Phase 2
Completed N=72
Long Term Safety of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease
Source: ClinicalTrials.gov NCT00619489 ↗Enrolled (actual)
72
Serious AEs
13.9%
Results posted
Jul 2014
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) — 21; 35; 2; 9 participants
Summary
This was an open-label study to provide an opportunity for participants with Ulcerative Colitis (UC) who previously completed Study C13002 (NCT01177228), and for treatment-naïve participants with UC or Crohn's Disease (CD) to receive treatment with vedolizumab, and to determine the long term safety of vedolizumab in patients afflicted with these diseases.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
21; 35; 2; 9; 5; 21 | — |
| PRIMARY Number of Participants With Clinically Significant Laboratory Findings |
3; 0; 0; 1; 0; 1 | — |
| PRIMARY Number of Participants With Signs and Symptoms of Progressive Multifocal Leukoencephalopathy (PML) |
0; 0 | — |
| PRIMARY Number of Participants With Human Anti-human Antibodies (HAHA) |
2; 1 | — |
| SECONDARY Serum Concentration of Vedolizumab Before Dosing |
25.2; 76.2; 11.2; 32.5; 8.40; 26.4 | — |
| SECONDARY Saturation of Receptors by Vedolizumab Before Dosing on Days 1, 43, 99, 155 and 267 by ACT-1 Assay |
NA; 14.6; 0.277; 0.311; 0.596; 0.288 | — |
| SECONDARY Saturation of Receptors by Vedolizumab Before Dosing Using the MAdCAM-1-Fc Assay |
NA; 18.5; 0.538; 0.705; 1.22; 0.838 | — |
Eligibility Criteria
Inclusion Criteria
- Confirmed and active ulcerative colitis (UC) or Crohn's Disease (CD)
- Crohn's Disease Activity Index (CDAI) Score of 220 - 450 for participants with CD
- Partial Mayo score of 2 - 7 for participants with UC
- Patient should be appropriate candidate for biologic therapy per guidelines
- Up-to-date on cancer screening
- No severe systemic disease
- Patients with evidence of abscess
- Agree to comply with study procedures including contraception
Exclusion Criteria
- Low lymphocyte counts
- History of imaging abnormalities, multiple sclerosis (MS), brain tumor or other neurological illness
- Active or recent serious infections
- Recent treatment with biologic (i.e., Remicade) or investigational drug
- Impending surgery
- Any participants with vedolizumab human anti-human antibody (HAHA) titers ≥1:125 or with a previous immediate hypersensitivity reaction during or shortly after vedolizumab infusion
Data sourced from ClinicalTrials.gov (NCT00619489). 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.