A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy
Public ClinicalTrials.gov record NCT01287897. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Crohn's Disease Who Are Anti-tnf Inadequate Responders (Andante)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a proof of concept study to determine the efficacy and safety of a monoclonal antibody with three doses versus placebo. Subjects will be randomized to a treatment and the dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate to severe refractory Crohn's Disease.
Study identification
- NCT ID
- NCT01287897
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 250 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
- Jan 31, 2011
- Primary completion
- Aug 31, 2014
- Completion
- Jan 31, 2015
- Last update posted
- Jan 20, 2016
2011 – 2015
United States locations
- U.S. sites
- 98
- U.S. states
- 23
- U.S. cities
- 48
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UAB Hospital | Birmingham | Alabama | 35249 | — |
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Simon Medical Imaging | Scottsdale | Arizona | 85258 | — |
| Digestive Health Research Unit | Scottsdale | Arizona | 85260 | — |
| Adobe Clinical Research, Llc | Tucson | Arizona | 85712 | — |
| Radiology Ltd | Tucson | Arizona | 85712 | — |
| UCSF Endoscopy Unit at Mount Zion | San Francisco | California | 94115 | — |
| University of California - San Francisco | San Francisco | California | 94115 | — |
| University of California San Francisco at Mount Zion | San Francisco | California | 94115 | — |
| Rocky Mountain Clinical Research, LLC | Denver | Colorado | 80222 | — |
| Rocky Mountain Gastroenterology Associates | Lakewood | Colorado | 80215 | — |
| Rocky Mountain Gastroenterology | Lakewood | Colorado | 80215 | — |
| Arapahoe Gastroenterology, PC | Littleton | Colorado | 80120 | — |
| Endoscopy Center of Connecticut, LLC | Guilford | Connecticut | 06437 | — |
| Endoscopy Center of Connecticut, LLC | Hamden | Connecticut | 06518 | — |
| Gastroenterology Center of Connecticut, PC | Hamden | Connecticut | 06518 | — |
| Medical Research Center of Connecticut, LLC | Hamden | Connecticut | 06518 | — |
| 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 | — |
| Advanced Research Institute, Inc. | New Port Richey | Florida | 34653 | — |
| International Clinical Research - US, LLC | Sanford | Florida | 32771 | — |
| Atlanta Center for Gastroenterology, P.C. | Decatur | Georgia | 30033 | — |
| Atlanta Endoscopy Center | Decatur | Georgia | 30033 | — |
| Decatur Health Imaging | Decatur | Georgia | 30033 | — |
| Gastrointestinal Specialists of Georgia, PC | Marietta | Georgia | 30060 | — |
| GI Diagnostics | Marietta | Georgia | 30067 | — |
| Illinois Gastroenterology Group, LLC | Arlington Heights | Illinois | 60005 | — |
| The University of Chicago Medical Center (Ucmc) | Chicago | Illinois | 60637 | — |
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| The University of Chicago Medical | Chicago | Illinois | 60637 | — |
| The University Of Chicago | Chicago | Illinois | 60637 | — |
| NorthShore University Health System | Evanston | Illinois | 60201 | — |
| Glenbrook Hospital Outpatient Pharmacy | Glenview | Illinois | 60025 | — |
| Glenbrook Hospital | Glenview | Illinois | 60026 | — |
| Central Indiana Gastroenterology Group | Anderson | Indiana | 46016 | — |
| Saint John's Research Institute | Anderson | Indiana | 46016 | — |
| University of Kentucky | Lexington | Kentucky | 40536 | — |
| University Of Louisville Healthcare Outpatient Center | Louisville | Kentucky | 40202 | — |
| University of Louisville Research Foundation | Louisville | Kentucky | 40202 | — |
| University Of Louisville | Louisville | Kentucky | 40202 | — |
| Digestive Disorders Associates | Annapolis | Maryland | 21401 | — |
| Disgestive Disorders Associates | Annapolis | Maryland | 21401 | — |
| Investigative Clinical Research | Annapolis | Maryland | 21401 | — |
| Maryland Diagnostics & Therapeutic Endo Center | Annapolis | Maryland | 21401 | — |
| Commonwealth Clinical Studies | Brockton | Massachusetts | 02302 | — |
| Prima CARE, PC | Fall River | Massachusetts | 02721 | — |
| St. Joseph Mercy Hospital | Ann Arbor | Michigan | 48106 | — |
| 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 | — |
| St. Joseph Mercy Hospital | Ypsilanti | Michigan | 48197 | — |
| Minnesota Gastroenterology, PA | Plymouth | Minnesota | 55446 | — |
| Weill Cornell Medical College of Cornell University-Greenberg | New York | New York | 10021 | — |
| 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 | — |
| New York Presbyterian Hospital | New York | New York | 10065 | — |
| Weill Cornell Imaging at New York Presbyterian Hospital | New York | New York | 10065 | — |
| Arthur asher Kornbluth, MD PC | New York | New York | 10128 | — |
| PMG Research of Winston-Salem | Winston-Salem | North Carolina | 27103 | — |
| 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 Endoscopy | Tulsa | Oklahoma | 74104 | — |
| Hillcrest Medical Center | Tulsa | Oklahoma | 74104 | — |
| Options Health Research, LLC | Tulsa | Oklahoma | 74104 | — |
| Utica Park Clinic X-Ray | Tulsa | Oklahoma | 74104 | — |
| Advanced Imaging | Tulsa | Oklahoma | 74137-4200 | — |
| Pittsburgh Gastroenterology Associates | Pittsburgh | Pennsylvania | 15243 | — |
| Research Protocol Management Specialists | Pittsburgh | Pennsylvania | 15243 | — |
| Pharma Resource | East Providence | Rhode Island | 02915 | — |
| Omega Medical Research | Warwick | Rhode Island | 02886 | — |
| Gastro One | Germantown | Tennessee | 38138 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | — |
| Professional Quality Research, Inc. | Austin | Texas | 78705 | — |
| Diagnostic Clinic of Houston, PA | Houston | Texas | 77004 | — |
| Houston Hospital for Specialized Surgery (Endoscopy Only) | Houston | Texas | 77004 | — |
| Baylor Clinic (Drug Storage) | Houston | Texas | 77030 | — |
| Baylor College of Medicine - Baylor Medical Center | Houston | Texas | 77030 | — |
| Ertan Digestive Disease Center | Houston | Texas | 77030 | — |
| Memorial Hermann Hospital | Houston | Texas | 77030 | — |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | — |
| The University of Texas Medical School at Houston | Houston | Texas | 77030 | — |
| Physicians Endoscopy Center (Colonoscopy) | Houston | Texas | 77036 | — |
| Texas Digestive Disease Consultants | Southlake | Texas | 76092 | — |
| One Step Diagnostic (X-Ray) | Sugar Land | Texas | 77478 | — |
| Pioneer Research Solutions, Inc. (Admin. Office) | Sugar Land | Texas | 77479 | — |
| Pioneer Research Solutions, Inc. | SugarLand | Texas | 77479 | — |
| Digestive Health Specialists of Tyler | Tyler | Texas | 75701 | — |
| University Of Utah HSC | Salt Lake City | Utah | 84132 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23298-0341 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | — |
| VCU Medical Investigational Drug Service (IDS) | Richmond | Virginia | 93298-5028 | — |
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 95 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01287897, 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 20, 2016 · Synced Sep 3, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01287897 live on ClinicalTrials.gov.