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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023034-23 | EudraCT Number | ||
| ANDANTE | Other Identifier | Alias Study Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo- SC injection | Placebo Comparator |
| |
| Drug Dose level 1 - SC injection | Experimental |
| |
| Drug Dose level 2 - SC injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04236921 SC injection | Drug | Placebo delivered SC, 2 doses separated by 4 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Crohn's Disease Activity Index (CDAI)-70 Response Rate at Week 8 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg | CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 8 were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score greater than or equal to (>=) 0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). | Baseline and Week 8 |
| The CDAI-70 Response Rate at Week 8 in Participants Who Received Placebo and PF-04236921 200 mg | CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 8 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 1, that will yield different estimates for placebo for the two different models. | Baseline and Week 8 |
| The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg | CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 12 were compared between placebo and and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). |
| Measure | Description | Time Frame |
|---|---|---|
| The CDAI-70 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg | CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Hospital | Birmingham | Alabama | 35249 | United States | ||
| University of Alabama at Birmingham |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29776017 | Derived | Li C, Shoji S, Beebe J. Pharmacokinetics and C-reactive protein modelling of anti-interleukin-6 antibody (PF-04236921) in healthy volunteers and patients with autoimmune disease. Br J Clin Pharmacol. 2018 Sep;84(9):2059-2074. doi: 10.1111/bcp.13641. Epub 2018 Jun 25. | |
| 29247068 | Derived | Danese S, Vermeire S, Hellstern P, Panaccione R, Rogler G, Fraser G, Kohn A, Desreumaux P, Leong RW, Comer GM, Cataldi F, Banerjee A, Maguire MK, Li C, Rath N, Beebe J, Schreiber S. Randomised trial and open-label extension study of an anti-interleukin-6 antibody in Crohn's disease (ANDANTE I and II). Gut. 2019 Jan;68(1):40-48. doi: 10.1136/gutjnl-2017-314562. Epub 2017 Dec 15. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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A total of 250 participants were randomized via Interactive Voice Response System (IVRS); of which, 247 received investigational product and 3 were randomized inadvertently and not dosed (2 did not meet entrance criteria and 1 did not consent properly and was not included in clinical database because the randomization page was not completed).
This study included a 28-day screening period, an induction period (Week 0-12) and a 28-week follow-up period. Participants who completed the induction treatment period could enter the follow-up period or an open-label extension study, NCT01345318. Participants who discontinued treatment during the induction period could enter the follow-up period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo administered subcutaneously (SC) in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study. |
| FG001 | PF-04236921 10 Milligram (mg) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| PF-04236921 SC injection |
| Drug |
Drug dose level 1 delivered SC, 2 doses separated by 4 weeks |
|
| PF-04236921 SC injection | Drug | Drug dose level 2 delivered SC, 2 doses separated by 4 weeks |
|
| Baseline and Week 12 |
| The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo and PF-04236921 200 mg | CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 12 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 3, that will yield different estimates for placebo for the two different models. | Baseline and Week 12 |
| Baseline and Weeks 2, 4, 6, and 10 |
| The CDAI-70 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg | CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 5, that will yield different estimates for placebo for the two different models. | Baseline and Weeks 2, 4, 6, and 10 |
| The CDAI Remission Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg | CDAI remission rate was defined as an absolute CDAI score less than (<) 150. The proportions of participants with CDAI remission were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). | Baseline and Weeks 2, 4, 6, 8, 10, and 12 |
| The CDAI Remission Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg | CDAI remission rate was defined as an absolute CDAI score <150. The proportions of participants with CDAI remission were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 7, that will yield different estimates for placebo for the two different models. | Baseline and Weeks 2, 4, 6, 8, 10, and 12 |
| The CDAI-100 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg | CDAI-100 response was defined as a decrease in CDAI score of 100 or greater from baseline. The proportions of participants with CDAI-100 response at Week 12 were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). | Baseline and Weeks 2, 4, 6, 8, 10, and 12 |
| The CDAI-100 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg | CDAI-100 response was defined as a decrease in CDAI score of 100 or greater from baseline. The proportions of participants with CDAI-100 response at Week 12 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 9, that will yield different estimates for placebo for the two different models. | Baseline and Weeks 2, 4, 6, 8, 10, and 12 |
| Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg | CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit, and higher score indicate more severe disease. The Outcome included a Linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). | Baseline and Weeks 2, 4, 6, 8, 10, and 12 |
| Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo and PF-04236921 200 mg | CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit, and higher score indicate more severe disease. The Outcome included a Linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 11, that will yield different estimates for placebo for the two different models. | Baseline and Weeks 2, 4, 6, 8, 10, and 12 |
| Percentages of Participants With Confirmed Positive Anti-drug Antibodies (ADAs) | The percentage of participants with confirmed positive ADA was summarized for each treatment arm. ADA positive was defined as ADA titer defined as ADA titer (ie, the reciprocal of the highest dilution that gives a value equivalent to the cut point of the assay) >= 4.32. | At baseline (Day 1) and at Weeks 4, 8, 12, 16, 24, 32 and 40 |
| Percentages of Participants With Confirmed Positive Neutralizing Antibodies (NAbs) | The percentage of participants with confirmed positive NAbs was summarized for each treatment arm. Only ADA positive samples were analyzed for Nab. A multi-tiered approach was utilized to detect NAbs. NAb serum samples were screened at tier one, and those found presumptively NAb positive was further tested with the confirmatory assay (tier two). The percentage of subjects with confirmed positive NAbs was summarized for each treatment. | At baseline (Day 1) and at Weeks 4, 8, 12, 16, 24, 32 and 40 |
| Serum PF-04236921 Concentration Over Time | Day 1 (predose), and at Weeks 2, 4 (Day 28, predose), 8, 10, 12, 16, 20, 24, 28, 32, 36, and 40 |
| Number of Participants Who Withdrew From the Study Due to Treatment-emergent Adverse Events (AEs) | An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. Treatment-emergent were events between first dose of treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Induction period: from Week 0 (Day 1) through Week 12; follow-up period: from Week 12 (or discontinuation from the induction period) through last subject visit (up to 28 weeks after completion of or discontinuation from the 12-week induction period) |
| Birmingham |
| Alabama |
| 35294 |
| United States |
| Simon Medical Imaging | Scottsdale | Arizona | 85258 | United States |
| Digestive Health Research Unit | Scottsdale | Arizona | 85260 | United States |
| Adobe Clinical Research, Llc | Tucson | Arizona | 85712 | United States |
| Radiology Ltd | Tucson | Arizona | 85712 | United States |
| UCSF Endoscopy Unit at Mount Zion | San Francisco | California | 94115 | United States |
| University of California - San Francisco | San Francisco | California | 94115 | United States |
| University of California San Francisco at Mount Zion | San Francisco | California | 94115 | United States |
| Rocky Mountain Clinical Research, LLC | Denver | Colorado | 80222 | United States |
| Rocky Mountain Gastroenterology Associates | Lakewood | Colorado | 80215 | United States |
| Rocky Mountain Gastroenterology | Lakewood | Colorado | 80215 | United States |
| Arapahoe Gastroenterology, PC | Littleton | Colorado | 80120 | United States |
| Endoscopy Center of Connecticut, LLC | Guilford | Connecticut | 06437 | United States |
| Endoscopy Center of Connecticut, LLC | Hamden | Connecticut | 06518 | United States |
| Gastroenterology Center of Connecticut, PC | Hamden | Connecticut | 06518 | United States |
| Medical Research Center of Connecticut, LLC | Hamden | Connecticut | 06518 | United States |
| Clinical Research of West Florida, Inc. | Clearwater | Florida | 33765 | United States |
| Gastroenterology Associates | Crystal River | Florida | 34429 | United States |
| Nature Coast Clinical Research | Inverness | Florida | 34452 | United States |
| Suncoast Endoscopy Center | Inverness | Florida | 34453 | United States |
| Advanced Research Institute, Inc. | New Port Richey | Florida | 34653 | United States |
| International Clinical Research - US, LLC | Sanford | Florida | 32771 | United States |
| Atlanta Center for Gastroenterology, P.C. | Decatur | Georgia | 30033 | United States |
| Atlanta Endoscopy Center | Decatur | Georgia | 30033 | United States |
| Decatur Health Imaging | Decatur | Georgia | 30033 | United States |
| Gastrointestinal Specialists of Georgia, PC | Marietta | Georgia | 30060 | United States |
| GI Diagnostics | Marietta | Georgia | 30067 | United States |
| Illinois Gastroenterology Group, LLC | Arlington Heights | Illinois | 60005 | United States |
| The University of Chicago Medical Center (Ucmc) | Chicago | Illinois | 60637 | United States |
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| The University of Chicago Medical | Chicago | Illinois | 60637 | United States |
| The University Of Chicago | Chicago | Illinois | 60637 | United States |
| NorthShore University Health System | Evanston | Illinois | 60201 | United States |
| Glenbrook Hospital Outpatient Pharmacy | Glenview | Illinois | 60025 | United States |
| Glenbrook Hospital | Glenview | Illinois | 60026 | United States |
| Central Indiana Gastroenterology Group | Anderson | Indiana | 46016 | United States |
| Saint John's Research Institute | Anderson | Indiana | 46016 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| University Of Louisville Healthcare Outpatient Center | Louisville | Kentucky | 40202 | United States |
| University of Louisville Research Foundation | Louisville | Kentucky | 40202 | United States |
| University Of Louisville | Louisville | Kentucky | 40202 | United States |
| Digestive Disorders Associates | Annapolis | Maryland | 21401 | United States |
| Disgestive Disorders Associates | Annapolis | Maryland | 21401 | United States |
| Investigative Clinical Research | Annapolis | Maryland | 21401 | United States |
| Maryland Diagnostics & Therapeutic Endo Center | Annapolis | Maryland | 21401 | United States |
| Commonwealth Clinical Studies | Brockton | Massachusetts | 02302 | United States |
| Prima CARE, PC | Fall River | Massachusetts | 02721 | United States |
| St. Joseph Mercy Hospital | Ann Arbor | Michigan | 48106 | United States |
| East Valley Endoscopy | Grand Rapids | Michigan | 49546 | United States |
| Gastroenterology Associates of Western Michigan | Wyoming | Michigan | 49519 | United States |
| Metro Health Hospital Endoscopy Unit | Wyoming | Michigan | 49519 | United States |
| Metro Health Hospital | Wyoming | Michigan | 49519 | United States |
| Huron Gastroenterology Associates | Ypsilanti | Michigan | 48197 | United States |
| St. Joseph Mercy Hospital | Ypsilanti | Michigan | 48197 | United States |
| Minnesota Gastroenterology, PA | Plymouth | Minnesota | 55446 | United States |
| Weill Cornell Medical College of Cornell University-Greenberg | New York | New York | 10021 | United States |
| Weill Cornell Medical College of Cornell University | New York | New York | 10021 | United States |
| Present Chapman, Steinlauf and Marion | New York | New York | 10028 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| New York Presbyterian Hospital - Weill Cornell Medical College Investigational Pharmacy | New York | New York | 10065 | United States |
| New York Presbyterian Hospital | New York | New York | 10065 | United States |
| Weill Cornell Imaging at New York Presbyterian Hospital | New York | New York | 10065 | United States |
| Arthur asher Kornbluth, MD PC | New York | New York | 10128 | United States |
| PMG Research of Winston-Salem | Winston-Salem | North Carolina | 27103 | United States |
| Oklahoma Foundation for Digestive Research | Oklahoma City | Oklahoma | 73102 | United States |
| Pharmacy: Wheeler and Stuckey, Inc. | Oklahoma City | Oklahoma | 73103 | United States |
| Colonoscopy and X-rays: OU Physicians Building | Oklahoma City | Oklahoma | 73104 | United States |
| Hillcrest Medical Center Endoscopy | Tulsa | Oklahoma | 74104 | United States |
| Hillcrest Medical Center | Tulsa | Oklahoma | 74104 | United States |
| Options Health Research, LLC | Tulsa | Oklahoma | 74104 | United States |
| Utica Park Clinic X-Ray | Tulsa | Oklahoma | 74104 | United States |
| Advanced Imaging | Tulsa | Oklahoma | 74137-4200 | United States |
| Pittsburgh Gastroenterology Associates | Pittsburgh | Pennsylvania | 15243 | United States |
| Research Protocol Management Specialists | Pittsburgh | Pennsylvania | 15243 | United States |
| Pharma Resource | East Providence | Rhode Island | 02915 | United States |
| Omega Medical Research | Warwick | Rhode Island | 02886 | United States |
| Gastro One | Germantown | Tennessee | 38138 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| Professional Quality Research, Inc. | Austin | Texas | 78705 | United States |
| Diagnostic Clinic of Houston, PA | Houston | Texas | 77004 | United States |
| Houston Hospital for Specialized Surgery (Endoscopy Only) | Houston | Texas | 77004 | United States |
| Baylor Clinic (Drug Storage) | Houston | Texas | 77030 | United States |
| Baylor College of Medicine - Baylor Medical Center | Houston | Texas | 77030 | United States |
| Ertan Digestive Disease Center | Houston | Texas | 77030 | United States |
| Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| The University of Texas Medical School at Houston | Houston | Texas | 77030 | United States |
| Physicians Endoscopy Center (Colonoscopy) | Houston | Texas | 77036 | United States |
| Texas Digestive Disease Consultants | Southlake | Texas | 76092 | United States |
| One Step Diagnostic (X-Ray) | Sugar Land | Texas | 77478 | United States |
| Pioneer Research Solutions, Inc. (Admin. Office) | Sugar Land | Texas | 77479 | United States |
| Pioneer Research Solutions, Inc. | SugarLand | Texas | 77479 | United States |
| Digestive Health Specialists of Tyler | Tyler | Texas | 75701 | United States |
| University Of Utah HSC | Salt Lake City | Utah | 84132 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298-0341 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| VCU Medical Investigational Drug Service (IDS) | Richmond | Virginia | 93298-5028 | United States |
| Concord Repatriation General Hospital | Concord | New South Wales | 2139 | Australia |
| Nepean Public Hospital | Kingswood | New South Wales | 2747 | Australia |
| Royal Brisbane and Women's Hospital | Herston, Brisbane | Queensland | 4029 | Australia |
| Mater Health Services | South Brisbane | Queensland | 4101 | Australia |
| Eastern Health, Box Hill Hospital | Box Hill | Victoria | 3128 | Australia |
| Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
| The Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| St. Vincent's Hospital Melbourne | Fitzroy | VIC 3065 | Australia |
| University Hospital Leuven | Leuven | Vlaams Brabant | 3000 | Belgium |
| CHU Saint-Pierre | Brussels | 1000 | Belgium |
| UZ Leuven Pharmacy | Leuven | 3000 | Belgium |
| An Spiessens H.-Hartziekenhuis Roeselare-Menen vzw | Roeselare | B-8800 | Belgium |
| Clinica do Coracao Samaritano | Goiânia | Goiás | 74535-170 | Brazil |
| Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda. | Goiânia | Goiás | 74535-170 | Brazil |
| Center X Diagnosticos | Goiânia | Goiás | 74535-900 | Brazil |
| Hospital Universitário Fraga Filho da UFRJ | Rio de Janeiro | Rio de Janeiro | 21941-913 | Brazil |
| Hospital Sao Lucas da PUCRS | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Faculdade de Medicina do ABC | Santo André | São Paulo | 09060-650 | Brazil |
| Hospital Israelita Albert Einstein | São Paulo | São Paulo | 05651-901 | Brazil |
| Hospital Nossa Senhora das Gracas | Curitiba | 80810-040 | Brazil |
| Heritage Medical Research Clinic - University of Calgary | Calgary | Alberta | T2N 4Z6 | Canada |
| London Health Science Centre - University Hospital | London | Ontario | N6A 5A5 | Canada |
| Mount Sinai Hospital | Toronto | Ontario | M5G 1X5 | Canada |
| McGill University Health Centre - Royal Victoria Hospital | Montreal | Quebec | H3A 1A1 | Canada |
| Klinicke centrum ISCARE I.V.F. - gastroenterologie | Prague | Prague | 170 04 | Czechia |
| Hepato-Gastroenterologie HK, s.r.o. | Hradec Králové | 500 12 | Czechia |
| Medial Pharma s.r.o., | Hradec Králové | 500 12 | Czechia |
| Fakultni nemocnice Olomouc | Olomouc | 775 20 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady | Prague | 100 34 | Czechia |
| Institut klinicke a experimentalni mediciny | Prague | 14021 | Czechia |
| IBD Clinical and Research centre | Prague | Czechia |
| Krajska zdravotni, a.s. | Ústí nad Labem | 40113 | Czechia |
| Aalborg Sygehus | Aalborg | 9100 | Denmark |
| Aarhus Universitetshospital, Aarhus Sygehus Aarhus University Hospital | Aarhus C | 8000 | Denmark |
| Rigshospitalet | Copenhagen | 2100 | Denmark |
| Gastroenheden | Herlev | 2730 | Denmark |
| Kirurgisk Afdeling 0143 | Hilleroed | 3400 | Denmark |
| Hvidovre Hospital | Hvidovre | 2650 | Denmark |
| Afdeling I, Gastroenterologisk Sektion | Koebenhavn NV | 2400 | Denmark |
| Medicinsk Afdeling, Gastroenterologisk Sektion | Koege | 4600 | Denmark |
| Hopital Huriez, CHRU de Lille | Lille | 59037 | France |
| Hopital Saint-Antoine - Service De Gastroenterologie | Paris | 75571 | France |
| Hopital de Brabois | Vandœuvre-lès-Nancy | 54500 | France |
| Medizinische Hochschule Hannover | Hanover | Lower Saxony | 30625 | Germany |
| "Charite - Campus Benjamin Franklin | Berlin | 12200 | Germany |
| Praxis Dr. Howaldt | Hamburg | 20148 | Germany |
| Universitaetsklinikum Schleswig-Holstein | Kiel | 24105 | Germany |
| Gastroenterologische Gemeinschaftspraxis Minden | Minden | 32423 | Germany |
| Universitaetsklinik Regensburg | Regensburg | 93053 | Germany |
| University General Hospital "Attikon" | Athens | 12462 | Greece |
| General Hospital of Athens "Evangelismos",1st Gastroenterology Department | Kolonaki Athens | 106 76 | Greece |
| Semmelweis Egyetem II. Sz. Belgyogyaszati Klinika | Budapest | 1088 | Hungary |
| Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak./I. Belgyogyaszati-Gasztroenterologiai | Budapest | 1125 | Hungary |
| Pannonia Maganorvosi Centrum Kft. | Budapest | 1136 | Hungary |
| Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum | Debrecen | 4032 | Hungary |
| Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar / I. sz. Belgyogyaszati Klinika | Szeged | 6720 | Hungary |
| Clinfan Kft. | Szekszárd | 7100 | Hungary |
| Beaumont Hospital | Dublin | 9 | Ireland |
| National Virus Reference Laboratory | Dublin | Dublin 4 | Ireland |
| Pathology, Haematology and Biochemistry Laboratories, St Vincent's Healthcare Group | Dublin | Dublin 4 | Ireland |
| Mater Misericordiae Hospital, Department of Clinical Chemistry and Clinical Haematology | Dublin | Dublin 7 | Ireland |
| St. Vincents University Hospital | Dublin | Ireland |
| University Hospital Galway | Galway | Ireland |
| The Institute Of Gastroenterology & Liver Diseases | Tel Litwinsky | Ramat Gan | 52621 | Israel |
| Institute of Gastroenterology | Haifa | 3339419 | Israel |
| The E. Wolfson Medical Center | Holon | 58100 | Israel |
| Shaare Zedek Medical Center | Jerusalem | 91031 | Israel |
| Hadassah Medical Center | Jerusalem | 91120 | Israel |
| Dept of Gastroenterology & Hepatology | Kfar Saba | 44281 | Israel |
| Rabin Medical Center, Beilinson Hospital | Petah Tikva | 49100 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Assaf Harofeh Medical Center | Ẕerifin | 70300 | Israel |
| Casa Sollievo della Sofferenza/Div.Gastroenterologia Endoscopia Digestiva | San Giovanni Rotondo Fg | Foggia | 71013 | Italy |
| Istituto Clinico Humanitas IRCCS | Rozzano | Milano | 20089 | Italy |
| Azienda Ospedaliera - Universita di Padova | Padova | Padova | 35128 | Italy |
| A. Gemelli University Hospital-Department of Medical Sciences - Division of Internal Medicine and | Rome | Province of Rome | 00168 | Italy |
| Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola Malpighi | Bologna | 40138 | Italy |
| Università Campus Biomedico | Roma | 00128 | Italy |
| Policlinico Tor Vergata | Roma | 00133 | Italy |
| Azienda Ospedaliera San Camillo Forlanini | Roma | 00151 | Italy |
| Shakespeare Specialist Group | Milford | Auckland | 0620 | New Zealand |
| Christchurch Hospital | Christchurch | Canterbury | 8011 | New Zealand |
| Department of Gastroenterology Research | Hamilton | Waikato Region | 3204 | New Zealand |
| P3 Research Limited | Wellington | 6021 | New Zealand |
| Spitalul Clinic Colentina | Bucharest | Sector 2 | 020125 | Romania |
| Universitaetsspital Zuerich | Zurich | 8091 | Switzerland |
| Hull and East Yorkshire Hospitals NHS Trust | Hull | East Yorkshire | HU3 2JZ | United Kingdom |
| Addenbrooke's Hospital, Department of Gastroenterology | Cambridge | CB2 0QQ | United Kingdom |
| Glasgow Royal Infirmary | Glasgow | G40SS | United Kingdom |
| Pharmacy Department | Hull | HU3 2JZ | United Kingdom |
| Barts and The London NHS Trust | London | E1 1BB | United Kingdom |
| Royal Free Hospital (Royal Free London NHS Foundation Trust) | London | NW3 2QG | United Kingdom |
| Royal Victoria Hospital | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| New Cross Hospital | Wolverhampton | WV10 0QP | United Kingdom |
| Newcross Hospital-The Royal Wolverhampton Hospitals NHS Trust | Wolverhampton | WV69AT | United Kingdom |
PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study. |
| FG002 | PF-04236921 50 mg | PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study. |
| FG003 | PF-04236921 200 mg | PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study. |
| Treated |
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| Completed Treatment Period |
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| Completed Follow-up Period |
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| Enrolled in NCT01345318 |
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| COMPLETED |
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| NOT COMPLETED |
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Baseline characteristics were summarized for the safety analysis set (SAS), which consisted of all participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study. |
| BG001 | PF-04236921 10 mg | PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study. |
| BG002 | PF-04236921 50 mg | PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study. |
| BG003 | PF-04236921 200 mg | PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study. |
| BG004 | Total | Total of all reporting groups |
| 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 | Years |
| |||||||||||||||
| 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 | The Crohn's Disease Activity Index (CDAI)-70 Response Rate at Week 8 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg | CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 8 were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score greater than or equal to (>=) 0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). | Primary analysis: full analysis set (FAS, defined as all randomized participants who received at least 1 dose of study treatment; 2 participants [10 mg arm] excluded due to a quality issue) excluding 200 mg (halted prematurely before reaching the planned sample size and thus no longer powered at the planned level to test against placebo). | Posted | Least Squares Mean | 90% Confidence Interval | Percentage of participants | Baseline and Week 8 |
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| Primary | The CDAI-70 Response Rate at Week 8 in Participants Who Received Placebo and PF-04236921 200 mg | CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 8 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 1, that will yield different estimates for placebo for the two different models. | The analysis was performed on FAS participants of the 200 mg and placebo arms, referred to as FAS 200 mg versus (vs) placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 and was no longer powered at the planned level to test against placebo. Thus, the 200 mg vs placebo comparison is a sensitivity analysis. | Posted | Least Squares Mean | 90% Confidence Interval | Percentage of participants | Baseline and Week 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg | CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 12 were compared between placebo and and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). | Primary analysis: FAS excluding 200 mg arm (halted prematurely before reaching the planned sample size and thus no longer powered at the planned level to test against placebo). | Posted | Least Squares Mean | 90% Confidence Interval | Percentage of participants | Baseline and Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo and PF-04236921 200 mg | CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 12 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 3, that will yield different estimates for placebo for the two different models. | The analysis was performed on FAS 200 mg vs placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 and was no longer powered at the planned level to test against placebo. Thus, the 200 mg vs placebo comparison is a sensitivity analysis. | Posted | Least Squares Mean | 90% Confidence Interval | Percentage of participants | Baseline and Week 12 |
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| Secondary | The CDAI-70 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg | CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). | The analysis was performed on the FAS excluding 200 mg arm (which was halted prematurely). "n" signifies the number of subjects with observed data of each arm at each time point. | Posted | Least Squares Mean | 90% Confidence Interval | Percentage of participants | Baseline and Weeks 2, 4, 6, and 10 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The CDAI-70 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg | CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 5, that will yield different estimates for placebo for the two different models. | The analysis was performed on the FAS 200 mg vs placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 participants. "n" signifies the number of subjects with observed data of each arm at each time point. | Posted | Least Squares Mean | 90% Confidence Interval | Percentage of participants | Baseline and Weeks 2, 4, 6, and 10 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The CDAI Remission Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg | CDAI remission rate was defined as an absolute CDAI score less than (<) 150. The proportions of participants with CDAI remission were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). | The analysis was performed on the FAS excluding 200 mg arm (which was halted prematurely). "n" signifies the number of subjects with observed data of each arm at each time point. | Posted | Least Squares Mean | 90% Confidence Interval | Percentage of participants | Baseline and Weeks 2, 4, 6, 8, 10, and 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The CDAI Remission Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg | CDAI remission rate was defined as an absolute CDAI score <150. The proportions of participants with CDAI remission were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 7, that will yield different estimates for placebo for the two different models. | The analysis was performed on the FAS 200 mg vs placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 participants. "n" signifies the number of subjects with observed data of each arm at each time point. | Posted | Least Squares Mean | 90% Confidence Interval | Percentage of participants | Baseline and Weeks 2, 4, 6, 8, 10, and 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The CDAI-100 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg | CDAI-100 response was defined as a decrease in CDAI score of 100 or greater from baseline. The proportions of participants with CDAI-100 response at Week 12 were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). | The analysis was performed on the FAS excluding 200 mg arm (which was halted prematurely). "n" signifies the number of subjects with observed data of each arm at each time point. | Posted | Least Squares Mean | 90% Confidence Interval | Percentage of participants | Baseline and Weeks 2, 4, 6, 8, 10, and 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The CDAI-100 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg | CDAI-100 response was defined as a decrease in CDAI score of 100 or greater from baseline. The proportions of participants with CDAI-100 response at Week 12 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 9, that will yield different estimates for placebo for the two different models. | The analysis was performed on the FAS 200 mg vs placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 participants. "n" signifies the number of subjects with observed data of each arm at each time point. | Posted | Least Squares Mean | 90% Confidence Interval | Percentage of participants | Baseline and Weeks 2, 4, 6, 8, 10, and 12 |
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| Secondary | Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg | CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit, and higher score indicate more severe disease. The Outcome included a Linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). | The analysis was performed on the FAS excluding 200 mg arm (which was halted prematurely). "n" signifies the number of subjects with observed data of each arm at each time point. | Posted | Least Squares Mean | 90% Confidence Interval | points on a scale | Baseline and Weeks 2, 4, 6, 8, 10, and 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo and PF-04236921 200 mg | CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit, and higher score indicate more severe disease. The Outcome included a Linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 11, that will yield different estimates for placebo for the two different models. | The analysis was performed on the FAS 200 mg vs placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 participants. "n" signifies the number of subjects with observed data of each arm at each time point. | Posted | Least Squares Mean | 90% Confidence Interval | points on a scale | Baseline and Weeks 2, 4, 6, 8, 10, and 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentages of Participants With Confirmed Positive Anti-drug Antibodies (ADAs) | The percentage of participants with confirmed positive ADA was summarized for each treatment arm. ADA positive was defined as ADA titer defined as ADA titer (ie, the reciprocal of the highest dilution that gives a value equivalent to the cut point of the assay) >= 4.32. | The SAS consisted of all participants who received at least 1 dose of study drug. "n" signifies number of participants with observed data at the time point of each arm. From Weeks 16 to 40, only participants who remained in the follow-up period of this study and did not enter NCT01405196 were analyzed. | Posted | Number | percentage of participants | At baseline (Day 1) and at Weeks 4, 8, 12, 16, 24, 32 and 40 |
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| Secondary | Percentages of Participants With Confirmed Positive Neutralizing Antibodies (NAbs) | The percentage of participants with confirmed positive NAbs was summarized for each treatment arm. Only ADA positive samples were analyzed for Nab. A multi-tiered approach was utilized to detect NAbs. NAb serum samples were screened at tier one, and those found presumptively NAb positive was further tested with the confirmatory assay (tier two). The percentage of subjects with confirmed positive NAbs was summarized for each treatment. | The SAS consisted of all participants who received at least 1 dose of study drug. "n" signifies number of participants with observed data at the time point of each arm. From Weeks 16 to 40, only participants who remained in the follow-up period of this study and did not enter NCT01405196 were analyzed. | Posted | Number | percentage of participants | At baseline (Day 1) and at Weeks 4, 8, 12, 16, 24, 32 and 40 |
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| Secondary | Serum PF-04236921 Concentration Over Time | The pharmacokinetic (PK) analysis set was the subset of participants from the SAS who provided at least 1 PK concentration (2 participants [10 mg arm] excluded due to a quality issue). "n" is the number of participants with PK data at the visit. From Weeks 16 to 40, only participants who remained in the follow-up period of this study were analyzed. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Day 1 (predose), and at Weeks 2, 4 (Day 28, predose), 8, 10, 12, 16, 20, 24, 28, 32, 36, and 40 |
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| Secondary | Number of Participants Who Withdrew From the Study Due to Treatment-emergent Adverse Events (AEs) | An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. Treatment-emergent were events between first dose of treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | The SAS consisted of all participants who received at least 1 dose of study drug. "n" signifies number of participants with observed data at the time point of each arm. From Weeks 16 to 40, only participants who remained in the follow-up period of this study and did not enter NCT01405196 were analyzed. | Posted | Number | participants | Induction period: from Week 0 (Day 1) through Week 12; follow-up period: from Week 12 (or discontinuation from the induction period) through last subject visit (up to 28 weeks after completion of or discontinuation from the 12-week induction period) |
|
The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study. | 11 | 69 | 36 | 69 | ||
| EG001 | PF-04236921 10 mg | PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study. | 11 | 67 | 38 | 67 | ||
| EG002 | PF-04236921 50 mg | PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study. | 12 | 71 | 48 | 71 | ||
| EG003 | PF-04236921 200 mg | PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study. | 11 | 40 | 20 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo positional | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Anal fistula | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Crohn's disease | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Haematochezia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Ileal fistula | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Intestinal perforation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Large intestinal stenosis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Large intestine perforation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pancreatitis acute | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Chest pain | General disorders | Non-systematic Assessment |
| ||
| Chills | General disorders | Non-systematic Assessment |
| ||
| Device occlusion | General disorders | Non-systematic Assessment |
| ||
| Malaise | General disorders | Non-systematic Assessment |
| ||
| Pyrexia | General disorders | Non-systematic Assessment |
| ||
| Abscess | Infections and infestations | Non-systematic Assessment |
| ||
| Anal abscess | Infections and infestations | Non-systematic Assessment |
| ||
| Groin abscess | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Retroperitoneal abscess | Infections and infestations | Non-systematic Assessment |
| ||
| Sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| Liver function test abnormal | Investigations | Non-systematic Assessment |
| ||
| Road traffic accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Non-systematic Assessment |
| ||
| Malnutrition | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Fistula | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| VIIth nerve paralysis | Nervous system disorders | Non-systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Nephrolithiasis | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Deep vein thrombosis | Vascular disorders | Non-systematic Assessment |
| ||
| Abscess intestinal | Infections and infestations | Non-systematic Assessment |
| ||
| Perirectal abscess | Infections and infestations | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Abdominal pain upper | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Crohn's disease | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Proctalgia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Pyrexia | General disorders | Non-systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
Enrollment into the 200 mg arm was halted on 14 August 2013 before reaching the planned sample size due to safety findings in NCT01405196. Hence the 200 mg vs placebo comparisons were excluded from the primary analyses and reported separately.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigators will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.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
| Male |
|
|
| GLMM |
Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates. |
| 0.0438 |
Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided). |
| Mean Difference (Final Values) |
| 18.7 |
| Standard Error of the Mean |
| 11.0 |
| 2-Sided |
| 90 |
| 0.7 |
| 36.7 |
| No |
| Superiority or Other |
| OG001 | PF-04236921 200 mg | PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study. |
|
|
|
| OG002 | PF-04236921 50 mg | PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study. |
|
|
|
| OG001 | PF-04236921 200 mg | PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study. |
|
|
|
| OG002 | PF-04236921 50 mg | PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study. |
|
|
|
| OG001 |
| PF-04236921 200 mg |
PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study. |
|
|
|
| OG002 | PF-04236921 50 mg | PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study. |
|
|
|
| OG001 |
| PF-04236921 200 mg |
PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study. |
|
|
|
PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
| OG002 | PF-04236921 50 mg | PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study. |
|
|
|
| OG001 | PF-04236921 200 mg | PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study. |
|
|
|
PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study. |
|
|
|
|
|
|
PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
|
| OG002 |
| PF-04236921 200 mg |
PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study. |
|
|
|
|
| OG002 | PF-04236921 50 mg | PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study. |
| OG003 | PF-04236921 200 mg | PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study. |
|
|