Rheumatoid ArthritisPAnTheRANCT02928276
Predictive Analytics for Theranosis in RA
A study testing RheumaKit: Prediction of the response to anti-TNFs DMARDs in people with Rheumatoid Arthritis, run by DNAlytics at 5 sites in 2 countries.
Trial summary
RA is the most common inflammatory, persistent and progressive disease of the joints with serious co-morbidities and huge health and socio-economic impact worldwide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- RheumaKit: Prediction of the response to anti-TNFs DMARDs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Nov 2016to Apr 2020
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must satisfy all of the following criteria:
- Signed the ICF and covered by health insurance.
- At least 18 years old.
- For women, use of a reliable method of birth control or remain abstinent during the study, or have had surgical sterilization or women above 60 years of age.
- Having undergone at least 3 months of synthetic DMARD treatment while being strictly eligible for it (diagnosed with RA) and being at a stable dose at least for the last month, and showing no satisfactory response to this therapy.
- Be eligible for biological DMARD treatment according to local regulation and practice.
- Willing and able to comply with scheduled visits, treatment plan, tests and other protocol procedures.
Who cannot join
- Patients must satisfy none of the following criteria:
- Arthritis history longer than 5 years.
- Biological DMARD therapy already initiated.
- Be diagnosed with septic arthritis.
- Be pregnant or breastfeeding/lactating women.
- Diagnosed with HIV, hepatitis B, hepatitis C, Crohn's disease, fibromyalgia.
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- Diagnosed with other inflammatory arthritic syndrome than RA.
- have a chronic pain condition that would confound evaluation of the patient.
- Be identified as at too high risk for biopsy or for biologic therapy.
- Be identified as having psychological, familial, social or geographical conditions which could potentially hamper compliance with the study protocol and follow-up schedule.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Belgium4 sites, 4 recruiting
- Recruiting
Clinique Universitaires Saint-Luc
Brussels, Bruxelles-capital, 1200
Aurore Maboge, MSc, +32 2 764 79 80, aurore.maboge@uclouvain.be
Patrick Durez, MD, PhD
- Recruiting
CHU Saint-Pierre
Brussels, 1000
Katty Renard, MSc, + 32.2.535.48.56, katty_renard@stpierre-bru.be
Laurent Méric de Bellfon, MD
- Recruiting
UZLeuven, Gasthuisberg
Leuven, 3000
Johan Joly, johan.joly@uzleuven.be
Rene Westhovens, MD, PhD
- Recruiting
CHU Liège
Liège
Anja Volders, avolders@chu.ulg.ac.be
Michel Malaise, MD, PhD
Spain1 site, 1 recruiting
- Recruiting
Parc Taulí Hospital Universitari
Sabadell, Catalunia, 08208
Lorena Blanco, lblanco@tauli.cat
Eduard Graell, MD
About this study
Official title: Prediction of the Response to Anti-TNFs DMARDs Based on the RheumaKit ® Platform (RK-Tx-01)
RA is the most common inflammatory, persistent and progressive disease of the joints with serious co-morbidities and huge health and socio-economic impact worldwide.
Read the detailed description
The current standard therapeutic strategy for RA patients is to initiate a DMARDs therapy, (e.g. MTX) with serious side effects. This also applies to some PSO or SNSA patients. MTX is however inefficient in about 40% of the cases. Other treatments (biological DMARDs) must thus be initiated, which have an overall similar effectiveness and side effects and an higher cost (around 13kEUR/year/patient). Therapeutic choices are based on symptoms and blood tests including markers of inflammation which are inadequate to predict disease evolution and response to treatments. Improving RA management requires to improve the adequacy of the therapeutic strategies. The earlier the disease is correctly addressed, the more likely its progression and irreversible damages to the joints will be limited. DNAlytics recently developed RheumaKit a differential diagnostic solution for UA patients. UA is a condition in which joint inflammation is present, but a precise diagnosis cannot be made, due to the lack of sensitivity of presently available diagnostic techniques. RheumaKit is a multi-gene expression solution that discriminates RA from other joint conditions. A diagnostic model train to identify patients suffering from RA, SNSA or OA. RheumaKit diagnostic accuracy is higher than 90%, a performance that is better than any other diagnostic solution designed until now, including the ACR/EULAR 2010 criteria for the diagnosis of RA. See working principle below. Beyond diagnosis, DNAlytics wants to make RheumaKit evolve towards treatment recommendation applications (theranostic applications) for patients eligible for biological DMARDs. On one hand, the diseases of these patients have been more and more described in terms of the activity of several metabolic pathways (T \& B cells activation, Extra cellular matrix, Inteferon, TNF). On the other hand, the existing treatments also have been more and more described in terms of the pathways they target. The RheumaKit signature contains many markers that are representative of these pathways of interest. RheumaKit thus now provides a snapshot of the activity of seven metabolic pathways known from literature to be related to diseases mechanisms, or to be target of existing treatments. In this study, DNAlytics wants to show that based on a score defined on the RheumaKit platform, the response or non- response to anti-TNFs, representing the largest category of biological DMARDs, can be predicted before treatment initiation.
- Conditions
- Rheumatoid Arthritis
- Being tested
- RheumaKit: Prediction of the response to anti-TNFs DMARDs
- Keywords
- Rheumakit, Rheumatoid Arthritis, anti-TNF
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RheumaKit: Prediction of the response to anti-TNFs DMARDsOther
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | All eligible patients Receives: Other: RheumaKit: Prediction of the response to anti-TNFs DMARDs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of a score
To show the ability of a score, computed prior to treatment initiation, to be predictive of the individual anti-TNF response. The score is based on the RheumaKit transcriptomic profiles from a set of small synovial biopsies from a given joint also harvested before anti-TNF treatment initiation.
Measured: Up to 12 months
Secondary outcomes (2)
Identify additional/alternative mappings
To identify additional/alternative mappings between components of gene expression profiles obtained via the RheumaKit assay (extended, and possibly combined to clinical and biological information) and efficacy of anti-TNFs biological DMARDs.
Measured: Up to 12 months
Validate the sample logistics at an international scale.
To validate the feasibility of the implementation of a molecular biology test in rheumatology based on synovial tissue at an international scale. This covers both logistics and patient agreeableness aspects.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2019 (estimated)
- Study completionApr 2020 (estimated)
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DNAlytics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Responsible party
- Sponsor
- Investigators
- Patrick Durez, MD, PhD, Principal investigator, Clinique Universitaire Saint-Luc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928276
- Sponsor's protocol ID
- RK-Tx-01
- Acronym
- PAnTheRA
- Status last verified
- Feb 2019
- First submitted
- 6 Sep 2016
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lauwerys BR, Hernandez-Lobato D, Gramme P, Ducreux J, Dessy A, Focant I, Ambroise J, Bearzatto B, Nzeusseu Toukap A, Van den Eynde BJ, Elewaut D, Gala JL, Durez P, Houssiau FA, Helleputte T, Dupont P. Heterogeneity of synovial molecular patterns in patients with arthritis. PLoS One. 2015 Apr 30;10(4):e0122104. doi: 10.1371/journal.pone.0122104. eCollection 2015.
PubMed 25927832
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of the Response to Anti-TNFs DMARDs Based on the RheumaKit ® Platform (RK-Tx-01)
- ClinicalTrials.gov ID
- NCT02928276
- Acronym / sponsor ID
- PAnTheRA / RK-Tx-01
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumakit, Rheumatoid Arthritis, anti-TNF
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- DNAlyticsIndustry (pharma, biotech, devices)
- Collaborators
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Study start
- Nov 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 10 Oct 2016 (estimated)
- 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.
RA is the most common inflammatory, persistent and progressive disease of the joints with serious co-morbidities and huge health and socio-economic impact worldwide.
Detailed description
The current standard therapeutic strategy for RA patients is to initiate a DMARDs therapy, (e.g. MTX) with serious side effects. This also applies to some PSO or SNSA patients. MTX is however inefficient in about 40% of the cases. Other treatments (biological DMARDs) must thus be initiated, which have an overall similar effectiveness and side effects and an higher cost (around 13kEUR/year/patient). Therapeutic choices are based on symptoms and blood tests including markers of inflammation which are inadequate to predict disease evolution and response to treatments. Improving RA management requires to improve the adequacy of the therapeutic strategies. The earlier the disease is correctly addressed, the more likely its progression and irreversible damages to the joints will be limited. DNAlytics recently developed RheumaKit a differential diagnostic solution for UA patients. UA is a condition in which joint inflammation is present, but a precise diagnosis cannot be made, due to the lack of sensitivity of presently available diagnostic techniques. RheumaKit is a multi-gene expression solution that discriminates RA from other joint conditions. A diagnostic model train to identify patients suffering from RA, SNSA or OA. RheumaKit diagnostic accuracy is higher than 90%, a performance that is better than any other diagnostic solution designed until now, including the ACR/EULAR 2010 criteria for the diagnosis of RA. See working principle below. Beyond diagnosis, DNAlytics wants to make RheumaKit evolve towards treatment recommendation applications (theranostic applications) for patients eligible for biological DMARDs. On one hand, the diseases of these patients have been more and more described in terms of the activity of several metabolic pathways (T \& B cells activation, Extra cellular matrix, Inteferon, TNF). On the other hand, the existing treatments also have been more and more described in terms of the pathways they target. The RheumaKit signature contains many markers that are representative of these pathways of interest. RheumaKit thus now provides a snapshot of the activity of seven metabolic pathways known from literature to be related to diseases mechanisms, or to be target of existing treatments. In this study, DNAlytics wants to show that based on a score defined on the RheumaKit platform, the response or non- response to anti-TNFs, representing the largest category of biological DMARDs, can be predicted before treatment initiation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Other: RheumaKit: Prediction of the response to anti-TNFs DMARDsAll eligible patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed the ICF and covered by health insurance.
- At least 18 years old.
- For women, use of a reliable method of birth control or remain abstinent during the study, or have had surgical sterilization or women above 60 years of age.
- Having undergone at least 3 months of synthetic DMARD treatment while being strictly eligible for it (diagnosed with RA) and being at a stable dose at least for the last month, and showing no satisfactory response to this therapy.
- Be eligible for biological DMARD treatment according to local regulation and practice.
Key exclusion criteria (10 listed)
- Arthritis history longer than 5 years.
- Biological DMARD therapy already initiated.
- Be diagnosed with septic arthritis.
- Be pregnant or breastfeeding/lactating women.
- Diagnosed with HIV, hepatitis B, hepatitis C, Crohn's disease, fibromyalgia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RheumaKit: Prediction of the response to anti-TNFs DMARDs | Other | All patients |
Primary outcome
Ability of a score
Time frame: Up to 12 months
To show the ability of a score, computed prior to treatment initiation, to be predictive of the individual anti-TNF response. The score is based on the RheumaKit transcriptomic profiles from a set of small synovial biopsies from a given joint also harvested before anti-TNF treatment initiation.
2 secondary outcomes
Identify additional/alternative mappings
Time frame: Up to 12 months
Validate the sample logistics at an international scale.
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2019.
- Background: PubMed 25927832Lauwerys BR, Hernandez-Lobato D, Gramme P, Ducreux J, Dessy A, Focant I, Ambroise J, Bearzatto B, Nzeusseu Toukap A, Van den Eynde BJ, Elewaut D, Gala JL, Durez P, Houssiau FA, Helleputte T, Dupont P. Heterogeneity of synovial molecular patterns in patients with arthritis. PLoS One. 2015 Apr 30;10(4):e0122104. doi: 10.1371/journal.pone.0122104. eCollection 2015.
- Individual participant dataSharing planned: No
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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.
Patrick Durez, MD, PhD principal investigator
Clinique Universitaire Saint-Luc
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RheumaKit: Prediction of the response to anti-TNFs DMARDs in people with Rheumatoid Arthritis, run by DNAlytics at 5 sites in 2 countries.
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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium, Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helleputte Thibault, PhD (+32 10 39 00 96, thibault.helleputte@dnalytics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability of a score (time frame: Up to 12 months). 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 NCT02928276, 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 7 Feb 2019.