UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031259
Receipt number R000035689
Scientific Title Glucocorticoid-tapering aimed maintenance therapy in patients with systemic lupus erythematosus
Date of disclosure of the study information 2018/03/01
Last modified on 2018/02/12 17:51:53

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Basic information

Public title

Glucocorticoid-tapering aimed maintenance therapy in patients with systemic lupus erythematosus

Acronym

BLISS-POST

Scientific Title

Glucocorticoid-tapering aimed maintenance therapy in patients with systemic lupus erythematosus

Scientific Title:Acronym

BLISS-POST

Region

Japan


Condition

Condition

systemic lupus erythematosus

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study is a clinical trial aiming to taper and discontinue glucocorticoid (GC) using belimumab in patients with systemic lupus erythematosus (SLE) and low disease activity. Following induction therapy, at least 3 years of immunosuppressive maintenance treatment is recommended to optimize outcomes and lupus maintenance treatment should aim for the lowest glucocorticoid dosage needed to control disease, and if possible.
On the other hand, accumulated evidence indicates the good safety and efficacy profile of belimumab in SLE for the maintenance therapy. Also, belimumab reduces serum soluble BAFF concentrations and thereby allows autoimmune B cells to undergo apoptosis, preventing escape and proliferation of new or existing autoimmune B-cell clones. We, therefore, have hypothesized that by the use of belimumab, the tapering of GC in patients with maintenance phase of SLE.
Within this context, this study is conducted with the goal of discontinuation of GC using belimumab for the maintenance phase of SLE treatments. In addition, peripheral blood immune phenotype, biomarkers, and autoantibodies will be evaluated to identify patients who will be able to withdraw GC. The result of study will not only reveal the appropriate treatment for lupus SLE patients after achieving remission, but also contribute to improvement of economic problems including reduction of medical expenses. If this study worked well, enormous benefit and flexibilitiy would be brought to many patients with SLE and other autoimmune diseases who are treated with GC.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Proportion of subjects who achieve glucocorticoid free [Time Frame: Week 52]

Key secondary outcomes

Secondary endpoints
1) Score of SELENA-SLEDAI [Time Frame: Week 24 and 52]
2) Mean changes from baseline in Physician's Global Assessment (PGA) using visual analogue scale (VAS) [Time Frame: Week 24 and 52]
3) Mean dose of glucocorticoids (Last Observation Carried Forward)
4) Annualized flare rate with flare defined as SELENA - SLEDAI score > 4 points [Time Frame: Week 52]

Exploratory endpoints
1) The mean duration, subjects achieve 50% dose reduction of glucocorticoid [Time Frame: Week 52]
2) The immunophenotype of peripheral blood by flow cytometric analysis [Time Frame: Week 52]
3) The differences of immunophenotype, biomarkers, and autoantibodies between the patients who could achieve glucocorticoid free and the patients who could not achieve glucocorticoid free [Time Frame: Week 52]


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

a) Diagnosed as SLE by American College of Rheumatology (ACR) classification criteria.
b) Patients who have low disease activity (SELENA-SLEDAI < 4 points)
c) Receipt of low dose GC (no more than prednisolone equivalent 10 mg) over 30 days
d) Receipt of HCQ and/or other immunosuppressive drug such as Azathioprine and MMF over 30 days.

Key exclusion criteria

a) Patients who contraindicated by package insert of BLM.
b) Receipt of B cell depleted therapy (biologic agent) within 1 year.
c) Receipt of cyclophosphamide (Endoxan) within 6 months.
d) Receipt of high dose GC (prednisolone equivalent 1mg/kg) within 6 months.
e) Receipt of plasma exchange within 6 months.
f) Have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases).
g) Have developed any other medical diseases (e.g., cardiopulmonary), laboratory abnormalities, or conditions (e.g., poor venous access) that in the opinion of the principal investigator, makes the subject unstable for the study.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiya Tanaka

Organization

School of Medicine, University of Occupational and Environmental Health, Japan

Division name

First Department of Internal Medicine

Zip code


Address

1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka, 807-8555, Japan

TEL

093-603-1611

Email

tanaka@med.uoeh-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Satoshi Kubo

Organization

School of Medicine, University of Occupational and Environmental Health, Japan

Division name

First Department of Internal Medicine

Zip code


Address

1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka, 807-8555, Japan

TEL

093-603-1611

Homepage URL


Email

kubosato@med.uoeh-u.ac.jp


Sponsor or person

Institute

First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2018 Year 03 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2018 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2018 Year 03 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Every patient will start belimumab (intravenous) in addition to each current therapy. Then, concomitant GC will be reduced by half at week 8. At week 16, the dose of GC will be reduced by quarter. Thereafter, the patients will withdraw the concomitant GC at week 24 (For details of the test, see the figure below).

The disease activity will be evaluated regularly. The disease activity will be evaluated regularly. If the disease activity exacerbates (SELENA - SLEDAI score > 4 points) or judges that the attending doctor should stop the trial, the patients be withdrawn this clinical trial immediately. In that case, the dose of GC will be restored. However, further increase and addition of other medicines are also possible at the discretion of the attending physician.

In this study, immunophenotype of peripheral blood will be analysed by flow cytometry at baseline, week 24, and week 52.


Management information

Registered date

2018 Year 02 Month 12 Day

Last modified on

2018 Year 02 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035689


Research Plan
Registered date File name

Research case data specifications
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Research case data
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