Treat-to-target in systemic lupus erythematosus: a pilot study

Conditions: Lupus
SLE
10003816

Registration Number: NL-OMON52205

Lead Sponsor: Amsterdam UMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Age 18 years or older
- Diagnosed with SLE according to the American College of Rheumatology (ACR)
revised criteria for the classification of SLE.
- Signed informed consent form

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Life-threatening SLE manifestations that require intensive care treatment
- Pregnancy or breastfeeding during the time period of the pilot study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>A mixed methods approach will be adopted to establish usability, feasibility<br /><br>and acceptability. Data will be collected to assess the following primary<br /><br>endpoints:<br /><br>• Usability: Adherence rates and System usability scale (SUS)<br /><br>• Feasibility: Recruitment and retention rates, time required to recruit to<br /><br>target sample, number of eligible participants required to recruit required<br /><br>sample size, rate of completion of the intervention (i.e. number of<br /><br>participants who complete all aspects of the intervention)<br /><br>• Acceptability: assess through qualitative and quantitative questionnaires. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Although the pilot study is not powered to detect clinically significant<br /><br>changes in clinical outcome measures, we will collect these as secondary data<br /><br>in order to generate interval estimates of the change and to also determine<br /><br>whether the testing components that would be used in a larger evaluation are<br /><br>feasible.<br /><br>- Changes in disease activity (reported by cSLEDAI-2k and PGA)<br /><br>- Damage accrual at week 24 (SDI),<br /><br>- HRQoL (SF-36)<br /><br>- Proportion of disease flares apparition (SLEDAI-2K flare index)<br /><br><br /><br>These data could enable the statistical power calculations for a subsequent<br /><br>larger scale evaluation to assess the effectiveness of the T2T intervention as<br /><br>part of routine outpatient care.</p><br>