Temporary Withholding of Immunosuppressant in Rheumatic diseases and Lupus (TWIRL) Study

Phase 2

Recruiting

Conditions: Systemic lupus erythematosus
Inflammatory and Immune System - Autoimmune diseases
Inflammatory and Immune System - Connective tissue diseases

Registration Number: ACTRN12623000397617

Lead Sponsor: Monash Health

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

•Patients with systemic lupus erythematosus, who are currently enrolled in the Australian Lupus Registry & Biobank.
•Receiving stable doses of mycophenolate and have not experienced a flare in the last 3 months.
•Combination with hydroxychloroquine will be permitted
•Prednisolone must be at a dose equal or lower than 7.5mg/day.

Exclusion Criteria

•Concomitant use of other biologics such as rituximab or belimumab in the last 6 months
•Other targeted synthetic disease modifying anti-rheumatic drugs such as JAK inhibitors
•Age >65 as a different, adjuvated vaccine is clinically recommended for this age group

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients achieving greater than 4-fold increase in antibody titre of Anti-influenza antibody in plasma by haemagglutination inhibition assay (HIA) in 2 of 4 influenza vaccine antigens compared to baseline[ Bloods collected at baseline (week 0) and 4 weeks following vaccination will be analysed to measure change in HIA]

Secondary Outcome Measures

Name	Time	Method
Patient flares will be assessed via both physician-reported and patient-reported measures. A patient-reported outcome measure in the form of RAPID3 (score 0-30) will be captured, with a flare defined as a RAPID3 score of greater than or equal to 13. [ Participants will be asked to complete the RAPID3 questionnaire at five timepoints: at baseline (week 0), week 2, 4, 8, and 12 following influenza vaccine.];Flares will also be captured by SFI (SLE Flare Index), a physician-reported measurment[ SFI will be assessed at baseline (week 0) and at a lupus clinic visit 5 weeks following influenza vaccine. ];Flare assessment by physician using the Physicians' Global Assessment (PGA), where a flare is defined as a change of 1 or greater from baseline.[ PGA will be assessed at baseline (week 0) and at a lupus clinic visit 5 weeks following influenza vaccine. ]