Predictive Analytics for Theranosis in RA (PAnTheRA)

February 6, 2019 updated by: DNAlytics

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1000
        • Recruiting
        • Chu Saint-Pierre
        • Contact:
        • Principal Investigator:
          • Laurent Méric de Bellfon, MD
        • Sub-Investigator:
          • Silvana Di Romana, MD
      • Leuven, Belgium, 3000
        • Recruiting
        • UZLeuven, Gasthuisberg
        • Contact:
        • Principal Investigator:
          • Rene Westhovens, MD, PhD
        • Principal Investigator:
          • Patrick Verschueren, MD, PhD
      • Liège, Belgium
        • Recruiting
        • CHU Liege
        • Contact:
        • Principal Investigator:
          • Michel Malaise, MD, PhD
    • Bruxelles-capital
      • Brussels, Bruxelles-capital, Belgium, 1200
        • Recruiting
        • Clinique Universitaires Saint-Luc
        • Contact:
        • Principal Investigator:
          • Patrick Durez, MD, PhD
  • Spain
    • Catalunia
      • Sabadell, Catalunia, Spain, 08208
        • Recruiting
        • Parc Tauli Hospital Universitari
        • Contact:
        • Principal Investigator:
          • Eduard Graell, MD
        • Sub-Investigator:
          • Antonio D Gomez, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All patients
All eligible patients
Other: RheumaKit: Prediction of the response to anti-TNFs DMARDs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify additional/alternative mappings
Time Frame: Up to 12 months
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.
Up to 12 months
Validate the sample logistics at an international scale.
Time Frame: Up to 12 months
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.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DNAlytics

Collaborators

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Patrick Durez, MD, PhD, Clinique Universitaire Saint-Luc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

April 1, 2020

Study Registration Dates

First Submitted

September 6, 2016

First Submitted That Met QC Criteria

October 7, 2016

First Posted (Estimate)

October 10, 2016

Study Record Updates

Last Update Posted (Actual)

February 7, 2019

Last Update Submitted That Met QC Criteria

February 6, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RK-Tx-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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