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 | 89 |
| 35 | 天疱瘡 | 7 |
| 46 | 悪性関節リウマチ | 28 |
| 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 | NCT04667117 (ClinicalTrials.gov) | December 17, 2020 | 8/12/2020 | A Multicenter Study to Assess Response to Influenza Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab | An Open-label Multicenter Study to Assess Response to Influenza Vaccine in Participants With Multiple Sclerosis Treated With Ofatumumab 20 mg Subcutaneously | Relapsing Multiple Sclerosis | Biological: Quadrivalent influenza vaccine;Drug: Ofatumumab | Novartis Pharmaceuticals | NULL | Not yet recruiting | 18 Years | 55 Years | All | 66 | Phase 4 | NULL |
| 2 | NCT04486716 (ClinicalTrials.gov) | October 19, 2020 | 23/7/2020 | A Single Arm Study Evaluating the Efficacy, Safety and Tolerability of Ofatumumab in Patients With Relapsing Multiple Sclerosis | A Single-arm, Prospective, Multi-center Study to Explore Maintained Efficacy With Ofatumumab Therapy in Patients With Relapsing Multiple Sclerosis Who Discontinue Intravenously Delivered Anti-CD20 Monoclonal Antibody (aCD20 mAb) Therapy (OLIKOS) | Relapsing Multiple Sclerosis | Drug: Ofatumumab | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 55 Years | All | 100 | Phase 3 | United States |
| 3 | EUCTR2019-001341-40-AT (EUCTR) | 10/09/2020 | 07/07/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 4 | NCT04510220 (ClinicalTrials.gov) | August 2020 | 31/7/2020 | 9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple Sclerosis | Open-label, Observational, Prospective, 9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: Ofatumumab;Drug: [F-18]PBR06 | Brigham and Women's Hospital | Novartis | Not yet recruiting | 18 Years | 60 Years | All | 10 | Phase 3 | United States |
| 5 | NCT04353492 (ClinicalTrials.gov) | July 14, 2020 | 16/4/2020 | An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Dimethyl Fumarate or Fingolimod to Ofatumumab | A Single-arm, Prospective, Multicentre, Open-label Study to Evaluate Ofatumumab Treatment Effectiveness and Patient Reported Outcomes in Patients With Relapsing Multiple Sclerosis Transitioning From Dimethyl Fumarate or Fingolimod Therapy | Relapsing Multiple Sclerosis | Biological: Ofatumumab | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 60 Years | All | 550 | Phase 3 | United States;Australia;Belgium;Bulgaria;Czechia;Germany;Greece;Hungary;Portugal;Russian Federation;Slovakia;Spain;Turkey |
| 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 | EUCTR2019-001341-40-PT (EUCTR) | 15/06/2020 | 31/03/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | Austria;Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 7 | EUCTR2019-001341-40-BG (EUCTR) | 12/06/2020 | 07/05/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 8 | EUCTR2019-001341-40-GR (EUCTR) | 20/05/2020 | 10/03/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | United States;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 9 | EUCTR2019-001341-40-CZ (EUCTR) | 07/05/2020 | 11/02/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway;Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom | ||
| 10 | EUCTR2019-001341-40-HU (EUCTR) | 29/04/2020 | 11/03/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 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 | EUCTR2019-001341-40-BE (EUCTR) | 29/04/2020 | 17/03/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 12 | EUCTR2019-001341-40-ES (EUCTR) | 24/04/2020 | 07/05/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy - ARTIOS | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Farmacéutica S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 13 | EUCTR2017-004703-51-GB (EUCTR) | 18/06/2019 | 15/10/2018 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2233 | Phase 3 | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | |||
| 14 | EUCTR2017-004703-51-BE (EUCTR) | 17/06/2019 | 15/01/2019 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2233 | Phase 3 | United States;Portugal;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Peru;South Africa;Latvia;Netherlands;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Norway;Japan;Sweden | ||
| 15 | EUCTR2017-004703-51-HR (EUCTR) | 06/05/2019 | 03/06/2019 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2233 | Phase 3 | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | EUCTR2017-004703-51-GR (EUCTR) | 24/04/2019 | 27/03/2019 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2233 | Phase 3 | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | |||
| 17 | EUCTR2017-004703-51-NL (EUCTR) | 29/03/2019 | 16/10/2018 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2233 | Phase 3 | United States;Portugal;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Peru;South Africa;Netherlands;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Norway;Japan;Sweden | ||
| 18 | EUCTR2017-004703-51-LV (EUCTR) | 28/03/2019 | 24/01/2019 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2233 | Phase 3 | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | |||
| 19 | EUCTR2017-004703-51-PT (EUCTR) | 18/03/2019 | 24/10/2018 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2233 | Phase 3 | United States;Portugal;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 20 | EUCTR2017-004703-51-LT (EUCTR) | 19/02/2019 | 03/12/2018 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2233 | Phase 3 | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | EUCTR2017-004703-51-ES (EUCTR) | 31/01/2019 | 25/10/2018 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Novartis Farmacéutica, S.A | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2233 | Phase 3 | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | |||
| 22 | EUCTR2017-004702-17-PL (EUCTR) | 25/01/2019 | 17/10/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy | ||
| 23 | EUCTR2017-004703-51-FR (EUCTR) | 18/01/2019 | 22/10/2018 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2233 | Phase 3 | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | |||
| 24 | EUCTR2017-004703-51-DK (EUCTR) | 18/01/2019 | 11/12/2018 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2233 | Phase 3 | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 25 | EUCTR2017-004703-51-DE (EUCTR) | 10/01/2019 | 27/09/2018 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2233 | Phase 3 | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | EUCTR2017-004703-51-FI (EUCTR) | 02/01/2019 | 11/12/2018 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2233 | Phase 3 | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | |||
| 27 | NCT03650114 (ClinicalTrials.gov) | December 28, 2018 | 17/8/2018 | Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS | An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Biological: Ofatumumab;Biological: Tetanus toxoid (TT) containing vaccine (Td, Tdap);Biological: 13-valent pneumococcal conjugate vaccine (13-PCV);Biological: 23-valent pneumococcal polysaccharide vaccine (23-PPV);Biological: Seasonal Quadrivalent influenza vaccine;Biological: Keyhole limpet hemocyanin (KLH) neo-antigen | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 2010 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Finland;France;Germany;Greece;Hungary;India;Israel;Japan;Latvia;Lithuania;Mexico;Netherlands;Norway;Peru;Poland;Portugal;Russian Federation;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;United Kingdom |
| 28 | EUCTR2017-004703-51-SE (EUCTR) | 17/12/2018 | 15/11/2018 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2233 | Phase 3 | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | |||
| 29 | EUCTR2017-004702-17-ES (EUCTR) | 12/12/2018 | 17/09/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Estonia;Czech Republic;Poland;Spain;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy | |||
| 30 | EUCTR2017-004702-17-BG (EUCTR) | 03/12/2018 | 23/10/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;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 |
| 31 | EUCTR2017-004703-51-HU (EUCTR) | 29/11/2018 | 11/10/2018 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2233 | Phase 3 | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 32 | EUCTR2017-004703-51-AT (EUCTR) | 28/11/2018 | 17/10/2018 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2233 | Phase 3 | United States;Portugal;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Peru;South Africa;Latvia;Netherlands;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Norway;Japan;Sweden | ||
| 33 | EUCTR2017-004703-51-SK (EUCTR) | 21/11/2018 | 28/09/2018 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2233 | Phase 3 | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 34 | EUCTR2017-004702-17-IT (EUCTR) | 07/11/2018 | 04/11/2020 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients - ND | Multiple sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10028053;Term: MS;System Organ Class: 10029205 - Nervous system disorders 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] | Trade Name: FORMISTIN - 10 MG COMPRESSE RIVESTITE CON FILM 20 COMPRESSE Product Name: Formistin 10 mg Product Code: [Formistin 10 mg] Trade Name: TACHIPIRINA - 500 MG COMPRESSE20 COMPRESSE Product Name: Tachipirina Product Code: [Tachipirina CPR 500mg] Other descriptive name: paracetamolo 500 mg Trade Name: SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML Product Name: Solumedrol IM 125mg/2ml Product Code: [Metilprednisolone] Other descriptive name: Metilprednisolone sodio succinato Trade Name: Arzerra Product Name: ofatumumab Product Code: [OMB157] INN or Proposed INN: Ofatumumab Other descriptive name: Ofatumumab Trade Name: Arzerra Product Name: ofatumumab Product Code: [OMB157] INN or Proposed INN: Ofatumumab Other descriptive name: OFATUMUMAB | NOVARTIS PHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Czechia;Estonia;Spain;Lithuania;Austria;Russian Federation;Italy;Czech Republic;Poland;Bulgaria;Germany;Latvia | ||
| 35 | EUCTR2017-004702-17-LV (EUCTR) | 02/11/2018 | 03/09/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Germany;Latvia;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 |
| 36 | EUCTR2017-004702-17-LT (EUCTR) | 31/10/2018 | 17/09/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy | ||
| 37 | EUCTR2017-004702-17-CZ (EUCTR) | 23/10/2018 | 16/08/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy | ||
| 38 | EUCTR2017-004702-17-EE (EUCTR) | 17/09/2018 | 28/08/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Czech Republic;Estonia;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy | ||
| 39 | NCT03560739 (ClinicalTrials.gov) | September 11, 2018 | 15/5/2018 | A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients | A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients | Multiple Sclerosis | Combination Product: ofatumumab with PRF;Combination Product: ofatumumab with AI | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 55 Years | All | 284 | Phase 2 | United States;Austria;Bulgaria;Czechia;Estonia;Latvia;Lithuania;Russian Federation;Spain |
| 40 | EUCTR2017-004702-17-AT (EUCTR) | 01/09/2018 | 10/08/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;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 |
| 41 | JPRN-JapicCTI-173711 | 15/3/2018 | 14/09/2017 | Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab | A 24-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Ofatumumab in Patients With Relapsing Multiple Sclerosis Followed by an Extended Treatment of at Least 24 Weeks With Open-label Ofatumumab | Relapsing Multiple Sclerosis | Intervention name : Ofatumumab INN of the intervention : - Dosage And administration of the intervention : Ofatumumab 20 mg subcutaneous injections every 4 weeks Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Placebo subcutaneous injection matching to ofatumumab every 4 weeks | Novartis Pharma K.K. | NULL | complete | 18 | 55 | BOTH | 30 | Phase 2 | Japan, Russia |
| 42 | NCT03249714 (ClinicalTrials.gov) | March 15, 2018 | 11/8/2017 | Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab | A 24-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Ofatumumab in Patients With Relapsing Multiple Sclerosis Followed by an Extended Treatment of at Least 24 Weeks With Open-label Ofatumumab | Relapsing Multiple Sclerosis | Drug: Ofatumumab subcutaneous injection;Drug: Placebo subcutaneous injection matching ofatumumab | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 55 Years | All | 64 | Phase 2 | Japan;Russian Federation |
| 43 | EUCTR2015-005418-31-FR (EUCTR) | 07/03/2017 | 12/01/2017 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 19.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Saudi Arabia;Slovakia;Greece;Spain;Thailand;Russian Federation;Israel;Chile;Switzerland;India;France;Australia;Denmark;Netherlands;Kuwait;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden | ||
| 44 | EUCTR2015-005419-33-HR (EUCTR) | 10/02/2017 | 05/06/2017 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany | ||
| 45 | EUCTR2015-005418-31-CZ (EUCTR) | 31/01/2017 | 14/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;Australia;Denmark;Netherlands;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 46 | EUCTR2015-005419-33-CZ (EUCTR) | 31/01/2017 | 20/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157G INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany | ||
| 47 | EUCTR2015-005419-33-BG (EUCTR) | 19/01/2017 | 25/11/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany;United States;Portugal | ||
| 48 | EUCTR2015-005418-31-NL (EUCTR) | 04/01/2017 | 08/08/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden | ||
| 49 | EUCTR2015-005418-31-HR (EUCTR) | 13/12/2016 | 15/12/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Israel;Chile;Russian Federation;Switzerland;India;Australia;Denmark;Netherlands;Kuwait;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden | ||
| 50 | EUCTR2015-005418-31-BG (EUCTR) | 01/12/2016 | 12/08/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 51 | EUCTR2015-005418-31-PL (EUCTR) | 11/11/2016 | 20/09/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden | ||
| 52 | EUCTR2015-005419-33-LV (EUCTR) | 03/11/2016 | 11/08/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | Portugal;United States;United Arab Emirates;Taiwan;Slovakia;Spain;Lebanon;Russian Federation;Switzerland;India;France;Australia;Peru;South Africa;Latvia;China;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Croatia;Bulgaria;Germany | ||
| 53 | EUCTR2015-005419-33-DE (EUCTR) | 21/10/2016 | 07/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157G INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany | ||
| 54 | EUCTR2015-005418-31-GR (EUCTR) | 21/10/2016 | 05/09/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Israel;Chile;Russian Federation;Switzerland;India;France;Australia;Denmark;Netherlands;Kuwait;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden | ||
| 55 | EUCTR2015-005418-31-BE (EUCTR) | 17/10/2016 | 07/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Chile;Switzerland;India;France;Australia;Denmark;Kuwait;Netherlands;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 56 | EUCTR2015-005419-33-FR (EUCTR) | 14/10/2016 | 12/01/2017 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 19.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | Portugal;United Arab Emirates;United States;Taiwan;Slovakia;Spain;Lebanon;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;China;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Croatia;Bulgaria;Germany | ||
| 57 | EUCTR2015-005418-31-GB (EUCTR) | 11/10/2016 | 11/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden | ||
| 58 | EUCTR2015-005419-33-GB (EUCTR) | 11/10/2016 | 13/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany | ||
| 59 | EUCTR2015-005419-33-PT (EUCTR) | 06/10/2016 | 28/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157G INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1313 | Phase 3 | United States;United Arab Emirates;Portugal;Taiwan;Slovakia;Spain;Lebanon;Russian Federation;Switzerland;India;France;Australia;Peru;South Africa;Latvia;China;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Germany | ||
| 60 | EUCTR2015-005419-33-LT (EUCTR) | 03/10/2016 | 23/08/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | Bulgaria;United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;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 |
| 61 | EUCTR2015-005419-33-BE (EUCTR) | 26/09/2016 | 11/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United Arab Emirates;United States;Portugal;Taiwan;Slovakia;Spain;Lebanon;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;China;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Croatia;Bulgaria;Germany | ||
| 62 | EUCTR2015-005418-31-DK (EUCTR) | 23/09/2016 | 13/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden | ||
| 63 | EUCTR2015-005418-31-HU (EUCTR) | 21/09/2016 | 08/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Chile;Switzerland;India;France;Australia;Denmark;Kuwait;Netherlands;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden | ||
| 64 | EUCTR2015-005419-33-HU (EUCTR) | 21/09/2016 | 08/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany | ||
| 65 | NCT02792218 (ClinicalTrials.gov) | September 20, 2016 | 2/6/2016 | Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: Ofatumumab subcutaneous injection;Drug: Teriflunomide-matching placebo capsules;Drug: Teriflunomide capsule;Drug: Matching placebo of ofatumumab subcutaneous injections | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 55 Years | All | 930 | Phase 3 | United States;Argentina;Australia;Belgium;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;France;Germany;Greece;Hungary;India;Israel;Italy;Mexico;Netherlands;Poland;Puerto Rico;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Thailand;Turkey;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 66 | EUCTR2015-005419-33-FI (EUCTR) | 20/09/2016 | 13/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany | ||
| 67 | EUCTR2015-005418-31-SK (EUCTR) | 19/09/2016 | 29/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden | ||
| 68 | EUCTR2015-005419-33-SK (EUCTR) | 19/09/2016 | 03/08/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany | ||
| 69 | EUCTR2015-005418-31-DE (EUCTR) | 13/09/2016 | 08/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157G INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden | ||
| 70 | EUCTR2015-005418-31-EE (EUCTR) | 12/09/2016 | 10/08/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 71 | EUCTR2015-005418-31-SE (EUCTR) | 06/09/2016 | 13/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden | ||
| 72 | EUCTR2015-005418-31-ES (EUCTR) | 03/09/2016 | 05/08/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Israel;Chile;Russian Federation;Switzerland;India;France;Australia;Denmark;Kuwait;Netherlands;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden | ||
| 73 | EUCTR2015-005419-33-ES (EUCTR) | 03/09/2016 | 05/08/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United Arab Emirates;Portugal;United States;Taiwan;Slovakia;Spain;Lebanon;Russian Federation;Switzerland;India;France;Australia;Peru;South Africa;Latvia;China;Finland;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Croatia;Bulgaria;Germany | ||
| 74 | NCT02792231 (ClinicalTrials.gov) | August 26, 2016 | 2/6/2016 | Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis. | A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis. | Relapsing Multiple Scelrosis | Drug: Ofatumumab subcutaneous injection;Drug: Teriflunomide-matching placebo capsules;Drug: Teriflunomide capsule;Drug: Matching placebo of ofatumumab subcutaneous injections | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 55 Years | All | 957 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;Finland;France;Germany;Hungary;India;Italy;Latvia;Lithuania;Mexico;Norway;Peru;Poland;Portugal;Russian Federation;Slovakia;South Africa;Spain;Switzerland;Taiwan;Turkey;United Kingdom |
| 75 | EUCTR2015-005419-33-AT (EUCTR) | 16/08/2016 | 15/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157G INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;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 |
| 76 | EUCTR2011-002333-19-IT (EUCTR) | 19/03/2012 | 14/03/2012 | Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis. | Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months’ administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS). - Ofatumumab sub-cutaneous in RRMS | Relapsing-Remitting Multiple Sclerosis (RRMS). MedDRA version: 14.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Arzerra INN or Proposed INN: OFATUMUMAB Other descriptive name: NA | GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD. | NULL | Not Recruiting | Female: yes Male: yes | 196 | United States;Czech Republic;Canada;Spain;Russian Federation;Netherlands;Germany;Italy | |||
| 77 | EUCTR2011-002333-19-CZ (EUCTR) | 27/02/2012 | 31/10/2011 | Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis. | A Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months’ administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) - Ofatumumab sub-cutaneous in RRMS | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 14.1;Level: LLT;Classification code 10070716;Term: Multiple sclerosis pseudo relapse;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Arzerra® Product Name: Ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 196 | United States;Czech Republic;Canada;Spain;Denmark;Bulgaria;Russian Federation;Netherlands;Germany;Norway;Italy | |||
| 78 | EUCTR2011-002333-19-DE (EUCTR) | 29/11/2011 | 09/09/2011 | Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis. | A Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months’ administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) - Ofatumumab sub-cutaneous in RRMS | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 15.0;Level: LLT;Classification code 10070716;Term: Multiple sclerosis pseudo relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 196 | United States;Czech Republic;Canada;Spain;Denmark;Bulgaria;Russian Federation;Netherlands;Norway;Germany;Italy | |||
| 79 | EUCTR2011-002333-19-DK (EUCTR) | 25/11/2011 | 18/10/2011 | Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis. | A Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months’ administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) - Ofatumumab sub-cutaneous in RRMS | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 17.1;Level: LLT;Classification code 10070716;Term: Multiple sclerosis pseudo relapse;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Arzerra® Product Name: Ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 196 | Phase 2 | United States;Czech Republic;Canada;Spain;Denmark;Russian Federation;Bulgaria;Norway;Netherlands;Germany;Italy | ||
| 80 | EUCTR2011-002333-19-NL (EUCTR) | 23/11/2011 | 05/10/2011 | Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis. | A Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months’ administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) - Ofatumumab sub-cutaneous in RRMS | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 14.0;Level: LLT;Classification code 10070716;Term: Multiple sclerosis pseudo relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Arzerra® Product Name: Ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 196 | United States;Czech Republic;Canada;Spain;Denmark;Bulgaria;Russian Federation;Germany;Norway;Netherlands;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 |
| 81 | NCT01457924 (ClinicalTrials.gov) | November 1, 2011 | 20/10/2011 | Ofatumumab Subcutaneous Administration in Subjects With Relapsing-Remitting Multiple Sclerosis | A Randomized, Double-blind, Placebo-controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months' Administration of Ofatumumab in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) | Multiple Sclerosis | Drug: Ofatumumab 3mg;Drug: Ofatumumab 30mg;Drug: Ofatumumab 60mg;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 18 Years | 55 Years | All | 232 | Phase 2 | United States;Bulgaria;Canada;Czechia;Denmark;Germany;Italy;Netherlands;Norway;Russian Federation;Spain;Czech Republic |
| 82 | EUCTR2011-002333-19-ES (EUCTR) | 21/10/2011 | 28/09/2011 | Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis. | A Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months? administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) - Ofatumumab sub-cutaneous in RRMS | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 14.0;Level: LLT;Classification code 10070716;Term: Multiple sclerosis pseudo relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Arzerra® Product Name: Ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra® Product Name: Ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | GlaxoSmithKline SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 196 | Germany;Czech Republic;Russian Federation;Canada;Netherlands;Denmark;Bulgaria;Norway;Spain;Italy;United States | |||
| 83 | EUCTR2007-004223-38-GB (EUCTR) | 05/01/2009 | 26/11/2007 | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | GlaxoSmithKline UK | NULL | Not Recruiting | Female: yes Male: yes | 57 | Phase 2 | Czech Republic;Belgium;Denmark;Germany;United Kingdom;Sweden | |||
| 84 | EUCTR2007-004223-38-DE (EUCTR) | 02/06/2008 | 24/01/2008 | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | Genmab A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 324 | Czech Republic;United Kingdom;Germany;Denmark;Sweden | |||
| 85 | EUCTR2007-004223-38-SE (EUCTR) | 05/05/2008 | 13/03/2008 | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline AB | NULL | Not Recruiting | Female: yes Male: yes | 57 | Germany;Czech Republic;United Kingdom;Denmark;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 86 | NCT00640328 (ClinicalTrials.gov) | May 2008 | 18/3/2008 | Ofatumumab Dose-finding in Relapsing Remitting Multiple Sclerosis (RRMS) Patients | A Double-blind, Randomized, Placebo Controlled, Multicenter, Dose-finding Trial of Ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) Patients | Multiple Sclerosis | Drug: Ofatumumab 100;Drug: Ofatumumab 300;Drug: Ofatumumab 700;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 18 Years | 55 Years | All | 38 | Phase 2 | Belgium;Czech Republic;Denmark;Former Serbia and Montenegro;Germany;Poland;Serbia;Sweden;United Kingdom |
| 87 | EUCTR2007-004223-38-BE (EUCTR) | 16/04/2008 | 06/05/2008 | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | Genmab A/S | NULL | Not Recruiting | Female: yes Male: yes | 324 | Sweden;Czech Republic;Belgium;Denmark;Germany;United Kingdom | |||
| 88 | EUCTR2007-004223-38-DK (EUCTR) | 04/04/2008 | 23/01/2008 | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline | NULL | Not Recruiting | Female: yes Male: yes | 57 | Czech Republic;Denmark;Germany;United Kingdom;Sweden | |||
| 89 | EUCTR2007-004223-38-CZ (EUCTR) | 27/02/2008 | 02/01/2008 | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline s.r.o. | NULL | Not Recruiting | Female: yes Male: yes | 57 | Germany;United Kingdom;Czech Republic;Denmark;Sweden |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Pemphigus | Drug: Ofatumumab;Drug: Acetaminophen/paracetamol;Drug: Antihistamine (cetirizine or equivalent);Drug: Prednisone/Prednisolone | 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 | 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] | Product Name: ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB 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 | ||
| 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 | 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] | 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 | |||
| 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 | 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] | 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 | ||
| 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 | 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] | 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 | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | EUCTR2013-001370-20-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 | 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] | Product Name: ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB Product Name: ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | 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 | ||
| 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 | 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 |
| 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 Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | 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 2A | 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 Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | 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;Phase 2A | 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 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 | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | 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 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. | Rheumatoid ArthritisArtritis Reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: GSK1841157 Other descriptive name: HuMax-CD20 | GlaxoSmithKline S.A. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 1;Phase 2A | 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 Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | 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 | ||
| 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 | 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 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 | Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | 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 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 | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | GlaxoSmithKline Research & Development | NULL | Not Recruiting | Female: yes Male: yes | 236 | Phase 3 | France;Spain;Denmark;Germany;Netherlands;Italy;United Kingdom;Sweden | |||
| 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 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 | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | 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 | 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 |
| 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 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 | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | 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 | ||
| 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 | EUCTR2007-002951-18-DK (EUCTR) | 03/06/2008 | 23/04/2008 | 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 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 | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | 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 | France;Spain;Denmark;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 12 | EUCTR2007-002951-18-FR (EUCTR) | 14/05/2008 | 18/03/2008 | 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 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 | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | Genmab A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 236 | Phase 3 | Germany;United Kingdom;Netherlands;Denmark;France;Spain;Italy;Sweden | ||
| 13 | EUCTR2007-004878-31-HU (EUCTR) | 09/04/2008 | 20/12/2007 | An open-label, international, multi-center, phase II, extension trial investigating long-term efficacy and safety of repeated treatment courses of ofatumumab, a fully human monoclonal anti-CD20 antibody, in adult patients with active rheumatoid arthritis who previously received ofatumumab or placebo in Trial Hx-CD20-403 - Long-term efficacy and safety of repeated ofatumumab courses in RA patients who were in Hx-CD20-403 | An open-label, international, multi-center, phase II, extension trial investigating long-term efficacy and safety of repeated treatment courses of ofatumumab, a fully human monoclonal anti-CD20 antibody, in adult patients with active rheumatoid arthritis who previously received ofatumumab or placebo in Trial Hx-CD20-403 - Long-term efficacy and safety of repeated ofatumumab courses in RA patients who were in Hx-CD20-403 | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline Research & Development Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 264 | Phase 2 | Hungary;Denmark;United Kingdom | ||
| 14 | EUCTR2007-002950-42-PL (EUCTR) | 09/01/2008 | 24/08/2007 | 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 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 | Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline Research and Development | NULL | Not Recruiting | Female: yes Male: yes | 248 | Phase 3 | Czech Republic;Hungary;Spain;Poland;Lithuania;United Kingdom | ||
| 15 | NCT00611455 (ClinicalTrials.gov) | January 1, 2008 | 16/1/2008 | Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to MTX Therapy | 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 Have Had an Inadequate Response to Methotrexate Therapy | Arthritis, Rheumatoid | Drug: ofatumumab;Drug: Placebo | GlaxoSmithKline | NULL | Terminated | 18 Years | N/A | All | 265 | Phase 3 | Argentina;Australia;Belgium;Chile;Czechia;Hungary;Peru;Poland;Romania;Russian Federation;South Africa;Spain;United Kingdom;Czech Republic |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT00655824 (ClinicalTrials.gov) | January 1, 2008 | 4/4/2008 | Long-term Efficacy and Safety of Repeated Ofatumumab Treatment Courses in RA Patients Who Previously Received Ofatumumab or Placebo in Trial Hx-CD20-403 | An Open-label, International, Multi-center, Phase II, Extension Trial Investigating Long-term Efficacy and Safety of Repeated Treatment Courses of Ofatumumab, a Fully Human Monoclonal Anti-CD20 Antibody, in Adult Patients With Active Rheumatoid Arthritis Who Previously Received Ofatumumab or Placebo | Arthritis, Rheumatoid | Drug: ofatumumab | GlaxoSmithKline | NULL | Terminated | 18 Years | N/A | All | 124 | Phase 2 | United States;Denmark;Hungary;Poland;United Kingdom |
| 17 | NCT00603525 (ClinicalTrials.gov) | January 2008 | 16/1/2008 | Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to TNF-a Antagonist Therapy | A Double-blind, Randomized, Placebo Controlled, Parallel Group, Multi-center, Phase III Trial of Ofatumumab Investigating Clinical Efficacy in Patients With Active Rheumatoid Arthritis Who Have Previously Had an Inadequate Response to One or More TNF Antagonist Therapies | Arthritis, Rheumatoid | Drug: Ofatumumab;Drug: Placebo | GlaxoSmithKline | NULL | Terminated | 18 Years | N/A | All | 169 | Phase 3 | Argentina;Denmark;France;Germany;Italy;Korea, Republic of;Netherlands;Norway;Peru;Spain;Sweden;United Kingdom |
| 18 | EUCTR2007-002951-18-NL (EUCTR) | 10/12/2007 | 09/08/2007 | 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 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 | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | 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 | ||
| 19 | EUCTR2007-004878-31-DK (EUCTR) | 10/12/2007 | 09/10/2007 | An open-label, international, multi-center, phase II, extension trial investigating long-term efficacy and safety of repeated treatment courses of ofatumumab, a fully human monoclonal anti-CD20 antibody, in adult patients with active rheumatoid arthritis who previously received ofatumumab or placebo in Trial Hx-CD20-403 - Long-term efficacy and safety of repeated ofatumumab courses in RA patients who were in Hx-CD20-403 | An open-label, international, multi-center, phase II, extension trial investigating long-term efficacy and safety of repeated treatment courses of ofatumumab, a fully human monoclonal anti-CD20 antibody, in adult patients with active rheumatoid arthritis who previously received ofatumumab or placebo in Trial Hx-CD20-403 - Long-term efficacy and safety of repeated ofatumumab courses in RA patients who were in Hx-CD20-403 | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 264 | Phase 2 | Hungary;Denmark;United Kingdom | ||
| 20 | EUCTR2007-004878-31-GB (EUCTR) | 07/12/2007 | 16/10/2007 | An open-label, international, multi-center, phase II, extension trial investigating long-term efficacy and safety of repeated treatment courses of ofatumumab, a fully human monoclonal anti-CD20 antibody, in adult patients with active rheumatoid arthritis who previously received ofatumumab or placebo in Trial Hx-CD20-403 - Long-term efficacy and safety of repeated ofatumumab courses in RA patients who were in Hx-CD20-403 | An open-label, international, multi-center, phase II, extension trial investigating long-term efficacy and safety of repeated treatment courses of ofatumumab, a fully human monoclonal anti-CD20 antibody, in adult patients with active rheumatoid arthritis who previously received ofatumumab or placebo in Trial Hx-CD20-403 - Long-term efficacy and safety of repeated ofatumumab courses in RA patients who were in Hx-CD20-403 | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 264 | Phase 2 | Hungary;Denmark;United Kingdom | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | EUCTR2007-002951-18-ES (EUCTR) | 27/11/2007 | 11/10/2007 | 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 therapyEstudio Fase III, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, multicéntrico, para investigar la eficacia clínica de ofatumumab en pacientes adultos con artritis reumatoide activa y respuesta inadecuada a la terapia con antagonistas TNFa - 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 ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapyEstudio Fase III, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, multicéntrico, para investigar la eficacia clínica de ofatumumab en pacientes adultos con artritis reumatoide activa y respuesta inadecuada a la terapia con antagonistas TNFa - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist | Rheumatoid ArthritisArtritis Reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | Genmab A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 236 | Phase 3 | Germany;United Kingdom;Netherlands;Denmark;France;Spain;Italy;Sweden | ||
| 22 | EUCTR2007-002950-42-ES (EUCTR) | 27/11/2007 | 11/10/2007 | 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 therapyEstudio Fase III, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, multicéntrico, para investigar la eficacia clínica de ofatumumab en pacientes adultos con artritis reumatoide activa y respuesta inadecuada a la terapia con metotrexato. - 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 ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapyEstudio Fase III, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, multicéntrico, para investigar la eficacia clínica de ofatumumab en pacientes adultos con artritis reumatoide activa y respuesta inadecuada a la terapia con metotrexato. - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX | Rheumatoid ArthritisArtritis Reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | 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;Belgium;Poland;Spain;Lithuania;United Kingdom | ||
| 23 | EUCTR2007-002945-18-IT (EUCTR) | 22/10/2007 | 07/02/2008 | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy and safety in adult patients with active rheumatoid arthritis receiving non-biologic background disease-modifying antirheumatic drugs - ND | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy and safety in adult patients with active rheumatoid arthritis receiving non-biologic background disease-modifying antirheumatic drugs - ND | Rheumatoid arthritis MedDRA version: 9.1;Level: HLT;Classification code 10039078;Term: Rheumatoid arthropathies | Product Name: Ofatumumab Product Code: HuMax-CD20 | GENMAB A/S | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Czech Republic;Italy | ||
| 24 | EUCTR2007-002950-42-HU (EUCTR) | 18/10/2007 | 31/07/2007 | 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 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 | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | 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;Belgium;Spain;Poland;Lithuania;United Kingdom | ||
| 25 | EUCTR2007-002945-18-CZ (EUCTR) | 15/10/2007 | 27/08/2007 | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy and safety in adult patients with active rheumatoid arthritis receiving non-biologic background disease-modifying antirheumatic drugs - Clinical efficacy and safety of ofatumumab in RA patients receiving background nonbiologic DMARDs | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy and safety in adult patients with active rheumatoid arthritis receiving non-biologic background disease-modifying antirheumatic drugs - Clinical efficacy and safety of ofatumumab in RA patients receiving background nonbiologic DMARDs | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | Genmab A/S | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Czech Republic | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | EUCTR2007-002950-42-CZ (EUCTR) | 15/10/2007 | 15/08/2007 | 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 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 | 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: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline Research and Development | NULL | Not Recruiting | Female: yes Male: yes | 248 | Phase 3 | Hungary;Czech Republic;Spain;Poland;Lithuania;United Kingdom | ||
| 27 | EUCTR2007-002951-18-IT (EUCTR) | 28/09/2007 | 05/10/2007 | 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-alfa; antagonist therapy - ND | 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-alfa; antagonist therapy - ND | Rheumatoid arthritis MedDRA version: 9.1;Level: HLT;Classification code 10039078;Term: Rheumatoid arthropathies | Product Name: Ofatumumab Product Code: HuMax-CD20 | Genmab A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 236 | Phase 3 | Germany;United Kingdom;Netherlands;Denmark;France;Spain;Italy;Sweden | ||
| 28 | EUCTR2007-002950-42-LT (EUCTR) | 13/09/2007 | 31/07/2007 | 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 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 | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | 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 | Hungary;United Kingdom;Czech Republic;Spain;Poland;Lithuania |