Clinical trial NCT03945019: CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD)
Official title: A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2019-05-10
Enrollment: 396
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 SC over Placebo SC in Patients With Moderately to Severely Active Crohn's Disease


Eligibility criteria: Inclusion Criteria:

* Patient is male or female aged 18 to 75 years, inclusive.
* Patient who has moderately to severely active CD with a score on the CDAI of 220 to 450 points

Exclusion Criteria:

* Patient who has previously received either a TNFα inhibitor or biological agent within 5 half-lives
* Patient who has previously demonstrated inadequate response or intolerance to TNFα inhibitors for the treatment of CD.

Primary outcomes:
measure: Percentage of Patients Achieving Clinical Remission (Based on CDAI) at Week 54
timeFrame: Week 54
measure: Percentage of Patients Achieving Endoscopic Response (Based on Central SES-CD) at Week 54
timeFrame: Week 54
Secondary outcomes:
measure: Percentage of Patients Achieving CDAI-100 Response at Week 54
timeFrame: Week 54
measure: Percentage of Patients Achieving Clinical Remission (Based on AP and SF) at Week 54
timeFrame: Week 54
measure: Percentage of Patients Achieving Endoscopic Remission (Based on Central SES-CD) at Week 54
timeFrame: Week 54
Other outcomes:
Locations:
city: Houston
country: United States
facility: Biopharma Informatic - Houston
state: Texas
city: Vitebsk
country: Belarus
facility: Vitebsk Regional Clinical Hospital
city: Sofia
country: Bulgaria
facility: Diagnostic and Consulting Center Aleksandrovska EOOD
city: Osijek
country: Croatia
facility: Clinical Hospital Centre Osijek
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: München
country: Germany
facility: Praxis Prof. Herbert Kellner
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Surat
country: India
facility: Nirmal Hospital
city: Ramat-Gan
country: Israel
facility: Sheba Medical Center
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A Gemelli-Rome
city: Kashiwa
country: Japan
facility: Tsujinaka Hospital
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Guadalajara
country: Mexico
facility: BRCR Global Mexico
city: Chisinau
country: Moldova, Republic of
facility: IMSP Institute of Clinical Cardiology
city: San Martín de Porres
country: Peru
facility: Hospital Nacional Cayetano Heredia
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki Nr 2 im. dr Jana Biziela w Bydgoszczy, Centrum Endoskopii Zabiegowej, Poradnia
city: Warszawa
country: Poland
facility: WIP Warsaw IBD Point Profesor Kierkus
city: Bucharest
country: Romania
facility: Dr.Carol Davila Emergency University Central Military Hospital
city: Pyatigorsk
country: Russian Federation
facility: Klinika YZI 4D
city: St. Petersburg
country: Russian Federation
facility: BioTekhServis
city: Belgrade
country: Serbia
facility: Clinical Hospital Centar Zvezdara
city: Banska Bystrica
country: Slovakia
facility: Fakultna nemocnica s poliklinikou F. D. Roosevelta
city: Johannesburg
country: South Africa
facility: CLINRESCO, ARWYP Medical Suites
city: Ferrol
country: Spain
facility: Hospital Arquitecto Marcide
city: Izmir
country: Turkey
facility: Ege University Medical Faculty
city: Cherkassy
country: Ukraine
facility: Communal Non-Commercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
city: Zaporizhzhia
country: Ukraine
facility: Municipal Nonprofit Enterprise Zaporizhzhia Regional Clinical Hospital Zaporizhzhia Regional Council
Study officials:
References: