B0151005 Open-Label Extension Study
Public ClinicalTrials.gov record NCT01345318. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter Open-label Extension Study For Subjects Who Participated In Study B0151003 (Andante Ii)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a multi-center Phase 2, open label, safety extension study in subjects with moderate to severe CD who are anti-TNF inadequate responders. Subjects eligible for this study will have completed the 12-week induction period of study B0151003 and will be enrolled as either responders or non responders.
Study identification
- NCT ID
- NCT01345318
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 191 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 2011 (Type not available)
- Primary completion
- Mar 2016 (Actual)
- Completion
- Mar 2016 (Actual)
- Last update posted
- Jan 12, 2024
2011 – 2016
United States locations
- U.S. sites
- 62
- U.S. states
- 16
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Simon Medical Imaging | Scottsdale | Arizona | 85258 | — |
| Digestive Health Research Unit | Scottsdale | Arizona | 85260 | — |
| Adobe Clinical Research, LLC | Tucson | Arizona | 85712 | — |
| Adobe Surgery Center | Tucson | Arizona | 85712 | — |
| Rocky Mountain Gastroenterology Associates | Lakewood | Colorado | 80215 | — |
| Rocky Mountain Gastroenterology | Littleton | Colorado | 80120 | — |
| Rocky Mountain Clinical Research, LLC. | Wheat Ridge | Colorado | 80033 | — |
| Rocky Mountain Clinical Research, LLC | Wheat Ridge | Colorado | 80033 | — |
| Medical Research Center of Connecticut, LLC | Hamden | Connecticut | 06518 | — |
| Gastroenterology Consultants of Clearwater | Clearwater | Florida | 33756 | — |
| Clinical Research of West Florida, Inc. | Clearwater | Florida | 33765 | — |
| Gastroenterology Associates | Crystal River | Florida | 34429 | — |
| Nature Coast Clinical Research | Inverness | Florida | 34452 | — |
| Suncoast Endoscopy Center | Inverness | Florida | 34453 | — |
| International Clinical Research - US, LLC | Sanford | Florida | 32771 | — |
| Atlanta Center for Gastroenterology, P.C. | Decatur | Georgia | 30033 | — |
| The Atlanta Center For Gastroenterology | Decatur | Georgia | 30033 | — |
| Gastointestinal Specialists of Georgia, PC | Marietta | Georgia | 30060 | — |
| Illinois Gastroenterology Group, LLC | Arlington Heights | Illinois | 60005 | — |
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| NorthShore University Health System | Evanston | Illinois | 60201 | — |
| University of Kentucky Chandler Medical Center | Lexington | Kentucky | 40536 | — |
| U of L Health Care Outpatient Center | Louisville | Kentucky | 40202 | — |
| University of Louisville Hospital | Louisville | Kentucky | 40202 | — |
| Digestive Disorders Associates | Annapolis | Maryland | 21401 | — |
| Drgestive Disorders Associates | Annapolis | Maryland | 21401 | — |
| East Valley Endoscopy | Grand Rapids | Michigan | 49546 | — |
| Gastroenterology Associates of Western Michigan | Wyoming | Michigan | 49519 | — |
| Metro Health Hospital Endoscopy Unit | Wyoming | Michigan | 49519 | — |
| Metro Health Hospital | Wyoming | Michigan | 49519 | — |
| Huron Gastroenterology Associates | Ypsilanti | Michigan | 48197 | — |
| Weill Cornell Medical College of Cornell University | New York | New York | 10021 | — |
| Present, Chapman, Steinlauf and Marion | New York | New York | 10028 | — |
| Mount Sinai School of Medicine | New York | New York | 10029 | — |
| New York Presbyterian Hospital - Weill Cornell Medical College Investigational Pharmacy | New York | New York | 10065 | — |
| Weill Cornell Imaging at New York Presbyterian Hospital | New York | New York | 10065 | — |
| Weill Cornell Medical College of Cornell University-Greenberg | New York | New York | 10065 | — |
| Arthur Asher Kombluth, MD PC | New York | New York | 10128 | — |
| Oklahoma Foundation for Digestive Research | Oklahoma City | Oklahoma | 73102 | — |
| Pharmacy: Wheeler and Stuckey, Inc. | Oklahoma City | Oklahoma | 73103 | — |
| Colonoscopy and X-rays: OU Physicians Building | Oklahoma City | Oklahoma | 73104 | — |
| Hillcrest Medical Center | Tulsa | Oklahoma | 74104 | — |
| Options Health Research, LLC | Tulsa | Oklahoma | 74104 | — |
| Pittsburgh Gastroenterology Associates | Pittsburgh | Pennsylvania | 15241 | — |
| Research Protocol Management Specialists | Pittsburgh | Pennsylvania | 15243 | — |
| Gastro One | Germantown | Tennessee | 38138 | — |
| Vanderbilt University Medical Center: IBD Clinic | Nashville | Tennessee | 37212-1375 | — |
| Vanderbilt University Medical Center-GI Research | Nashville | Tennessee | 37212-1610 | — |
| IBD Center-Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | — |
| Vanderbilt University Medical Center-IDS | Nashville | Tennessee | 37212 | — |
| Professional Quality Research, Inc. | Austin | Texas | 78705 | — |
| Austin Gastroenterology, PA | Austin | Texas | 78745 | — |
| Diagnostic Clinic Of Houston Pa | Houston | Texas | 77004 | — |
| Diagnostic Clinic of Houston, PA | Houston | Texas | 77004 | — |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | — |
| The University of TX Health Sci. Ctr at Houston | Houston | Texas | 77030 | — |
| Texas Digestive Disease Consultants | Southlake | Texas | 76092 | — |
| Clinical Pathologiy Laboratories, Inc, DBA DRL Labs | Tyler | Texas | 75701 | — |
| Digestive Health Specialists of Tyler | Tyler | Texas | 75701 | — |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | — |
| VC Medical Center Investigative Drug Service (IDS) [Ship Drug To] | Richmond | Virginia | 23298 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 65 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01345318, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 12, 2024 · Synced Nov 8, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01345318 live on ClinicalTrials.gov.