NCT07825233Toborzás még nem indult
Pix-Risk: Early Detection of Rheumatoid Arthritis Via the DETECTRA Platform
A Randomised, Two-arm, Parallel-assigned Open-label Standard-of-care Controlled Trial to Investigate the Efficacy of Using the Remote Patient Monitoring Platform DETECTRA to Shorten Time-to-diagnosis of Rheumatoid Arthritis in At-risk Patients.
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 17.
Rövid összefoglaló (regiszter, angolul)
The goal of this clinical trial is to learn if a remote monitoring application called DETECTRA can help doctors diagnose rheumatoid arthritis earlier in people who are at risk of developing the disease. It will also learn about the safety and usefulness of this approach. The main questions it aims to answer are: Does monitoring symptoms through the DETECTRA application help doctors diagnose rheumatoid arthritis earlier than standard medical follow-up? Does the use of the application help doctors identify signs of arthritis and arrange a medical consultation sooner? How does the disease progress in participants, and how well are their symptoms controlled? A total of 142 adults will take part in the study. Participants will be randomly assigned to one of two groups: 1. Receive standard medical care 2. Receive standard medical care and use the DETECTRA application Participants using the application will: Answer questions about their symptoms every 2 weeks Take photographs of their hands using their smartphone Have their information reviewed remotely by doctors The study will also look at how participants use the application and whether remote monitoring could be useful for the healthcare system.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 142 (tervezett)
- Első benyújtás
- 2026. szept. 5.
- Kezdés
- 2026. szept. 28.
- Elsődleges befejezés
- 2029. júl. 31.
- Fő szponzor
- Centre Hospitalier Universitaire Vaudois
- Betegségek
- Rheumatoid arthritis
- NCT-szám
- NCT07825233
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 142
- 2026. szept. 28. és az elsődleges befejezés (2029. júl. 31.) között
- 5 helyszín, 4 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Korábbi kezelés
- Any previous b, ts, and csDMARDs use
- Haematological or oncological treatments involving induction and / or maintenance chemotherapy within the last 5 years are not permitted
- Participation in another investigation with an investigational drug or another MD within the 30 days preceding the trial or currently participating or planning to participate in an interventional trial
Más betegség
- Severe cognitive impairment, severe psychiatric conditions or other inability to follow the procedures of the study
- Any Immunosuppressive therapy for other autoimmune conditions with B-cell depletion
Laborértékek
- Known microcrystal disease (e.g. gout, calcium pyrophosphate deposition) if hands are affected or pre-existing immune-mediated rheumatic diseases such as systemic lupus erythematosus or Sjögren's disease
Életkor
- Immunosuppressive therapy for other autoimmune conditions <2 years ago
Egyéb
- Deformation of the hands or patients who have undergone joint arthrodesis or arthroplasty
- Fulfilling the ACR/EULAR 2010 classification criteria for diagnosis of RA (≥ 6 points)
- Known or suspected clinical synovitis by physician in > 3 small joints (with or without involvement of large joints)
- Lymphoedema in arms or hands following an axillary lymph node dissection
- Inability to provide written informed consent
- No regular (at least every 2 weeks) access to a smartphone
- Adults who lack capacity to consent, known pregnant and breastfeeding women
- Subjects for whom routine examination of the musculoskeletal system is not possible, or whose hands cannot be imaged (e.g., bandages that cannot be removed for hand picture taking, or injuries affecting the PIP joints both persisting for > 49 days)
- Enrolment of the PI, his/her family members, employees and other dependent persons
Kiket keres a vizsgálat
- Must provide and sign the study's Informed Consent prior to any study-related procedures
- Able to understand and interact with the study team
- Agree to comply in good faith with all conditions of the recordings, and to attend all required study procedures.
- Arthralgia (including hand joints PIP and or MCP)
- Joint symptoms (arthralgia or stiffness) of recent onset (symptoms <1 year)
- Known positive ACPA-titer with written proof
- Aged 18 years-old or more
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (5)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Medical University Vienna | Vienna | Ausztria | Ismeretlen állapot |
| Centre Hospitalier Unversitaire Vaudois | Lausanne | Svájc | Ismeretlen állapot |
| Charité Universitätsmedizin Berlin | Berlin | Németország | Ismeretlen állapot |
| Ruhr University Bochum | Bochum | Németország | Ismeretlen állapot |
| Copenhagen Center for Arthritis Research (COPECARE), Rigshospitalet | Copenhagen | Dánia | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.