Rheumatoid Arthritis
Conditions
Keywords
Treatment non-response, Tumor necrosis factor inhibitor (TNFi), Rheumatoid Arthritis, Disease modifying anti-rheumatic therapy, Biologic therapy
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.
Interventions
None listed
Sponsors
Harvard Medical School (HMS and HSDM)
Brigham and Women's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed