An observational study in Rheumatoid Arthritis, sponsored by Scipher Medicine. Status unknown at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-04-30.
Sponsored by Scipher Medicine · Observational
Prospective, multi-center-observational study conducted within the US, collecting patient samples for research and development to train, test, and validate precision medicine classifiers. These molecular signature response classifiers (MSRC) aim to predict response status to JAK, T-cell, and IL-6 inhibitor therapies in patients with rheumatoid arthritis (RA).
2,963 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.
This study's planned enrollment of 1,100 is above the median of 176 across 854 observational studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Scipher Medicine is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
RA patients with moderate or high disease activity and are eligible for treatment with a JAK, T-cell, or IL-6 inhibitor therapy who are either naïve to biologic and targeted synthetic DMARDs or TNFi-exposed.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient must be initiating one of the following listed therapies (including biosimilars).
Concomitant treatments are permitted per standard of care and are not limited to the following:
a.csDMARD i.Methotrexate ii.Sulfasalazine iii.Leflunomide iv.Hydroxychloroquine b.Non-steroidal anti-inflammatory drugs c.Corticosteroids
Exclusion Criteria:
Other: Lab Collection Only
2 Paxgene and 1 SST tubes will be collected at 2 timepoints throughout the study.
The rate of MSRC to predict the patients response
The rate of MSRC to predict the patients response status based on actual clinical disease activity measure at 6 months. Determine performance characteristics of the MSRC being developed, trained, and validated to predict a patient's response status to specific biologic or targeted therapies.
Time frame: 6 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
Started Apr 2024 (actual). Primary completion is estimated for Jun 2025, 14 months after the start.
Of 121 industry-sponsored observational studies under Arthritis, Rheumatoid, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 96. This study's planned 14 months is below that.
Counting every sponsor, half of 317 studies reached it within 47 months; a quarter within 24 and three quarters within 93.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Scipher Medicine