Improving rates of remission by using a digital health app for triaging patients with axial spondyloarthritis and high disease activity to subsequently adapt medication (DATAX)

Improving rates of remission by using a digital health app for triaging patients with axial spondyloarthritis and high disease activity to subsequently adapt medication (DATAX) - DATAX

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00032408

Enrollment

330

Registered

2024-02-07

Start date

2024-02-12

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

M45

Interventions

Group 1: A T2T (treat to target) algorithm that follows current international scientific recommendations for the treatment of axSpA (axial spondyloarthritis) and is operationalized through a patient-c

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: • Diagnosis of axSpA according to their rheumatologist • High disease activity defined as BASDAI = 4 • Treatment initiation with continuous NSAIDs (nonsteroidal anti-inflammatory drug) medication is planned • bDMARD-naïve • Willingness to adhere to the study intervention, especially willigness to document disease activity measures frequently • Willingness of the patient to use their own smartphone to install (to download the app from the app stores: Apple’s App Store or Google’s Play Store on their mobile device) the RheCORD app and for documentation of disease activity

Exclusion criteria

Exclusion criteria: • Patient received two full courses of NSAIDs at a daily full dose for at least 2 weeks each • have contraindications to NSAIDs • taking high potency opioid analgesics (e.g. methadone) • comorbidities which cause back pain or might confound initiation and evaluation of the treatment response, such as fibromyalgia • concurrent liver disease (ALT >2 times upper limit of normal) • renal disease (creatinine clearance <30 ml/minute) • Any medical condition that would preclude the participant from adhering to the protocol • Insufficient knowledge of the German language

Design outcomes

Primary

Measure	Time frame
Remission defined as ASDAS (Ankylosing Spondylitis Disease Activity Score) <1.3 in week 24	—

Secondary

Measure	Time frame
• Time to reach ASDAS (Ankylosing Spondylitis Disease Activity Score) <1.3, • ASDAS <1.3 in week 12, • BASDAI50 response, • changes of medication based on BASDAI levels, • patient switching to bDMARD (biologic disease-modifying antirheumatic drugs) treatment, • changes of pain level, physical function and health-related quality of life	—

Countries

Germany

Contacts

Public ContactUta Kiltz

St. Elisabeth Gruppe GmbH

Uta.Kiltz@elisabethgruppe.de+492325592131

Outcome results

None listed

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