--- title: "Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease" nct_id: NCT01276509 overall_status: COMPLETED phase: PHASE2 sponsor: Shire study_type: INTERVENTIONAL primary_condition: "Crohn's Disease" countries: United States, Austria, Belgium, Bulgaria, Canada, France, Germany, Japan, Netherlands, Norway, Poland, Serbia, Slovakia, South Africa, South Korea, Spain canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01276509.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01276509" ct_last_update_post_date: 2021-06-03 last_seen_at: "2026-05-12T06:36:45.295Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease **Official 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) **NCT ID:** [NCT01276509](https://clinicaltrials.gov/study/NCT01276509) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 265 - **Lead Sponsor:** Shire - **Conditions:** Crohn's Disease - **Start Date:** 2011-04-06 - **Completion Date:** 2015-10-09 - **CT.gov Last Update:** 2021-06-03 ## Brief Summary 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. ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 75 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **Placebo-SC Injection** (PLACEBO_COMPARATOR) — Placebo delivered SC, 3 doses separated by 4 weeks. - **Drug Dose level 1- SC injection** (EXPERIMENTAL) — Drug dose level 1 delivered SC, 3 doses separated by 4 weeks. - **Drug Dose level 2-SC injection** (EXPERIMENTAL) — Drug dose level 2 delievered SC, 3 doses separated by 4 weeks. - **Drug Dose level 3- SC injection** (EXPERIMENTAL) — Drug dose level 3 delivered SC, 3 doses separated by 4 weeks. ## Interventions - **PF-00547659 SC injection** (DRUG) — Placebo delivered SC, 3 doses separated by 4 weeks - **PF-00547659 SC injection** (DRUG) — Drug dose level 1 delivered SC, 3 doses separated by 4 weeks - **PF-00547659 SC injection** (DRUG) — Drug dose level 2 delivered SC, 3 doses separated by 4 weeks - **PF-00547659 SC injection** (DRUG) — Drug dose level 3 delivered SC, 3 doses separated by 4 weeks ## Primary Outcomes - **Percentage of Participants With Crohn's Disease Activity Index (CDAI) 70 Response Rate** _(time frame: Week 8 and week 12)_ — 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. ## Secondary Outcomes - **Safety and Tolerability of PF-00547659 Dose Levels Versus Placebo** _(time frame: Week 0-12)_ - **Number of Adverse Events (AEs) - PF-00547659 Dose Levels Versus Placebo** _(time frame: Week 0-12)_ - **Percentage of Participants With a Crohn's Disease Activity Index (CDAI) Remission** _(time frame: Weeks 8 and week 12)_ - **Crohn's Disease Activity Index (CDAI)-70 Response Rates Over Time** _(time frame: Week 2, 4, 6, 8, 10 and 12)_ - **Crohn's Disease Activity Index (CDAI) -100 Response Rates Over Timer** _(time frame: Week 2, 4, 6, 8, 10 and 12)_ - **Immunogenicity Assessment of Anti-drug Antibodies (ADAs)** _(time frame: Day 1, Week 4, Week 8, Week 12, Week 20, Week 28, Week 36)_ - **The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf)** _(time frame: Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252)_ - **The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero to Time Tau (AUCtau)** _(time frame: Day 1, 14, and 28)_ - **The Pharmacokinetics (PK) of Total PF-00547659 - Maximum Observed Concentration (Cmax)** _(time frame: Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252)_ - **The Pharmacokinetics (PK) of Total PF-00547659 - Time for Cmax (Tmax)** _(time frame: Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252)_ - **The Pharmacokinetics (PK) of Total PF-00547659 - Terminal Half Life (Thalf)** _(time frame: Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252)_ - **The Pharmacokinetics (PK) of Total PF-00547659 - Apparent Clearance (CL/F)** _(time frame: Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252)_ ## Locations (137) - Clopton Clinic, Jonesboro, Arkansas, United States - Gastroenterology Specialists of Arkansas, Jonesboro, Arkansas, United States - Little Rock Diagnostic Clinic, P.A., Little Rock, Arkansas, United States - UCSD Medical Center-Thornton Hospital, La Jolla, California, United States - Community Clinical Trials, Orange, California, United States - Gastro Diagnostics, Orange, California, United States - Inland Gastroenterology Medical Associates, Inc., Redlands, California, United States - BioMark Research Inc., Whittier, California, United States - Clinical Research of the Rockies, Lafayette, Colorado, United States - Rocky Mountain Gastroenterology Associates, Thornton, Colorado, United States - Connecticut Clinical Research Foundation, Bristol, Connecticut, 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 - Mayo Clinic Jacksonville, Jacksonville, Florida, United States - Florida Center for Gastroenterology, Largo, Florida, United States - Sylvester Comprehensive Cancer Center, Miami, Florida, United States - University of Miami Hospital and Clinic, Miami, Florida, United States - University of Miami Hospital, Miami, Florida, United States - University of Miami, Miami, Florida, United States - Cirtus Ambulartory Surgery Center, Orlando, Florida, United States - Internal Medicine Specialists, Orlando, Florida, 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 - Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research, Chevy Chase, Maryland, United States - UMass Memorial Medical Center, Worcester, Massachusetts, United States - University of Massachusetts Worcester, Worcester, Massachusetts, United States - Center for Digestive Health, Troy, Michigan, United States - Surgical Centers of Michigan, Troy, Michigan, United States - Minneapolis Heart Institute, West Health Campus, Minneapolis, Minnesota, United States - Noran Neurology Clinic, Minneapolis, Minnesota, United States - Consulting Radiology (Xray testing only), Plymouth, Minnesota, United States - Minnesota Gastroenterology, P.A., Plymouth, Minnesota, United States - Mayo Clinic, Rochester, Minnesota, United States - Surgery Center of Columbia, Columbia, Missouri, United States - Audrain Medical Center, Mexico, Missouri, United States - Center for Digestive and Liver Diseases, Inc., Mexico, Missouri, United States - Barnes-Jewish Hospital - Investigational Drug Services, St Louis, Missouri, United States - Center for Advanced Medicine, St Louis, Missouri, United States - Washington University School of Medicine, St Louis, Missouri, United States - Albany Medical College, Albany, New York, United States - Life Medi-Research And Management, Brooklyn, New York, United States - New York Hospital Queens, Flushing, New York, 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 - 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 - Premier Medical Group of the Hudson Valley, Poughkeepsie, 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 - Hillsborough Campus, Hillsborough, North Carolina, United States - Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States - The Offices of Dr. Vincent Armenio, M.D., East Providence, Rhode Island, United States - Pharma Resource, East Providence, Rhode Island, United States - Bayside Endoscopy Center, Providence, Rhode Island, United States - Nashville Medical Research Institute, Nashville, Tennessee, United States - Pasadena Gastroenterology Associates, P.A. dba Digestive Health Center, Pasadena, Texas, United States - University of Utah HSC, Salt Lake City, Utah, United States - Charlottesville Gastroenterology Associates, Charlottesville, Virginia, United States - Charlottesville Medical Research, Charlottesville, Virginia, United States - University of Washington Medical Center, Seattle, Washington, United States - Allegiance Research Specialists, Wauwatosa, Wisconsin, United States - GI Associates, Wauwatosa, Wisconsin, United States - AKH Wien Universitaetsklinik fuer Innere Medizin III, Vienna, Austria - UZ Gasthuisberg, Leuven, Belgium - Centre Hospitalier Universitaire de Liege, Liège, Belgium - Centre Hospitalier Universitaire de Liège - Labo Biologie Clinique, Liège, Belgium - Centre Hospitalier de Mouscron, Mouscron, Belgium - 4-MHAT, Sofia, Bulgaria - MBAL Sofiamed OOD,Otdelenie po gastroenterologia, Sofia, Bulgaria - Vancouver Coastal Health - Vancouver General Hospital, Vancouver, British Columbia, Canada - Vancouver Coastal Health - Vancouver Hospital, Vancouver, British Columbia, Canada - Oshawa Clinic, Oshawa, Ontario, Canada - Toronto Digestive Disease Associates Inc., Vaughan, Ontario, Canada - CHU Amiens Hopital Nord Service d'Hepato-Gastroenterologie, Amiens, France - Hopital Saint-Andre, Bordeaux, France - Hopital Beaujon- Essais cliniques, Clichy, France - Hopital de l'Archet 2 - CHU de Nice, Nice, France - Hopital Cochin-Essais Cliniques, Paris, France - Hopital Charles Nicolle, Rouen, France - Hopital Nord, Saint-Priest-en-Jarez, France - Hopital Rangueil, Toulouse, France - 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, Lübeck, Germany - Gastroenterologische Gemeinschaftspraxis Minden, Minden, Germany - Universitaetsklinikum Regensburg, Regensburg, Germany - Robert-Bosch-Krankenhaus, Stuttgart, Germany - Universitaetklinikum Ulm, Ulm, Germany - National Hospital Organization Hirosaki National Hospital, Hirosaki, Aomori, Japan - National Hospital Organization Takasaki General Medical Center, Takasaki, Gunma, Japan - Jikei University Hospital, Minato-ku, Tokyo, Japan - Keio University Hospital, Shinjuku-ku, Tokyo, Japan - Aichi Medical University Hospital, Aichi, Japan - Chiba University Hospital, Chiba, Japan - Yokohama City University Medical Center, Kanagawa, Japan - Academic Medical Center, Amsterdam, North Holland, Netherlands - University Medical Center Groningen (UMCG), Groningen, Provincie Groningen, Netherlands - Maastricht University Medical Center, Maastricht, Netherlands - Asker And Baerum Hospital, Gjettum, Norway - Oslo Universitetssykehus, Oslo, Norway - Lovisenberg Diakonale Sykehus, Oslo, Norway - 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, Warsaw, Poland - Lexmedica, Wroclaw, Poland - Military Medical Academy, Belgrade, Serbia - Clinical Hospital Centre Bezanijska Kosa, Belgrade, Serbia - Clinical Center Nis Clinic for Gastroenterology and Hepatology, Niš, Serbia - Clinical Hospital Center Zemun, Zemun, Serbia - 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., Nové Mesto nad Váhom, Slovakia - Wits Clinical Research, Johannesburg, Gauteng, South Africa - Parklands Medical Centre, Durban, KwaZulu-Natal, South Africa - Kingsbury Hospital, Cape Town, Western Cape, South Africa - Pusan National University Hospital, Busan, South Korea - Yeungnam University Hospital, Daegu, South Korea - Seoul National University Hospital, Seoul, South Korea - Kangbuk Samsung Hospital, Seoul, South Korea - Yonsei University College of Medicine, Severance Hospital, Seoul, South Korea - Samsung Medical Center, Seoul, South Korea - Asan Medical Center, Seoul, South Korea - Hospital Puerta de Hierro Majadahonda, Majadahonda, Madrid, Spain - Hospital Clinic de Barcelona, Barcelona, Spain - Hospital Universitari Bellvitge, Barcelona, Spain - Hospital Universitario de La Princesa, Madrid, Spain - Hospital General Universitario Gregorio Maranon, Madrid, Spain - Corporacio Sanitaria Parc Tauli de Sabadell, Sabadell, Spain ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.clopton clinic|jonesboro|arkansas|united states` — added _(2026-05-12)_ - `locations.gastroenterology specialists of arkansas|jonesboro|arkansas|united states` — added _(2026-05-12)_ - `locations.little rock diagnostic clinic, p.a.|little rock|arkansas|united states` — added _(2026-05-12)_ - `locations.ucsd medical center-thornton hospital|la jolla|california|united states` — added _(2026-05-12)_ - `locations.community clinical trials|orange|california|united states` — added _(2026-05-12)_ - `locations.gastro diagnostics|orange|california|united states` — added _(2026-05-12)_ - `locations.inland gastroenterology medical associates, inc.|redlands|california|united states` — added _(2026-05-12)_ - `locations.biomark research inc.|whittier|california|united states` — added _(2026-05-12)_ - `locations.clinical research of the rockies|lafayette|colorado|united states` — added _(2026-05-12)_ - `locations.rocky mountain gastroenterology associates|thornton|colorado|united states` — added _(2026-05-12)_ - `locations.connecticut clinical research foundation|bristol|connecticut|united states` — added _(2026-05-12)_ - `locations.shands endoscopy center|gainesville|florida|united states` — added _(2026-05-12)_ - `locations.shands hospital at the university of florida|gainesville|florida|united states` — added _(2026-05-12)_ - `locations.shands medical plaza|gainesville|florida|united states` — added _(2026-05-12)_ - `locations.mayo clinic jacksonville|jacksonville|florida|united states` — added _(2026-05-12)_ - `locations.florida center for gastroenterology|largo|florida|united states` — added _(2026-05-12)_ - `locations.sylvester comprehensive cancer center|miami|florida|united states` — added _(2026-05-12)_ - `locations.university of miami hospital and clinic|miami|florida|united states` — added _(2026-05-12)_ - `locations.university of miami hospital|miami|florida|united states` — added _(2026-05-12)_ - `locations.university of miami|miami|florida|united states` — added _(2026-05-12)_ - `locations.cirtus ambulartory surgery center|orlando|florida|united states` — added _(2026-05-12)_ - `locations.internal medicine specialists|orlando|florida|united states` — added _(2026-05-12)_ - `locations.heartland medical research (administrative only)|clive|iowa|united states` — added _(2026-05-12)_ - `locations.iowa digestive disease center|clive|iowa|united states` — added _(2026-05-12)_ - `locations.iowa endoscopy center (colonoscopy only)|clive|iowa|united states` — added _(2026-05-12)_ - `locations.metropolitan gastroenterology group, pc - chevy chase clinical research|chevy chase|maryland|united states` — added _(2026-05-12)_ - `locations.umass memorial medical center|worcester|massachusetts|united states` — added _(2026-05-12)_ - `locations.university of massachusetts worcester|worcester|massachusetts|united states` — added _(2026-05-12)_ - `locations.center for digestive health|troy|michigan|united states` — added _(2026-05-12)_ - `locations.surgical centers of michigan|troy|michigan|united states` — added _(2026-05-12)_ - `locations.minneapolis heart institute, west health campus|minneapolis|minnesota|united states` — added _(2026-05-12)_ - `locations.noran neurology clinic|minneapolis|minnesota|united states` — added _(2026-05-12)_ - `locations.consulting radiology (xray testing only)|plymouth|minnesota|united states` — added _(2026-05-12)_ - `locations.minnesota gastroenterology, p.a.|plymouth|minnesota|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT01276509.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT01276509* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*