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NCT06778343Recruiting

Biomarkers in Inflammatory Rheumatic Diseases Diagnosis

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

Source: ClinicalTrials.gov · Last updated 20 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
134 (estimated)
First submitted
10 Jan 2025
Start date
31 Jan 2023
Primary completion date
31 Mar 2025
Lead sponsor
Universidade Nova de Lisboa
NCT number
NCT06778343

What you commit to

  • Study type: Observational
  • Planned participants: 134
  • From 31 Jan 2023 to the primary completion date, 31 Mar 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;
  • 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;
  • Infections requiring hospitalization or intravenous treatment with antibiotics within 30 days or oral treatment with antibiotics within 14 days before enrollment;

Other illness

  • History of clinically significant (per Investigator\'s judgment) drug or alcohol abuse within the last 6 months;
  • 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;

Age

  • 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.

Other

  • Current pregnancy or breastfeeding;

Who the study is looking for

  • 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.

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
ULS Lisboa Ocidental, Hospital de Egas Moniz
Coordinator of this site? Confirm its status
LisbonPortugalRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.