Rheumatoid ArthritisPREDICTNCT06390709
PREDICT Therapy Selection for JAK, T-cell, or IL-6 Inhibitor Therapies Using a Molecular Signature Response Classifier (PREDICT)
An observational study of Rheumatoid Arthritis, run by Scipher Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Lab Collection Only
- How many people
- 1,100 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patient is eighteen years of age, or older (≥18) at time of consent.
- Patient must meet the criteria for RA as defined by the 2010ACR/EULAR classification at Visit 1 and documented by enrolling PI.
- Patient has active RA, with moderate or high disease activity as confirmed by a CDAI score of >10 at Visit 1.
- Patients must have a history of failure, contraindication, or intolerance to at least one csDMARD therapy.
- Patient must be b/tsDMARD-naïve or TNFi-exposed prior to baseline visit only.
- Patient must be initiating one of the following listed therapies (including biosimilars).
Show all 13Show fewer
- JAK inhibitor therapy (only tofacitinib or upadacitinib)
- T-cell inhibitor therapy (abatacept)
- IL-6 inhibitor therapy (only tocilizumab)
- 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
- Patient may participate in another observational study.
- Patient is willing and able to complete the informed consent process and comply with all study procedures and visit schedule.
Who cannot join
- Patient has previously participated in a Scipher Medicine study (NETWORK-004, AIMs in RA, DRIVE, or INFORM).
- Patients who have been treated with an altMOA (non-TNFi therapy) therapy for RA prior to baseline (Visit 1).
- Women who are known to be pregnant or breast-feeding or plan to get pregnant during the study duration.
- Concurrent treatment with an investigational product or use of an investigational product within 28 days of Visit 1.
- The use of RA therapies outside of an FDA approved indication.
- Patient is currently receiving systemic antimicrobial treatment for viral, bacterial, fungal, or parasitic infection at the time of baseline visit (Visit 1).
- 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).
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Medvin Clinical Research//Amicus Arthritis
Whittier, California, 90602
Stesy Torres, 562-758-6600, stesy@medvinresearch.com
Tien-I Karleen Su
About this study
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).
- Conditions
- Rheumatoid Arthritis
- Being tested
- Lab Collection Only
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lab Collection OnlyOther
2 Paxgene and 1 SST tubes will be collected at 2 timepoints throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| JAK/T-cell/IL-6 | Not described Receives: Other: Lab Collection Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start8 Apr 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scipher Medicine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390709
- Sponsor's protocol ID
- PREDICT-001
- Acronym
- PREDICT
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREDICT Therapy Selection for JAK, T-cell, or IL-6 Inhibitor Therapies Using a Molecular Signature Response Classifier (PREDICT)
- ClinicalTrials.gov ID
- NCT06390709
- Acronym / sponsor ID
- PREDICT / PREDICT-001
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Scipher MedicineIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JAK/T-cell/IL-6 | – | Other: Lab Collection Only |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (13 listed)
- Patient is eighteen years of age, or older (≥18) at time of consent.
- Patient must meet the criteria for RA as defined by the 2010ACR/EULAR classification at Visit 1 and documented by enrolling PI.
- Patient has active RA, with moderate or high disease activity as confirmed by a CDAI score of >10 at Visit 1.
- Patients must have a history of failure, contraindication, or intolerance to at least one csDMARD therapy.
- Patient must be b/tsDMARD-naïve or TNFi-exposed prior to baseline visit only.
Key exclusion criteria (8 listed)
- Patient has previously participated in a Scipher Medicine study (NETWORK-004, AIMs in RA, DRIVE, or INFORM).
- Patients who have been treated with an altMOA (non-TNFi therapy) therapy for RA prior to baseline (Visit 1).
- Women who are known to be pregnant or breast-feeding or plan to get pregnant during the study duration.
- Concurrent treatment with an investigational product or use of an investigational product within 28 days of Visit 1.
- The use of RA therapies outside of an FDA approved indication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lab Collection Only2 Paxgene and 1 SST tubes will be collected at 2 timepoints throughout the study. | Other | JAK/T-cell/IL-6 |
Primary outcome
The rate of MSRC to predict the patients response
Time frame: 6 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Scipher Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact April Cobb (3363806400, april.cobb@scipher.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of MSRC to predict the patients response (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.