Last reviewed · How we verify
NCT04749160: SMART²T
Smart Marker Annunciating Response to Rheumatologic Treatments SMART²T
trial testing Connected device in Rheumatoid Arthritis in 26 participants. Completed in 20 February 2022.
20 February 2022
Quick facts
| Lead sponsor | Centre Hospitalier Universitaire de Saint Etienne |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 26 |
| Start date | 4 June 2021 |
| Primary completion | 20 February 2022 |
| Estimated completion | 20 February 2022 |
| Sites | 13 locations across France |
Drugs / interventions tested
- Connected device
Conditions studied
- Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Who can join
18 and older, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
European recommendations indicate to start a conventional synthetic disease modifying antirheumatic drug (csDMARD) as soon as possible to reach the remission in early RA or low disease activity in established RA. If the target is not achieved with the first csDMARD and in presence of poor prognostic, addition of a biologic (b)DMARD or a targeted synthetic (ts)DMARD should be considered . Nevertheless, as many as one-third of patients have persistent disease activity and insufficient (inadequate) response to a first b/tsDMARD according to international recommendations. This relatively long time (3 to 6 months) between treatment initiation and determination of individual clinical response represents: * a risk for the patient who could be usually exposed to potential side effects, * a loss of chance for the patient who will not receive an adequate treatment during the most favorable period and thus may develop irreversible lesions * a cost for the healthcare system, especially in terms of expensive drug reimbursements, notwithstanding the increasing use of biosimilars. Despite 20 years of research, no biomarker or no way are available in the daily practice to predict disease activity and the non-response to a b/tDMARD \[11\]. Thus exploration of a new approach is totally in purpose. The aim of this project is to benefit from the declarative PRO (Patient Reported Outcomes), the physical activity and sleep quality to predict the individual clinical response to the b/tsDMARDs
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04749160
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Connected device
Trials testing the same drug.
- NCT03529383 — Efficacy of Exercise Using Connected Activity Trackers and Therapeutic Education in Localized Breast Cancer · NA · completed
Other recruiting trials for Rheumatoid Arthritis
Currently open trials in the same condition.
- NCT07433335 — A Study to Assess the Safety and Tolerability of SR-878 in Patients With Rheumatoid Arthritis · Phase 1 · recruiting
- NCT07491016 — Efficacy and Safety of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis · recruiting
- NCT07171983 — A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis · Phase 1 · recruiting
- NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
- NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) · Phase 1 · recruiting
Other Centre Hospitalier Universitaire de Saint Etienne trials
Trials by the same sponsor.
- NCT07326579 — Effects of a Sleep Education Program on the Health Status of Healthcare Workers Working 12-hour Alternating Day-night Sh · NA · not yet recruiting
- NCT07504003 — Influence of Training Session Duration on Improvements in Physiological Resilience to Exercise · NA · recruiting
- NCT07483710 — Association Between Muscle L3 CT Scan Muscle Derived Parameters of Muscle Function Upon Intensive Care Unit Admission an · NA · not yet recruiting
- NCT06845176 — Combining Motor Imagery and Tendon Vibration on the Effectiveness of Motor Imagery · NA · recruiting
- NCT07344298 — Less is Better? Effectiveness of a Short Local Vibration Protocol on Neuromuscular Function · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04749160 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centre Hospitalier Universitaire de Saint Etienne
- Last refreshed: 18 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04749160.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing