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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

Tracking Information
First Submitted Date  ICMJE January 11, 2019
First Posted Date  ICMJE January 15, 2019
Last Update Posted Date January 18, 2019
Estimated Study Start Date  ICMJE June 2019
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus
Official Title  ICMJE Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus: a Randomized Placebo-controlled Equivalence Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Systemic Lupus Erythematosus
  • Glucocorticoids
  • Therapy Withdrawal
Intervention  ICMJE Drug: oral Prednisone 5mg
patients randomized to this arm will stop prednisone 5 mg
Study Arms  ICMJE
  • Experimental: GC withdrawal
    Intervention: Drug: oral Prednisone 5mg
  • Placebo Comparator: non GC withdrawal
    Intervention: Drug: oral Prednisone 5mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 11, 2019)
321
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2023
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marta Mosca, MD 050992519 marta.mosca@med.inipi.it
Contact: Chiara Tani, MD chiara.tani@ao-pisa.toscana.it
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03804723
Other Study ID Numbers  ICMJE 001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Marta Mosca, University of Pisa
Study Sponsor  ICMJE University of Pisa
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Pisa
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP