Long Term Safety of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

NCT00619489 | Completed Phase 2 Results

• 2 other identifiers: C13004U1111-1156-8608
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ulcerative Colitis; Crohn's Disease

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Adverse Events (AEs)

  An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with the treatment. The investigator systematically collected information adequate to determine both the outcome and severity of the AE, and whether or not it was drug-related or met the criteria for classification as a serious adverse event (SAE). An SAE was defined as an AE that resulted in (or posed risk for) death, inpatient hospitalization (or prolonging hospitalization), or congenital, persistent or significant disability/incapacity. The intensity for each AE was defined according to the following criteria: Mild: Awareness of sign or symptom, but easily tolerated; Moderate: Discomfort enough to cause interference with normal daily activities; Severe: Inability to perform normal daily activities.

  From Day 1 to Day 637

• Number of Participants With Clinically Significant Laboratory Findings

  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are enzymes in the blood.

  through Day 637

• Number of Participants With Signs and Symptoms of Progressive Multifocal Leukoencephalopathy (PML)

  At every visit, before receiving study treatment participants were evaluated by clinic staff for signs of PML using a PML symptom checklist.

  through Day 637

• Number of Participants With Human Anti-human Antibodies (HAHA)

  Samples collected prior to dosing on Days 1, 43, 155, 267, 379, 491, and 637.

Secondary Outcomes (3)

• Serum Concentration of Vedolizumab Before Dosing

  Days 43, 99, 155 and 267, predose

• Saturation of Receptors by Vedolizumab Before Dosing on Days 1, 43, 99, 155 and 267 by ACT-1 Assay

  Days 43, 99, 155 and 267, predose

• Saturation of Receptors by Vedolizumab Before Dosing Using the MAdCAM-1-Fc Assay

  Days 43, 99, 155 and 267, predose

Study Arms (2)

Vedolizumab 2 mg/kg

EXPERIMENTAL

Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks.

Drug: vedolizumab

Vedolizumab 6 mg/kg

EXPERIMENTAL

Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks.

Drug: vedolizumab

Interventions

vedolizumab DRUG

Vedolizumab for intravenous (IV) infusion

Also known as: Entyvio, MLN0002, MLN02, LDP-02

Vedolizumab 2 mg/kg; Vedolizumab 6 mg/kg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, Canada

Location

Related Publications (1)

• Colombel JF, Sands BE, Rutgeerts P, Sandborn W, Danese S, D'Haens G, Panaccione R, Loftus EV Jr, Sankoh S, Fox I, Parikh A, Milch C, Abhyankar B, Feagan BG. The safety of vedolizumab for ulcerative colitis and Crohn's disease. Gut. 2017 May;66(5):839-851. doi: 10.1136/gutjnl-2015-311079. Epub 2016 Feb 18.

  PMID: 26893500 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease

Interventions

vedolizumab; LDP-02

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Millennium Pharmaceuticals Inc

clinicaltrialregistry@tpna.com

800-778-2860

Study Officials

• Medical Monitor

  Millennium Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2008
• First Posted: February 21, 2008
• Study Start: December 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: July 18, 2014
• Results First Posted: July 18, 2014

Record last verified: 2014-06

Locations

CA (1)