Rheumatoid ArthritisPPM:RANTNCT05447182
People-Powered Medicine (PPM): Rheumatoid Arthritis Non-responders to Biologic Therapies (RANT)
An observational study of Rheumatoid Arthritis, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2021to 31 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- If the reason for failed TNFi therapy was due to a contraindication or adverse reaction
- Unable to provide blood sample
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Keywords
- Treatment non-response, Tumor necrosis factor inhibitor (TNFi), Rheumatoid Arthritis, Disease modifying anti-rheumatic therapy, Biologic therapy
- Medical subject headings
- Arthritis, Rheumatoid
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, averaging 1 year
Secondary outcomes (1)
Subgroup analyses of treatment non-responders
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start6 Jul 2021
- Primary completion30 Jun 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM)
- Responsible party
- Principal investigator, Katherine P Liao, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447182
- Sponsor's protocol ID
- IRB20-1219
- Acronym
- PPM:RANT
- Status last verified
- Feb 2024
- First submitted
- 5 Aug 2021
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40669748
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- People-Powered Medicine (PPM): Rheumatoid Arthritis Non-responders to Biologic Therapies (RANT)
- ClinicalTrials.gov ID
- NCT05447182
- Acronym / sponsor ID
- PPM:RANT / IRB20-1219
- Conditions
- Rheumatoid Arthritis
- Keywords
- Treatment non-response, Tumor necrosis factor inhibitor (TNFi), Rheumatoid Arthritis, Disease modifying anti-rheumatic therapy, Biologic therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM)
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- If the reason for failed TNFi therapy was due to a contraindication or adverse reaction
- Unable to provide blood sample
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Whole genome sequencing
Time frame: 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.
1 secondary outcome
Subgroup analyses of treatment non-responders
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Derived from this study: PubMed 40669748McDermott 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole genome sequencing (time frame: Through study completion, averaging 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05447182, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.