Searched query = "Systemic lupus erythematosus", "SLE"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
|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||ChiCTR1800017540||2018-08-01||2018-08-03||A randomized controlled trial for the long-term outcomes of MMF on new onset SLE patients with high titers of anti-dsDNA antibody for reducing main organ involvement||A randomized controlled trial for the long-term outcomes of MMF on new onset SLE patients with high titers of anti-dsDNA antibody for reducing main organ involvement||systemic lupus erythematosus||1:prednisone;2:Mycophenolate Mofetil;||Ruijin Hospital||NULL||Recruiting||18||65||Both||1:50;2:50;||China|
|November 20, 2013||13/9/2013||Randomized MMF Withdrawal in Systemic Lupus Erythematosus (SLE)||An Investigator-Initiated, Phase II, Randomized, Withdrawal Study of Mycophenolate Mofetil (MMF) in Patients With Stable, Quiescent Systemic Lupus Erythematosus (SLE)||Systemic Lupus Erythematosus;SLE||Drug: Mycophenolate Mofetil;Drug: Hydroxychloroquine or Chloroquine;Drug: Prednisone||National Institute of Allergy and Infectious Diseases (NIAID)||Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc.||Terminated||18 Years||70 Years||All||102||Phase 2||United States|
|22/09/2005||16/08/2005||A prospective, randomized, double-blind, placebo controlled trial evaluating the effects of Mycophenolate Mofetil (MMF) on 'surrogate markers' for atherosclerosis in female patients with systemic lupus erythematosus (SLE) - MMF in SLE (Missile)||A prospective, randomized, double-blind, placebo controlled trial evaluating the effects of Mycophenolate Mofetil (MMF) on 'surrogate markers' for atherosclerosis in female patients with systemic lupus erythematosus (SLE) - MMF in SLE (Missile)||Atherosclerosis in patients with Systemic Lupus Erythematosis||Guy's & St Thomas' NHS Foundation Trust||NULL||Not Recruiting|| Female: yes|
|100||Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes||United Kingdom|