Clinical trial NCT05447182: People-Powered Medicine (PPM): Rheumatoid Arthritis Non-responders to Biologic Therapies (RANT)
Official title: People-Powered Medicine (PPM): Rheumatoid Arthritis Non-responders to Biologic Therapies (RANT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Treatment non-response
Tumor necrosis factor inhibitor (TNFi)
Rheumatoid Arthritis
Disease modifying anti-rheumatic therapy
Biologic therapy
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Harvard Medical School (HMS and HSDM)
First posted: 2022-07-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with rheumatoid arthritis (RA) that have failed TNFi therapy and another bDMARD or small molecule approved for RA.

TNFi= adalimumab (Humira), certolizumab (Cimzia), etanercept (Enbrel), infliximab (Remicade), golimumab (Simponi)

bDMARDs or small molecules for RA in addition to TNFi above: abatacept (Orencia), baricitinib (Olumiant), sarilumab (Kevzara), tocilizumab (Actemra), rituximab (Rituxan), tofacitinib (Xeljanz), upadacitinib (Rinvoq)

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.

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.

Eligibility criteria: 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

Exclusion Criteria:

* If the reason for failed TNFi therapy was due to a contraindication or adverse reaction
* Unable to provide blood sample

Primary outcomes:
measure: Whole genome sequencing
timeFrame: Through study completion, averaging 1 year
Secondary outcomes:
measure: Subgroup analyses of treatment non-responders
timeFrame: 1 year
Other outcomes:
measure: Other potential predictors of poor response to biologic therapies
timeFrame: Retrospective data up to 10 years prior to enrollment
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References: