BLISS-POST

JRCT ID: jRCTs071190045

Registered date:14/02/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Systemic Lupus Erythematosus
• Date of first enrollment: 26/02/2020
• Target sample size: 100
• Study type: Interventional

Intervention(s)

The patient begins berimumab with a half-dose reduction in steroids at week 8, a further half-dose reduction at week 16, and discontinuation of steroids at week 24.
The investigator periodically assesses disease activity and discontinues protocol treatment if SLE relapses and steroids need to be increased. However, follow-up is conducted until 52 weeks.

Outcome(s)

• Primary Outcome: Proportion of subjects who achieve glucocorticoid free at Week 24

Secondary Outcome

Evaluate the following items after the start of belimumab administration.
1) Proportion of subjects who achieve glucocorticoid free at Week 52
2) Score of SELENA-SLEDAI at Week 24 and 52
3) Mean changes from baseline in Physician's Global Assessment (PGA) at Week 24 and 52
4) Mean dose of glucocorticoids at Week 52
5) The mean duration of achieve 50% dose reduction of glucocorticoid
6) Day to flare

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients diagnosed with systemic lupus erythematosus (SLE) under the 1997 American College of Rheumatology (ACR) criteria and has active disease with SELENA-SLEDAI score less than 5
2) Patients aged over 18 years (all gender)
3) Patients who have administered glucocorticoid with constant dosage (10mg/day or less in prednisolone) for 30 days or more before informed consent
4) Patients who have been treated with hydroxychloroquine and/or immunosuppressive drugs for systemic lupus erythematosus and whose dosage is constant for 30 days or more before informed consent
5) Patients have negative urine pregnancy test. (Female patients of childbearing potential)
6) Patients prevent pregnancy during the study.
7) Written informed consent for participation of this study by the patient himself if the patient is over 20 years old (the patients himself/herself and a signer if the patient is under 20 years old)

Exclude criteria

1) Patients with a history of anaphylaxis to contrast media or biological agents
2) Periods from last dose date of B cell targeted drugs (Rituximab and Belimumab and no limited to these) to informed consent date is within 1 year
3) Last dose date of Abatacept to informed consent date is within 1 year
4) Period from the last dose date of anti-TNF therapy, IL-1 receptor antagonist and immunoglobulin intravenous is within 3 months to informed consent date
5) Period from last dose date of cyclophosphamide intravenous is within 6 months to informed consent date
6) Patients who have not reached 30 days or 5 times their half-life, whichever is longer, from last administration date of a non-biological product in a trial phase to informed consent date
7) Period from last administration date of a biological product in a trial phase to informed consent date is within 1 year
8) Period from last administration date of high dose glucocorticoid (10mg/day or more in prednisolone) or plasma exchange to informed consent date is within 6 months
9) Patients who have received raw vaccine 30 days or less before informed consent date
10) Patients who underwent an operation of major organ transplant (heart, kidneys, lungs, liver) or a hematopoietic stem cell/ bone marrow transplant
11) Patients with complications of malignancy or a history of malignancy within the past 5 years (within 5 years prior to obtaining consent)
Excluding the following
(1) Basal cell carcinoma and spinous cell carcinoma treated by local resection alone with no evidence of metastasis for 3 years
(2) Intraepithelial carcinoma of the cervix treated by local treatment only, with no evidence of metastasis for 3 years
12) Patient with a history of self harm within 6 months before informed consent date
13) Patients who have Type 4 or 5 of Suicide Idea under Columbia Suicide Severity Rating Scale(C-SSRS) at screening
14) Patients with a history of drug or alcohol abuse or dependence within one year prior to informed consent
15) Patients with a history of primary immunodeficiency
16) Patients with a past or present history of infection
Patients who have received parenteral antibacterial, antiviral, antifungal, or antiparasitic drugs within 60 days prior to enrollment
Currently receiving anti-infection therapy for chronic infections (such as uberculosis, pneumocystis pneumonia, cytomegalovirus, herpes simplex virus, shingles and atypical mycobacterial infections)
Hospitalized for treatment of infection prior to within 60 days before administration of Belimumab
Patients with history of HIV test positive
17) Patients with a past or present history of hepatitis
HBs antigen or HBc antibody positive
Hepatitis C antibody positive (HCV antibody, HCV-RNA quantification, etc.)
18) Patients with serious IgG deficiency (IgG concentration<400 mg/dL at screening)
19) Patients with IgA deficiency (IgA concentration<10 mg/dL at screening)
20) Patients who are lactating and unable to stop
21) Patients who are not inappropriate to participate in this study for any reason by the judgement of investigators

Related Information

• Primary Sponsor: Tanaka Yoshiya
• Source(s) of Monetary Support: GlaxoSmithKline K.K.