Actively Recruiting
Biomarkers in Inflammatory Rheumatic Diseases Diagnosis
Led by Universidade Nova de Lisboa · Updated on 2025-01-20
134
Participants Needed
1
Research Sites
125 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
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.
CONDITIONS
Official Title
Biomarkers in Inflammatory Rheumatic Diseases Diagnosis
Who Can Participate
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
Trial Site Locations
Total: 1 location
1
ULS Lisboa Ocidental, Hospital de Egas Moniz
Lisbon, Portugal, 1349-019 Lisboa
Actively Recruiting
Research Team
F
Fernando Pimentel-Santos, PhD Agg
CONTACT
I
Ian Lopes Teixeira, MSc
CONTACT
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
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.
Already have an account? Log in here