Biomarkers in Inflammatory Rheumatic Diseases Diagnosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorUniversidade Nova de Lisboa
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
Current pregnancy or breastfeeding;
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;
Trial population
People that satisfy the eligibity criteria with AS, RA, SLE and healthy individuals (as controls) currently living in Portugal.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
134 Participants
are grouped into 4 trial groupsGroup A: Control
Group B: Ankylosing Spondylitis
Group C: Rheumatic Arthritis
Group D: Systemic Lupus Erythematosus
Trial outcomes
Primary outcomes
1
Identify a transcriptomic signature to optimize patient stratification (between AS, RA and SLE)
Time frame
From enrollment to the end of the study at 12 weeks.Secondary outcomes
1
Identify novel signaling pathways that may represent new therapeutic targets
Time frame
From enrollment to the end of the study at 12 weeks.2
Compare transcriptomic signatures in different levels of disease activity
Time frame
From enrollment to the end of the study at 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidade Nova de Lisboa
Lead sponsor
Centro Hospitalar Lisboa Ocidental
Collaborator
Source ClinicalTrials.gov