiting | 10 Years | 17 Years | All | 180 | Phase 3 | United States;Australia;Austria;Belgium;France;Germany;India;Latvia;Mexico;Poland;Portugal;Russian Federation;Slovakia;Spain;Turkey United States;Australia;Austria;Belgium;France;Germany;India;Latvia;Mexico;Poland;Portugal;Russian F ... |
9 | EUCTR2020-002700-39-SK (EUCTR) | 04/10/2021 | 16/06/2021 | Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis. Efficacy and safety of ofatumumaband siponimod compared to fingolimod in pediatric patients with mul ... | A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ... | Multiple Sclerosis in pediatric patients MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] Multiple Sclerosis in pediatric patients MedDRA version: 20.1;Level: PT;Classification code 10028245 ... | Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Siponimod Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade ... | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Portugal;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany United States;Portugal;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation; ... | ||
10 | EUCTR2020-002700-39-PL (EUCTR) | 29/09/2021 | 10/08/2021 | Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis. Efficacy and safety of ofatumumaband siponimod compared to fingolimod in pediatric patients with mul ... | A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ... | Multiple Sclerosis in pediatric patients MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] Multiple Sclerosis in pediatric patients MedDRA version: 20.1;Level: PT;Classification code 10028245 ... | Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade ... | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Serbia;United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Romania;Croatia;Germany Serbia;United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile; ... |
35. 天疱瘡
臨床試験数 : 98 / 薬物数 : 126 - (DrugBank : 41) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 168
Showing 1 to 7 of 7 diseases
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 | NCT02613910 (ClinicalTrials.gov) | December 23, 2015 | 23/11/2015 | Long-Term Extension Study of Ofatumumab in Subjects With Pemphigus Vulgaris | OPV117059: A Long-Term Extension Study of Ofatumumab Injection for Subcutaneous Use in Subjects With Pemphigus Vulgaris OPV117059: A Long-Term Extension Study of OfatumumabInjection for Subcutaneous Use in Subjects With ... | Pemphigus | Drug: Ofatumumab;Drug: Acetaminophen/paracetamol;Drug: Antihistamine (cetirizine or equivalent);Drug: Prednisone/Prednisolone Drug: Ofatumumab;Drug: Acetaminophen/paracetamol;Drug: Antihistamine (cetirizine or equivalent);Drug ... | GlaxoSmithKline | NULL | Terminated | N/A | N/A | All | 1 | Phase 3 | United States |
2 | EUCTR2013-001370-20-PL (EUCTR) | 03/07/2015 | 23/04/2015 | Study of subcutaneous Ofatumumab Injections for Pemphigus Vulgaris | OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the E ... | Pemphigus Vulgaris MedDRA version: 19.1;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] Pemphigus Vulgaris MedDRA version: 19.1;Level: LLT;Classification code 10052802;Term: Pemphigus vulg ... | Product Name: ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB Product Name: ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB Product Name: ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB Product Name: ofatumu ... | Glaxo Group Ltd | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 3 | United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;Japan;Korea, Republic of United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;J ... | ||
3 | EUCTR2013-001370-20-FR (EUCTR) | 20/04/2015 | 13/07/2015 | Study of subcutaneous Ofatumumab Injections for Pemphigus Vulgaris | OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the E ... | Pemphigus Vulgaris MedDRA version: 18.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] Pemphigus Vulgaris MedDRA version: 18.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulg ... | Product Name: ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | Glaxo Group Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 136 | United States;France;Poland;Ukraine;Croatia;Australia;Russian Federation;Israel;Italy;Japan;China;Korea, Republic of United States;France;Poland;Ukraine;Croatia;Australia;Russian Federation;Israel;Italy;Japan;China;Ko ... | |||
4 | EUCTR2013-001370-20-GR (EUCTR) | 12/12/2014 | 11/12/2014 | Study of subcutaneous Ofatumumab Injections for Pemphigus Vulgaris | OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the E ... | Pemphigus Vulgaris MedDRA version: 17.1;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] Pemphigus Vulgaris MedDRA version: 17.1;Level: LLT;Classification code 10052802;Term: Pemphigus vulg ... | Product Name: ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | Glaxo Group Ltd | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 3 | United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;Japan;Korea, Republic of United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;J ... | ||
5 | EUCTR2013-001370-20-IT (EUCTR) | 26/11/2014 | 25/08/2014 | Study of subcutaneous Ofatumumab Injections for Pemphigus Vulgaris | OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the E ... | Pemphigus Vulgaris MedDRA version: 17.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] Pemphigus Vulgaris MedDRA version: 17.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulg ... | Product Name: ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | Glaxo Group Ltd | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 3 | United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;Japan;Korea, Republic of United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;J ... | ||
6 | EUCTR2013-001370-20-HR (EUCTR) | 17/11/2014 | 02/12/2014 | Study of subcutaneous Ofatumumab Injections for Pemphigus Vulgaris | OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the E ... | Pemphigus Vulgaris MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] Pemphigus Vulgaris MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulg ... | Product Name: ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB Product Name: ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB Product Name: ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB Product Name: ofatumu ... | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 3 | United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;Japan;Korea, Republic of United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;J ... | ||
7 | NCT01920477 (ClinicalTrials.gov) | August 13, 2013 | 3/7/2013 | Efficacy and Safety of Ofatumumab in Treatment of Pemphigus Vulgaris | OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects With Pemphigus Vulgaris OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the E ... | Pemphigus Vulgaris | Biological: Ofatumumab;Biological: Placebo | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 70 Years | All | 35 | Phase 3 | United States;Australia;Greece;Israel;Italy;Japan;Poland;Romania;Croatia;France;Korea, Republic of;Russian Federation;Ukraine United States;Australia;Greece;Israel;Italy;Japan;Poland;Romania;Croatia;France;Korea, Republic of;R ... |
46. 悪性関節リウマチ
臨床試験数 : 4,325 / 薬物数 : 2,671 - (DrugBank : 417) / 標的遺伝子数 : 187 - 標的パスウェイ数 : 224
Showing 1 to 10 of 28 diseases
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 | EUCTR2008-002046-27-DE (EUCTR) | 08/12/2008 | 08/07/2008 | Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate Clinical phase I/IIA study of subcutaneous administration of Ofatumumabin Rheumatoid Arthritis patie ... | Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate Clinical phase I/IIA study of subcutaneous administration of Ofatumumabin Rheumatoid Arthritis patie ... | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid ar ... | Product Name: Ofatumumab Product Code: GSK1841157 Other descriptive name: HuMax-CD20 | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 1/2 | Germany;Belgium;France;Spain | ||
2 | EUCTR2008-002046-27-BE (EUCTR) | 05/11/2008 | 17/09/2008 | Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate Clinical phase I/IIA study of subcutaneous administration of Ofatumumabin Rheumatoid Arthritis patie ... | Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate Clinical phase I/IIA study of subcutaneous administration of Ofatumumabin Rheumatoid Arthritis patie ... | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid ar ... | Product Name: Ofatumumab Product Code: GSK1841157 Other descriptive name: HuMax-CD20 | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 1/2 | Germany;Belgium;France;Spain | ||
3 | EUCTR2007-002950-42-GB (EUCTR) | 27/10/2008 | 20/03/2008 | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofa ... | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofa ... | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid ar ... | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline Research & Development | NULL | Not Recruiting | Female: yes Male: yes | 248 | Phase 3 | Czech Republic;Hungary;Belgium;Spain;Poland;Lithuania;United Kingdom | ||
4 | EUCTR2008-002046-27-ES (EUCTR) | 14/10/2008 | 06/05/2010 | Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate. Ensayo clínico fase I/IIA de administración subcutánea de ofatumumab en pacientes con artritis reumatoide tratados con dosis estables de metotrexato. Clinical phase I/IIA study of subcutaneous administration of Ofatumumabin Rheumatoid Arthritis patie ... | Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate. Ensayo clínico fase I/IIA de administración subcutánea de ofatumumab en pacientes con artritis reumatoide tratados con dosis estables de metotrexato. Clinical phase I/IIA study of subcutaneous administration of Ofatumumabin Rheumatoid Arthritis patie ... | Rheumatoid ArthritisArtritis Reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis Rheumatoid ArthritisArtritis Reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073; ... | Product Name: Ofatumumab Product Code: GSK1841157 Other descriptive name: HuMax-CD20 | GlaxoSmithKline S.A. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 1/2 | Germany;Belgium;France;Spain | ||
5 | EUCTR2008-002046-27-FR (EUCTR) | 05/09/2008 | 15/07/2008 | OFA110867 : Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate OFA110867 : Clinical phase I/IIA study of subcutaneous administration of Ofatumumabin Rheumatoid Art ... | OFA110867 : Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate OFA110867 : Clinical phase I/IIA study of subcutaneous administration of Ofatumumabin Rheumatoid Art ... | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid ar ... | Product Name: Ofatumumab Product Code: GSK1841157 Other descriptive name: HuMax-CD20 | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 1;Phase 2 | France;Spain;Belgium;Germany | ||
6 | EUCTR2007-002951-18-DE (EUCTR) | 16/08/2008 | 30/06/2008 | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofa ... | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofa ... | Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid ar ... | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline Research & Development | NULL | Not Recruiting | Female: yes Male: yes | 236 | Phase 3 | France;Spain;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
7 | EUCTR2007-002951-18-GB (EUCTR) | 07/08/2008 | 14/03/2008 | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofa ... | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofa ... | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid ar ... | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline Research & Development | NULL | Not Recruiting | Female: yes Male: yes | 236 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ... | Denmark;Germany;Netherlands;Italy;United Kingdom;Sweden;Spain;France | ||
8 | EUCTR2007-002950-42-BE (EUCTR) | 25/07/2008 | 24/06/2008 | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofa ... | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofa ... | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid ar ... | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | Genmab A/S | NULL | Not Recruiting | Female: yes Male: yes | 248 | Phase 3 | Czech Republic;Hungary;Spain;Poland;Belgium;Lithuania;United Kingdom | ||
9 | NCT00686868 (ClinicalTrials.gov) | June 13, 2008 | 28/5/2008 | Study to Evaluate SC Route of Administration of Ofatumumab in RA Patients | Clinical Phase I/IIA Study of Subcutaneously Administration of Ofatumumab in Rheumatoid Arthritis Patients on Stable Dose Methotrexate Clinical Phase I/IIA Study of Subcutaneously Administration of Ofatumumabin Rheumatoid Arthritis Pat ... | Arthritis, Rheumatoid | Other: placebo;Drug: ofatumumab | GlaxoSmithKline | NULL | Completed | 18 Years | N/A | All | 35 | Phase 1 | United States;Australia;Belgium;France;Italy;New Zealand;Poland;Russian Federation;Spain;Canada;Germany;Hungary;Netherlands United States;Australia;Belgium;France;Italy;New Zealand;Poland;Russian Federation;Spain;Canada;Germ ... |
10 | EUCTR2007-002951-18-SE (EUCTR) | 11/06/2008 | 25/03/2008 | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofa ... | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofa ... | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid ar ... | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | Genmab A/S | NULL | Not Recruiting | Female: yes Male: yes | 236 | Phase 3 | Germany;United Kingdom;Netherlands;Denmark;France;Spain;Italy;Sweden |