Predictive Analytics for Theranosis in RA (PAnTheRA)
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ClinicalTrials.gov Identifier: NCT02928276 |
Recruitment Status : Unknown
Verified February 2019 by DNAlytics.
Recruitment status was: Recruiting
First Posted : October 10, 2016
Last Update Posted : February 7, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rheumatoid Arthritis | Other: RheumaKit: Prediction of the response to anti-TNFs DMARDs | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 110 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Prediction of the Response to Anti-TNFs DMARDs Based on the RheumaKit ® Platform (RK-Tx-01) |
Study Start Date : | November 2016 |
Estimated Primary Completion Date : | December 2019 |
Estimated Study Completion Date : | April 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: All patients
All eligible patients
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Other: RheumaKit: Prediction of the response to anti-TNFs DMARDs |
- 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.
- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02928276
Contact: Helleputte Thibault, PhD | +32 10 39 00 96 | thibault.helleputte@dnalytics.com |
Belgium | |
Clinique Universitaires Saint-Luc | Recruiting |
Brussels, Bruxelles-capital, Belgium, 1200 | |
Contact: Aurore Maboge, MSc +32 2 764 79 80 aurore.maboge@uclouvain.be | |
Principal Investigator: Patrick Durez, MD, PhD | |
Sub-Investigator: Bernard Lauwerys, MD, PhD | |
CHU Saint-Pierre | Recruiting |
Bruxelles, Belgium, 1000 | |
Contact: Katty Renard, MSc + 32.2.535.48.56 katty_renard@stpierre-bru.be | |
Principal Investigator: Laurent Méric de Bellfon, MD | |
Sub-Investigator: Silvana Di Romana, MD | |
UZLeuven, Gasthuisberg | Recruiting |
Leuven, Belgium, 3000 | |
Contact: Johan Joly johan.joly@uzleuven.be | |
Principal Investigator: Rene Westhovens, MD, PhD | |
Principal Investigator: Patrick Verschueren, MD, PhD | |
CHU Liège | Recruiting |
Liège, Belgium | |
Contact: Anja Volders avolders@chu.ulg.ac.be | |
Principal Investigator: Michel Malaise, MD, PhD | |
Spain | |
Parc Taulí Hospital Universitari | Recruiting |
Sabadell, Catalunia, Spain, 08208 | |
Contact: Lorena Blanco lblanco@tauli.cat | |
Principal Investigator: Eduard Graell, MD | |
Sub-Investigator: Antonio D Gomez, MD |
Principal Investigator: | Patrick Durez, MD, PhD | Clinique Universitaire Saint-Luc |
Responsible Party: | DNAlytics |
ClinicalTrials.gov Identifier: | NCT02928276 |
Other Study ID Numbers: |
RK-Tx-01 |
First Posted: | October 10, 2016 Key Record Dates |
Last Update Posted: | February 7, 2019 |
Last Verified: | February 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Rheumakit Rheumatoid Arthritis anti-TNF |
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |