lupus SLE Systemic lupus erthematosus
Conditions
Interventions
None listed
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Flare biomarker study: 1. Age at the time of inclusion >= 18 years. 2. Diagnosis of SLE according to the EULAR/ACR criteria. 3. BILAG C, D or E only. 4. No restriction regarding current or previous therapies, except for hydroxychloroquine (HCQ) or chloroquine treatment which should be administered unless contraindicated or documented intolerance in the past. - Response biomarker study: 1. Age at the time of inclusion >= 18 years. 2. Diagnosis of SLE according to the EULAR/ACR criteria. 3. Patients should have at least one of the following: i. active arthritis, attributed to SLE (BILAG A or B in the musculoskeletal domain). ii. active skin disease, attributed to SLE (BILAG A or B in the mucocutaneous domain). iii. active biopsy-proven lupus nephritis (LN; ISN/RPS class III, IV or V), with or without extrarenal organ involvement. iv. active CNS involvement as a main manifestation (with or without other organ involvement) along with initiation of new treatment for CNS involvement (BILAG A or B in the neuropsychiatric domain). 4. Stable standard therapy for at least 30 days, including hydroxychloroquine (HCQ) or chloroquine treatment, unless contraindicated or documented intolerance.
Exclusion criteria
Exclusion criteria: - Flare biomarker study: 1. Pregnancy (at baseline). 2. Initiation or intensification of immunosuppressive therapy or a prednisone equivalent dose of > 10 mg/day within 30 days prior to baseline. - Response biomarker study: 1. Serological activity only without signs of clinically active disease. 2. Pregnancy (at baseline).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Flare biomarker study: Proportion of patients developing a flare within 24 months of follow-up, defined as a new BILAG A or B in any clinical domain. The impact of the presence of anti-SARS-CoV-2 antibodies of different isotypes (IgA, IgG, IgM) on this outcome will be addressed. - Response biomarker study: BICLA response at week 52 from baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Flare biomarker study: Proportion of patients developing a flare within 24 months of follow-up, defined according to the SELENA-SLEDAI Flare Index (SFI). The impact of the presence of anti-SARS-CoV-2 antibodies of different isotypes (IgA, IgG, IgM) on this outcome will be addressed. - Reponse biomarker study: SLE Responder Index (SRI)-4, SRI-5 and SRI-6 response (at all time points); Time to BICLA response and SRI response; failure to attain BICLA response or SRI-4, SRI-5 and SRI-6 response (at all time points); Change in SLEDAI-2K scores, Physician*s Global Assessment (PhGA, on a scale 0-3) and Patient*s Global Assessment (PGA, on a 0-10 VAS) (at all time points); LLDAS, and its individual components (at all time points); Remission according to DORIS, and its individual components (at all time points); Flare, based on BILAG (any new worsening in BILAG, or any new BILAG A or B) or SELENA-SLEDAI Flare Index (SFI) (at all time points); Renal response/non-response, according to the 2019 EULAR/EDTA recommendations; Organ-specific outcome measures (e.g. CLASI for mucocutaneous involvement, 44 joint assessment of tender and swollen joints for articular involvement) (at all time points); Worsening in SLICC/ACR Damage Index (SDI) score (at week 52); Health-related quality of life (HRQoL), assessed with EQ-5D-5L, FACIT-F, Medical Outcomes Study 36-item Short Form health survey (SF-36), Epworth Sleepiness scale (ESS) and Lupus-QoL (at week 26 and week 52); Impact of anti-SARS-CoV-2 antibodies of different isotypes (IgA, IgG, IgM) on attainment of or time to BICLA, SRI, LLDAS and DORIS, change in SLEDAI-2K, PhGA, PGA and SDI scores, change in organ specific index scores, and HRQoL outcomes. | — |
Countries
Netherlands
Outcome results
None listed