Triple Combination Therapy in High Risk Crohn's Disease (CD)

• Register: ClinicalTrials.gov
• Last refreshed on: 5 June 2023
• Main ID: NCT02764762
• Date of registration: 05/05/2016
• Prospective Registration: Yes
• Primary sponsor: Takeda
• Public title: Triple Combination Therapy in High Risk Crohn's Disease (CD)
• Scientific title: An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Triple Combination Therapy With Vedolizumab IV, Adalimumab SC, and Oral Methotrexate in Early Treatment of Subjects With Crohn's Disease Stratified at Higher Risk for Developing Complications
• Date of first enrolment: April 18, 2017
• Target sample size: 55
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02764762
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Canada, United States

Contacts

• Name: Medical Director
• Affiliation: Takeda

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Has an initial diagnosis of CD established within 24 months prior to screening with
involvement of the ileum and/or colon that can be assessed by ileocolonoscopy.

2. Has moderate to severely active CD during Screening defined by a centrally assessed
simple endoscopic score for Crohn disease (SES-CD) score >=7 (or >=4 if isolated ileal
disease).

Exclusion Criteria:

Gastrointestinal (GI) Exclusion Criteria

1. Has a diagnosis of ulcerative colitis (UC) or indeterminate colitis.

2. Has clinical evidence of a current abdominal abscess or a history of prior abdominal
abscess.

3. Has a known perianal fistula with abscess. (The participant may have a perianal
fistula without abscess.)

4. Has a known fistula (other than perianal fistula).



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Drug: Adalimumab

Drug: Methotrexate

Drug: Vedolizumab

Primary Outcome(s)

Percentage of Participants Achieving Endoscopic Remission at Week 26 [Time Frame: Week 26]

Secondary Outcome(s)

Percentage of Participants Using Oral Corticosteroids at Baseline Who Have Discontinued Corticosteroids and Are in Clinical Remission at Weeks 10, 26, and 102 [Time Frame: Weeks 10, 26 and 102]

Change From Baseline in Fecal Calprotectin Concentrations at Weeks 10, 14, 26, 52, 78, and 102 [Time Frame: Baseline, Weeks 10, 14, 26, 52, 78 and 102]

Change From Baseline in C-reactive Protein (CRP) Levels at Weeks 10 and 26 [Time Frame: Baseline, Weeks 10 and 26]

Percentage of Participants Achieving Clinical Remission and CRP <5 Milligram Per Liter (mg/L) at Weeks 26, 52, 78, and 102 [Time Frame: Weeks 26, 52, 78 and 102]

Percentage of Participants Achieving Clinical Remission at Weeks 10 and 26 [Time Frame: Weeks 10 and 26]

Percentage of Participants Achieving Deep Remission at Week 26 [Time Frame: Week 26]

Percentage of Participants Achieving Clinical Remission and Endoscopic Response as a Measure of Mucosal Healing at Week 26 [Time Frame: Week 26]

Percentage of Participants Achieving Endoscopic Response at Week 26 [Time Frame: Week 26]

Percentage of Participants Maintaining Endoscopic Remission at Week 102 [Time Frame: Week 102]

Change From Baseline in SES-CD Score at Week 26 [Time Frame: Baseline and Week 26]

Percentage of Participants Maintaining Clinical Remission and Endoscopic Response as a Measure of Mucosal Healing at Week 102 [Time Frame: Week 102]

Percentage of Participants With First Exacerbation of CD [Time Frame: After 26 Weeks up to Week 128]

Percentage of Participants Achieving Endoscopic Healing at Week 26 [Time Frame: Week 26]

Percentage of Participants Maintaining Endoscopic Healing at Week 102 [Time Frame: Week 102]

Percentage of Participants Maintaining Clinical Remission at Weeks 52, 78, and 102 [Time Frame: Weeks 52, 78 and 102]

Percentage of Participants Maintaining Deep Remission at Week 102 [Time Frame: Week 102]

Percentage of Participants Achieving Clinical Response at Weeks 10 and 26 [Time Frame: Weeks 10 and 26]

Percentage of Participants Maintaining Endoscopic Response at Week 102 [Time Frame: Week 102]

Secondary ID(s)

U1111-1175-9094

Vedolizumab-4006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 21/10/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02764762