Serum soluble vascular cell adhesion molecule-1 overexpression is a disease marker in patients with first-time diagnosed antinuclear antibodies: a prospective, observational pilot study (sVCAM-1 in ANA-positive patients)

Study identification

• EU PAS number:
  EUPAS22154
• Study ID:
  22155
• Official title and acronym:
  Serum soluble vascular cell adhesion molecule-1 overexpression is a disease marker in patients with first-time diagnosed antinuclear antibodies: a prospective, observational pilot study (sVCAM-1 in ANA-positive patients)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Objective: Antinuclear antibodies (ANA) serve as screening tests for connective tissue diseases but have low specificity. In this pilot study we aimed to identify patients with first-time positive ANA and musculoskeletal complaints, and correlate serum soluble vascular adhesion molecules as biomarkers.Methods: Prospective, observational study with 100 ANA-positive patients, comparing them to age- and gender-matched healthy controls (HC, n=75). Serum levels of soluble intercellular adhesion molecule-1 (sICAM-1), endothelial-leukocyte adhesion molecule-1 (sELAM-1), and vascular cell adhesion molecule-1 (sVCAM-1) were measured. A subgroup of patients with systemic sclerosis (SSc) treated with immunosuppressants was followed over 10 months.Results: Patients belonged to three main entities: Rheumatoid arthritis (RA, n=32), collagen diseases (CD, n=56) also including systemic sclerosis (SSc, n=11), and other autoimmune diseases (n=12). sICAM-1 was similar among groups. sELAM-1 was elevated by 1.9-fold in only in SSc. sVCAM-1 was elevated by 3.1-fold in RA, by 3.3-fold in CD, and other autoimmune diseases by 3.4-fold. 7 SSc-patients with immunosuppression had a 2.7-fold increased sVCAM-1 at baseline and reached the levels of healthy controls after 5 months, while CRP, ESR and clinical parameters remained unchained. Conclusion: This study suggests that sVCAM-1 is a disease marker independent from standard serum parameters in several rheumatic diseases.
• Study status:
  Finalised

Research institutions and networks

Institutions

Dr. Mara Oleszowsky

Study timelines

Date when funding contract was signed

Actual:02/01/2012

Study start date

Actual:02/01/2012

Data analysis start date

Actual:02/01/2012

Date of interim report, if expected

Actual:02/01/2012

Date of final study report

Actual:04/01/2018

Sources of funding

Other

Pharmaceutical company and other private sector 

More details on funding

Actelion, UNI Bonn

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable