49. Systemic lupus erythematosus Clinical trials / Disease details
Clinical trials : 946 / Drugs : 722 - (DrugBank : 186) / Drug target genes : 117 - Drug target pathways : 199
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 |
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1 | JPRN-jRCTs011190011 | 13/03/2020 | 13/03/2020 | Steroid-Independent protocol using BELImumab for disease flare in patients with systemic lupUS erythematosus | Steroid-Independent protocol using BELImumab for disease flare in patients with systemic lupUS erythematosus - Sibelius Study | 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 (= 0.4mg/kg/day, maximum 20 mg/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 = 7.5mg/day at screening could not be further increased. | Atsumi Tatsuya | NULL | Recruiting | >= 18age old | Not applicable | Both | 48 | Phase 4 | Japan |
2 | NCT03122431 (ClinicalTrials.gov) | June 5, 2017 | 17/4/2017 | Relevance of Monitoring Blood and Salivar Levels of Drugs Used in Rheumatic Autoimmune Diseases | Relevance of Monitoring Blood Levels Compared to Salivar Levels of Drugs Used in Rheumatic Autoimmune Diseases: Adherence and Understanding the Possible Underlying Mechanisms Involved in Effectiveness and in Adverse Effects | Systemic Lupus Erythematosus (SLE);Juvenile SLE;Cutaneous Lupus | Drug: Thalidomide;Drug: Hydroxychloroquine reduced;Drug: standard dose of HCQ | University of Sao Paulo General Hospital | Fundação de Amparo à Pesquisa do Estado de São Paulo | Completed | 5 Years | 64 Years | All | 93 | Phase 4 | Brazil |
3 | NCT02842814 (ClinicalTrials.gov) | October 2016 | 3/6/2016 | Prediction of Relapse Risk in Stable Systemic Lupus Erythematosus | Evaluation and Prediction of Relapse Risk After Glucocorticoid Withdrawal in Patients With Stable Systemic Lupus Erythematosus: An Open-labeled Multi-centric Randomized Controlled Study From China | Systemic Lupus Erythematosus | Other: Drug free;Drug: HCQ;Drug: GC+HCQ | Peking Union Medical College Hospital | Xiangya Hospital of Central South University;Shengjing Hospital;People's Hospital of Xinjiang Uygur Autonomous Region;Anhui Provincial Hospital | Recruiting | 18 Years | 60 Years | All | 350 | N/A | China |
4 | EUCTR2014-005418-45-SE (EUCTR) | 04/05/2015 | 18/03/2015 | Are risk factors factors of pertaining to or involving the heart and blood vessels and markers characterized or caused by inflammation in Rheumatoid Arthritis (a chronic, systemic inflammatory disorder that primarily affects joints) and Systemic Lupus Erythematosus (systemic disease in which the body’s immune system mistakenly attacks healthy tissue)improved? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE) | Improved cardiovascular risk factors and inflammatory markers in Rheumatoid Arthritis and Systemic Lupus Erythematosus? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE) - HCQCVDRASLE | Rheumatoid Arthritis and Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Plaquenil INN or Proposed INN: HYDROXYCHLOROQUINE | Christine Bengtsson | Solveig Wållberg-Jonsson | Not Recruiting | Female: yes Male: yes | Phase 2 | Sweden |