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Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus

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ClinicalTrials.gov Identifier: NCT03804723
Recruitment Status : Not yet recruiting
First Posted : January 15, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Marta Mosca, University of Pisa

Brief Summary:
This is a 36 months, randomized, double-blind, placebo-controlled, parallel-groups, equivalence multicenter trial in patients with inactive Systemic Lupus Erythematosus to evaluate if low disease activity can be sustained with withdrawal of glucocorticoids in patients on stable clinical remission or low disease activity.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Glucocorticoids Therapy Withdrawal Drug: oral Prednisone 5mg Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 321 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a 36 month, randomized, double-blind, placebo-controlled, parallel-groups, equivalence multicenter trial in patients with inactive SLE to evaluate if low disease activity can be sustained with withdrawal of glucocorticoids
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus: a Randomized Placebo-controlled Equivalence Trial
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus Steroids
Drug Information available for: Prednisone

Arm Intervention/treatment
Experimental: GC withdrawal Drug: oral Prednisone 5mg
patients randomized to this arm will stop prednisone 5 mg

Placebo Comparator: non GC withdrawal Drug: oral Prednisone 5mg
patients randomized to this arm will stop prednisone 5 mg




Primary Outcome Measures :
  1. disease flare [ Time Frame: 35 months ]
    The primary endpoint is the proportion of patients who will experience a disease during the follow-up period in the groups given prednisone 5 mg or placebo in the double-blind period.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of SLE according to the EULAR/ACR criteria within three years from screening visit
  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national subject privacy regulations
  • Aged 18 to 75 years old, inclusive, at the time of informed consent
  • Documented diagnosis of SLE according to the current ACR criteria
  • Stable immunosuppressive treatment for SLE for a minimum of one year/six months
  • Stable treatment with antimalarials for a minimum of 3 months
  • stable (lasting for at least 6 months) low disease activity

Exclusion Criteria:

  • Disease activity (non LLDAS) within 6 months prior to screening
  • Concomitant ongoing conditions (e.g. asthma, Crohn's disease) that require treatment with systemic GC (excluding topical or inhaled GC).
  • Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, social) likely to affect the subject returning for follow-up visits on schedule
  • Nursing mothers, pregnant women or women planning to become pregnant during the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03804723


Contacts
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Contact: Marta Mosca, MD 050992519 marta.mosca@med.inipi.it
Contact: Chiara Tani, MD chiara.tani@ao-pisa.toscana.it

Sponsors and Collaborators
University of Pisa

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Responsible Party: Marta Mosca, Assistant Professor of Rheumatology, University of Pisa
ClinicalTrials.gov Identifier: NCT03804723     History of Changes
Other Study ID Numbers: 001
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Prednisone
Glucocorticoids
Anti-Inflammatory Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents