Crohn's Disease Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-centre Study To Investigate The Safety And Efficacy Of Cp-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease
| Verified date | June 2015 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease. The study hypothesis is that at least one dose of the tested drug is more effective than placebo (inactive drug).
| Status | Completed |
| Enrollment | 280 |
| Est. completion date | March 2015 |
| Est. primary completion date | February 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Male or female subjects between the ages of 18 and 75 years at screening (upper age limit will be 64 years in India and 65 years in the Netherlands). - Subjects with clinical diagnosis of Crohn's disease for at least 6 months prior to screening. - Subjects with active moderate to severe ileal, ileocolic, or colonic CD defined by a baseline score of Crohn's Disease Activity Index (CDAI) of 220 to 450 at baseline. Exclusion Criteria: - Diagnosis of indeterminate colitis, ulcerative colitis (UC), or clinical findings suggestive of UC. - Subjects diagnosed with Crohn's disease but without previous exposure to treatment (i.e., treatment-naïve). - Subjects receiving the following treatment for Crohn's disease: - Azathioprine, 6-mercaptopurine or methotrexate within 2 weeks prior to baseline. - Anti-TNFa therapy within 8 weeks prior to baseline. - Interferon therapy within 8 weeks prior to baseline. - Cyclosporine, mycophenolate, or tacrolimus within 4 weeks prior to baseline. - Intravenous corticosteroids within 2 weeks prior to baseline. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Monash Medical Center | Clayton | Victoria |
| Australia | Nepean Public Hospital | Kingswood | New South Wales |
| Australia | Royal Melbourne Hospital | Parkville | Victoria |
| Austria | AKH Wien Universitaetsklinik fuer Innere Medizin III | Wien | |
| Bulgaria | 4-MBAL, Parvo vatreshno otdelenie | Sofia | |
| Bulgaria | DKTs Sveta Anna, Gastroenterologichen cabinet | Sofia | |
| Bulgaria | MBAL na Voennomeditsinska akademia, Sofia Dept of Gastroenterology | Sofia | |
| Bulgaria | MBAL Sofiamed OOD, Otdelenie po gastroenterologia | Sofia | |
| Bulgaria | MBAL Sveti Ivan Rilski, Klinika po Gastroenterologia | Sofia | |
| Bulgaria | MBAL Voennomeditsinska Akademia | Sofia | |
| Canada | University of Calgary | Calgary | Alberta |
| Canada | London Health Sciences Centre - University Hospital | London | Ontario |
| Canada | Hopital Maisonneuve-Rosemont | Montreal | Quebec |
| Canada | Inflammatory Bowel Disease Centre, Montreal General Hospital, McGill University Health Centre | Montreal | Quebec |
| Canada | McGill University Health Centre - Royal Victoria Hospital | Montreal | Quebec |
| Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
| Canada | Office of Dr. David C. Pearson | Victoria | British Columbia |
| Canada | Office of Drs. Ranjith Andrew Singh and Jamie D. Papp | Victoria | British Columbia |
| Canada | PerCuro Clinical Research Ltd. | Victoria | British Columbia |
| Croatia | University Hospital Centre Rijeka | Rijeka | |
| Croatia | University Hospital Center Zagreb | Zagreb | |
| Czech Republic | Hepato-Gastroenterologie HK, s.r.o. | Hradec Kralove | |
| Czech Republic | RDG centrum s.r.o. | Hradec Kralove | |
| Czech Republic | Medial Pharma spol.s.r.o. | Hradec Králové | |
| France | Hopital Huriez, CHRU de Lille | Lille Cedex | |
| France | Hopital Haut-Leveque | Pessac | |
| France | Hopital Robert Debre | Reims CEDEX | |
| Germany | Charite - Campus Benjamin Franklin | Berlin | |
| Germany | Charite - Campus Berlin Mitte | Berlin | |
| Germany | Charite-Campus Berlin Mitte, Med. Klinik mit Schwerpunkt, Gastroent., Hepat., Endokrinol. | Berlin | |
| Germany | Universitaetsklinikum Schleswig-Holstein | Kiel | |
| Germany | Gastroenterologische Gemeinschaftspraxis Minden | Minden | |
| Germany | Universitaetsklinikum Ulm, Klinik fuer Innere Medizin I | Ulm | |
| Greece | General Hospital of Athens "Evangelismos",1st Gastroenterology Department | Kolonaki Athens | |
| Hungary | EUROMEDIC Diagnosztikai Központ Budapest - Magyar Honvédség, Honvédkórház | Budapest | |
| Hungary | Laboratorium Kft. Fovarosi es Pest Megyei Mikrobiologiai Laboratorium | Budapest | |
| Hungary | Laboratorium Kft. Fovarosi és Pest Megyei Mikrobiologiai Laboratorium | Budapest | |
| Hungary | Magyar Honvedseg Honvedkorhaz II. telephely/Gasztroenterologiai Osztaly | Budapest | |
| Hungary | MH. Honvedkorhaz II. telephely/Gasztroenterologiai Osztaly | Budapest | |
| Hungary | Pannonia Maganorvosi Centrum Kft | Budapest | |
| Hungary | Peterfy Sandor Utcai Korhaz, Rendelointezet es Baleseti Kozpont, I. sz. Belgyogyaszat | Budapest | |
| Hungary | Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszat es Gastroenterologia | Budapest | |
| Hungary | Synlab Budapest Diagnosztikai Központ Mikrobiológiai Laboratóriuma | Budapest, Hungary | |
| Hungary | Bugát Pál Hospital | Gyongyos | |
| Hungary | Bugat Pal Korh. Eu-i Szolg. Kozhasznu Nonprofit Kft./Medical Investment Noninvaziv Matrix Belgy. O. | Gyongyos | |
| Hungary | Somogy megyei Kaposi Mor Oktato Korhaz / Belgyogyaszati osztaly | Kaposvar | |
| Hungary | Clinfan Kft. | Szekszard | |
| Israel | Digestive Diseases Institute, Shaare Zedek Medical Center | Jerusalem | |
| Israel | Meir Medical Center | Kfar Saba | |
| Israel | Rabin Medical Center, Beilinson Hospital | Petach Tikva | |
| Israel | Tel Aviv Sourasky Medical Center | Tel Aviv | |
| Japan | Tokyo Medical And Dental University Hospital, Faculty of Medicine | Bunkyo-ku | Tokyo |
| Japan | Toho University Sakura Medical Center | Chiba | |
| Japan | Fukuoka University Chikushi Hospital | Chikushino | Fukuoka |
| Japan | The Hospital of Hyogo College of Medicine | Nishinomiya | Hyogo |
| Japan | Osaka City University Hospital | Osaka | |
| Japan | Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital | Sapporo | Hokkaido |
| Japan | National Hospital Organization Sendai Medical Center | Sendai | Miyagi |
| Japan | Keio University Hospital | Shinjuku-ku | Tokyo |
| Korea, Republic of | ASAN Medical Center | Seoul | |
| Korea, Republic of | Samsung Medical Center | Seoul | |
| Korea, Republic of | Severance Hospital, Yeonsei University Health System | Seoul | |
| Netherlands | Academisch Medisch Centrum | Amsterdam | |
| Netherlands | VU University Medical Center | Amsterdam | |
| South Africa | Kingsbury Hospital | Claremont | Western Cape |
| South Africa | Parklands Medical Centre | Durban | |
| Spain | Hospital Clinic de Barcelona | Barcelona | |
| Spain | Hospital Puerta de Hierro Majadahonda | Madrid | |
| Spain | Hospital Universitario de La Princesa | Madrid | |
| Ukraine | State Institution "Institute of Gastroenterology of AMS of Ukraine" | Dnipropetrovsk | |
| Ukraine | Donetsk National Medical University n.a M. Gorky | Donetsk | |
| Ukraine | Donetsk National Medical University n.a M. Gorky, Faculty of Internal Medicine #2 | Donetsk | |
| Ukraine | State Institution "Institute of Therapy n.a. L.T. Mala of AMS of Ukraine" | Kharkiv | |
| Ukraine | Lviv National Medical University n.a Danylo Halytsky, Faculty of Surgery#1 with Proctology Course | Lviv | |
| Ukraine | Municipal Institution "Odesa Regional Clinical Hospital". Odesa Regional Centre of Gastroenterology. | Odesa | |
| Ukraine | Medical Clinical Research Center Health Clinic on base LLC "Medical Diagnostic Center Slaomed" | Vinnitsa | |
| United States | ACRI - Phase 1, LLC | Anaheim | California |
| United States | Advanced Clinical Research Institute - Phase 1, LLC | Anaheim | California |
| United States | AGMG Endoscopy Center | Anaheim | California |
| United States | East Ann Arbor Health and Geriatrics Center | Ann Arbor | Michigan |
| United States | University of Michigan Health Systems | Ann Arbor | Michigan |
| United States | University Hospitals Chagrin Highlands Health Center | Beachwood | Ohio |
| United States | Charlotte Gastroenterology and Hepatology, PLLC | Charlotte | North Carolina |
| United States | Charlotte Radiology (Chest X-Ray Only) | Charlotte | North Carolina |
| United States | Clinical Research Institute of Michigan LLC | Chesterfield | Michigan |
| United States | Chevy Chase Endoscopy Center | Chevy Chase | Maryland |
| United States | Metropolitan Gastroenterology Group, PC | Chevy Chase | Maryland |
| United States | Clinical Research of West Florida, Inc. | Clearwater | Florida |
| United States | Gasteroenterology Consultants of Clearwater | Clearwater | Florida |
| United States | West Coast Endoscopy Center | Clearwater | Florida |
| United States | Cleveland Clinic | Cleveland | Ohio |
| United States | Investigational Drug Services - University Hospitals Case Medical Center | Cleveland | Ohio |
| United States | University Hospitals Case Medical Center | Cleveland | Ohio |
| United States | Heartland Medical Research, Inc (Administrative Only) | Clive | Iowa |
| United States | Iowa Digestive Disease Center | Clive | Iowa |
| United States | Iowa Endoscopy Center (Colonoscopy Only) | Clive | Iowa |
| United States | Iowa Radiology (MRI, X-Ray Only) | Clive | Iowa |
| United States | Citrus Surgery & Endoscopy Center (Colonoscopy & Biopsy Only) | Crystal River | Florida |
| United States | Dayton Gastroenterology, Inc. | Dayton | Ohio |
| United States | Investigational Drug Service | Gainesville | Florida |
| United States | Shands Endoscopy Center | Gainesville | Florida |
| United States | Shands Hospital at the University of Florida | Gainesville | Florida |
| United States | Shands Medical Plaza and Cancer Center | Gainesville | Florida |
| United States | NYU Langone Long Island Clinical Research Associates | Great Neck | New York |
| United States | NYU Langone Nassau Gastroenterology Associates | Great Neck | New York |
| United States | Endoscopy Center of Connecticut, LLC | Guilford | Connecticut |
| United States | Endoscopy Center of Connecticut, LLC | Hamden | Connecticut |
| United States | Gastroenterology Center of Connecticut, PC | Hamden | Connecticut |
| United States | Medical Research Center of Connecticut, LLC | Hamden | Connecticut |
| United States | UT Health Science Center | Houston | Texas |
| United States | Nature Coast Clinical Research | Inverness | Florida |
| United States | Suncoast Endoscopy Center (Colonoscopy Only) | Inverness | Florida |
| United States | Clinical Research Of The Rockies | Lafayette | Colorado |
| United States | Regional Gastroenterology Associates of Lancaster, Ltd. | Lancaster | Pennsylvania |
| United States | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire |
| United States | University of Kentucky Chandler Medical Center | Lexington | Kentucky |
| United States | Endoscopy Center of the Rockies - Longmont | Longmont | Colorado |
| United States | Gastroenterology Associates of Central Georgia, LLC | Macon | Georgia |
| United States | Great Lakes Gastroenterology | Mentor | Ohio |
| United States | The Endoscopy Center of Lake County | Mentor | Ohio |
| United States | Medical Diagnostic Imaging (MDI) X-ray and MRI only | Milwaukee | Wisconsin |
| United States | The Center for Digestive Health | Milwaukee | Wisconsin |
| United States | Wisconsin Center for Advanced Research | Milwaukee | Wisconsin |
| United States | Wisconsin Center for Advanced Research - GI Associates, LLC | Milwaukee | Wisconsin |
| United States | FQL Research, LLC | Miramar | Florida |
| United States | Gastroenterology Group of Naples | Naples | Florida |
| United States | Cardiology Consultants (ECG Site Only) | Norfolk | Virginia |
| United States | Digestive and Liver Disease Specialists | Norfolk | Virginia |
| United States | Southwest Gastroenterology | Oak Lawn | Illinois |
| United States | Alliance Clinical Resarch | Oceanside | California |
| United States | North Florida Gastroenterology Research, LLC | Orange Park | Florida |
| United States | Internal Medicine Specialists | Orlando | Florida |
| United States | Premier Medical Group of the Hudson Valley, PC | Poughkeepsie | New York |
| United States | Alliance Clinical Research, LLC | Poway | California |
| United States | University of Utah | Salt Lake City | Utah |
| United States | Sharp Rees-Stealy Medical Group, Inc. | San Diego | California |
| United States | Sharp Rees-Stealy Medical Group, Inc. | San Diego | California |
| United States | Cotton-O'Neil Clinical Research Center, Digestive Health | Topeka | Kansas |
| United States | Stormont-Vail MRA Center of Kansas | Topeka | Kansas |
| United States | Center for Digestive Health | Troy | Michigan |
| United States | Digestive Health Specialists of Tyler | Tyler | Texas |
| United States | MRI & CT Diagnostics | Virginia Beach | Virginia |
| United States | Metropolitan Gastroenterology Group, PC | Washingdon | District of Columbia |
| United States | Allegiance Research Specialists | Wauwatosa | Wisconsin |
| United States | GI Associates | Wauwatosa | Wisconsin |
| United States | University Hospitals Westlake Medical Center | Westlake | Ohio |
| United States | Great Lakes Gastroenterology | Willoughby | Ohio |
| United States | Florida Medical Clinic, P.A. | Zephyrhills | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Australia, Austria, Bulgaria, Canada, Croatia, Czech Republic, France, Germany, Greece, Hungary, Israel, Japan, Korea, Republic of, Netherlands, South Africa, Spain, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The proportion of subjects in clinical remission at week 8 as defined by a Crohn's disease activity index (CDAI) score of less than 150 points. | week 8 | No | |
| Secondary | The proportions of subjects in clinical remission (CDAI<150) at Week 2 and 4. | week 2 and 4 | No | |
| Secondary | The proportion of subjects achieving clinical response-70 at Week 2, 4, and 8 as defined by a decrease in CDAI score of at least 70 points from baseline. | week 2, 4 and 8 | No | |
| Secondary | The proportion of subjects achieving clinical response-100 at Week 2, 4, and 8 as defined by a decrease in CDAI score of at least 100 points from baseline. | week 2, 4 and 8 | No | |
| Secondary | The proportion of subjects achieving either clinical response-100 or clinical remission (CDAI<150) at Week 2, 4, and 8. | week 2, 4 and 8 | No |
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