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 Maintenance Therapy In Subjects With Moderate To Severe Crohn's Disease
| Verified date | September 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 who completed the double-blind induction treatment in Study A3921083 and achieved clinical response-100 and/or clinical remission (CDAI<150) at Week 8.
| Status | Completed |
| Enrollment | 178 |
| Est. completion date | July 2015 |
| Est. primary completion date | July 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Subjects who met study entry criteria, and who completed Week 8 visit of Induction Study A3921083. - Subjects who achieve clinical response-100 (reduction in CDAI by 100 points) and/or clinical remission (CDAI<150) in Study A3921083. - Women of childbearing potential must test negative for pregnancy prior to study enrolment. Exclusion Criteria: - Subjects who had major protocol violation (as determined by the Sponsor) in the A3921083 study. - Subjects likely to require any type of surgery during the study period. - Fecal culture/toxin assay indicating presence of pathogenic infection. |
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 Centre | Clayton | Victoria |
| Australia | Nepean Public Hospital | Kingswood | New South Wales |
| Australia | Royal Melbourne Hospital | Melbourne | Victoria |
| Austria | AKH Wien Universitaetsklinik fuer Innere Medizin III | Wien | |
| Bulgaria | 4 MBAL Parvo vatreshno otdelenie | Sofia | |
| Bulgaria | MBAL Sofiamed OOD, Otdelenie po gastroenterologia | Sofia | |
| Canada | London Health Sciences Centre - University Hospital | London | Ontario |
| Canada | McGill University Health Centre - Royal Victoria Hospital | Montreal | Quebec |
| 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 |
| Czech Republic | Hepato-Gastroenterologie HK, s.r.o. | Hradec Kralove | |
| Czech Republic | RDG centrum s.r.o. (Radiology only) | Hradec Kralove | |
| Czech Republic | Medial Pharma spol.s.r.o. (Pharmacy only) | Hradec Králové | |
| France | Hopital Huriez CHRU de Lille | Lille Cedex | |
| France | Hôpital Haut-Lévêque/Service d hépato-gastroentérologie | Pessac Cedex | |
| Germany | Charite - Campus Benjamin Franklin | Berlin | |
| Germany | Charite - Campus Berlin Mitte | Berlin | |
| Germany | Charite, Universitaetsmedizin Berlin, Campus Virchow-Klinikum | Berlin | |
| Germany | Universitaetsklinikum Schleswig-Holstein | Kiel | |
| Germany | Universitaetsklinikum Ulm, Klinik fuer lnnere Medizin II | Ulm | |
| Greece | General Hospital of Athens "Evangelismos",1st Gastroenterology Department | Kolonaki Athens | |
| Hungary | Laboratorium Kft. Fovarosi és Pest Megyei Mikrobiologiai Laboratorium | Budapest | |
| Hungary | Pannonia Magánorvosi 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 | Bugat Pal Korhaz Egeszsegugyi Szolgaltato Kozhasznu Nonprofit Kft., | Gyongyos | |
| Hungary | Laboratórium Kft. Somogy Megyei Mikrobiológiai Laboratórium | Kaposvár | |
| Hungary | Clinfan Kft. | Szekszard | |
| Israel | Digestive Disease Institute | Jerusalem | |
| Israel | Meir Medical Center | Kfar Saba | |
| Israel | Tel Aviv Sourasky Medical Center | Tel -Aviv | |
| Japan | Toho University Sakura Medical Center | Chiba | |
| Japan | Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital | Hokkaido | |
| Japan | The Hospital of Hyogo College of Medicine | Nishinomiya | Hyogo |
| Japan | Osaka City University Hospital | Osaka | |
| Japan | National Hospital Organization Sendai Medical Center | Sendai | Miyagi |
| Korea, Republic of | ASAN Medical Center,Division of Gastroenterology,Department of Internal Medicine | Seoul | |
| Korea, Republic of | Samsung Medical Center, Division of Gastroenterology, Department of Internal Medicine | Seoul | |
| Korea, Republic of | Severance Hospital, Yeonsei University Health System | Seoul | |
| Korea, Republic of | Severance Hospital, Yonsei University Health System | Seoul | |
| Netherlands | Academisch Medisch Centrum | Amsterdam | |
| Netherlands | VU University Medical Center | Amsterdam | |
| South Africa | Kingsbury Hospital | Cape Town | Western Cape |
| South Africa | Parklands Medical Centre | Durban | |
| Spain | Comite Etico de Investigacion Clinica | Barcelona | |
| Spain | Hospital Clinic de Barcelona | Barcelona | |
| Spain | Hospital Universitario de La Princesa | Madrid | |
| Ukraine | Donetsk National Medical University n.a M. Gorky, Faculty of Internal Medicine #2 | Donetsk | |
| Ukraine | Municipal Institution "Odesa Regional Clinical Hospital", Odesa Regional Centre of Gastroenterology. | Odesa | |
| Ukraine | Medical Clinical Research Center of Medical Center "Health Clinic" LLC | Vinnitsa | |
| United States | ACMG Endoscopy Center | Anaheim | California |
| United States | ACRI - Phase I, LLC | Anaheim | California |
| United States | Advanced Clinical Research Institute-Phase 1, LLC | Anaheim | California |
| United States | University of Michigan Health Systems | Ann Arbor | 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 | West Coast Clinical Trials | Cypress | California |
| 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 | University of Florida - College of Medicine | Gainsville | Florida |
| United States | NYU Langone Long Island Clinical Research Associates | Great Neck | New York |
| United States | Clinical Research Of The Rockies | Lafayette | Colorado |
| United States | Gastroenterology Associates of Central Georgia, LLC | Macon | Georgia |
| United States | Great Lakes Gastroenterology | Mentor | Ohio |
| United States | The Center for Digestive Health | Milwaukee | Wisconsin |
| United States | Wisconsin Center for Advanced Research - GI Associates, LLC | Milwaukee | Wisconsin |
| United States | Gastroenterology Group of Naples | Naples | Florida |
| United States | Gulfshore Endoscopy Center (Endoscopies Only) | Naples | Florida |
| United States | Cardiology Consultants | Norfolk | Virginia |
| United States | Digestive & Liver Desease Specialists | Norfolk | Virginia |
| United States | Alliance Clinical Research | 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 | University of Utah HSC | Salt Lake City | Utah |
| United States | Cotton-O'Neil Clinical Research Center, Digestive Health | Topeka | Kansas |
| United States | Center for Digestive Health | Troy | Michigan |
| United States | Surgical Centers of Michigan | Troy | Michigan |
| United States | Digestive Health Specialists of Tyler | Tyler | Texas |
| United States | Endoscopy Center of Tyler | Tyler | Texas |
| United States | Metropolitan Gastroenterology Group, P C | Washington DC | Virginia |
| United States | Allegiance Research Specialists, LLC | Wauwatosa | Wisconsin |
| United States | GI Associates | Wauwatosa | Wisconsin |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Australia, Austria, Bulgaria, Canada, 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 maintaining clinical response-100, as defined by a decrease in CDAI score at least 100 points from A3921083 baseline, or being in clinical remission, as defined by a CDAI score less than 150, at Week 26. | Week 26 | No | |
| Secondary | The proportion of subjects maintaining clinical response-100 or being in clinical remission at Weeks 4, 8, 12, 20 and 26 from the A3921083 Baseline. | Week 4, 8,12,20 and 26 | No | |
| Secondary | The proportion of subjects maintaining at least a clinical response-100 at Weeks 4, 8, 12, 20 and 26. | Week 4, 8,12, 20 and 26 | No | |
| Secondary | The proportion of subjects in clinical remission at Weeks 4, 8, 12, 20 and 26. | week 4, 8, 12, 20 and 26 | No | |
| Secondary | The proportion of subjects in clinical remission at Weeks 4, 8, 12, 20, and 26 among subjects in clinical remission at baseline of maintenance study. | week 4, 8,12, 20 and 26 | No | |
| Secondary | The proportion of subjects in sustained clinical remission in the maintenance phase. Sustained clinical remission is defined as being in clinical remission at both Weeks 20 and 26. | week 20 and 26 | No | |
| Secondary | The proportion of subjects achieving sustained clinical response in the maintenance phase. Sustained clinical response is defined as having at least a clinical response-100 at both Weeks 20 and 26 from the A3921083 Baseline. | week 20 and 26 | No | |
| Secondary | The proportion of subjects achieving a steroid-free clinical remission at Week 26 of the maintenance phase among subjects on steroids at baseline. | week 26 | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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