Clinical trial NCT04075825: Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula
Official title: A Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn's Disease Who Have Participated in ADMIRE II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Complex Perianal Fistula
Keywords: Drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2019-09-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The main aim is to follow-up on long term side effect and symptom improvement of Darvadstrocel in the treatment of complex perianal fistula in adults. Participants will not receive any drug in this study.

Detailed description: The drug being tested in this study is called darvadstrocel (Cx601). Darvadstrocel is being tested to treat people who have complex perianal fistula in CD. This study will look at the long-term safety and efficacy of darvadstrocel in the treatment of complex perianal fistula in CD.

The study will enroll approximately 150 patients. Participants who received darvadstrocel or placebo in study ADMIRE-CD II (Cx601-0303, NCT03279081) and who have completed the 52 weeks of the study will be enrolled in this long-term extension study.

This multi-center study will be conducted worldwide. The overall time to participate in this study is 104 weeks (in addition to the 52 weeks on ADMIRE-CD II study). Participants will make multiple visits to the clinic and will be contacted by telephone every 3 months for a follow-up assessment. After unblinding of the ADMIRE-CD II study, the LTE study will be conducted as an open-label study. Participants will remain in the treatment group assigned in the ADMIRE-CD II study.

Eligibility criteria: Inclusion Criteria:

1. Has participated in and completed the ADMIRE-CD II (NCT03279081) study (i.e., did not discontinue).

Exclusion Criteria:

1. Has been more than 3 months since the participant completed the ADMIRE-CD II study.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Baseline (Week 0) up to Week 104 of this study (Week 52 up to Week 156 in relation to ADMIRE-CD II)
measure: Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)
timeFrame: Baseline (Week 0) up to Week 104 of this study (Week 52 up to Week 156 in relation to ADMIRE-CD II)
measure: Number of Participants With Specific Adverse Events of Special Interest (AESIs)
timeFrame: Baseline (Week 0) up to Week 104 of this study (Week 52 up to Week 156 in relation to ADMIRE-CD II)
Secondary outcomes:
measure: Percentage of Participants Who Achieve Clinical Remission at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study)
timeFrame: At Weeks 52 and 104 of this study (Weeks 104 and 156 in relation to ADMIRE-CD II, respectively)
measure: Percentage of Participants Who Achieve Clinical Response at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study)
timeFrame: At Weeks 52 and 104 of this study (Weeks 104 and 156 in relation to ADMIRE-CD II, respectively)
measure: Percentage of Participants With Relapse at Week 156 After Achieving Combined Remission at Week 52 of ADMIRE-CD II
timeFrame: At Week 104 of this study (Week 156 in relation to ADMIRE-CD II)
measure: Percentage of Participants Who Achieve Combined Remission at Week 156 (After IMP Administration in ADMIRE-CD II Study)
timeFrame: At Week 104 of this study (Week 156 in relation to ADMIRE-CD II)
measure: Percentage of Participants With New Anal Abscess in Treated Fistula at Week 156
timeFrame: At Week 104 of this study (Week 156 in relation to ADMIRE-CD II)
measure: Change From Baseline of ADMIRE-CD II in Scores of Discharge Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156
timeFrame: From Baseline of ADMIRE-CD II up to Weeks 52 and 104 of this study (From Baseline up to Weeks 104 and 156 in relation to ADMIRE-CD II, respectively)
measure: Change From Baseline of ADMIRE-CD II in Scores of Pain Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156
timeFrame: From Baseline of ADMIRE-CD II up to Weeks 52 and 104 of this study (From Baseline up to Weeks 104 and 156 in relation to ADMIRE-CD II, respectively)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: West Hollywood
country: United States
facility: Cedar-Sinai Medical Center
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Tampa
country: United States
facility: USF Health South Tampa Center for Advanced Healthcare
state: Florida
city: Tampa
country: United States
facility: AdventHealth Tampa
state: Florida
city: Indianapolis
country: United States
facility: Indiana University - Colon and Rectal
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center (KUMC) - University of Kansas Liver Center - Hepatology Clinic
state: Kansas
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
city: Boston
country: United States
facility: Massachussetts General Hospital - Gastroenterology
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic College of Medicine - Division of Colon and Rectal Surgery - Division of Colon and Rectal Surgery
state: Minnesota
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center - Cancer Center
state: New Hampshire
city: Morristown
country: United States
facility: Morristown Medical Center - Gastroenterology
state: New Jersey
city: Manhasset
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Hershey
country: United States
facility: Penn State Hershey Medical Center - Surgery
state: Pennsylvania
city: Providence
country: United States
facility: Brown Surgical Associates,Inc.
state: Rhode Island
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center - Gastroenterology
state: Washington
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams Brabant
city: Antwerpen
country: Belgium
facility: GZA Sint-Vincentius
city: Horovice
country: Czechia
facility: NH Hospital a.s.
city: Hradec Kralove
country: Czechia
facility: FN Hradec Kralove
city: Paris
country: France
facility: Paris St. Joseph Hospital
state: Ile-de-France
city: Vandoeuvre Les Nancy Cedex
country: France
facility: CHRU de Brabois Hopitaux de Brabois
state: Nancy
city: Lille
country: France
facility: CHRU de Lille - Hopital Claude Huriez - Gastroenterologie
state: Nord
city: Clermont-Ferrand cedex 1
country: France
facility: CHU de Clermont-Ferrand - Estaing
city: Paris
country: France
facility: Hopital Saint Louis
city: Pierre Benite Cedex
country: France
facility: Centre Hospitalier Lyon Sud
city: Rennes
country: France
facility: CHRU Hopital de Pontchaillou - Maladies De L'Appareil Digesti
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar
state: Csongrad
city: Budapest
country: Hungary
facility: MH Egeszsegugyi Kozpont
state: Pest
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Altalanos Orvostudomanyi Kar
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus Gyermekgyogyaszati Klinika
city: Petah Tikva
country: Israel
facility: Rabin Medical Center, Beilinson Hospital -Gastroenterology
state: HaMerkaz
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Hadassah Medical Center, Ein-
state: Yerushalayim
city: Haifa
country: Israel
facility: Rambam Medical Centre
city: Tel Hashomer
country: Israel
facility: The Chaim Sheba Medical Center
city: Modena
country: Italy
facility: AOU Policlinico di Modena - Gastroenterologia
city: Roma
country: Italy
facility: Complesso Integrato Columbus, Universita Cattolica del Sacro Cuore
city: Roma
country: Italy
facility: PU A. Gemelli, Universita Cattolica del Sacro Cuore
city: Wroclaw
country: Poland
facility: Centrum Medyczne Melita Medical
state: Dolnoslaskie
city: Warszawa
country: Poland
facility: Wielospecjalistyczny Szpital Medicover
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Baleares
city: Badalona
country: Spain
facility: H.U. G.Trias i Pujol
state: Barcelona
city: Sabadell
country: Spain
facility: Parc Tauli Hospital Universitari
state: Barcelona
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Del Mar
city: Barcelona
country: Spain
facility: Hospital Clinic De Barcelona
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Pontevedra
country: Spain
facility: C.H.U. de Pontevedra
city: Sevilla
country: Spain
facility: H.U.V. del Rocio
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: