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BASS

BASS study: B-cells and Auto-antibodies in progression to Systemic Sclerosis. A Dutch prospective multicenter study in patients with very early and early systemic sclerosis. - BASS

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON58315
Enrollment
125
Registered
2025-06-16
Start date
2026-05-07
Completion date
Unknown
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic sclerosis, Scleroderma, CREST Syndrome, SSc Scleroderma

Interventions

N.A.

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: A: very early SSc patients, fulfilling at least one of the following three criteria: - Raynaud’s phenomenon - Puffy fingers less than 3 years  - Abnormal nailfold capillaries including capillary enlargement (>= 50 um) and/ or loss (=< 7 capillaries per mm)AND - Not fulfilling the ACR/EULAR 2013 criteria (less than 9 points)  OR         B: established SSc, fulfilling all criteria:            - Fulfilling ACR/EULAR 2013 criteria             - Clinical diagnosis of SSc according to the treating physician            - First SSc attributed symptom other than Raynaud’s less then 24 months before inclusion. 2. Presence of ATA+ or ACA+ antibodies 3. Age of =18 years 4. Written informed consent for this study

Exclusion criteria

Exclusion criteria: Patients with another systemic auto-immune diseasePatients who underwent an autologous stem cell transplantationPatients who received B cell depleting therapy in the past 6 months Patients who received prednisolone > 1 mg/ kg > 4 weeks in the past 6 months or >= 1000 mg methylprednisolone IV during the past month 

Design outcomes

Primary

MeasureTime frame
Disease progression 

Secondary

MeasureTime frame
Health related quality of life and brief illness perception questionnaires in patients with very early and early SSc.

Countries

Netherlands

Contacts

Public ContactJ.K. Vries-Bouwstra

Leids Universitair Medisch Centrum

j.k.de_vries-bouwstra@lumc.nl+31 71 5263423

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: May 22, 2026