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Status unknownNCT06390709PREDICTUpdated Apr 30, 2024

PREDICT Therapy Selection for JAK, T-cell, or IL-6 Inhibitor Therapies Using a Molecular Signature Response Classifier (PREDICT)

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

The sponsor has not verified this record recently (last verified Apr 2024), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,100
Ages
18 Years to 100 Years
Sex
All
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Study summary

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).

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Conditions studied

  • Rheumatoid Arthritis
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In context

Arthritis, Rheumatoid

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 →

Lead sponsor

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.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Inclusion criteria

  1. Patient is eighteen years of age, or older (≥18) at time of consent.
  2. Patient must meet the criteria for RA as defined by the 2010ACR/EULAR classification at Visit 1 and documented by enrolling PI.
  3. Patient has active RA, with moderate or high disease activity as confirmed by a CDAI score of >10 at Visit 1.
  4. Patients must have a history of failure, contraindication, or intolerance to at least one csDMARD therapy.
  5. Patient must be b/tsDMARD-naïve or TNFi-exposed prior to baseline visit only.
  6. Patient must be initiating one of the following listed therapies (including biosimilars).

    1. JAK inhibitor therapy (only tofacitinib or upadacitinib)
    2. T-cell inhibitor therapy (abatacept)
    3. IL-6 inhibitor therapy (only tocilizumab)
  7. 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

  8. Patient may participate in another observational study.
  9. Patient is willing and able to complete the informed consent process and comply with all study procedures and visit schedule.

Exclusion criteria

Exclusion Criteria:

  1. Patient has previously participated in a Scipher Medicine study (NETWORK-004, AIMs in RA, DRIVE, or INFORM).
  2. Patients who have been treated with an altMOA (non-TNFi therapy) therapy for RA prior to baseline (Visit 1).
  3. Women who are known to be pregnant or breast-feeding or plan to get pregnant during the study duration.
  4. Concurrent treatment with an investigational product or use of an investigational product within 28 days of Visit 1.
  5. The use of RA therapies outside of an FDA approved indication.
  6. Patient is currently receiving systemic antimicrobial treatment for viral, bacterial, fungal, or parasitic infection at the time of baseline visit (Visit 1).
  7. Any known active, chronic, or recurrent invasive infection (e.g., listeriosis and histoplasmosis) and viral infection that, based on the Investigator's clinical assessment, makes the patient an unsuitable candidate for the study. This includes hepatitis B virus (HBV) or hepatitis C virus (HCV), recurrent or disseminated (even a single episode) herpes zoster, disseminated (even a single episode) herpes simplex, or human immunodeficiency virus (HIV).
  8. Patient with any known active malignancy except non-melanoma skin cancer, localized prostate cancer treated with curative intent with no evidence of progression, low-risk or very low-risk (per standard guidelines) localized prostate cancer under surveillance/watchful waiting (without intent to treat),or carcinoma in situ of any type.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,100 participants (estimated)
Patient registry
No

Groups and cohorts

  • JAK/T-cell/IL-6

    Other: Lab Collection Only

Interventions

  • OtherLab Collection Only

    2 Paxgene and 1 SST tubes will be collected at 2 timepoints throughout the study.

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What researchers measure

Primary outcomes

  1. 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

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Study locations

1 of 1 sites recruiting
  • Medvin Clinical Research//Amicus Arthritis
    Whittier, California 90602, United States
    Recruiting
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References and documents

Study documents

  • Protocol and informed consent form · Feb 22, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

Registered
Apr 15, 2024
First posted
Apr 30, 2024
StartActual
Apr 8, 2024
Primary completionEst.
Jun 30, 2025
CompletionEst.
Dec 31, 2025
Last update
Apr 30, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06390709
Lead sponsor
Scipher Medicine
Responsible party
Sponsor
First posted
Apr 30, 2024
Start date
Apr 8, 2024
Primary completion
Jun 30, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Apr 30, 2024

Study contacts

April Cobb
Contact
april.cobb@scipher.com
3363806400

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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