Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula

• Register: ClinicalTrials.gov
• Last refreshed on: 6 May 2024
• Main ID: NCT04075825
• Date of registration: 22/08/2019
• Prospective Registration: Yes
• Primary sponsor: Takeda
• Public title: Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula
• Scientific 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
• Date of first enrolment: November 4, 2019
• Target sample size: 151
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT04075825
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Belgium, Czechia, France, Hungary, Israel, Italy, Poland, Spain, United States

Contacts

• Name: Study Director
• Affiliation: Takeda

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Complex Perianal Fistula

Crohn's Disease

Intervention(s)

Biological: Darvadstrocel

Primary Outcome(s)

Number of Participants With Serious Adverse Events (SAEs) [Time Frame: Baseline (Week 52 of ADMIRE-CD II) up to Week 156 after IMP administration]

Number of Participants With Specific Adverse Events of Special Interest (AESIs) [Time Frame: Baseline (Week 52 of ADMIRE-CD II) up to Week 156 after IMP administration]

Number of Participants With Adverse Events (AEs) [Time Frame: Baseline (Week 52 of ADMIRE-CD II) up to Week 156 after investigational medicinal product (IMP) administration]

Secondary Outcome(s)

Change from Baseline of ADMIRE-CD II in Scores of Discharge Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156 [Time Frame: Weeks 104 and 156]

Percentage of Participants who Achieve Clinical Remission at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study) [Time Frame: Baseline of ADMIRE-CD II and Weeks 104 and 156]

Change from Baseline of ADMIRE-CD II in Scores of Pain Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156 [Time Frame: Weeks 104 and 156]

Percentage of Participants who Achieve Combined Clinical Remission at Week 156 (After IMP Administration in ADMIRE-CD II Study) [Time Frame: Baseline of ADMIRE-CD II and Week 156]

Percentage of Participants With Relapse [Time Frame: Up to Week 156]

Percentage of Participants who Achieve Clinical Response at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study) [Time Frame: Baseline of ADMIRE-CD II and Weeks 104 and 156]

Percentage of Participants With New Anal Abscess in Treated Fistula at Week 156 [Time Frame: Week 156]

Secondary ID(s)

2019-000333-39

Darvadstrocel-3003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors