Sjögren's disease & overlap diseases
Clinical trial eligibility of a real-world connective tissue disease cohort: Results from the LEAP cohort
Authors' conclusion
In an unselected, real-world CTD cohort, up to half of patients are ineligible for clinical trials due to not meeting classification criteria, overlapping features or a lack of trials within their primary disease.
Study context
- Population
- Multicentre unselected real-world CTD cohort (LEAP cohort); classification criteria used in phase-III CTD trials applied42 CTD trials reviewed
- Participants
- 391 participants
- Outcome
- Proportion of real-world CTD patients eligible for phase-III clinical trials
Methodological detailsmulticentre, review of published phase-III trials (clinicaltrials.gov)
- Multicentre
- Review of published phase-III trials (clinicaltrials.gov)
Main finding
As reported in the abstract
Eligible for recruitment
187 of 391
47.8 %
Undifferentiated CTD (UCTD) or MCTD, excluded for no eligible diagnosis
91 of 391
23.3 %
pSS, SLE, systemic sclerosis (SSc) or idiopathic inflammatory myopathy (IIM) meeting classification criteria for their diagnosis
211 of 300
70.3 %
Meeting criteria for >1 CTD
24 of 211
11.4 %
Observational data: associations, not effects.
Further findings
Review of phase-III CTD trials: eligibility requirements
- CTD trials identified
- 42
- Trials requiring classification criteria for the respective disease
- N = 38, 90 %
- Trials excluding patients with overlapping connective tissue diseases (CTDs)
- Eight (19.0 %)
- Trials excluding specific overlapping features (e.g. pulmonary arterial hypertension)
- two (4.8 %)
- Trials explicitly allowing overlap syndromes
- One
- No trials in MCTD or UCTD
Patients with UCTD or MCTD, excluded for not having an eligible diagnosis
- UCTD or MCTD
- 91/391, 23.3 %
pSS, SLE, SSc or IIM: meeting classification criteria for their diagnosis, and for >1 CTD
- Met classification criteria for their respective diagnosis
- 211/300 (70.3 %)
- Met criteria for >1 CTD
- 24/211 (11.4 %)
Original publication
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