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

Qualifiers

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 design

Treatments tested in this trial

  • Not listed

Trial groups

134 Participants
are grouped into 4 trial groups

Sponsors and collaborators

Universidade Nova de Lisboa

Lead sponsor

Centro Hospitalar Lisboa Ocidental

Collaborator