A phase 2b randomized, double-blind, active- and placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of induction and maintenance combination therapy with guselkumab and golimumab in participants with moderately to severely active crohn’s disease
Source : Translated by artificial intelligence
see original text
Une étude multicentrique, en double aveugle, randomisée de phase 2b, contrôlée par placebo et par un traitement actif, en groupes parallèles, visant à évaluer l'efficacité et la sécurité de la thérapie d'induction et de maintenance combinée avec le Guselkumab et le Golimumab chez des participants atteints d'une maladie de Crohn modérément à sévèrement active
Etre âgé de plus de 18 ans, Avoir une maladie de Crohn active ,Etre intolérant ou avoir échoué a au moins un traitement conventionnel tel que les corticostéroïdes, immunosuppresseur, agent biologique,
Exclusion criteria
Présence d'une stomie, Avoir eu un cancer dans les 5 dernières années, Etre enceinte ou allaitante, présence d'un abcès, Tuberculose,
Cohorts
Proposed Therapy or Intervention
Intervention
Guselkumab, Golimumab, JNJ-JNJ- 78934804 (combinaison de Guselkumab et golimumab
Cohorts
Centre intégré de santé et de services sociaux des Laurentides
Data not available
Current data since :
May 09, 2024 00:15
Centre intégré universitaire de santé et de services sociaux de l'Est-de-l'Île-de-Montréal
Data not available
Current data since :
March 25, 2024 00:17
Centre universitaire de santé McGill
Data not available
Current data since :
September 27, 2023 09:24
Centre intégré universitaire de santé et de services sociaux du Saguenay–Lac-Saint-Jean
Data not available
Current data since :
October 28, 2023 00:30
Centre hospitalier de l'Université de Montréal
Data not available
Current data since :
September 27, 2023 09:24
other centers
Name
Medical condition
Treatment
Recruitment status
Group 1: Placebo
Data not available
Participants will receive placebo subcutaneously (SC). All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Unknown
Group 2: Guselkumab
Data not available
Participants will receive guselkumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Unknown
Group 3: Golimumab
Data not available
Participants will receive golimumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Unknown
Group 4: JNJ-78934804 (High-dose)
Data not available
Participants will receive JNJ-78934804 dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Unknown
Group 5: JNJ-78934804 (Mid-dose)
Data not available
Participants will receive JNJ-78934804 dose regimen 2 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Unknown
Group 6: JNJ-78934804 (Low-dose)
Data not available
Participants will receive JNJ-78934804 dose regimen 3 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Unknown
Group 1: Placebo
Recruitment status
unknown
Participants will receive placebo subcutaneously (SC). All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Group 2: Guselkumab
Recruitment status
unknown
Participants will receive guselkumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Group 3: Golimumab
Recruitment status
unknown
Participants will receive golimumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Group 4: JNJ-78934804 (High-dose)
Recruitment status
unknown
Participants will receive JNJ-78934804 dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Group 5: JNJ-78934804 (Mid-dose)
Recruitment status
unknown
Participants will receive JNJ-78934804 dose regimen 2 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Group 6: JNJ-78934804 (Low-dose)
Recruitment status
unknown
Participants will receive JNJ-78934804 dose regimen 3 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Current data since :
April 23, 2024 20:00
Study's description
Study description
Study summary
The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab.
Locations
Locations
Main center
CENTRE INTÉGRÉ UNIVERSITAIRE DE SANTÉ ET DE SERVICES SOCIAUX DE L'EST-DE-L'ÎLE-DE-MONTRÉAL
Montréal
QUÉBEC, CANADA
Local recruitment
Recruiting status:
UPCOMING
Participating centers
10
shown
out of
431
centers
CENTRE HOSPITALIER DE L'UNIVERSITÉ DE MONTRÉAL
Montréal
QUÉBEC, CANADA
Local recruitment
Recruiting status:
POSSIBLY OPEN
Contact details for recruitment
Data not available
Local project contacts
Data not available
CENTRE INTÉGRÉ DE SANTÉ ET DE SERVICES SOCIAUX DES LAURENTIDES
Saint-jérôme
QUEBEC, CANADA
Local recruitment
Recruiting status:
ON HOLD
CENTRE INTÉGRÉ UNIVERSITAIRE DE SANTÉ ET DE SERVICES SOCIAUX DU SAGUENAY–LAC-SAINT-JEAN
Chicoutimi
QUÉBEC, CANADA
Local recruitment
Recruiting status:
POSSIBLY OPEN
Contact details for recruitment
Data not available
Local project contacts
researchers:
A. Michaud-Herbst
co-researchers:
L. Morin
J. Picard
CENTRE UNIVERSITAIRE DE SANTÉ MCGILL
Montréal
QUÉBEC, CANADA
Local recruitment
Recruiting status:
POSSIBLY OPEN
Contact details for recruitment
Data not available
Local project contacts
Data not available
A.O. PER L' EMERGENZA CANNIZZARO - U.O. CHIRURGIA GENERALE
