Biomarkers in Inflammatory Rheumatic Diseases Diagnosis

NCT06778343 | Recruiting

• 1 other identifier: CNTO1275ARA4001 (BIRDD)
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

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

Ankylosing Spondylitis; Rheumatic Arthritis; Systemic Lupus Erythematosus

Keywords

Biomarker; Diagnosis

Outcome Measures

Primary Outcomes (1)

• Identify a transcriptomic signature to optimize patient stratification (between AS, RA and SLE)

  From enrollment to the end of the study at 12 weeks.

Secondary Outcomes (2)

• Identify novel signaling pathways that may represent new therapeutic targets

  From enrollment to the end of the study at 12 weeks.

• Compare transcriptomic signatures in different levels of disease activity

  From enrollment to the end of the study at 12 weeks

Study Arms (4)

Control

Ankylosing Spondylitis

Rheumatic Arthritis

Systemic Lupus Erythematosus

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People that satisfy the eligibity criteria with AS, RA, SLE and healthy individuals (as controls) currently living in Portugal.

You may qualify if:

• 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;
• If entering the study on MTX, leflunomide, SSZ, and/or hydroxychloroquine, subject must be on a stable dose of MTX (≤ 25 mg/week) and/or SSZ (≤ 3 g/day) and/or hydroxychloroquine (≤ 400 mg/day) or leflunomide (≤ 20 mg/day) for at least 28 days prior to the screening visit. A combination of up to two background csDMARDs is allowed;
• Subject is judged to be in good health as determined by the Principal Investigator based upon the results of medical history, laboratory profile, physical examination, x-Ray performed at the Screening Visit.

You may not qualify if:

• 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;
• History of clinically significant (per Investigator\'s judgment) drug or alcohol abuse within the last 6 months;
• Subject has a history of inflammatory arthritis of different etiology other than AS, RA or SLE (including but not limited to PsA, mixed connective tissue disease, reactive arthritis, scleroderma, polymyositis, dermatomyositis, fibromyalgia), or any arthritis with onset prior to 17 years of age;
• Any uncontrolled medical condition (e.g., uncontrolled diabetes mellitus, unstable ischemic heart disease);
• History of any malignancy;
• Positive serology for hepatitis B, hepatitis C, or human immunodeficiency virus;
• Infections requiring hospitalization or intravenous treatment with antibiotics within 30 days or oral treatment with antibiotics within 14 days before enrollment;
• Note : Healthy Controls should be matched by gender and age. People with acute infections or injuries (in the last 6 months) or non-controlled chronic diseases (cardiac, metabolic, lung, neurologic, gastro-intestinal or renal) will be exclude. Family history of Auto-Immune diseases as diagnosed by a rheumatologist will be also excluded.

Sponsors & Collaborators

• Universidade Nova de Lisboa: lead
• Centro Hospitalar Lisboa Ocidental Hospital Egas Moniz: collaborator

Study Sites (1)

ULS Lisboa Ocidental, Hospital de Egas Moniz

Lisbon, 1349-019 Lisboa, Portugal

RECRUITING

Related Publications (7)

• Pimentel-Santos FM, Ligeiro D, Matos M, Mourao AF, Costa J, Santos H, Barcelos A, Godinho F, Pinto P, Cruz M, Fonseca JE, Guedes-Pinto H, Branco JC, Brown MA, Thomas GP. Whole blood transcriptional profiling in ankylosing spondylitis identifies novel candidate genes that might contribute to the inflammatory and tissue-destructive disease aspects. Arthritis Res Ther. 2011 Apr 7;13(2):R57. doi: 10.1186/ar3309.

  PMID: 21470430 RESULT

• Eilertsen GO, Becker-Merok A, Nossent JC. The influence of the 1997 updated classification criteria for systemic lupus erythematosus: epidemiology, disease presentation, and patient management. J Rheumatol. 2009 Mar;36(3):552-9. doi: 10.3899/jrheum.080574. Epub 2009 Jan 22.

  PMID: 19208593 RESULT

• van der Linden MP, Knevel R, Huizinga TW, van der Helm-van Mil AH. 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. Arthritis Rheum. 2011 Jan;63(1):37-42. doi: 10.1002/art.30100.

  PMID: 20967854 RESULT

• van der Linden SM, Valkenburg HA, de Jongh BM, Cats A. The risk of developing ankylosing spondylitis in HLA-B27 positive individuals. A comparison of relatives of spondylitis patients with the general population. Arthritis Rheum. 1984 Mar;27(3):241-9. doi: 10.1002/art.1780270301.

  PMID: 6608352 RESULT

• Oglesby A, Korves C, Laliberte F, Dennis G, Rao S, Suthoff ED, Wei R, Duh MS. Impact of early versus late systemic lupus erythematosus diagnosis on clinical and economic outcomes. Appl Health Econ Health Policy. 2014 Apr;12(2):179-90. doi: 10.1007/s40258-014-0085-x.

  PMID: 24573911 RESULT

• Monti S, Montecucco C, Bugatti S, Caporali R. Rheumatoid arthritis treatment: the earlier the better to prevent joint damage. RMD Open. 2015 Aug 15;1(Suppl 1):e000057. doi: 10.1136/rmdopen-2015-000057. eCollection 2015.

  PMID: 26557378 RESULT

• Wendling D, Claudepierre P, Prati C. Early diagnosis and management are crucial in spondyloarthritis. Joint Bone Spine. 2013 Dec;80(6):582-5. doi: 10.1016/j.jbspin.2013.03.003. Epub 2013 Apr 8.

  PMID: 23578940 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral Blood Samples

MeSH Terms

Conditions

Spondylitis, Ankylosing; Rheumatic Fever; Lupus Erythematosus, Systemic; Disease

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Fernando Pimentel-Santos, PhD Agg

CONTACT

00351917305093; pimentel.santos@nms.unl.pt

Ian Lopes Teixeira, MSc

CONTACT

00351926234952; ian.teixeira@nms.unl.pt

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 16, 2025
• Study Start: January 31, 2023
• Primary Completion: March 31, 2025
• Study Completion: June 30, 2025
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)