SC belimumab 200 mg
( DrugBank: - / KEGG DRUG: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 49 | 全身性エリテマトーデス | 49 |
49. 全身性エリテマトーデス
臨床試験数 : 993 / 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
Showing 1 to 10 of 49 trials
| 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 | JPRN-jRCTs011190011 (jRCTs011190011) | 13/03/202020200313 | 13/03/202020200313 | Steroid-Independent protocol using BELImumab for disease flare in patients with systemic lupUS erythematosus Steroid-Independent protocol using BELImumabfor disease flare in patients with systemic lupUS erythe ... | Steroid-Independent protocol using BELImumab for disease flare in patients with systemic lupUS erythematosus - Sibelius Study Steroid-Independent protocol using BELImumabfor disease flare in patients with systemic lupUS erythe ... | Systemic lupus erythematosus Systemic lupus erhythematosus;D008180 | Subjects who have met the entry criteria will be randomly to one of the two treatment groups based on a computer-generated randomization schedule as follows: 1) BEL group and 2) CS increased group using standard CS therapy (CS group) . 1. Subjects in BEL group will receive BEL 200 mg weekly SC on Day 0, and then every 7 days through week 24 or BEL 10mg/kg IV on Day 0, 14, 28 and every 1 month. 2. Subjects in CS group will receive prednisolone (mg Subjects who have met the entry criteria will be randomly to one of the two treatment groups based o ... /day) or equivalent dose for a maximum of 2 weeks followed by steroid tapering schedule according to the ACR Ad hoc working group on steroid-sparing criteria in Lupus and The British Society for Rheumatology guideline for the management of SLE in adults. All subjects will start treatment with MMF oral 1g/day In both groups, if subjects are not on treatment with HCQ, their drug will be started at a dose individually adjusted on basis of the patient's height (from 200 to 400mg/day). In the BEL group, the baseline dose of CS screening could not be further increased. | Atsumi Tatsuya | NULL | Recruiting | >= 18age old | Not applicable | Both | 48 | Phase 4 | Japan |
| 2 | EUCTR2018-004645-16-NL (EUCTR) | 29/01/202020200129 | 29/10/201920191029 | A study of belimumab in children with lupus | A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants with Systemic Lupus Erythematosus (SLE) - Ph 2,Benlysta, PLUTO-SC, PK-PD study in pediatric patients with SLE A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of S ... | Lupus - SLE MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] Lupus - SLE MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythem ... | Trade Name: Benlysta Product Name: Belimumab Product Code: GSK1550188 INN or Proposed INN: BELIMUMAB Other descriptive name: LymphoStat-B®, monoclonal anti-BLyS, LSB, BENLYSTA® Trade Name: Benlysta Product Name: Belimumab Product Code: GSK1550188 INN or Proposed INN: BELIMUMAB Oth ... | GlaxoSmithKline Research & Development Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | United States;Mexico;Argentina;Spain;Germany;Netherlands;Japan | ||
| 3 | EUCTR2018-004645-16-DE (EUCTR) | 27/12/201920191227 | 18/09/201920190918 | A study of belimumab in children with lupus | A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants with Systemic Lupus Erythematosus (SLE) - Ph 2,Benlysta, PLUTO-SC, PK-PD study in pediatric patients with SLE A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of S ... | Lupus - SLE MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] Lupus - SLE MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythem ... | Trade Name: Benlysta Product Name: Belimumab Product Code: GSK1550188 INN or Proposed INN: BELIMUMAB Other descriptive name: LymphoStat-B®, monoclonal anti-BLyS, LSB, BENLYSTA® Trade Name: Benlysta Product Name: Belimumab Product Code: GSK1550188 INN or Proposed INN: BELIMUMAB Oth ... | GlaxoSmithKline Research & Development Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | United States;Mexico;Argentina;Spain;Netherlands;Germany;Japan | ||
| 4 | EUCTR2018-004645-16-ES (EUCTR) | 16/12/201920191216 | 11/11/201920191111 | A study of belimumab in children with lupus | A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants with Systemic Lupus Erythematosus (SLE) - Ph 2,Benlysta, PLUTO-SC, PK-PD study in pediatric patients with SLE A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of S ... | Lupus - SLE MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] Lupus - SLE MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythem ... | Trade Name: Benlysta Product Name: Belimumab Product Code: GSK1550188 INN or Proposed INN: BELIMUMAB Other descriptive name: LymphoStat-B®, monoclonal anti-BLyS, LSB, BENLYSTA® Trade Name: Benlysta Product Name: Belimumab Product Code: GSK1550188 INN or Proposed INN: BELIMUMAB Oth ... | GlaxoSmithKline, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | United States;Mexico;Argentina;Spain;Netherlands;Germany;Japan | ||
| 5 | NCT04136145 (ClinicalTrials.gov) | October 28, 201920191028 | 21/10/201920191021 | Single Dose Study to Investigate the Pharmacokinetics (PK) and Safety of Belimumab 200 Milligrams (mg) Intravenous and 200 mg Subcutaneous Via Auto-injector in Chinese Healthy Subjects Single Dose Study to Investigate the Pharmacokinetics (PK) and Safety of Belimumab 200Milligrams (mg ... | An Open-label, Randomized, Parallel Group, Single Dose Study to Investigate the PK and Safety of Belimumab 200 mg Intravenous and 200 mg Subcutaneous Via Auto-injector in Chinese Healthy Participants An Open-label, Randomized, Parallel Group, Single Dose Study to Investigate the PK and Safety of Bel ... | Systemic Lupus Erythematosus | Drug: Belimumab for IV;Drug: Belimumab for SC | GlaxoSmithKline | NULL | Completed | 18 Years | 45 Years | All | 36 | Phase 1 | China |
| 6 | NCT03125486 (ClinicalTrials.gov) | April 7, 201720170407 | 18/4/201720170418 | Compassionate Use for Subcutaneous (SC) Belimumab | Compassionate Use for Subcutaneous (SC) Belimumab | Systemic Lupus Erythematosus | Drug: SC belimumab 200 mg | GlaxoSmithKline | NULL | No longer available | 18 Years | N/A | All | United States | ||
| 7 | NCT01894360 (ClinicalTrials.gov) | October 14, 201320131014 | 3/7/201320130703 | A Study to Estimate the Relative Bioavailability, Tolerability and Safety of a Single Dose of Belimumab Self-Administered Subcutaneously (SC) by Healthy Subjects A Study to Estimate the Relative Bioavailability, Tolerability and Safety of a Single Dose of Belimu ... | A Randomized, Parallel-Group, Open-Label Study to Estimate the Relative Bioavailability, Tolerability and Safety of a Single Dose of Belimumab Administered Subcutaneously to Healthy Subjects by Prefilled Syringe or Autoinjector A Randomized, Parallel-Group, Open-Label Study to Estimate the Relative Bioavailability, Tolerabilit ... | Systemic Lupus Erythematosus | Drug: Belimumab 200 mg/mL | GlaxoSmithKline | NULL | Completed | 18 Years | 55 Years | All | 81 | Phase 1 | United States |
| 8 | EUCTR2011-003814-18-PL (EUCTR) | 06/06/201220120606 | 19/06/201220120619 | A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the ... | Systemic lupus erythematosis (SLE) MedDRA version: 18.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Systemic lupus erythematosis (SLE) MedDRA version: 18.1;Level: LLT;Classification code 10042944;Term ... | Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta | Human Genome Sciences, a wholly owned subsidiary of GlaxoSmithKline, Plc | NULL | Not Recruiting | Female: yes Male: yes | 816 | Phase 3 | United States;Portugal;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden United States;Portugal;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Col ... | ||
| 9 | EUCTR2011-003814-18-PT (EUCTR) | 01/06/201220120601 | 21/02/201220120221 | A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the ... | Systemic lupus erythematosis (SLE) MedDRA version: 18.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Systemic lupus erythematosis (SLE) MedDRA version: 18.1;Level: LLT;Classification code 10042944;Term ... | Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta | Human Genome Sciences, a wholly owned subsidiary of GlaxoSmithKline, Plc | NULL | Not Recruiting | Female: yes Male: yes | 816 | Phase 3 | Serbia;United States;Portugal;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden Serbia;United States;Portugal;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Col ... | ||
| 10 | EUCTR2011-003814-18-BE (EUCTR) | 29/05/201220120529 | 01/02/201220120201 | A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the ... | Systemic lupus erythematosis (SLE) MedDRA version: 15.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Systemic lupus erythematosis (SLE) MedDRA version: 15.1;Level: LLT;Classification code 10042944;Term ... | Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta | Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 816 | Phase 3 | Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Col ... |