Efficacy and Safety of Belimumab in SLE Patients

Systemic Lupus Erythematosus Clinical Trial

Official title:

Efficacy and Safety of Belimumab for Prevention of Disease Flares in SLE Patients With Low Disease Activity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04515719
• Other study ID #: Btrial
• Status: Recruiting
• Phase: Phase 4
• Start date: March 19, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: December 2021
• Source: RenJi Hospital
• Contact: Fangfang Sun
• Phone: 86-021-34506393
• Email: fiona_rj[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Systemic lupus erythematosus (SLE) is a chronic inflammatory systemic autoimmune disease. Recurrent relapses of disease and development of long-term organ damage are two key unsolved clinical problems. Belimumab is the only FDA-approved biological agent for SLE. Data showed that treatment with belimumab on the background of standard therapy was effective in active SLE patients. However, the efficacy of low-dose belimumab for prevention of disease flares in SLE patients with low disease activity is to be explored.

Description:

Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune disease with the incidence of about 70/100,000 in China. Recurrent relapses of disease and development of long-term organ damage are two key unsolved clinical problems. Its pathogenesis is still unclear, but B cells have been confirmed to play a vital role in it. Belimumab, a B-lymphocyte stimulating factor (Blys) inhibitor, was the only FDA-approved biological agent for SLE. BLISS-52 showed that more active lupus patients had their SELENA-SLEDAI score reduced by at least 4 points during 52 weeks with belimumab 10 mg/kg (58% vs 46%, p=0·0024) than with placebo. But there was limited data about belimumab in SLE patients with low disease activity. Our previous study indicated that even these patients still have an annual flare rate of 30-40%. Therefore, we try to explore whether low-dose of belimumab could prevent the disease flares in SLE patients with low disease activity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 334
• Est. completion date: June 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age 18-70 years;

2. Patients with low disease activity (score= 6 at screening on SLEDAI); no British Isles Lupus Assessment Group (BILAG) A and no more than one B;

3. A stable treatment regimen with fixed doses of prednisone (= 20mg/day), antimalarial, or immunosuppressive drugs (azathioprine/mycophenolate mofetil/ methotrexate/ciclosporin/leflunomide/tacrolimus) for at least 30 days.

4. Sign the informed consent;

Exclusion Criteria:

1. Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) > 2 times upper normal limits;

2. Creatinine clearance rate < 60ml/min;

3. Exposure to cyclophosphamide within past 6 months before screening;

4. Exposure to any B cell targeted therapy (Rituximab/belimumab) within past 1 year before screening;

5. History of Malignancy;

6. History of herpes zoster with past 3 months before screening.

7. Chronic HBV/HCV hepatitis;

8. Current infections (HIV/tuberculosis)

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Biological:
• Belimumab
Belimumab 2mg/kg intravenously
• Placebo
Placebo intravenously

Locations

Country	Name	City	State
China	Shuang Ye, MD	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Navarra SV, Guzmán RM, Gallacher AE, Hall S, Levy RA, Jimenez RE, Li EK, Thomas M, Kim HY, León MG, Tanasescu C, Nasonov E, Lan JL, Pineda L, Zhong ZJ, Freimuth W, Petri MA; BLISS-52 Study Group. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet. 2011 Feb 26;377(9767):721-31. doi: 10.1016/S0140-6736(10)61354-2. Epub 2011 Feb 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subgroup analysis	subgroup analysis aiming to investigate which population will benefit most from belimumab with prespecified factors including age, gender, SLE duration, SELENA- SLEDAI, BILAG, PGA, serology, baseline LLDAS attainment and prednisone dose.	52 weeks
Primary	Percentage of patients with disease flares	Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).	52 weeks
Secondary	Percentage of patients with mild/moderate flares	Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).	52 weeks
Secondary	Percentage of patients with major flares	Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).	52 weeks
Secondary	Time to first disease flare	Time to first disease flare	52 weeks
Secondary	prednisone dose at each visit	compare the prednisone dose at each visit	52 weeks
Secondary	SELENA-SLEDAI score at each visit	compare the disease activity measured by SELENA-SLEDAI score at each visit	52 weeks
Secondary	BiLAG score at each visit	compare the disease activity measured by BILAG score at each visit	52 weeks
Secondary	The percentage of patients achieving prednisone-free successfully	the percentage of patients achieving prednisone-free successfully	52 weeks
Secondary	Number of participants with adverse events as assessed by CTCAE v4.0	the safety of belimumab	52 weeks