NCT02928276

Brief 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.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable rheumatoid-arthritis

Geographic Reach
2 countries

5 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

September 6, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 10, 2016

Completed
22 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

February 7, 2019

Status Verified

February 1, 2019

Enrollment Period

3.1 years

First QC Date

September 6, 2016

Last Update Submit

February 6, 2019

Conditions

Rheumatoid Arthritis

Keywords

RheumakitRheumatoid Arthritisanti-TNF

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 12 months

Secondary Outcomes (2)

  • Identify additional/alternative mappings

    Up to 12 months

  • Validate the sample logistics at an international scale.

    Up to 12 months

Study Arms (1)

All patients

EXPERIMENTAL

All eligible patients

Other: RheumaKit: Prediction of the response to anti-TNFs DMARDs

Interventions

RheumaKit: Prediction of the response to anti-TNFs DMARDsOTHER
All patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Clinique Universitaires Saint-Luc

Brussels, Bruxelles-capital, 1200, Belgium

RECRUITING

CHU Saint-Pierre

Brussels, 1000, Belgium

RECRUITING

UZLeuven, Gasthuisberg

Leuven, 3000, Belgium

RECRUITING

CHU Liège

Liège, Belgium

RECRUITING

Parc Taulí Hospital Universitari

Sabadell, Catalunia, 08208, Spain

RECRUITING

Related Publications (1)

  • 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.

    PMID: 25927832BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

  • Patrick Durez, MD, PhD

    Clinique Universitaire Saint-Luc

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Helleputte Thibault, PhD

CONTACT

+32 10 39 00 96thibault.helleputte@dnalytics.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2016

First Posted

October 10, 2016

Study Start

November 1, 2016

Primary Completion

December 1, 2019

Study Completion

April 1, 2020

Last Updated

February 7, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)BE(4)