Identifying biomarkers for early diagnosis of inflammatory rheumatic diseases

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

This study is trying to find specific markers in the body that can help doctors diagnose inflammatory rheumatic diseases like Ankylosing Spondylitis, Rheumatoid Arthritis, and Systemic Lupus Erythematosus earlier and more accurately.

Quick facts

• Study type: Observational
• Enrollment: 134 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Universidade Nova de Lisboa (Academic / other)
• Drugs / interventions: prednisone
• Locations: 1 site (Lisbon)
• Trial ID: NCT06778343 on ClinicalTrials.gov

What this trial studies

This study focuses on the early diagnosis of Ankylosing Spondylitis, Rheumatoid Arthritis, and Systemic Lupus Erythematosus, which are often challenging due to nonspecific early symptoms. By analyzing biological samples from patients with established diagnoses and healthy controls, the study aims to identify reliable biomarkers that can facilitate earlier diagnosis. The methodology includes a transcriptomic approach to assess the biological samples, which may lead to improved diagnostic criteria and treatment strategies. The ultimate goal is to enhance patient outcomes through timely intervention.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with Ankylosing Spondylitis, Rheumatoid Arthritis, or Systemic Lupus Erythematosus who can provide informed consent.

Not a fit: Patients without a confirmed diagnosis of the targeted rheumatic diseases or those unable to provide informed consent may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier and more accurate diagnoses of inflammatory rheumatic diseases, improving patient prognosis.

How similar studies have performed: Other studies have shown promise in identifying biomarkers for similar conditions, suggesting that this approach may yield valuable insights.

Eligibility criteria

Inclusion Criteria:

* Diagnosis of AS, RA, SLE according the mentioned criteria;
* Ability to provide informed consent;
* If entering the study on NSAIDs, tramadol, combination of paracetamol and codeine or hydrocodone, and/or non-opioid analgesics, subject must be on stable dose(s) for at least 14 days prior to the screening visit;
* If entering the study on oral corticosteroids, subject must be on a stable dose of prednisone (≤ 10 mg/day), or oral corticosteroid equivalents, for at least 14 days prior to the screening visit;
* If entering the study on MTX, leflunomide, SSZ, and/or hydroxychloroquine, subject must be on a stable dose of MTX (≤ 25 mg/week) and/or SSZ (≤ 3 g/day) and/or hydroxychloroquine (≤ 400 mg/day) or leflunomide (≤ 20 mg/day) for at least 28 days prior to the screening visit. A combination of up to two background csDMARDs is allowed;
* Subject is judged to be in good health as determined by the Principal Investigator based upon the results of medical history, laboratory profile, physical examination, x-Ray performed at the Screening Visit.

Exclusion Criteria:

* Current pregnancy or breastfeeding;
* Prior exposure to any biologic therapy;
* Intra-articular joint or tendon sheaths injections, spinal/paraspinal injection(s), or parenteral administration of corticosteroids within 28 days prior to the Baseline Visit. Inhaled or topical corticosteroids are allowed;
* Receipt of any live vaccine within 4 weeks prior to the screening visit;
* History of clinically significant (per Investigator\'s judgment) drug or alcohol abuse within the last 6 months;
* Subject has a history of inflammatory arthritis of different etiology other than AS, RA or SLE (including but not limited to PsA, mixed connective tissue disease, reactive arthritis, scleroderma, polymyositis, dermatomyositis, fibromyalgia), or any arthritis with onset prior to 17 years of age;
* Any uncontrolled medical condition (e.g., uncontrolled diabetes mellitus, unstable ischemic heart disease);
* History of any malignancy;
* Positive serology for hepatitis B, hepatitis C, or human immunodeficiency virus;
* Infections requiring hospitalization or intravenous treatment with antibiotics within 30 days or oral treatment with antibiotics within 14 days before enrollment;
* Note : Healthy Controls should be matched by gender and age. People with acute infections or injuries (in the last 6 months) or non-controlled chronic diseases (cardiac, metabolic, lung, neurologic, gastro-intestinal or renal) will be exclude. Family history of Auto-Immune diseases as diagnosed by a rheumatologist will be also excluded.

Where this trial is running

Lisbon

• ULS Lisboa Ocidental, Hospital de Egas Moniz — Lisbon, Portugal (Recruiting)

Study contacts

• Study coordinator: Fernando Pimentel-Santos, PhD Agg

Conditions Ankylosing Spondylitis; Rheumatic Arthritis; Systemic Lupus Erythematosus; Biomarker; Diagnosis