Biomarkers in Inflammatory Rheumatic Diseases Diagnosis
Ankylosing Spondylitis, Rheumatoid Arthritis, and Systemic Lupus Erythematosus
Led by Universidade Nova de Lisboa · Updated on 2025-01-20
134
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
Official Title
Who Can Participate
AI-Screening
Trial Site Locations
Research Team
How is the study designed?
Frequently Asked Questions
Published Results
Sponsors
U
Universidade Nova de Lisboa
Lead Sponsor
C
Centro Hospitalar Lisboa Ocidental
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating biomarkers to improve early diagnosis and patient classification among three inflammatory rheumatic diseases: Ankylosing Spondylitis (AS), Rheumatoid Arthritis (RA), and Systemic Lupus Erythematosus (SLE). Early diagnosis is challenging due to nonspecific symptoms and difficulty distinguishing these diseases from infections or cancer. The study aims to identify specific transcriptomic signatures to better stratify patients and support earlier diagnosis and treatment.
The study involves analyzing peripheral blood samples from 34 patients with AS, 34 with RA, 34 with SLE, and 34 healthy controls matched by age and gender. Laboratory analysis uses transcriptomic approaches to identify disease-specific biomarkers. The goal is to develop a diagnostic chip for clinical use, with results confirmed by quantitative real-time protein chain reaction and validated in a new patient set.
Participants will be assessed from enrollment through 12 weeks to identify transcriptomic signatures for patient stratification. The study includes medical history review, physical exams, laboratory tests, and imaging at screening. Researchers monitor biomarker levels and disease classification over the study period to optimize diagnosis. Safety and health status are evaluated to ensure participant well-being throughout the trial.
CONDITIONS
Official Title
Biomarkers in Inflammatory Rheumatic Diseases Diagnosis
Who Can Participate
Age: 18Years - 65Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
Diagnosis of AS, RA, or SLE according to specified criteria
Ability to provide informed consent
Stable dose of NSAIDs, tramadol, combination of paracetamol and codeine, hydrocodone, or non-opioid analgesics for at least 14 days before screening
Stable dose of oral corticosteroids (prednisone ≤ 10 mg/day or equivalent) for at least 14 days before screening
Stable dose of MTX (≤ 25 mg/week), leflunomide (≤ 20 mg/day), SSZ (≤ 3 g/day), and/or hydroxychloroquine (≤ 400 mg/day) for at least 28 days before screening; up to two background csDMARDs allowed
Judged to be in good health by the Principal Investigator based on medical history, lab tests, physical exam, and x-Ray at screening
You will not qualify if you...
Current pregnancy or breastfeeding
Prior exposure to any biologic therapy
Intra-articular joint or tendon sheath injections, spinal/paraspinal injections, or parenteral corticosteroids within 28 days before baseline; inhaled or topical corticosteroids allowed
Receipt of any live vaccine within 4 weeks before screening
History of significant drug or alcohol abuse in last 6 months
History of inflammatory arthritis other than AS, RA, or SLE, including PsA, mixed connective tissue disease, reactive arthritis, scleroderma, polymyositis, dermatomyositis, fibromyalgia, or arthritis starting before age 17
Any uncontrolled medical condition such as uncontrolled diabetes or unstable heart disease
History of any malignancy
Positive tests for hepatitis B, hepatitis C, or HIV
Infections requiring hospitalization or IV antibiotics within 30 days, or oral antibiotics within 14 days before enrollment
For healthy controls: exclusion if acute infections or injuries in last 6 months, uncontrolled chronic diseases, or family history of autoimmune diseases diagnosed by a rheumatologist
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Trial Site Locations
Total: 1 location
1
ULS Lisboa Ocidental, Hospital de Egas Moniz
Lisbon, Portugal, 1349-019 Lisboa
Actively Recruiting
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Research Team
F
Fernando Pimentel-Santos, PhD Agg
I
Ian Lopes Teixeira, MSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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