Crohn's Disease Clinical Trial
— OPERAOfficial title:
A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-00547659 In Subjects With Crohn's Disease (Opera)
| Verified date | May 2021 |
| Source | Takeda |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Adults with Crohn's disease that is clinically active despite conventional treatment will be eligible for this study. Patients may receive one of three doses of PF-00547659 (experimental drug) or placebo (inactive drug). Disease activity will be measured every two weeks.
| Status | Completed |
| Enrollment | 265 |
| Est. completion date | October 9, 2015 |
| Est. primary completion date | February 7, 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | Inclusion Criteria: - Subjects must have failed or are intolerant to anti-TNFs and/or immunosuppressants (AZA, 6-MP, and/or MTX). - hsCRP greater than 3mg/L - Ulcerations demonstrated by colonoscopy performed during screening or 8 weeks prior to screening Exclusion Criteria: - Pregnant or breast feeding - Short bowel syndrome due to multiple small bowel resections - Presence of a stoma |
| Country | Name | City | State |
|---|---|---|---|
| Austria | AKH Wien Universitaetsklinik fuer Innere Medizin III | Wien | |
| Belgium | UZ Gasthuisberg | Leuven | |
| Belgium | Centre Hospitalier Universitaire de Liege | Liege | |
| Belgium | Centre Hospitalier Universitaire de Liège - Labo Biologie Clinique | Liege | |
| Belgium | Centre Hospitalier de Mouscron | Mouscron | |
| Bulgaria | 4-MHAT | Sofia | |
| Bulgaria | MBAL Sofiamed OOD,Otdelenie po gastroenterologia | Sofia | |
| Canada | Oshawa Clinic | Oshawa | Ontario |
| Canada | Vancouver Coastal Health - Vancouver General Hospital | Vancouver | British Columbia |
| Canada | Vancouver Coastal Health - Vancouver Hospital | Vancouver | British Columbia |
| Canada | Toronto Digestive Disease Associates Inc. | Vaughan | Ontario |
| France | CHU Amiens Hopital Nord Service d'Hepato-Gastroenterologie | Amiens Cedex 01 | |
| France | Hopital Saint-Andre | Bordeaux cedex | |
| France | Hopital Beaujon- Essais cliniques | Clichy Cedex | |
| France | Hopital de l'Archet 2 - CHU de Nice | NICE Cedex 3 | |
| France | Hopital Cochin-Essais Cliniques | Paris | |
| France | Hopital Charles Nicolle | Rouen Cedex 1 | |
| France | Hopital Nord | St Priest En Jarez | |
| France | Hopital Rangueil | Toulouse cedex 09 | |
| Germany | Charite - Campus Berlin Mitte Medizinische Klinik | Berlin | |
| Germany | Krankenhaus Martha-Maria Halle-Doelau gGmbH | Halle | |
| Germany | Universitaetsklinikum Schleswig-Holstein | Kiel | |
| Germany | Universitaetsfrauenklinikum Schleswig-Holstein Medizinische Klinik I, Gastroenterologie/Hepatologie | Luebeck | |
| Germany | Gastroenterologische Gemeinschaftspraxis Minden | Minden | |
| Germany | Universitaetsklinikum Regensburg | Regensburg | |
| Germany | Robert-Bosch-Krankenhaus | Stuttgart | |
| Germany | Universitaetklinikum Ulm | Ulm | |
| Japan | Aichi Medical University Hospital | Aichi | |
| Japan | Chiba University Hospital | Chiba | |
| Japan | National Hospital Organization Hirosaki National Hospital | Hirosaki | Aomori |
| Japan | Yokohama City University Medical Center | Kanagawa | |
| Japan | Jikei University Hospital | Minato-ku | Tokyo |
| Japan | Keio University Hospital | Shinjuku-ku | Tokyo |
| Japan | National Hospital Organization Takasaki General Medical Center | Takasaki | Gunma |
| Korea, Republic of | Pusan National University Hospital | Busan | |
| Korea, Republic of | Yeungnam University Hospital | Daegu | |
| Korea, Republic of | Asan Medical Center | Seoul | |
| Korea, Republic of | Kangbuk Samsung Hospital | Seoul | |
| Korea, Republic of | Samsung Medical Center | Seoul | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Korea, Republic of | Yonsei University College of Medicine, Severance Hospital | Seoul | |
| Netherlands | Academic Medical Center | Amsterdam | NH |
| Netherlands | University Medical Center Groningen (UMCG) | Groningen | GR |
| Netherlands | Maastricht University Medical Center | Maastricht | |
| Norway | Asker And Baerum Hospital | Gjettum | |
| Norway | Lovisenberg Diakonale Sykehus | Oslo | |
| Norway | Oslo Universitetssykehus | Oslo | |
| Poland | Szpital Uniwersytecki nr 2 im dr. Jana Bizieta w Bydgoszczy Centrum Endoskopii Zabiegowej | Bydgoszcz | |
| Poland | Centrum Medyczne-Szpital Swietej Rodziny Sp. z o.o. | Lodz | |
| Poland | Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych w Warszawie | Warszawa | |
| Poland | Lexmedica | Wroclaw | |
| Serbia | Clinical Hospital Centre Bezanijska Kosa | Belgrade | |
| Serbia | Military Medical Academy | Belgrade | |
| Serbia | Clinical Center Nis Clinic for Gastroenterology and Hepatology | Nis | |
| Serbia | Clinical Hospital Center Zemun | Zemun | |
| Slovakia | Gastroentero-Hepatologicke centrum THALION, LAMA MEDICAL CARE s.r.o. | Bratislava | |
| Slovakia | Medak s.r.o. | Bratislava | |
| Slovakia | Gastroenterologicke a hepatologicke centrum Nitra, KM Management spol. s r.o. | Nitra | |
| Slovakia | Synergy group, a.s. | Nove Mesto Nad Vahom | |
| South Africa | Kingsbury Hospital | Cape Town | Western CAPE |
| South Africa | Parklands Medical Centre | Durban | Kwa-zulu - Natal |
| South Africa | Wits Clinical Research | Johannesburg | Gauteng |
| Spain | Hospital Clinic de Barcelona | Barcelona | |
| Spain | Hospital Universitari Bellvitge | Barcelona | |
| Spain | Hospital General Universitario Gregorio Maranon | Madrid | |
| Spain | Hospital Universitario de La Princesa | Madrid | |
| Spain | Hospital Puerta de Hierro Majadahonda | Majadahonda | Madrid |
| Spain | Corporacio Sanitaria Parc Tauli de Sabadell | Sabadell | |
| United States | Albany Medical College | Albany | New York |
| United States | Connecticut Clinical Research Foundation | Bristol | Connecticut |
| United States | Life Medi-Research And Management | Brooklyn | New York |
| United States | CTRC Hospital - UNC Memorial Hospital | Chapel Hill | North Carolina |
| United States | North Carolina Memorial Hospital Endoscopy Center | Chapel Hill | North Carolina |
| United States | UNC Hospitals Department of Pharmacy | Chapel Hill | North Carolina |
| United States | UNC Hospitals Endoscopy | Chapel Hill | North Carolina |
| United States | Charlottesville Gastroenterology Associates | Charlottesville | Virginia |
| United States | Charlottesville Medical Research | Charlottesville | Virginia |
| United States | Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research | Chevy Chase | Maryland |
| United States | Heartland Medical Research (Administrative Only) | Clive | Iowa |
| United States | Iowa Digestive Disease Center | Clive | Iowa |
| United States | Iowa Endoscopy Center (Colonoscopy Only) | Clive | Iowa |
| United States | Surgery Center of Columbia | Columbia | Missouri |
| United States | Pharma Resource | East Providence | Rhode Island |
| United States | The Offices of Dr. Vincent Armenio, M.D. | East Providence | Rhode Island |
| United States | New York Hospital Queens | Flushing | New York |
| United States | Shands Endoscopy Center | Gainesville | Florida |
| United States | Shands Hospital at the University of Florida | Gainesville | Florida |
| United States | Shands Medical Plaza | Gainesville | Florida |
| United States | Long Island Clinical Research Associates, LLP | Great Neck | New York |
| United States | Nassau Gastroenterology Associates Office Based Surgery | Great Neck | New York |
| United States | Nassau Gastroenterology Associates, P.C. | Great Neck | New York |
| United States | North Shore Primary Care, P.C. | Great Neck | New York |
| United States | Hillsborough Campus | Hillsborough | North Carolina |
| United States | Mayo Clinic Jacksonville | Jacksonville | Florida |
| United States | Clopton Clinic | Jonesboro | Arkansas |
| United States | Gastroenterology Specialists of Arkansas | Jonesboro | Arkansas |
| United States | UCSD Medical Center-Thornton Hospital | La Jolla | California |
| United States | Clinical Research of the Rockies | Lafayette | Colorado |
| United States | Florida Center for Gastroenterology | Largo | Florida |
| United States | Little Rock Diagnostic Clinic, P.A. | Little Rock | Arkansas |
| United States | Audrain Medical Center | Mexico | Missouri |
| United States | Center for Digestive and Liver Diseases, Inc. | Mexico | Missouri |
| United States | Sylvester Comprehensive Cancer Center | Miami | Florida |
| United States | University of Miami | Miami | Florida |
| United States | University of Miami Hospital | Miami | Florida |
| United States | University of Miami Hospital and Clinic | Miami | Florida |
| United States | Minneapolis Heart Institute, West Health Campus | Minneapolis | Minnesota |
| United States | Noran Neurology Clinic | Minneapolis | Minnesota |
| United States | Nashville Medical Research Institute | Nashville | Tennessee |
| United States | Beth Israel Medical Center - Phillip Ambulatory Care Center | New York | New York |
| United States | East side Endoscopy, LLC (for colonscopy testing only) | New York | New York |
| United States | Lenox Hill Endoscopy Center | New York | New York |
| United States | Community Clinical Trials | Orange | California |
| United States | Gastro Diagnostics | Orange | California |
| United States | Cirtus Ambulartory Surgery Center | Orlando | Florida |
| United States | Internal Medicine Specialists | Orlando | Florida |
| United States | Pasadena Gastroenterology Associates, P.A. dba Digestive Health Center | Pasadena | Texas |
| United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
| United States | Consulting Radiology (Xray testing only) | Plymouth | Minnesota |
| United States | Minnesota Gastroenterology, P.A. | Plymouth | Minnesota |
| United States | Premier Medical Group of the Hudson Valley | Poughkeepsie | New York |
| United States | Bayside Endoscopy Center | Providence | Rhode Island |
| United States | Inland Gastroenterology Medical Associates, Inc. | Redlands | California |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | Barnes-Jewish Hospital - Investigational Drug Services | Saint Louis | Missouri |
| United States | Center for Advanced Medicine | Saint Louis | Missouri |
| United States | Washington University School of Medicine | Saint Louis | Missouri |
| United States | University of Utah HSC | Salt Lake City | Utah |
| United States | University of Washington Medical Center | Seattle | Washington |
| United States | Rocky Mountain Gastroenterology Associates | Thornton | Colorado |
| United States | Center for Digestive Health | Troy | Michigan |
| United States | Surgical Centers of Michigan | Troy | Michigan |
| United States | Allegiance Research Specialists | Wauwatosa | Wisconsin |
| United States | GI Associates | Wauwatosa | Wisconsin |
| United States | BioMark Research Inc. | Whittier | California |
| United States | UMass Memorial Medical Center | Worcester | Massachusetts |
| United States | University of Massachusetts Worcester | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Shire |
United States, Austria, Belgium, Bulgaria, Canada, France, Germany, Japan, Korea, Republic of, Netherlands, Norway, Poland, Serbia, Slovakia, South Africa, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With Crohn's Disease Activity Index (CDAI) 70 Response Rate | Crohn's Disease Activity Index (CDAI) is a number which consists of information collected from a 7-day diary from the participants regarding symptoms. Remission is considered a score of 150 or less. Active disease is considered 200 or greater. A response to therapy is considered a decline in CDAI score of 70-points from baseline. CDAI response rate at week 8 and week 12 was measured between the investigational product group and the placebo group. | Week 8 and week 12 | |
| Secondary | Safety and Tolerability of PF-00547659 Dose Levels Versus Placebo | Number of participants with adverse events (AEs), withdrawals due to AEs and Serious AEs (SAEs) were reported. | Week 0-12 | |
| Secondary | Number of Adverse Events (AEs) - PF-00547659 Dose Levels Versus Placebo | Number of adverse events (all causalities and treatment related) was reported between the investigational product groups and the placebo group. | Week 0-12 | |
| Secondary | Percentage of Participants With a Crohn's Disease Activity Index (CDAI) Remission | Percentage of participants with a CDAI remission (defined as a CDAI reduction to <150 points). | Weeks 8 and week 12 | |
| Secondary | Crohn's Disease Activity Index (CDAI)-70 Response Rates Over Time | Percentage of participants with Crohn's Disease Activity Index (CDAI)-70 response were reported. | Week 2, 4, 6, 8, 10 and 12 | |
| Secondary | Crohn's Disease Activity Index (CDAI) -100 Response Rates Over Timer | Percentage of participants with Crohn's Disease Activity Index (CDAI)-100 response were reported. | Week 2, 4, 6, 8, 10 and 12 | |
| Secondary | Immunogenicity Assessment of Anti-drug Antibodies (ADAs) | Confirmed cumulative incidence of anti-drug antibodies development to PF-00547659 | Day 1, Week 4, Week 8, Week 12, Week 20, Week 28, Week 36 | |
| Secondary | The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) | The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to area under the concentration-time profile (AUC), clearance (CL) and half life were estimated using data pooled from both typical and additional PK groups. AUCinf is area under the concentration time profile from time zero extrapolated to infinite time. | Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252 | |
| Secondary | The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero to Time Tau (AUCtau) | The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. AUCtau is area under the concentration time profile from time zero to time tau, the dosing interval, where tau = 672 hours (4 weeks) | Day 1, 14, and 28 | |
| Secondary | The Pharmacokinetics (PK) of Total PF-00547659 - Maximum Observed Concentration (Cmax) | The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Cmax is maximum observed concentration. | Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252 | |
| Secondary | The Pharmacokinetics (PK) of Total PF-00547659 - Time for Cmax (Tmax) | The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Tmax is time for Cmax. | Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252 | |
| Secondary | The Pharmacokinetics (PK) of Total PF-00547659 - Terminal Half Life (Thalf) | The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Thalf is terminal half life. | Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252 | |
| Secondary | The Pharmacokinetics (PK) of Total PF-00547659 - Apparent Clearance (CL/F) | The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. CL/F is apparent clearance. | Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252 |
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