Predicting therapy response in rheumatoid arthritis using molecular signatures

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

This study is testing if certain biological markers can help predict how well people with active rheumatoid arthritis will respond to different treatments after their previous therapies didn't work.

Quick facts

• Study type: Observational
• Enrollment: 1100 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Scipher Medicine (Industry-sponsored)
• Drugs / interventions: tocilizumab, tofacitinib, upadacitinib, Methotrexate
• Locations: 1 site (Whittier, California)
• Trial ID: NCT06390709 on ClinicalTrials.gov

What this trial studies

This observational study aims to collect patient samples to develop and validate molecular signature response classifiers (MSRC) that predict how patients with rheumatoid arthritis will respond to specific therapies, including JAK inhibitors, T-cell inhibitors, and IL-6 inhibitors. Conducted across multiple centers in the US, the study focuses on patients who have active rheumatoid arthritis and have previously failed other treatments. By analyzing these samples, researchers hope to enhance precision medicine approaches in treating rheumatoid arthritis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with active rheumatoid arthritis who have previously failed or are intolerant to at least one conventional DMARD therapy.

Not a fit: Patients who have not been exposed to any DMARD therapies or those with low disease activity may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective treatment options for patients with rheumatoid arthritis.

How similar studies have performed: Other studies have shown promise in using molecular signatures to predict treatment responses, indicating that this approach has potential based on prior research.

Eligibility criteria

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:

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.

Where this trial is running

Whittier, California

• Medvin Clinical Research//Amicus Arthritis — Whittier, California, United States (Recruiting)

Study contacts

• Study coordinator: April Cobb

Conditions Rheumatoid Arthritis