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SLE and Arthralgia- The role of musculoskeletal ultrasound (US) and fluorescence optical Imaging (FOI) Xiralite® in the diagnostic of inflammatory joint and tendon involvement in SLE

SLE and Arthralgia- The role of musculoskeletal ultrasound (US) and fluorescence optical Imaging (FOI) Xiralite® in the diagnostic of inflammatory joint and tendon involvement in SLE - SLE & A

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00023484
Enrollment
118
Registered
2021-02-05
Start date
2019-04-26
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Systemic lupus erythematosus

Interventions

Group 1: Musculosceletal ultrasound of predefined joints and fluorescence optical imaging (FOI) of both Hands at baseline visit (only one visit)

Sponsors

GlaxoSmithKline GmbH & Co. KG
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: -Diagnosis of systemic lupus erythematosus. -Arthralgia at recruitment time. -No visible joint swelling detectable. -No alternations in therapy regime (e.g. corticosteroid treatment) four weeks prior to recruitment. -Examination with FOI is medically indicated

Exclusion criteria

Exclusion criteria: -Diagnosis of rheumatic disease other than SLE. -Visible, clinically detectable joint swelling at recruitment. -Gout or bacterial Arthritis. -Psychiatric disease disabling full understanding of protocol, consent form and patient information form

Design outcomes

Primary

MeasureTime frame
The aim of the study is to detect pre/-subclinical inflammatory joint and tendon involvement in SLE patients with arthralgia, i.e. without clinical Arthritis (no clinical joint swelling) using musculosceletal US and FOI via Xiralite®. We aim to define US and FOI findings according to international standards using EULAR/OMERACT definition, to compare the findings of these two modalities (US vs. FOI), as well to compare US and FOI findings to clinical characteristics/parameters such as joint pain, pain scores, morning stiffness, functionally scores and to the main disease activity scores SLEDAI and BILAG.

Secondary

MeasureTime frame
US and FOI should be examined for their inter- and intra-reader reliability.

Countries

Germany

Contacts

Public ContactSarah Ohrndorf

Med. Klinik mit SP Rheumatologie und Klin. Immunologie, Charité-Universitätsmedizin Berlin

sarah.ohrndorf@charite.de+49(0)30450513247

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026