Clinical trial • Phase IV • Immunology

GOLIMUMAB for Rheumatoid arthritis

Phase IV trial of GOLIMUMAB for Rheumatoid arthritis.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Rheumatoid arthritis
Trial Stage
Phase IV
Drug Modality
Monoclonal antibody | Small molecule | Other antibody | Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
19-08-2024
First CTIS Authorization Date
16-10-2024

Trial design

Randomised, open-label, two comparator arms: (1) methotrexate or leflunomide + targeted therapy (a biologic or a jak/stat inhibitor); (2) methotrexate or leflunomide + sulfasalazine + hydroxychloroquine (triple conventional dmard therapy). doses/schedules are not specified in the arm descriptions in the available data (inclusion criteria require methotrexate ≥15 mg/week or leflunomide 10–20 mg/day).-controlled Phase IV trial across 21 sites in France.

Randomised
Yes
Open Label
Yes
Comparator
Two comparator arms: (1) Methotrexate or leflunomide + targeted therapy (a biologic or a JAK/STAT inhibitor); (2) Methotrexate or leflunomide + sulfasalazine + hydroxychloroquine (triple conventional DMARD therapy). Doses/schedules are not specified in the arm descriptions in the available data (inclusion criteria require methotrexate ≥15 mg/week or leflunomide 10–20 mg/day).
Target Sample Size
270
Trial Duration For Participant
365

Eligibility

Recruits 270 Vulnerable-population considerations: Minors are excluded (Age greater or equal to 18 years). Specific vulnerable groups explicitly listed in exclusion criteria: "Patient under law protection" and "Prisoners" are excluded. Informed consent requirement: "Written informed consent, dated and signed before initiating any trial-related procedure.".

Pregnancy Exclusion
Pregnancy, breastfeeding, desire of pregnancy in the 12 months
Vulnerable Population
Vulnerable-population considerations: Minors are excluded (Age greater or equal to 18 years). Specific vulnerable groups explicitly listed in exclusion criteria: "Patient under law protection" and "Prisoners" are excluded. Informed consent requirement: "Written informed consent, dated and signed before initiating any trial-related procedure."

Inclusion criteria

  • {"criterion_text":"- Patient with rheumatoid arthritis according to EULAR/ACR 2010 criteria\n- DAS28-CRP>3.2\n- Insufficient response to methotrexate at a weekly dose ≥ 15mg after at least 3 months or to leflunomide at a dose of 10 (in case 20 mg are not well tolerated) to 20 mg per day after 3 months of treatment\n- RA radiographic erosions and/or serum rheumatoid factor and/or anti-Cyclic Citrullinated Peptide (Anti-CCP)\n- Age greater or equal to 18 years\n- Written informed consent, dated and signed before initiating any trial-related procedure\n- Affiliation to a social insurance system\n- Women of child bearing potential, negative β-HCG assay (blood test)\n- Effective method of birth control during the study and continuing after the discontinuation of the investigational drug or study. The duration will depend on the drug used (referred to the summary product characteristic)."}

Exclusion criteria

  • {"criterion_text":"- Previous treatment with or contraindication to targeted therapies (biologic or JAK/STAT inhibitor)*\n- Participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatment\n- Women of child bearing potential, unless they are using an effective method of birth control\n- Patient under law protection\n- Prisoners\n- Previous treatment with or contraindication to triple therapy*\n- Other inflammatory arthritis except those associated to Sjögren’s syndrome\n- Contraindication to all biologics/ JAK/STAT inhibitors or to methotrexate, leflunomide, sulfasalazine and hydroxychloroquine\n- Corticosteroids at a dose >15 mg/d of equivalent prednisone for at least 4 weeks before the inclusion\n- Absence of tuberculosis screening for patients in the biologic arm\n- Patient who cannot be followed during 12 months\n- Pregnancy, breastfeeding, desire of pregnancy in the 12 months\n- Drug addiction, addiction to alcohol"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Low disease activity (DAS28-CRP<3.2) and a daily dose ≤ 7.5 mg of equivalent prednisone under the randomized strategy after, at least, 11 months of follow up.","definition_or_measurement_approach":"Defined as DAS28-CRP <3.2 and daily prednisone-equivalent dose ≤ 7.5 mg at (by) month 11 of follow-up."}

Secondary endpoints

  • {"endpoint_text":"- Serious adverse events rate","definition_or_measurement_approach":"Rate (proportion) of serious adverse events during study follow-up."}
  • {"endpoint_text":"- Blood concentrations of hydroxychloroquine, leflunomide, sulfasalazine and methotrexate in the triple therapy group and methotrexate, leflunomide, biologic / JAK/STAT inhibitor and anti-drug antibody in the other group at 6, and 12 months","definition_or_measurement_approach":"Plasma concentrations of specified drugs and anti-drug antibodies measured at months 6 and 12."}
  • {"endpoint_text":"- Clinical disease activity index (CDAI) at inclusion, 3, 6, 9 and 12 months","definition_or_measurement_approach":"CDAI score assessed at baseline and at months 3, 6, 9 and 12."}
  • {"endpoint_text":"- DAS 28 CRP score at inclusion, 3, 6, 9 and12 months","definition_or_measurement_approach":"DAS28-CRP assessed at baseline and at months 3, 6, 9 and 12."}
  • {"endpoint_text":"- 52010 ACR/EULAR classification Criteria for RA, ACR 20, 50, 70 and Boolean remission at 3, 6, 9 and 12 months","definition_or_measurement_approach":"Proportion of patients meeting ACR20/50/70 and Boolean remission criteria at months 3, 6, 9 and 12."}
  • {"endpoint_text":"- Modified Sharp Van der Hejde score at inclusion and at 12 month","definition_or_measurement_approach":"Radiographic scoring (modified Sharp-van der Heijde) on baseline and month 12 radiographs (hands and feet)."}
  • {"endpoint_text":"- Change in comedications (corticosteroids, dose of methotrexate or leflunomide, subcutaneous use of methotrexate), treatment observance","definition_or_measurement_approach":"Assessment of changes in concomitant medications and treatment adherence at scheduled visits."}
  • {"endpoint_text":"- SF36 score, Rapid score, HAQ score, RAID score, FACIT score at inclusion, 3, 6, 9 and at 12 months","definition_or_measurement_approach":"Patient-reported outcome measures (SF-36, Rapid, HAQ, RAID, FACIT) collected at baseline and months 3, 6, 9 and 12."}
  • {"endpoint_text":"- QUALISEX score at inclusion, 6 months and at 12 months","definition_or_measurement_approach":"QUALISEX questionnaire score assessed at baseline, month 6 and month 12."}
  • {"endpoint_text":"- Medico-economic evaluation results at inclusion, 3, 6, 9 and at 12 months","definition_or_measurement_approach":"Health economic questionnaire results collected at baseline and months 3, 6, 9 and 12."}

Recruitment

Planned Sample Size
270
Recruitment Window Months
156
Consent Approach
Written informed consent is required: "Written informed consent, dated and signed before initiating any trial-related procedure." Participants are adults (Age ≥ 18). A subject information and informed consent form document is listed ('L1_ SIS and ICF_Majeur').

Geography

Total Number Of Sites
21
Total Number Of Participants
270

France

Earliest CTIS Part Ii Submission Date
03-10-2024
Latest Decision Or Authorization Date
14-02-2025
Processing Time Days
134
Number Of Sites
21
Number Of Participants
270

Sites

Site Name
Centre Hospitalier Universitaire D Orleans
Department Name
Rheumatology
Principal Investigator Name
Carine SALLIOT
Principal Investigator Email
carine.salliot@chr-orleans.fr
Contact Person Name
Carine SALLIOT
Contact Person Email
carine.salliot@chr-orleans.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Rheumatology
Principal Investigator Name
Jacques-Eric GOTTENBERG
Principal Investigator Email
jacques-eric.gottenberg@chru-strasbourg.fr
Contact Person Name
Jacques-Eric GOTTENBERG
Site Name
Centre Hospitalier Departemental Vendee
Department Name
Rheumatology
Principal Investigator Name
Grégoire CORMIER
Principal Investigator Email
gregoire.cormier@chd-vendee.fr
Contact Person Name
Grégoire CORMIER
Contact Person Email
gregoire.cormier@chd-vendee.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Rheumatology
Principal Investigator Name
Jacques MOREL
Principal Investigator Email
j-morel@chu-montpellier.fr
Contact Person Name
Jacques MOREL
Contact Person Email
j-morel@chu-montpellier.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Rheumatology
Principal Investigator Name
Augustin LATOURTE
Principal Investigator Email
augustin.latourte@aphp.fr
Contact Person Name
Augustin LATOURTE
Contact Person Email
augustin.latourte@aphp.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Rheumatology
Principal Investigator Name
Elisabeth GERVAIS
Principal Investigator Email
e.gervais@chu-poitiers.fr
Contact Person Name
Elisabeth GERVAIS
Contact Person Email
e.gervais@chu-poitiers.fr
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Rheumatology
Principal Investigator Name
Christian MARCELLI
Principal Investigator Email
marcelli-c@chu-caen.fr
Contact Person Name
Christian MARCELLI
Contact Person Email
marcelli-c@chu-caen.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Rheumatology
Principal Investigator Name
Bruno FAUTREL
Principal Investigator Email
bruno.fautrel@psl.aphp.fr
Contact Person Name
Bruno FAUTREL
Contact Person Email
bruno.fautrel@psl.aphp.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Rheumatology
Principal Investigator Name
Francis BERENBAUM
Principal Investigator Email
francis.berenbaum@sat.aphp.fr
Contact Person Name
Francis BERENBAUM
Contact Person Email
francis.berenbaum@sat.aphp.fr
Site Name
Groupement Des Hopitaux De L'Institut Catholique De Lille
Department Name
Rheumatology
Principal Investigator Name
Tristan PASCART
Principal Investigator Email
pascart.tristan@ghicl.net
Contact Person Name
Tristan PASCART
Contact Person Email
pascart.tristan@ghicl.net
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Rheumatology
Principal Investigator Name
Xavier MARIETTE
Principal Investigator Email
xavier.mariette@bct.ap-hop-paris.fr
Contact Person Name
Xavier MARIETTE
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Rheumatology
Principal Investigator Name
Adrien LE PLUART
Principal Investigator Email
adrien.lepluart@chu-nantes.fr
Contact Person Name
Adrien LE PLUART
Contact Person Email
adrien.lepluart@chu-nantes.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Rheumatology
Principal Investigator Name
Alain SARAUX
Principal Investigator Email
alain.saraux@chu-brest.fr
Contact Person Name
Alain SARAUX
Contact Person Email
alain.saraux@chu-brest.fr
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Rheumatology
Principal Investigator Name
Thierry THOMAS
Principal Investigator Email
thierry.thomas@chu-st-etienne.fr
Contact Person Name
Thierry THOMAS
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
Rheumatology
Principal Investigator Name
Thierry LEQUERRE
Principal Investigator Email
thierry.lequerre@chu-rouen.fr
Contact Person Name
Thierry LEQUERRE
Contact Person Email
thierry.lequerre@chu-rouen.fr
Site Name
Centre Hospitalier Jean Rougier
Department Name
Rheumatology
Principal Investigator Name
Slim LASSOUED
Principal Investigator Email
slim.lassoued@ch-cahors.fr
Contact Person Name
Slim LASSOUED
Contact Person Email
slim.lassoued@ch-cahors.fr
Site Name
CHU Besancon
Department Name
Rheumatology
Principal Investigator Name
Daniel WENDLING
Principal Investigator Email
dwendling@chu-besancon.fr
Contact Person Name
Daniel WENDLING
Contact Person Email
dwendling@chu-besancon.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Rheumatology
Principal Investigator Name
Arnaud CONSTANTIN
Principal Investigator Email
arnaud.constantin@chu-toulouse.fr
Contact Person Name
Arnaud CONSTANTIN
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Rheumatology
Principal Investigator Name
Christophe RICHEZ
Principal Investigator Email
j-morel@chu-montpellier.fr
Contact Person Name
Christophe RICHEZ
Contact Person Email
j-morel@chu-montpellier.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Rheumatology
Principal Investigator Name
Philippe GAUDIN
Principal Investigator Email
pgaudin@chu-grenoble.fr
Contact Person Name
Philippe GAUDIN
Contact Person Email
pgaudin@chu-grenoble.fr
Site Name
Groupe Hospitalier Du Havre
Department Name
rheumatology
Principal Investigator Name
Charles ZARNITSKY
Principal Investigator Email
charles.zarnitsky@ch-havre.fr
Contact Person Name
Charles ZARNITSKY
Contact Person Email
charles.zarnitsky@ch-havre.fr

Sponsor

Primary sponsor

Full Name
Les Hopitaux Universitaires De Strasbourg
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
GOLIMUMAB
Active Substance
GOLIMUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS USE
Maximum Dose
100 mg
Investigational Product Name
ABATACEPT
Active Substance
ABATACEPT
Modality
Other antibody
Routes Of Administration
INTRAVENOUS (IV) OR SUBCUTANEOUS (SC)
Route
INTRAVENOUS (IV) OR SUBCUTANEOUS (SC)
Maximum Dose
12.5 mg/kg
Investigational Product Name
BARICITINIB
Active Substance
BARICITINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Maximum Dose
4 mg
Investigational Product Name
FILGOTINIB
Active Substance
FILGOTINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Maximum Dose
200 mg
Investigational Product Name
INFLIXIMAB
Active Substance
INFLIXIMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Maximum Dose
7.5 mg/kg
Investigational Product Name
SARILUMAB
Active Substance
SARILUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS USE
Maximum Dose
200 mg
Investigational Product Name
TOCILIZUMAB
Active Substance
TOCILIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS (IV) OR SUBCUTANEOUS (SC)
Route
INTRAVENOUS (IV) OR SUBCUTANEOUS (SC)
Maximum Dose
800 mg
Investigational Product Name
TOFACITINIB
Active Substance
TOFACITINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Maximum Dose
11 mg
Investigational Product Name
LEFLUNOMIDE
Active Substance
LEFLUNOMIDE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Maximum Dose
100 mg
Investigational Product Name
RITUXIMAB
Active Substance
RITUXIMAB
Modality
Monoclonal antibody
Routes Of Administration
CONCENTRATE FOR SOLUTION FOR INFUSION (IV) OR SUBCUTANEOUS (SC)
Route
INTRAVENOUS (IV) OR SUBCUTANEOUS (SC)
Maximum Dose
1000 mg
Investigational Product Name
CERTOLIZUMAB PEGOL
Active Substance
CERTOLIZUMAB PEGOL
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS USE
Maximum Dose
400 mg
Investigational Product Name
SULFASALAZINE
Active Substance
SULFASALAZINE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Maximum Dose
2 g
Investigational Product Name
HYDROXYCHLOROQUINE SULFATE
Active Substance
HYDROXYCHLOROQUINE SULFATE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Maximum Dose
600 mg
Investigational Product Name
UPADACITINIB
Active Substance
UPADACITINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Maximum Dose
15 mg
Investigational Product Name
ADALIMUMAB
Active Substance
ADALIMUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS USE
Maximum Dose
40 mg
Investigational Product Name
METHOTREXATE
Active Substance
METHOTREXATE
Modality
Small molecule
Routes Of Administration
SUBCUTANEOUS USE / ORAL USE / SOLUTION FOR INJECTION
Route
SUBCUTANEOUS / ORAL / INJECTION
Maximum Dose
25 mg
Investigational Product Name
ETANERCEPT
Active Substance
ETANERCEPT
Modality
Other antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS USE
Maximum Dose
50 mg
Combination Treatment
Yes

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