NCT06778343

Biomarkers in Inflammatory Rheumatic Diseases Diagnosis

BIRDD: Biomarkers in Inflammatory Rheumatic Diseases Diagnosis - Ankylosing Spondylitis, Rheumatoid Arthritis and Systemic Lupus Erythematosus

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 134 (estimated)
• Sponsor: Universidade Nova de Lisboa · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Ankylosing spondylitis (AS), Rheumatoid Arthritis (RA) and Systemic Lupus Erythematosus (SLE) are three diseases where early diagnosis remains a major challenge. However, early diagnosis is the main determinant for a better prognosis. In the early stage, symptoms may be nonspecific and often difficult to establish a differential diagnosis between rheumatic diseases and other diseases, namely infectious and cancer diseases.

Detailed description

The management of these diseases has undergone major advances in recent years, both in terms of the drugs armamentarium and therapeutic strategy. Treating disease to target, aiming at remission, through a tight control protocol is regarded as the standard of care. These principles were imported from RA and became the main strategy to approach several rheumatic inflammatory diseases. Reaching clinical and radiographic disease remission has therefore become an achievable goal. Increasing evidence has demonstrated that early diagnosis, prompt treatment initiation and early achievement of remission are the major predictors of good long-term clinical, functional and radiographic outcomes. The main reason for diagnostic delays is that classification criteria sets, including, imaging or biochemical changes, require time to occur. Rheumatoid factor, anti-CCP, ANA, anti-DNA and anti-Sm autoantibodies are often negative in the early stages of the disease; HLA B27 gene has a low specificity for AS. New criteria are now available and some biomarkers are emerging that allow earlier patient diagnosis. This new paradigm, needs new research trying to identify the most reliable biomarkers with relevance for clinical use. The investigators intend to analyse biological samples, peripheral blood, from patients with well-established diagnosis (34 AS, 34 RA and 34 SLE) and 34 healthy controls (crossed by gender and age). Laboratory analysis will be based on transcriptomic approach trying to put in evidence specific biomarkers for each disease. The method is based on a analytical methodology already proven with success in stratifying patients. The main objective of this study will be the development of a diagnostic chip to be implemented in clinical practice. The results should be confirmed in the same set of patients using quantitative real-time protein chain reaction (RT-PCR) and the validation in a new set of patients. The main objective of this project is to establish a quick method to stratify patients of the three diseases- AS, SLE, RA.

Conditions

• Ankylosing Spondylitis
• Rheumatic Arthritis
• Systemic Lupus Erythematosus

Timeline

• Start date: 2023-01-31
• Primary completion: 2025-03-31
• Completion: 2025-06-30
• First posted: 2025-01-16
• Last updated: 2025-01-20

Locations

1 site across 1 country: Portugal