NCT05447182

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 6, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 5, 2021

Completed
11 months until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

February 5, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

August 5, 2021

Last Update Submit

February 2, 2024

Conditions

Rheumatoid Arthritis

Keywords

Treatment non-responseTumor necrosis factor inhibitor (TNFi)Rheumatoid ArthritisDisease modifying anti-rheumatic therapyBiologic therapy

Outcome Measures

Primary Outcomes (1)

  • Whole genome sequencing

    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.

    Through study completion, averaging 1 year

Secondary Outcomes (1)

  • Subgroup analyses of treatment non-responders

    1 year

Other Outcomes (1)

  • Other potential predictors of poor response to biologic therapies

    Retrospective data up to 10 years prior to enrollment

Eligibility Criteria

Age18 Years - 95 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsParticipant eligibility is based on self-representation of gender identity
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • McDermott GC, Jeffway M, Seyok T, Zhang H, Myasoedova E, Davis JM 3rd, Giles J, Coblyn J, Helfgott S, Massarotti E, Sands R, Weinblatt ME, Johansson T, Schmajuk G, Michaud K, Perry C, Churchill S, Liao KP. Rationale and design of the rheumatoid arthritis non-responders to treatment (RANT) study: Use of a bioinformatics platform and "decentralized" clinical recruitment design. Contemp Clin Trials. 2025 Sep;156:108000. doi: 10.1016/j.cct.2025.108000. Epub 2025 Jul 14.

    PMID: 40669748DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

One-time blood draw to measure proteomics and conduct whole genome sequencing.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine and Biomedical Informatics

Study Record Dates

First Submitted

August 5, 2021

First Posted

July 7, 2022

Study Start

July 6, 2021

Primary Completion

June 30, 2023

Study Completion

October 31, 2023

Last Updated

February 5, 2024

Record last verified: 2024-02

Locations

US(1)