A randomized, controlled multicentre study to evaluate the safety andefficacy of Mida Rheuma App use added to care as usual in adult subjects withRheumatoid Arthritis

Not Applicable

Recruiting

• Conditions: M05; M06; Seropositive rheumatoid arthritis; Other rheumatoid arthritis

• Registration Number: DRKS00025966
• Lead Sponsor: Midaia GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 188

Inclusion Criteria

Adult subjects (male or female) 18 years and over that meet the
corresponding specific classification criteria of RA (ICD-10 M05 and
M06, according to classification criteria: RA, ACR/ European
League Against Rheumatism (EULAR) 2010).
- German-speaking person who has a smartphone and an e-mail
account, and is able to use both of them
- If using Disease-modifying antirheumatic drugs (DMARDs) therapy,
subjects are permitted to use any conventional synthetic
(csDMARDs), targeted synthetic (tsDMARDs) or biological
(bDMARDs), alone or in combination and must have been on a
stable dose of the drug for at least 4 weeks prior to study inclusion
day.
- If taking systemic or steroids, must have been on a stable dose of
the drug for at least 4 weeks prior to study inclusion day.
- If taking non-steroidal anti-inflammatory drugs (NSAIDs), these must
be at a stable dose for at least 2 weeks prior to study inclusion day.
- Disease activity of =>6.1 according to RAPID3 at baseline.

Exclusion Criteria

- Presence of disorders which, in the opinion of the investigator, significantly complicate the work with the phone that would prevent or substantially complicate Mobile Application use. These disorders can include but are not limited to mental disorders or functional impairment (e.g., physical impairments).
- The subject has any condition or circumstances that, in the opinion of the investigator, may make a subject unlikely or unable to complete the study or comply with study procedures and requirements.
- History of other inflammatory arthritis, or combination of RA with psoriatic arthritis (PsA), ankylosing spondylitis (AS), or axial spondyloarthritis (axSpA).
- Patients with acute fever, acute viral or bacterial infections, other autoimmune diseases (i.e., MS), other severe diseases (i.e., congestive heart failure, heart attack), and uncontrolled conditions: apoplexy, seizures, Parkinson's disease, severe COPD or allergic diseases.
- Patients taking antibiotics and antihistamine.
- Receipt of an intra-articular or parenteral corticosteroid injection within 4 weeks prior to screening.
- The subject for whom a change in arthritis treatment is planned since the start of screening within the next 17 weeks.
- Previous use of any Midaia Software or equivalent digital therapeutic in the past 12 months.
- The female subject is pregnant or breast feeding or intending to become pregnant or breastfeeding during the study.

Study & Design

• Study Type: interventional
• Study Design: Not specified