Actively Recruiting

Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID06778343

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

13 weeks

Total Duration

On this page

Sponsors

U

Universidade Nova de Lisboa

Lead Sponsor

C

Centro Hospitalar Lisboa Ocidental

Collaborating Sponsor

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

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

AI-Screening

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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

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

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Published Research Related To This Trial

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...

https://pubmed.ncbi.nlm.nih.gov/21470430

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

https://pubmed.ncbi.nlm.nih.gov/19208593

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.

M P M van der Linden, R Knevel, T W J Huizinga...

https://pubmed.ncbi.nlm.nih.gov/20967854

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...

https://pubmed.ncbi.nlm.nih.gov/6608352