PPM:RANT: People-Powered Medicine (PPM): Rheumatoid Arthritis Non-responders to Biologic Therapies (RANT)

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05447182

Collaborator

Harvard Medical School (HMS and HSDM) (Other)

300

Enrollment

Location

17.9

Anticipated Duration (Months)

16.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators are interested in enrolling patients with rheumatoid arthritis (RA) who had a difficult time getting their disease under control even after trying multiple RA therapies. The investigators believe that there may be common patterns in the genes of this group of RA patients compared to those with more "textbook RA." Understanding genetic factors can help doctors to know in advance who may not respond to conventional therapies and start with treatments that work. Learning about underlying genes that influence treatment may help the investigators to identify new targets for therapy, to ultimately improve the lives of patients with RA and inflammatory arthritis.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis

Detailed Description

The investigators are looking for patients with rheumatoid arthritis (RA) with an inadequate response to tumor necrosis factor inhibitor (TNFi) and another biologic disease modifying anti-rheumatic drug (bDMARD) or small molecule approved for treating RA. The investigators are conducting this research to learn more about RA and the genetic patterns associated with patients whose RA cannot be well controlled with most RA treatments. Investigators anticipate that these patients will differ from "classic" RA patients in their biomarker and genetic composition and that they represent a mixed group of individuals who may be similar in ways that are not currently being measured.

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

People-Powered Medicine (PPM): Rheumatoid Arthritis Non-responders to Biologic Therapies (RANT)

Actual Study Start Date :

Jul 6, 2021

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Outcome Measures

Primary Outcome Measures

Whole genome sequencing [Through study completion, averaging 1 year]
Genomic data will be applied in an established bioinformatics pipeline to screen for uncommon variants and test association with exceptional treatment non-responders compared with TNFi responders.

Secondary Outcome Measures

Subgroup analyses of treatment non-responders [1 year]
Patients who eventually find a therapy that controls their RA. The investigators will use prospective questionnaire data to subgroup patients into those who eventually find a treatment that works vs those who do not.

Other Outcome Measures

Other potential predictors of poor response to biologic therapies [Retrospective data up to 10 years prior to enrollment]
Electronic health data will be used to assess for common features of patients who have poor response to therapy compared to TNFi responders.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age > 18 years
RA diagnosed by a rheumatologist
Poor control of RA disease activity with tumor necrosis factor inhibitor (TNFi) and another biologic therapy or small molecule approved for RA