Questions & Answers

The first study participant is expected to be enrolled in January 2021.

Data collection is conducted through an electronic CRF platform administered at the Karolinska Institutet. Investigators are provided with links to the eCRFs, one for each visit.

It takes differently long time depending on the visit. You can see the instruments constituting the eCRFs in the section Assessments and eCRFs. The longest data registration is for baseline, since it includes the EULAR/ACR classification criteria for SLE and kindey histopathology. Even if some instruments seem to be long, data in several sections within the instruments are automatically imputed by the eCRF system.

No, a repeat kidney biopsy due to worsening does not constitute a protocol violation. The repeat kidney biopsy in this case is not a per-protocol repeat kidney biopsy, and the incidence has to be registered as a flare. In the initial analysis, the patient will be analysed in the arm they were assigned. In secondary analyses, the patient might be analysed in the opposite arm, depending on when the biopsy was performed.

It depends on the design of the clinical trial. If the interventional part of the clinical trial is limited to one year, then it is possible since the first year of ReBioLup is observational, not interventional. The randomization for ReBioLup is always conducted at baseline, but the interventional part of ReBioLup starts from month 12 when the repeat kidney biopsy (for 50% of the patients) has been performed and will steer the intensity of immunosuppression.

No, kidney pathology is assessed at the participating centres (for the purpose of therapeutic decision making), but slides will be sent to UCLouvain for digitalisation and central review (for the purpose of analysis).

The tissue collection procedure has been designed to be simple. Two very small fragments obtained from the kidney biopsies (no larger than a pinhead) will be isolated, dropped into a 2.5% glutaraldehyde solution (together), and stored at 4 °C until shipment to the coordinating centre UCLouvain.

Yes, please contact the ReBioLup coordinator at [email protected] and ask for the risk/benefit profile of ReBioLup.

Yes, a small fee per patient enrolled will be provided to the participating sites. However, since ReBioLup is an investigator-initiated endeavour, this fee is limited.