DRKS00025966
Recruiting
未知
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 - MAppRCT-RA-SpA-2020
Midaia GmbH0 sites188 target enrollmentOctober 17, 2022
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- M05
- Sponsor
- Midaia GmbH
- Enrollment
- 188
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Stem cell transplantation versus disease modifying therapy (alemtuzumab or ocrelizumab) for patients with highly active relapsing remitting MSHighly active relapsing remitting multiple sclerosisMedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]EUCTR2019-001549-42-GBSheffield Teaching Hospitals198
Recruiting
Not Applicable
A multicenter randomized controlled study to evaluate the effectiveness to share monitoring of daily symptoms between patients and physicians in the treatment of Parkinson's diseaseParkinson's DiseaseJPRN-UMIN000047860Juntendo University Hospital110
Not yet recruiting
Not Applicable
South Korean study to prevent cognitive impairment and protect brain health through multidomain interventions via face-to-face and video communication platforms in mild cognitive impairmentMental and behavioural disordersKCT0006592Inha University Hospital300
Completed
Not Applicable
The Early Nasojejunal Tube to Meet Energy Requirements in Intensive Care StudyMechanically-ventilated, medical-surgical critically ill patients with reduced gastric motilityOther - Research that is not of generic health relevance and not applicable to specific health categories listed aboveACTRN12605000149662ICU Rsearch Department, The Alfred Hospital, Melbourne Victoria180
Completed
Not Applicable
Randomised controlled multicenter study to evaluate safety and performance of Geistlich Wound Matrix versus autologous skin graft in the treatment of skin defectssurgical skin lesionDRKS00010930Geistlich Pharma AG48