Helping Doctors and Patients Work Together to Improve Lupus Care: A Randomized Study

Bridging Patient and Physician Perceptions to Improve Outcomes in Systemic Lupus Erythematosus: A Randomized Controlled Trial Using Value-Based Care -

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

REBEC

Registry ID

RBR-378kp32

Enrollment

520

Registered

2026-03-17

Start date

2020-11-28

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic lupus erythematosus Autoimmune Diseases

Interventions

This is a prospective randomized clinical study with two parallel groups and blinded group allocation involving a total of 520 participants with 260 participants in each group. Participants will be al

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Diagnosis of systemic lupus erythematosus according to the Systemic Lupus International Collaborating Clinics (SLICC) criteria; age 18 years or older; participants of both genders; ability to read understand and sign the informed consent form; current or recurrent episode of disease activity assessed by the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI = 4) within the last two months prompting a clinical decision to modify treatment at study initiation

Exclusion criteria

Exclusion criteria: Overlap with other autoimmune diseases; illiteracy

Design outcomes

Primary

Measure	Time frame
To evaluate disease activity in patients with systemic lupus erythematosus; assessed through clinical assessment using the Systemic Lupus Erythematosus Disease Activity Index, conducted by a trained professional; the index score was observed at 6 and 12 months of follow-up	—

Secondary

Measure	Time frame
Compare the percentage of patients achieving a = 4-point reduction in the Systemic Lupus Erythematosus Disease Activity Index at 12 months; assess at 6 and 12 months adherence to treatment, number of relapses, prednisone dosage, Patient-Reported Outcome Measures, percentage of patients with treatment modification, percentage achieving new target outcomes, and patient satisfaction with treatment; assessed using the Systemic Lupus Erythematosus Disease Activity Index for disease activity, adherence and Patient-Reported Outcome Measures by validated questionnaires, relapses and prednisone dosage from clinical records, treatment modification and target outcomes according to protocol, satisfaction by validated questionnaire; observed at 6 and 12 months	—

Measure

Time frame

Compare the percentage of patients achieving a = 4-point reduction in the Systemic Lupus Erythematosus Disease Activity Index at 12 months; assess at 6 and 12 months adherence to treatment, number of relapses, prednisone dosage, Patient-Reported Outcome Measures, percentage of patients with treatment modification, percentage achieving new target outcomes, and patient satisfaction with treatment; assessed using the Systemic Lupus Erythematosus Disease Activity Index for disease activity, adherence and Patient-Reported Outcome Measures by validated questionnaires, relapses and prednisone dosage from clinical records, treatment modification and target outcomes according to protocol, satisfaction by validated questionnaire; observed at 6 and 12 months

—

Countries

Contacts

Public ContactLuciana Seguro

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HCFMUSP)

luciana.seguro@hc.fm.usp.br+55-11-999916381

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Apr 4, 2026