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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 8 June 2020
Main ID:  EUCTR2019-003700-12-FR
Date of registration: 04/06/2020
Prospective Registration: No
Primary sponsor: CHU Saint-Etienne
Public title: Association between metabolits of methotrexate and clinical response in rheumatoid arthritis patients
Scientific title: Association between methotrexate erythrocyte polyglutamate concentration and biological drug concentration and clinical response in rheumatoid arthritis patients treated with subcutaneous injectable methotrexate and a first biological drug
Date of first enrolment: 13/03/2020
Target sample size: 60
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-003700-12
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes
Countries of recruitment
France
Contacts
Name: Project manager   
Address:  URCIP - Batiment Recherche - Hôpital Nord 42055 Saint-Etienne France
Telephone: +330477829458
Email: florence.rancon@chu-st-etienne.fr
Affiliation:  CHU Saint-Etienne
Name: Project manager   
Address:  URCIP - Batiment Recherche - Hôpital Nord 42055 Saint-Etienne France
Telephone: +330477829458
Email: florence.rancon@chu-st-etienne.fr
Affiliation:  CHU Saint-Etienne
Key inclusion & exclusion criteria
Inclusion criteria:
RA patients with MTX treatment for at least 6months, and with a stable dose for 3 months (= 15 mg/semaine) and with first bDMARD treatment for at least 6 months

RA Patient in remission (DAS 28<2.6) .
or RA patients with a High Disease Activity Rheumatoid Arthritis activity (DAS 28>3.2)

Patients followed in the Rheumatology Department at the CHU de St Etienne.
Social security affiliation.
Signed informed consent.
Age >= 18 years

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion criteria:
Patients treated with another csDMARD.
Another diagnostic than RA



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
rheumatoid arthritis
MedDRA version: 21.0 Level: LLT Classification code 10042952 Term: Systemic rheumatoid arthritis System Organ Class: 100000004859
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Intervention(s)

Product Name: Methotrexate
Product Code: MTX
Pharmaceutical Form: Concentrate and solvent for cutaneous solution
Other descriptive name: METHOTREXATE DISODIUM
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 15-

Product Code: bDMARD
Pharmaceutical Form:
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
INN or Proposed INN: CERTOLIZUMAB PEGOL
CAS Number: 428863-50-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
INN or Proposed INN: GOLIMUMAB
CAS Number: 476181-74-5
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 50-100-

Primary Outcome(s)
Main Objective: Correlation between PG-MTX concentrations and clinical response to methotrexate + first biological drug in rheumatoid arthritis patients
Primary end point(s): PG-MTX concentrations
Secondary Objective: Demonstrate that PG-MTX metabolits concentration are lower in non responder patients than in responder patients
Find association between PG-MTX metabolits concentration and Biodrugs concentration
Correlation between PG-MTX metabolits concentration and CQR score
Timepoint(s) of evaluation of this end point: Day 1
Secondary Outcome(s)
Secondary end point(s): PG-MTX metabolits concentration
Biodrugs concentration
CQR score
Timepoint(s) of evaluation of this end point: day 1
Secondary ID(s)
19CH114
Source(s) of Monetary Support
MEDAC
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 13/03/2020
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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