Phase 4
Completed N=55
Triple Combination Therapy in High Risk Crohn's Disease (CD)
Source: ClinicalTrials.gov NCT02764762 ↗Enrolled (actual)
55
Serious AEs
5.9%
Results posted
Oct 2021
Primary outcomePrimary: Percentage of Participants Achieving Endoscopic Remission at Week 26 — 34.5 percentage of participants
◆ Published Evidence
Established
95citations · ~48 / year
Vedolizumab, Adalimumab, and Methotrexate Combination Therapy in Crohn's Disease (EXPLORER).
Summary
The purpose of this study is to determine the effect of triple combination therapy with an anti-integrin (vedolizumab intravenous [IV]), a tumor necrosis factor (TNF) antagonist (adalimumab subcutaneously [SC]), and an immunomodulator (oral methotrexate) on endoscopic remission in participants with newly-diagnosed CD stratified at higher risk for complications.
Linked Publications
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Vedolizumab, Adalimumab, and Methotrexate Combination Therapy in Crohn's Disease (EXPLORER).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Endoscopic Remission at Week 26 |
34.5 | — |
| SECONDARY Percentage of Participants Achieving Endoscopic Healing at Week 26 |
43.6 | — |
| SECONDARY Percentage of Participants Achieving Endoscopic Response at Week 26 |
56.4 | — |
| SECONDARY Change From Baseline in SES-CD Score at Week 26 |
12.6; -8.9 | — |
| SECONDARY Percentage of Participants Achieving Deep Remission at Week 26 |
21.8 | — |
| SECONDARY Percentage of Participants Achieving Clinical Remission and Endoscopic Response as a Measure of Mucosal Healing at Week 26 |
38.2 | — |
| SECONDARY Percentage of Participants Achieving Clinical Remission at Weeks 10 and 26 |
60.0; 54.5 | — |
| SECONDARY Percentage of Participants Achieving Clinical Response at Weeks 10 and 26 |
49.1; 43.6 | — |
| SECONDARY Change From Baseline in C-reactive Protein (CRP) Levels at Weeks 10 and 26 |
7.60; -4.80; -5.50 | — |
| SECONDARY Change From Baseline in Fecal Calprotectin Concentrations at Weeks 10, 14, 26, 52, 78, and 102 |
1301.0; 1210.0; -864.0; -556.0; -860.5; -350.0 | — |
| SECONDARY Percentage of Participants Achieving Clinical Remission and CRP <5 Milligram Per Liter (mg/L) at Weeks 26, 52, 78, and 102 |
51.3; 44.1; 26.5; 20.6 | — |
| SECONDARY Percentage of Participants Using Oral Corticosteroids at Baseline Who Have Discontinued Corticosteroids and Are in Clinical Remission at Weeks 10, 26, and 102 |
50.0; 56.3; 21.4 | — |
| SECONDARY Percentage of Participants Maintaining Clinical Remission at Weeks 52, 78, and 102 |
50.0; 33.3; 20.0 | — |
| SECONDARY Percentage of Participants Maintaining Clinical Response at Weeks 52, 78, and 102 |
66.7; 45.8; 29.2 | — |
| SECONDARY Percentage of Participants Maintaining Endoscopic Remission at Week 102 |
27.8 | — |
| SECONDARY Percentage of Participants Maintaining Deep Remission at Week 102 |
8.3 | — |
| SECONDARY Percentage of Participants Maintaining Endoscopic Healing at Week 102 |
34.8 | — |
| SECONDARY Percentage of Participants Maintaining Endoscopic Response at Week 102 |
50.0 | — |
| SECONDARY Percentage of Participants Maintaining Clinical Remission and Endoscopic Response as a Measure of Mucosal Healing at Week 102 |
19.0 | — |
| SECONDARY Percentage of Participants With First Exacerbation of CD |
62.2 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
- 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
- Has a diagnosis of ulcerative colitis (UC) or indeterminate colitis.
- Has clinical evidence of a current abdominal abscess or a history of prior abdominal abscess.
- Has a known perianal fistula with abscess. (The participant may have a perianal fistula without abscess.)
- Has a known fistula (other than perianal fistula).
Data sourced from ClinicalTrials.gov (NCT02764762) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.