Systemic lupus erythematosus Systemic lupus erhythematosus
Conditions
Interventions
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 usi
age, dose of PSL on day 0, SLEDAI
Sponsors
Michihito Kono
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 or over with SLE diagnosis according to the ACR revised classification criteria 2. Repeat seropositive for ANA and/or anti-dsDNA antibody 3. Non-severe SLE flares (mild or moderate) 1) SELENA-SLEDAI score of >/= 6 points or >/= 1 BILAG 2004 index level B 2) Treatment with low dose CS (Corticosteroid, prednisolone (PSL) or equivalent </= 7.5 mg/day 3) Are on a stable SLE therapy for at least 30 days prior to Day 0
Exclusion criteria
Exclusion criteria: 1. Severe organ threatening SLE 1) severe active lupus nephritis (>3 g/gCre proteinuria using spot urine protein to creatinine ratio, or serum creatinine > 2.5 mg/dL) 2) severe active neuropsychiatric SLE 2. Pregnancy or lactation 3. Are on treatment with > 7.5 mg/day of prednisolone at Day 0 4. Required > 20 mg/day prednisolone or equivalent over 2 weeks after the first dose of study medication. 5. Have background treatment with belimumab (BEL). 6. Have maculopathy and visual field defect. 7. Have any conditions that cannot use mycophenolate mofetil (MMF) or hydroxychloroquine HCQ. 8. Have an active infection 9. Infection history 1) Currently on any suppressive therapy for a chronic infection 2) Hospitalization for treatment of infection within 60 days of Day 0. 3) Use of parenteral (IV or IM) antibiotics (anti-bacterial, antiviral, anti-fungal, or anti-parasitic agents) within 60 days of Day 0. 10. Have the following excluded concomitant medications 1) Anti-B-cell therapy Wash-out of 5 therapeutic half-lives after prior B-cell therapy, or until pharmacodynamic effect would be minimal (e.g., 1 year following rituximab) 2) 90 days prior to BEL: Intravenous cyclophosphamide Intravenous immunoglobulins 3) 30 days prior to BEL (or 5 half-lives, whichever is greater) Any biologic or non-biologic investigational agent 4) Live vaccines within 30 days prior to baseline or concurrently with BEL 5) Other medications, including HCQ, should be maintained at the same dose prior to BEL.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All adverse events (AES) and all serious adverse events (SAES) (reported throughout the 12-weeks of treatment. AES include: Any new AES not present at Day 0 OR any increase in severity grade of signs, symptoms, or laboratory abnormalities OR any SAES | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Efficacy at 12 and 24 weeks 2)Safety at 12 and 24 weeks | — |
Contacts
Public ContactMichihito Kono
Hokkaido University Hospital
Outcome results
None listed