Study of Biomarkers for Early Diagnosis and Patient Stratification in 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
13 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying three inflammatory rheumatic diseases Ankylosing Spondylitis AS, Rheumatoid Arthritis RA, and Systemic Lupus Erythematosus SLE. Early diagnosis of these diseases is difficult but crucial for better outcomes. The study aims to identify new biomarkers that can help diagnose these diseases sooner, improving patient care and treatment strategies by using a transcriptomic approach on blood samples.
The study will analyze blood samples from patients with confirmed diagnoses of AS, RA, and SLE, along with healthy controls matched by age and gender. Researchers will use advanced methods to find specific biomarkers for each disease and develop a diagnostic chip to aid clinical practice. Results will be validated using quantitative real-time protein chain reaction and tested on new patient groups.
Participants will provide biological samples and undergo assessments to help researchers identify transcriptomic signatures that distinguish the three diseases. The study will measure these signatures over 12 weeks while monitoring disease activity. The goal is to improve patient stratification and discover new therapeutic targets. The study includes healthy volunteers and lasts from enrollment until 12 weeks later.
CONDITIONS
Brief Title
Biomarkers in Inflammatory Rheumatic Diseases Diagnosis
Research Team
F
Fernando Pimentel-Santos, PhD Agg
I
Ian Lopes Teixeira, MSc
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match. Sign up to get personalized trial recommendations delivered to your inbox.
Diagnosis of Ankylosing Spondylitis, Rheumatoid Arthritis, or Systemic Lupus Erythematosus according to specified criteria
Ability to provide informed consent
Stable doses of NSAIDs, tramadol, paracetamol with 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 methotrexate (≤ 25 mg/week), sulfasalazine (≤ 3 g/day), hydroxychloroquine (≤ 400 mg/day), or leflunomide (≤ 20 mg/day) for at least 28 days before screening; up to two background csDMARDs allowed
Judged to be in good health 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
Joint or tendon injections, spinal injections, or parenteral corticosteroids within 28 days before baseline visit (inhaled or topical corticosteroids allowed)
Receipt of any live vaccine within 4 weeks prior to screening
History of significant drug or alcohol abuse within 6 months
History of inflammatory arthritis other than AS, RA, or SLE, or arthritis onset 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 intravenous antibiotics within 30 days, or oral antibiotics within 14 days before enrollment
Healthy controls must be age- and gender-matched and free of acute infections, injuries in last 6 months, uncontrolled chronic diseases, or family history of autoimmune diseases diagnosed by a rheumatologist
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - 12 weeks
Participants provide biological samples and undergo laboratory analysis to identify biomarkers for inflammatory rheumatic diseases.
1 baseline visit and periodic sample collections during the study
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
Similar Trials
Study of TREX1 Gene Mutations Linked to Skin Symptoms in Systemic Lupus Erythematosus
Exploring Genetic and Autoantibody Connections in Lupus Patients
Study to Identify Targets of Disease-Related T Cells in Adults with Autoimmune Diseases
Study Evaluating Safety and Effectiveness of CD19 CAR-T Cell Therapy for Adults with Active Systemic Lupus Erythematosus
Study of CD19 Universal CAR-b3b4T Cell Treatment for Adults With Active Systemic Lupus Erythematosus
A Phase 1 Study to Evaluate Safety and Effects of MK-1045 Given by IV in Adults With Lupus or Rheumatoid Arthritis
Phase II Study of TQH3906 Capsules for Treating Systemic Lupus Erythematosus
Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial
Study of VENT-03 Tablets to Treat Adults With Active Cutaneous Lupus Erythematosus, With or Without Systemic Lupus Erythematosus A Phase 2a Randomized, Double-Blind, Placebo-Controlled Trial with Open-Label Extension
Phase 1b Study of Budoprutug for Adults Aged 18 to 65 With Active Systemic Lupus Erythematosus SLE Assessing Safety, Tolerability, and Drug Effects
Phase 2 Study of Inebilizumab and Blinatumomab to Treat Adults With Active Systemic Lupus Erythematosus and Refractory Rheumatoid Arthritis
Phase 3 Study of MIL62 Monoclonal Antibody Injection for Treating Systemic Lupus Erythematosus
Have more questions? Get in touch with our team for quick support
Published Research Related To This Trial
The risk of developing ankylosing spondylitis in HLA-B27 positive individuals. A comparison of relatives of spondylitis patients with the general population.
S M van der Linden, H A Valkenburg, B M de Jongh...
Classification of rheumatoid arthritis: comparison of the 1987 American College of Rheumatology criteria and the 2010 American College of Rheumatology/European League Against Rheumatism criteria.
Whole blood transcriptional profiling in ankylosing spondylitis identifies novel candidate genes that might contribute to the inflammatory and tissue-destructive disease aspects.
Fernando M Pimentel-Santos, Dário Ligeiro, Mafalda Matos...
The influence of the 1997 updated classification criteria for systemic lupus erythematosus: epidemiology, disease presentation, and patient management.
Gro Østli Eilertsen, Andrea Becker-Merok, Johannes C Nossent