ClinicalTrials.gov record
A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)
ClinicalTrials.gov ID: NCT03283085
Public ClinicalTrials.gov record NCT03283085. 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 Phase 3 Long-term Safety Extension Study of SHP647 in Subjects With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)
Study identification
- NCT ID
- NCT03283085
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Shire
- Industry
- Enrollment
- 557 participants
Conditions and interventions
Conditions
Interventions
- 25 mg Ontamalimab Drug
- 75 mg Ontamalimab Drug
Drug
Eligibility (public fields only)
- Age range
- 16 Years to 80 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
- Feb 26, 2018
- Primary completion
- Dec 12, 2023
- Completion
- Dec 12, 2023
- Last update posted
- Jun 20, 2024
2018 – 2023
United States locations
- U.S. sites
- 103
- U.S. states
- 29
- U.S. cities
- 91
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Digestive Health Mesa - East | Mesa | Arizona | 85206 | — |
| Elite Clinical Studies - Phoenix - Clinedge - PPDS | Phoenix | Arizona | 85018 | — |
| Arizona Digestive Health | Sun City | Arizona | 85351 | — |
| CATS Research Center - University of Arizona | Tucson | Arizona | 85724 | — |
| Atria Clinical Research - Clinedge - PPDS | Little Rock | Arkansas | 72209 | — |
| Advanced Research Center | Anaheim | California | 92805 | — |
| Kindred Medical Institute for Clinical Trials, LLC | Corona | California | 92879 | — |
| United Medical Doctors | Encinitas | California | 92024-1350 | — |
| University of California San Diego | La Jolla | California | 92093 | — |
| OM Research LLC - Lancaster - ClinEdge - PPDS | Lancaster | California | 93534 | — |
| Tibor Rubin VA Medical Center - NAVREF | Long Beach | California | 90822 | — |
| VA Long Beach Healthcare System - NAVREF - PPDS | Long Beach | California | 90822 | — |
| Facey Medical Foundation | Mission Hills | California | 91345 | — |
| United Medical Doctors | Murrieta | California | 92563 | — |
| Alliance Clinical Research-(Vestavia Hills) | Poway | California | 92064 | — |
| Inland Empire Liver Foundation | Rialto | California | 92377 | — |
| University of California San Francisco | San Francisco | California | 94158 | — |
| Care Access Research, San Pablo | San Pablo | California | 94806 | — |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80903 | — |
| Asthma and Allergy Associates PC - CRN - PPDS | Colorado Springs | Colorado | 80907 | — |
| Renaissance Research Medical Group, INC | Cape Coral | Florida | 33991 | — |
| Gastro Florida | Clearwater | Florida | 33756 | — |
| Advanced Clinical Research Network | Coral Gables | Florida | 33134 | — |
| Alliance Medical Research LLC | Coral Springs | Florida | 33071 | — |
| ENCORE Borland-Groover Clinical Research - ERN - PPDS | Jacksonville | Florida | 32256 | — |
| SIH Research | Kissimmee | Florida | 34741 | — |
| Hi Tech and Global Research, LLc | Miami | Florida | 33135 | — |
| Nuren Medical and Research Center | Miami | Florida | 33144 | — |
| Sanchez Clinical Research, Inc | Miami | Florida | 33157 | — |
| Advanced Clinical Research Network | Miami | Florida | 33174 | — |
| Crystal Biomedical Research | Miami Lakes | Florida | 33065 | — |
| Gastroenterology Group of Naples | Naples | Florida | 34102 | — |
| Pharma Research International Inc | Naples | Florida | 34110 | — |
| Bayside Clinical Research - New Port Richey | New Port Richey | Florida | 34655 | — |
| Omega Research Consultants LLC - Clinedge - PPDS | Orlando | Florida | 32810 | — |
| Accel Research Sites - St. Petersburg - ERN - PPDS | Pinellas Park | Florida | 33781 | — |
| BRCR Medical Center, Inc | Plantation | Florida | 33322 | — |
| East Coast Institute for Research, LLC | Saint Augustine | Florida | 32086 | — |
| DBC Research | Tamarac | Florida | 33321 | — |
| Gastrointestinal Diseases, Inc Research - IACT- HyperCore - PPDS | Columbus | Georgia | 31904 | — |
| Atlanta Center For Gastroenterology PC | Decatur | Georgia | 30033 | — |
| Infinite Clinical Trials | Morrow | Georgia | 30260 | — |
| Atlanta Gastroenterology Specialists, PC | Suwanee | Georgia | 30024 | — |
| Loretto Hospital | Chicago | Illinois | 60644 | — |
| IL Gastroenterology Group | Gurnee | Illinois | 60041 | — |
| Edward Hines Jr VA Hospital - NAVREF - PPDS | Hines | Illinois | 60141 | — |
| Dupage Medical Group | Oakbrook Terrace | Illinois | 60181 | — |
| Medisphere Medical Research Center LLC | Evansville | Indiana | 47714 | — |
| Laporte County Institute For Clinical Research | Michigan City | Indiana | 46360 | — |
| Cotton O'Neil Clinical Research Center | Topeka | Kansas | 66606 | — |
| Gastroenterology Associates of Hazard | Hazard | Kentucky | 41701 | — |
| CroNOLA, LLC. | Houma | Louisiana | 70360 | — |
| Clinical Trials of SWLA LLC | Lake Charles | Louisiana | 70601 | — |
| DelRicht Clinical Research, LLC - ClinEdge - PPDS | New Orleans | Louisiana | 70115 | — |
| Louisiana Research Center LLC | Shreveport | Louisiana | 71103 | — |
| Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | — |
| Commonwealth Clinical Studies LLC | Brockton | Massachusetts | 02302 | — |
| UMass Memorial Medical Center | Worcester | Massachusetts | 01655 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | 48047 | — |
| National Clinical, LLC | Hamtramck | Michigan | 48212 | — |
| Gastroenterology Associates of Western Michigan, PLC | Wyoming | Michigan | 49519 | — |
| Mayo Clinic Health System - PPDS | Duluth | Minnesota | 55805 | — |
| Minnesota Gastroenterology PA | Saint Paul | Minnesota | 55114 | — |
| Digestive Health Center PA | Ocean Springs | Mississippi | 39564 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| St Louis Center For Clinical Research | St Louis | Missouri | 63128 | — |
| Advanced Biomedical Research of America | Las Vegas | Nevada | 89123 | — |
| Encompass Care | North Las Vegas | Nevada | 89086 | — |
| New York Total Medical Care PC | Brooklyn | New York | 11215 | — |
| NYU Langone Long Island Clinical Research Associates | Great Neck | New York | 11021 | — |
| Weill Cornell Medical College | New York | New York | 10021 | — |
| Southtowns Gastroenterology, PLLC | Orchard Park | New York | 14127 | — |
| East Carolina Gastroenterology | Jacksonville | North Carolina | 28546 | — |
| Piedmont Healthcare | Statesville | North Carolina | 28625 | — |
| Gastro Health Research | Cincinnati | Ohio | 45219 | — |
| Consultants For Clinical Research Inc | Cincinnati | Ohio | 45249 | — |
| Consultants For Clinical Research Inc | Fairfield | Ohio | 45014 | — |
| Prestige Clinical Research | Franklin | Ohio | 45005 | — |
| Ohio Clinical Research Partners LLC | Mentor | Ohio | 44060 | — |
| Veteran's Research and Education Foundation - NAVREF - PPDS | Oklahoma City | Oklahoma | 73104 | — |
| Veterans Research Foundation of Pittsburgh - NAVREF - PPDS | Pittsburgh | Pennsylvania | 15240 | — |
| Penn State Hershey Medical Group | State College | Pennsylvania | 16803 | — |
| Digestive Disease Associates | Wyomissing | Pennsylvania | 19610 | — |
| Gastro One | Germantown | Tennessee | 38138 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | — |
| Advanced Gastroenterology-Union City | Union City | Tennessee | 38237 | — |
| Northside Gastroenterology | Cypress | Texas | 77429 | — |
| Digestive Health Associates of Texas, P.A.dba DHAT Research Institute | Garland | Texas | 75044 | — |
| Precision Research Institute, LLC | Houston | Texas | 77039 | — |
| Biopharma Informatic Inc. | Houston | Texas | 77043 | — |
| Southwest Clinical Trials | Houston | Texas | 77074 | — |
| Aztec Medical Research | Houston | Texas | 77079 | — |
| Biopharma Informatic Research Center | Houston | Texas | 77084 | — |
| Southern Star Research Institute LLC | San Antonio | Texas | 78229 | — |
| DM Clinical Research - ERN - PPDS | Tomball | Texas | 77375 | — |
| Inquest Clinical Research/Coastal Gastroenterology Associates, PA - TDDC - PPDS | Webster | Texas | 77598 | — |
| HP Clinical Research | Bountiful | Utah | 84010 | — |
| Mid Atlantic Health Specialists | Galax | Virginia | 24333 | — |
| Winchester Gastroenterology Associates | Winchester | Virginia | 22601-2872 | — |
| CHI Franciscan Digestive Care Associates | Tacoma | Washington | 98405 | — |
| Exemplar Research, Inc. - Elkins | Elkins | West Virginia | 26241 | — |
| West Virginia University Hospital | Morgantown | West Virginia | 26506 | — |
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 316 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03283085, 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 Jun 20, 2024 · Synced Apr 29, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03283085 live on ClinicalTrials.gov.