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

• Register: ChiCTR
• Last refreshed on: 17 October 2022
• Main ID: ChiCTR1800017540
• Date of registration: 2018-08-03
• Prospective Registration: Yes
• Primary sponsor: Ruijin Hospital
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 2018-09-01
• Target sample size: 1:65;2:65;
• Recruitment status: Completed
• URL: http://www.chictr.org.cn/showproj.aspx?proj=29721
• Study type: Interventional study
• Study design: Parallel
• Phase: 4

Countries of recruitment

China

Contacts

• Name: Junna Ye
• Affiliation: Ruijin Hospital

• Name: Junna Ye
• Affiliation: Ruijin Hospital

Key inclusion & exclusion criteria

Inclusion criteria:
1. Aged between 18 and 65 years;
2. Diagnosed with SLE at the time of screening by fulfilling ACR 2019 classified criteria or its 2017 version ;
3. Have not received any prior SLE treatment;
4. Have a positive antinuclear antibody (HEp-2 titer >= 1:80);
5. Have a positive anti-dsDNA antibody (anti-dsDNA (ELISA) >= 300 IU/mL; anti-dsDNA (CLFT) >= 1:10 );
6. Do not have major organ involvement (i.e., brain, heart, liver, kidney, lung, muscle, gastrointestinal tract). Participants were permitted to have rash, arthritis, alopecia, oral ulcer, and mild hematologic system involvement (white blood cell > 1.5*10^9/L and < 4*10^9/L, hemaglobin > 90g/L and < 120g/L, platelet > 60*10^9/L and < 100*10^9/L).

Exclusion criteria:
1.SLE patients who had been treated;
2.Liver and kidney dysfunction (Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) > 2 times upper normal limits; creatinine clearance rate < 60ml/min);
3.Cancer;
4.Recent infection or hematologic diseases not caused by SLE;
5.Pregnancy or planned to be pregnant;
6.Patients who are not willing to join the study.


Age minimum: 18
Age maximum: 65
Gender: Both

Health Condition(s) or Problem(s) studied

systemic lupus erythematosus

Intervention(s)

1:Hydroxychloroquine (5mg/kg/day) plus prednisone (0.5mg/kg/day);2:Hydroxychloroquine (5mg/kg/day) plus prednisone (0.5mg/kg/day) plus Mycophenolate Mofetil 500mg bid;

Primary Outcome(s)

the proportion of patients who have flares (mild to moderate flares and severe flares) defined by modified SELENA-SLEDAI Flare Index (SFI) at 96 weeks of follow-up;

Secondary Outcome(s)

The proportion of lupus low disease activity state (LLDAS) at week 96;Short form-36 (SF-36) score of before and after treatment in two groups;The proportion of adverse events of two groups in the follow-ups;Changes in SLEDAI-2000 score;Changes in prednisone dose;

Source(s) of Monetary Support

81801592, 82101876, 2021YFC2501304, SHDC2020CR4011, SPROG202006, Ruijin-Zhongmeihuadong Lupus Funding

Ethics review

Status: Approved
Approval date: 18/07/2018
Contact:

Yifeng Wang