Dataset Information

Mock Recruitment for the Study of Antimalarials in an Incomplete Lupus Erythematosus Trial.

ABSTRACT:

Objective

Recruitment to randomized clinical trials is expensive and often falls short of goals, limiting achievement of measurable outcomes. To prepare for a trial in patients with incomplete forms of lupus, a mock recruitment protocol was carried out at 4 proposed study sites. The objective was to determine levels of interest in patients and to uncover potential barriers to enrollment.

Methods

After obtaining institutional review board approval, study coordinators approached individuals who generally fit proposed criteria for the trial. A standardized script was followed in a structured interview. Levels of interest were determined and any reasons for concerns were collected with an open-ended format.

Results

A total of 45 subjects were interviewed, of which 73% expressed an interest in the trial, and 64% said they were likely to enroll. Concerns of those who were not interested included risk of hydroxychloroquine, desire not to receive placebo, and lack of time for participation.

Conclusion

The mock recruitment suggests that the trial will be attractive to suitable patients. The concerns raised support other data indicating that provision of information is crucial to achieving enrollment goals. Mock recruitment of potential investigators should be considered also to address referral concerns.

SUBMITTER: Karp DR

PROVIDER: S-EPMC6487234 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Mock Recruitment for the Study of Antimalarials in an Incomplete Lupus Erythematosus Trial.

Karp David R DR Chong Benjamin F BF James Judith A JA Arriens Cristina C Ishimori Mariko M Wallace Daniel J DJ Liao Duanping D Olsen Nancy J NJ

Arthritis care & research 20191101 11

<h4>Objective</h4>Recruitment to randomized clinical trials is expensive and often falls short of goals, limiting achievement of measurable outcomes. To prepare for a trial in patients with incomplete forms of lupus, a mock recruitment protocol was carried out at 4 proposed study sites. The objective was to determine levels of interest in patients and to uncover potential barriers to enrollment.<h4>Methods</h4>After obtaining institutional review board approval, study coordinators approached ind ...[more]

PMID: 30369087

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Project description:BACKGROUND:Onset of systemic lupus erythematosus (SLE) is preceded by a preclinical phase characterized by expression of autoantibodies and nonspecific clinical symptoms. Hydroxychloroquine is a treatment for lupus that is widely used based on longstanding experience and a very good safety profile. Existing data suggest that treatment with hydroxychloroquine may postpone the onset of disease. However, prospective studies that prove and quantify the efficacy of hydroxychloroquine in the preclinical phase of lupus have not been done. This study will test the hypothesis that early hydroxychloroquine use can prevent accumulation of clinical abnormalities and modify immune responses that define SLE. METHODS:A randomized, double-blind, placebo-controlled trial of hydroxychloroquine vs placebo will be conducted. Participants will have incomplete lupus erythematosus as defined by the presence of antinuclear antibody (ANA) positivity at a titer of 1:80 or greater, as well as one or two additional criteria from the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria. The age range will be 15-45?years and the treatment phase will be 96?weeks. The primary endpoint will be the increase in the number of features of SLE defined by the 2012 SLICC classification schema. Secondary outcomes will include the proportion of participants who transition to a classification of SLE as defined by SLICC criteria. DISCUSSION:A major challenge for improving therapies in patients with SLE is early detection of disease. The ANA test that is widely used to screen for SLE has low specificity and interpretation of its significance is challenging. The Study of Anti-Malarials in Incomplete Lupus Erythematosus (SMILE) trial will provide insights into the appropriate target population for intervention, and will assess whether hydroxychloroquine can slow progression as measured by the accumulation of criteria. Ophthalmologic safety in this population will be assessed. The study will investigate candidate biomarkers that will guide treatment decisions and will accumulate a specimen biobank that will be available to the lupus research community for further in-depth mechanistic studies. This trial is a first step toward testing the feasibility of disease prevention strategies in SLE. TRIAL REGISTRATION:ClinicalTrials.gov, NCT 03030118 . Registered on 24 January 2017.

Project description:ObjectiveIncomplete lupus erythematosus (ILE) involves clinical and/or serologic manifestations consistent with but insufficient for systemic lupus erythematosus (SLE) classification. Because the nature of ILE is poorly understood and no treatment recommendations exist, we examined the clinical manifestations, medication history, and immunologic features in a diverse collection of ILE and SLE patients.MethodsMedical records of subjects enrolled in the Lupus Family Registry and Repository were reviewed for medication history and American College of Rheumatology (ACR) classification criteria to identify ILE patients (3 ACR criteria; n = 440) and SLE patients (≥4 ACR criteria; n = 3,397). Participants completed the Connective Tissue Disease Screening Questionnaire. Anticardiolipin and plasma B lymphocyte stimulator (BLyS) were measured by enzyme-linked immunosorbent assay, antinuclear antibodies (ANAs) by indirect immunofluorescence, and 13 autoantibodies by bead-based assays.ResultsOn average, ILE patients were older than SLE patients (46.2 years versus 42.0 years; P < 0.0001), and fewer ILE patients were African American (23.9% versus 32.2%; P < 0.001). ILE patients exhibited fewer autoantibody specificities than SLE patients (1.3 versus 2.6; P < 0.0001) and were less likely to have ANA titers ≥1:1,080 (10.5% versus 19.5%; P < 0.0001). BLyS levels were intermediate in ILE patients (controls < ILE; P = 0.016; ILE < SLE; P = 0.008). Pericarditis, renal, or neurologic manifestations occurred in 12.5% of ILE patients and were associated with non-European American race/ethnicity (P = 0.012). Hydroxychloroquine use increased over time, but was less frequent in ILE than SLE patients (65.2% versus 83.1%; P < 0.0001).ConclusionAlthough usually characterized by milder symptoms, ILE manifestations may require immunomodulatory treatments. Longitudinal studies are necessary to understand how ILE affects organ damage and future SLE risk, and to delineate molecular pathways unique to ILE.

Dataset Information

Mock Recruitment for the Study of Antimalarials in an Incomplete Lupus Erythematosus Trial.

Objective

Methods

Results

Conclusion

Publications

Mock Recruitment for the Study of Antimalarials in an Incomplete Lupus Erythematosus Trial.

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