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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024638-48 | EudraCT Number |
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This study provides open-label drug to eligible patients who have completed a prior study of PF-00547659. The primary endpoint for this study is long-term safety.
The rationale for conducting this open-label extension (OLE) study is primarily to evaluate long term safety of PF 00547659. This protocol also provides the opportunity for continued treatment for subjects responding to treatment from the feeder study. It also provides an opportunity for initial treatment for subjects randomized to placebo in the feeder study. This is a multi center Phase 2, open label, safety extension study for feeder studies which evaluate PF 00546759 in subjects with moderate to severe Crohn's disease. Subjects eligible for this study will have completed the 12 week double blind induction period in study A7281006 and will be stratified by responders or non responders based on change in CDAI in that study, without unblinding treatment assignment from study A7281006. Additionally, subjects who have completed study A7281008 with a clinical response, as defined by that protocol, will also be eligible for this study and treated as "responders". All subjects entering this study must have discontinued immunosuppressant therapy.
Subjects entering this study will be given a 75 mg SC dose at baseline and then every 4 weeks through Week 72. After the active treatment period, the subjects will enter a 24 month follow up period including 6 monthly visits followed by 18 month extended contact (every 6 month telephone contacts). At Week 96, subjects will undergo an End of Study visit but will continue the every 6 month telephone contacts until Week 168.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-Label Treatment | Experimental | Subjects eligible for this study will have completed the 12 week double blind induction period in study A7281006 and will be stratified by responders or non responders based on change in CDAI in that study, without unblinding treatment assignment from study A7281006. Additionally, subjects who have completed study A7281008 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-00547659 | Drug | 75 mg SC once monthly for 72 weeks. Subjects may escalate to 225 mg or de-escalate to 22.5 mg one time. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With On-Treatment Adverse Events (AEs), AEs Led to Withdrawal, and Serious Adverse Events (SAEs) | AEs included adverse drug reactions, illnesses with onset during the study, exacerbation of previous illnesses, clinically significant changes in physical examination findings and abnormal objective test findings (ECG, laboratory). An SAE was defined as any AE at any dose that resulted in death; was life threatening (immediate risk of death); required in-subject hospitalization or prolongation of existing hospitalization; resulted in a persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); or resulted in congenital anomaly/birth defect. | From start of study treatment up to Week 72 (Treatment Period) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Positive Anti-Drug (PF-00547659) Antibodies | Positive Anti-Drug Antibodies result was defined as ADA titre value greater than or equal to (>=) 4.64 at at least one of the time points. | Baseline up to Week 96 |
| Serum Trough Concentrations of PF-00547659 Versus Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Medical Center - Thorton Hospital | La Jolla | California | 92037 | United States | ||
| Community Clinical Trials |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34427633 | Derived | D'Haens GR, Reinisch W, Lee SD, Tarabar D, Louis E, Klopocka M, Klaus J, Schreiber S, Il Park D, Hebuterne X, Nagy P, Cataldi F, Martin SW, Nayak S, Banerjee A, Gorelick KJ, Sandborn WJ. Long-Term Safety and Efficacy of the Anti-Mucosal Addressin Cell Adhesion Molecule-1 Monoclonal Antibody Ontamalimab (SHP647) for the Treatment of Crohn's Disease: The OPERA II Study. Inflamm Bowel Dis. 2022 Jul 1;28(7):1034-1044. doi: 10.1093/ibd/izab215. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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A total of 268 participants (225 participants from Feeder Study A7281006 [NCT01276509] and 43 participants from Feeder Study A7281008 [NCT01387594]) were enrolled and overall 149 participants completed the study.
The study was conducted at 81 centers in Austria, Belgium, Canada, France, Germany, Japan, Netherlands, Norway, Poland, Republic of Korea, Serbia, Slovakia, South Africa, Spain and United States between 22 July 2011 (first participant first visit) and 27 July 2016 (last participant last visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-00547659 75 mg | Participants received PF-00547659 75 milligram (mg) subcutaneous injection once in every 4 weeks through Week 72. One time dose escalation to 225 mg subcutaneous injection was allowed after 8 weeks of the study for the participants who experienced clinical deterioration or unacceptably low level of response to study drug. One time dose de-escalation to 22.5 mg subcutaneous injection due to intolerance or AEs was also allowed after the investigator carefully assessed the status of the participant. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Serum trough concentrations of PF-00547659 were analyzed using population Pharmacokinetic (PK) methodology. |
| Week 4,8,12,16,20,24,28,32,36,40,44,48,52,56,60,64,68,72,76,80,84,88,92,96 |
| Orange |
| California |
| 92868 |
| United States |
| GastroDiagnostics | Orange | California | 92868 | United States |
| Clinical Research of the Rockies | Lafayette | Colorado | 80026 | United States |
| Rmga - Rmcr | Thornton | Colorado | 80229 | United States |
| Rocky Mountain Gastroenterology Associates | Thornton | Colorado | 80229 | United States |
| MGG Group Co., Inc. | Washington D.C. | District of Columbia | 20006 | United States |
| Florida Center for Gastroenterology | Largo | Florida | 33777 | United States |
| Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
| University of Miami Crohn's and Colitis Center | Miami | Florida | 33136 | United States |
| University of Miami Hospital and Clinic (IP Shipment Only) | Miami | Florida | 33136 | United States |
| University of Miami Hospital and Clinic | Miami | Florida | 33136 | United States |
| University of Miami Hospital | Miami | Florida | 33136 | United States |
| Citrus Ambulatory Surgery Center | Orlando | Florida | 32806 | United States |
| Internal Medicine Specialists | Orlando | Florida | 32806 | United States |
| Heartland Medical Research, Inc. | Clive | Iowa | 50325 | United States |
| Iowa Digestive Disease Center | Clive | Iowa | 50325 | United States |
| Iowa Endoscopy Center (Colonoscopy Only) | Clive | Iowa | 50325 | United States |
| Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | United States |
| UMass Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| University of Massachusetts Worcester | Worcester | Massachusetts | 01655 | United States |
| Center for Digestive Health | Troy | Michigan | 48098 | United States |
| Surgical Centers of Michigan | Troy | Michigan | 48098 | United States |
| Surgery Center of Columbia | Columbia | Missouri | 65201 | United States |
| Audrain Medical Center | Mexico | Missouri | 65265 | United States |
| Center for Digestive and Liver Diseases, Inc. | Mexico | Missouri | 65265 | United States |
| Barnes-Jewish Hospital - Investigational Drug Services | St Louis | Missouri | 63108 | United States |
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Center for Advanced Medicine | St Louis | Missouri | 63110 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Albany Medical College | Albany | New York | 12208 | United States |
| New York Hospital Queens | Flushing | New York | 11355 | United States |
| Long Island Clinical Research Associates, LLP | Great Neck | New York | 11021 | United States |
| Nassau Gastroenterology Associates Office Based Surgery | Great Neck | New York | 11021 | United States |
| Nassau Gastroenterology Associates, P.C. | Great Neck | New York | 11021 | United States |
| North Shore Primary Care, P.C. | Great Neck | New York | 11021 | United States |
| Lenox Hill Endoscopy Center | New York | New York | 10075 | United States |
| Synergy First | New York | New York | 11230 | United States |
| Premier Medical Group of the Hudson Valley, PC | Poughkeepsie | New York | 12601 | United States |
| CTRC Hospital, UNC Memorial Hospital | Chapel Hill | North Carolina | 27514 | United States |
| North Carolina Memorial Hospital Endoscopy Center | Chapel Hill | North Carolina | 27514 | United States |
| UNC Hospitals | Chapel Hill | North Carolina | 27514 | United States |
| UNC Hospitals Endoscopy | Chapel Hill | North Carolina | 27517 | United States |
| Hillsborough Campus | Hillsborough | North Carolina | 27278 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| Allegiance Research Specialists | Wauwatosa | Wisconsin | 53226 | United States |
| AKH Wien Universitaetsklinik fuer Innere Medizin III | Vienna | 1090 | Austria |
| AKH Wien | Vienna | 1090 | Austria |
| Hospital Erasme | Brussels | B-1070 | Belgium |
| UZ Gasthuisberg - Pharmacy | Leuven | B-3000 | Belgium |
| UZ Gasthuisberg | Leuven | B-3000 | Belgium |
| Centre Hospitalier Universitaire De Liege-Domaine Universitaire du Sart Tilman | Liège | 4000 | Belgium |
| Centre Hospitalier de Mouscron | Mouscron | 7700 | Belgium |
| Oshawa Clinic | Oshawa | Ontario | L1H 1B9 | Canada |
| Toronto Digestive Disease Associates Inc. | Vaughan | Ontario | L4L 4Y7 | Canada |
| Hopital Beaujon | Clichy | 92110 | France |
| CHRU de Lille, Pharamcie Centrale | Lille | 59037 | France |
| CIC - Hopital Cardiologique | Lille | 59037 | France |
| Hopital Huriez, CHRU de Lille | Lille | 59037 | France |
| Hopital de l'Archet 2 - CHU de Nice | Nice | 06202 | France |
| Hopital Saint-Louis | Paris | 75010 | France |
| Hopital Nord | Saint-Priest-en-Jarez | 42270 | France |
| Hopital Rangueil | Toulouse | 31059 | France |
| Robert Bosch Krankenhaus GmbH | Stuttgart | Baden-Wurttemberg | 70376 | Germany |
| Universitaetsklinikum Ulm | Ulm | Baden-Wurttemberg | 89081 | Germany |
| "Charite - Campus Berlin Mitte Medizinische Klinik | Berlin | 10117 | Germany |
| Charite, Universitaetsmedizin Berlin, Campus Virchow-Klinikum | Berlin | 13353 | Germany |
| Krankenhaus Martha-Maria Halle-Doelau gGmbH | Halle | 06120 | Germany |
| Universitaetsklinikum Schleswig-Holstein, Campus Kiel | Kiel | 24105 | Germany |
| Universitaetsfrauenklinikum Schleswig-Holstein | Lübeck | 23538 | Germany |
| Gastroenterologische Gemeinschaftspraxis Minden | Minden | 32423 | Germany |
| Universitaetsklinik Regensburg | Regensburg | 93042 | Germany |
| National Hospital Organization Takasaki General Medical Center | Takasaki | Gunma | 370-0829 | Japan |
| Yokohama City University Medical Center | Yokohama | Kanagawa | 232-0024 | Japan |
| The Jikei University Hospital | Minato-Ku | Tokyo | 105-8471 | Japan |
| Keio University Hospital | Shinjuku-Ku | Tokyo | 160-8582 | Japan |
| National Hospital Organization Hirosaki National Hospital | Aomori | Toyko | 036-8545 | Japan |
| Chiba University Hospital | Chiba | 260-8677 | Japan |
| Academic Medical Center | Amsterdam | 1105 AZ | Netherlands |
| University Medical Center Groningen | Groningen | 9713GZ | Netherlands |
| Maastricht University Medical Center | Maastricht | 6229 HX | Netherlands |
| Sykehusapoteket Asker og Baerum | Gjettum | Norway | 1346 | Norway |
| Oslo Universitetssykehus | Oslo | 0424 | Norway |
| Lovisenberg Diakonale Sykehus | Oslo | 0440 | Norway |
| Vestre Viken HF | Rud | 1309 | Norway |
| Centrum Endoskopii Zabiegowej | Bydgoszcz | 85-168 | Poland |
| NZOZ Centrum Medyczne Szpital Sw. Rodziny | Lodz | 90-302 | Poland |
| Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie | Warsaw | 02-507 | Poland |
| Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych W Warszawie | Warsaw | 02-507 | Poland |
| Lexmedica | Wroclaw | 53-114 | Poland |
| Military Medical Academy | Belgrade | 11000 | Serbia |
| Clinical Hospital Centre Bezanijska Kosa | Belgrade | 11080 | Serbia |
| Clinical Hospital Center Zemun, Clinical Department for Gastroenterology and Hepatology | Zemun | 11080 | Serbia |
| Gastroentero-Hepatologicke centrum THALION, LAMA MEDICAL CARE s.r.o. | Bratislava | 831 04 | Slovakia |
| Medak s.r.o. | Bratislava | 851 01 | Slovakia |
| KM Management spol. s r.o. | Nitra | 949 01 | Slovakia |
| Synergy group, a.s. | Nové Mesto nad Váhom | 915 01 | Slovakia |
| Wits Clinical Research | Johannesburg | Gauteng, South Africa | 2193 | South Africa |
| Parklands Medical Centre | Durban | KwaZulu-Natal | 4091 | South Africa |
| Kingsbury Hospital | Cape Town | Western Cape | 7708 | South Africa |
| Yeungnam University Hospital | Daegu | Korea, Republic of | 705-717 | South Korea |
| Pusan National University Hospital | Busan | 602-739 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Kangbuk Samsung Hospital | Seoul | 110-746 | South Korea |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| Asan Medical Center | Seoul | 138-736 | South Korea |
| Corporacio Sanitaria Parc Tauli de Sabadell | Sabadell | Barcelona | 08208 | Spain |
| Corporacio Sanitaria Parc Tauli de Sabadell | Sabadell | Catalonia | 08208 | Spain |
| Hospital Puerta de Hierro Majadahonda | Majadahonda | Madrid | 28222 | Spain |
| Hospital Universitario de La Princesa | Madrid | 28006 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28007 | Spain |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The modified intent-to-treat (mITT) population included all enrolled participants who received at least 1 dose of investigational product.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PF-00547659 75 mg | Participants received PF-00547659 75 mg subcutaneous injection once in every 4 weeks through Week 72. One time dose escalation to 225 mg subcutaneous injection was allowed after 8 weeks of the study for the participants who experienced clinical deterioration or unacceptably low level of response to study drug. One time dose de-escalation to 22.5 mg subcutaneous injection due to intolerance or AEs was also allowed after the investigator carefully assessed the status of the participant. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | year |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With On-Treatment Adverse Events (AEs), AEs Led to Withdrawal, and Serious Adverse Events (SAEs) | AEs included adverse drug reactions, illnesses with onset during the study, exacerbation of previous illnesses, clinically significant changes in physical examination findings and abnormal objective test findings (ECG, laboratory). An SAE was defined as any AE at any dose that resulted in death; was life threatening (immediate risk of death); required in-subject hospitalization or prolongation of existing hospitalization; resulted in a persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); or resulted in congenital anomaly/birth defect. | The modified intent-to-treat (mITT) population included all enrolled participants who received at least 1 dose of investigational product. | Posted | Count of Participants | Participants | From start of study treatment up to Week 72 (Treatment Period) |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Positive Anti-Drug (PF-00547659) Antibodies | Positive Anti-Drug Antibodies result was defined as ADA titre value greater than or equal to (>=) 4.64 at at least one of the time points. | The modified intent-to-treat (mITT) population included all enrolled participants who received at least 1 dose of investigational product. | Posted | Count of Participants | Participants | Baseline up to Week 96 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Serum Trough Concentrations of PF-00547659 Versus Time | Serum trough concentrations of PF-00547659 were analyzed using population Pharmacokinetic (PK) methodology. | PK population included all enrolled participants who received at least 1 dose of investigational product and had data on at least 1 PK concentration. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Week 4,8,12,16,20,24,28,32,36,40,44,48,52,56,60,64,68,72,76,80,84,88,92,96 |
|
|
From Start of Study Treatment up to Safety Follow up (Week 96)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PF-00547659 75 mg | Participants received PF-00547659 75 mg subcutaneous injection once in every 4 weeks through Week 72. One time dose escalation to 225 mg subcutaneous injection was allowed after 8 weeks of the study for the participants who experienced clinical deterioration or unacceptably low level of response to study drug. One time dose de-escalation to 22.5 mg subcutaneous injection due to intolerance or AEs was also allowed after the investigator carefully assessed the status of the participant. | 2 | 268 | 118 | 268 | 206 | 268 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Arthritis enteropathic | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Adrenocortical insufficiency acute | Endocrine disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Abdominal hernia obstructive | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Anal stenosis | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Enterocutaneous fistula | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Ileal stenosis | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Intestinal fistula | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Intestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Large intestinal stenosis | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Abscess intestinal | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Abscess neck | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Postoperative abscess | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Rotavirus infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Splenic abscess | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Vulval abscess | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Anastomotic leak | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Stomal hernia | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase mm increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Bladder dysfunction | Renal and urinary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Urinoma | Renal and urinary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Hepatic cyst | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Intracranial venous sinus thrombosis | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Benign breast lump removal | Surgical and medical procedures | MedDRA 19.0 | Non-systematic Assessment |
| |
| Female genital tract fistula | Reproductive system and breast disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Perineal fistula | Reproductive system and breast disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pyoderma gangrenosum | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
Sponsor has the right to review disclosures, requesting a delay of up to 60 days. The first publication must be a joint publication covering all centers. However, if a joint manuscript has not been submitted for publication within 12 months of completion or termination of study at all participating sites, Investigator may publish individual site results separately. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000597368 | ontamalimab |
Not provided
Not provided
Not provided
| Title | Measurements |
|---|---|
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