Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease (OPERA)

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)

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.

Study Overview

• Status: Completed
• Conditions: Crohn's Disease
• Intervention / Treatment: Drug: PF-00547659 SC injection; Drug: PF-00547659 SC injection; Drug: PF-00547659 SC injection; Drug: PF-00547659 SC injection

• Study Type: Interventional
• Enrollment (Actual): 265
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria, 1090
    • AKH Wien Universitaetsklinik fuer Innere Medizin III
• Belgium
  • Leuven, Belgium, B-3000
    • UZ Gasthuisberg
  • Liege, Belgium, 4000
    • Centre Hospitalier Universitaire de Liège
  • Liege, Belgium, 4000
    • Centre Hospitalier Universitaire de Liège - Labo Biologie Clinique
  • Mouscron, Belgium, 7700
    • Centre Hospitalier de Mouscron
• Bulgaria
  • Sofia, Bulgaria, 1000
    • 4-MHAT
  • Sofia, Bulgaria, 1979
    • MBAL Sofiamed OOD,Otdelenie po gastroenterologia
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver Coastal Health - Vancouver General Hospital
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver Coastal Health - Vancouver Hospital
  • Ontario
    • Oshawa, Ontario, Canada, L1H 1B9
      • Oshawa Clinic
    • Vaughan, Ontario, Canada, L4L 4Y7
      • Toronto Digestive Disease Associates Inc.
• France
  • Amiens Cedex 01, France, 80054
    • CHU Amiens Hopital Nord Service d'Hepato-Gastroenterologie
  • Bordeaux cedex, France, 33075
    • Hopital Saint-Andre
  • Clichy Cedex, France, 92110
    • Hopital Beaujon- Essais cliniques
  • NICE Cedex 3, France, 06202
    • Hopital de l'Archet 2 - CHU de Nice
  • Paris, France, 75014
    • Hopital Cochin-Essais Cliniques
  • Rouen Cedex 1, France, 76031
    • Hopital Charles Nicolle
  • St Priest En Jarez, France, 42270
    • Hopital Nord
  • Toulouse cedex 09, France, 31059
    • Hôpital Rangueil
• Germany
  • Berlin, Germany, 10117
    • Charite - Campus Berlin Mitte Medizinische Klinik
  • Halle, Germany, 06120
    • Krankenhaus Martha-Maria Halle-Doelau gGmbH
  • Kiel, Germany, 24105
    • Universitaetsklinikum Schleswig-Holstein
  • Luebeck, Germany, 23538
    • Universitaetsfrauenklinikum Schleswig-Holstein Medizinische Klinik I, Gastroenterologie/Hepatologie
  • Minden, Germany, 32423
    • Gastroenterologische Gemeinschaftspraxis Minden
  • Regensburg, Germany, 93042
    • Universitaetsklinikum Regensburg
  • Stuttgart, Germany, 70376
    • Robert-Bosch-Krankenhaus
  • Ulm, Germany, 89081
    • Universitaetklinikum Ulm
• Japan
  • Aichi, Japan, 480-1195
    • Aichi Medical University Hospital
  • Chiba, Japan, 260-8677
    • Chiba University Hospital
  • Kanagawa, Japan, 232-0024
    • Yokohama City University Medical Center
  • Aomori
    • Hirosaki, Aomori, Japan, 036-8545
      • National Hospital Organization Hirosaki National Hospital
  • Gunma
    • Takasaki, Gunma, Japan, 370-0829
      • National Hospital Organization Takasaki General Medical Center
  • Tokyo
    • Minato-ku, Tokyo, Japan, 105-8471
      • Jikei University Hospital
    • Shinjuku-ku, Tokyo, Japan, 160-8582
      • Keio University Hospital
• Korea, Republic of
  • Busan, Korea, Republic of, 602-739
    • Pusan National University Hospital
  • Daegu, Korea, Republic of, 705-717
    • Yeungnam University Hospital
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 110-746
    • Kangbuk Samsung Hospital
  • Seoul, Korea, Republic of, 120-752
    • Yonsei University College of Medicine, Severance Hospital
• Netherlands
  • Maastricht, Netherlands, 6229 HX
    • Maastricht University Medical Center
  • GR
    • Groningen, GR, Netherlands, 9713GZ
      • University Medical Center Groningen (UMCG)
  • NH
    • Amsterdam, NH, Netherlands, 1105 AZ
      • Academic Medical Center
• Norway
  • Gjettum, Norway, 1346
    • Asker and Baerum Hospital
  • Oslo, Norway, 0424
    • Oslo Universitetssykehus
  • Oslo, Norway, 0440
    • Lovisenberg Diakonale Sykehus
• Poland
  • Bydgoszcz, Poland, 85-168
    • Szpital Uniwersytecki nr 2 im dr. Jana Bizieta w Bydgoszczy Centrum Endoskopii Zabiegowej
  • Lodz, Poland, 90-302
    • Centrum Medyczne-Szpital Swietej Rodziny Sp. z o.o.
  • Warszawa, Poland, 02-507
    • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych W Warszawie
  • Wroclaw, Poland, 53-114
    • Lexmedica
• Serbia
  • Belgrade, Serbia, 11000
    • Military Medical Academy
  • Belgrade, Serbia, 11080
    • Clinical Hospital Centre Bezanijska Kosa
  • Nis, Serbia, 18000
    • Clinical Center Nis Clinic for Gastroenterology and Hepatology
  • Zemun, Serbia, 11080
    • Clinical Hospital Center Zemun
• Slovakia
  • Bratislava, Slovakia, 831 04
    • Gastroentero-Hepatologicke centrum THALION, LAMA MEDICAL CARE s.r.o.
  • Bratislava, Slovakia, 851 01
    • Medak s.r.o.
  • Nitra, Slovakia, 949 01
    • Gastroenterologicke a hepatologicke centrum Nitra, KM Management spol. s r.o.
  • Nove Mesto Nad Vahom, Slovakia, 915 01
    • Synergy group, a.s.
• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2193
      • Wits Clinical Research
  • Kwa-zulu - Natal
    • Durban, Kwa-zulu - Natal, South Africa, 4091
      • Parklands Medical Centre
  • Western CAPE
    • Cape Town, Western CAPE, South Africa, 7708
      • Kingsbury Hospital
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 08907
    • Hospital Universitari Bellvitge
  • Madrid, Spain, 28006
    • Hospital Universitario de La Princesa
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon
  • Sabadell, Spain, 08208
    • Corporacio Sanitaria Parc Tauli de Sabadell
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Puerta de Hierro Majadahonda
• United States
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Clopton Clinic
    • Jonesboro, Arkansas, United States, 72401
      • Gastroenterology Specialists of Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Little Rock Diagnostic Clinic, P.A.
  • California
    • La Jolla, California, United States, 92037
      • UCSD Medical Center-Thornton Hospital
    • Orange, California, United States, 92868
      • Community Clinical Trials
    • Orange, California, United States, 92868
      • Gastro Diagnostics
    • Redlands, California, United States, 92374
      • Inland Gastroenterology Medical Associates, Inc.
    • Whittier, California, United States, 90603
      • BioMark Research Inc.
  • Colorado
    • Lafayette, Colorado, United States, 80026
      • Clinical Research of the Rockies
    • Thornton, Colorado, United States, 80229
      • Rocky Mountain Gastroenterology Associates
  • Connecticut
    • Bristol, Connecticut, United States, 06010
      • Connecticut Clinical Research Foundation
  • Florida
    • Gainesville, Florida, United States, 32610
      • Shands Hospital at the University of Florida
    • Gainesville, Florida, United States, 32608
      • Shands Endoscopy Center
    • Gainesville, Florida, United States, 32610
      • Shands Medical Plaza
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Jacksonville
    • Largo, Florida, United States, 33777
      • Florida Center for Gastroenterology
    • Miami, Florida, United States, 33136
      • Sylvester Comprehensive Cancer Center
    • Miami, Florida, United States, 33136
      • University of Miami Hospital
    • Miami, Florida, United States, 33136
      • University of Miami Hospital and Clinic
    • Miami, Florida, United States, FL 33136
      • University of Miami
    • Orlando, Florida, United States, 32806
      • Internal Medicine Specialists
    • Orlando, Florida, United States, 32806
      • Cirtus Ambulartory Surgery Center
  • Iowa
    • Clive, Iowa, United States, 50325
      • Iowa Digestive Disease Center
    • Clive, Iowa, United States, 50325
      • Heartland Medical Research (Administrative Only)
    • Clive, Iowa, United States, 50325
      • Iowa Endoscopy Center (Colonoscopy Only)
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • UMass Memorial Medical Center
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Worcester
  • Michigan
    • Troy, Michigan, United States, 48098
      • Center for Digestive Health
    • Troy, Michigan, United States, 48098
      • Surgical Centers of Michigan
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Minneapolis Heart Institute, West Health Campus
    • Minneapolis, Minnesota, United States, 55407
      • Noran Neurology Clinic
    • Plymouth, Minnesota, United States, 55446
      • Minnesota Gastroenterology, P.A.
    • Plymouth, Minnesota, United States, 55446
      • Consulting Radiology (Xray testing only)
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Surgery Center of Columbia
    • Mexico, Missouri, United States, 65265
      • Audrain Medical Center
    • Mexico, Missouri, United States, 65265
      • Center for Digestive and Liver Diseases, Inc.
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
    • Saint Louis, Missouri, United States, 63110
      • Center for Advanced Medicine
    • Saint Louis, Missouri, United States, 63110
      • Barnes-Jewish Hospital - Investigational Drug Services
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical College
    • Brooklyn, New York, United States, 11206
      • Life Medi-research and Management
    • Flushing, New York, United States, 11355
      • New York Hospital Queens
    • Great Neck, New York, United States, 11021
      • Long Island Clinical Research Associates, LLP
    • Great Neck, New York, United States, 11021
      • Nassau Gastroenterology Associates Office Based Surgery
    • Great Neck, New York, United States, 11021
      • Nassau Gastroenterology Associates, P.C.
    • Great Neck, New York, United States, 11021
      • North Shore Primary Care, P.C.
    • New York, New York, United States, 10003
      • Beth Israel Medical Center - Phillip Ambulatory Care Center
    • New York, New York, United States, 10010
      • East side Endoscopy, LLC (for colonscopy testing only)
    • New York, New York, United States, 10075
      • Lenox Hill Endoscopy Center
    • Poughkeepsie, New York, United States, 12601
      • Premier Medical Group of the Hudson Valley
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • CTRC Hospital - UNC Memorial Hospital
    • Chapel Hill, North Carolina, United States, 27514
      • North Carolina Memorial Hospital Endoscopy Center
    • Chapel Hill, North Carolina, United States, 27514
      • UNC Hospitals Department of Pharmacy
    • Chapel Hill, North Carolina, United States, 27517
      • UNC Hospitals Endoscopy
    • Hillsborough, North Carolina, United States, 27278
      • Hillsborough Campus
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • The Offices of Dr. Vincent Armenio, M.D.
    • East Providence, Rhode Island, United States, 02915
      • Pharma Resource
    • Providence, Rhode Island, United States, 02905
      • Bayside Endoscopy Center
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • Nashville Medical Research Institute
  • Texas
    • Pasadena, Texas, United States, 77505
      • Pasadena Gastroenterology Associates, P.A. dba Digestive Health Center
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah HSC
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research
    • Charlottesville, Virginia, United States, 22902
      • Charlottesville Gastroenterology Associates
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center
  • Wisconsin
    • Wauwatosa, Wisconsin, United States, 53226
      • Allegiance Research Specialists
    • Wauwatosa, Wisconsin, United States, 53226
      • GI Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo-SC Injection; Placebo delivered SC, 3 doses separated by 4 weeks.	Drug: PF-00547659 SC injection; Placebo delivered SC, 3 doses separated by 4 weeks; Drug: PF-00547659 SC injection; Drug dose level 1 delivered SC, 3 doses separated by 4 weeks; Drug: PF-00547659 SC injection; Drug dose level 2 delivered SC, 3 doses separated by 4 weeks; Drug: PF-00547659 SC injection; Drug dose level 3 delivered SC, 3 doses separated by 4 weeks
Experimental: Drug Dose level 1- SC injection; Drug dose level 1 delivered SC, 3 doses separated by 4 weeks.	Drug: PF-00547659 SC injection; Placebo delivered SC, 3 doses separated by 4 weeks; Drug: PF-00547659 SC injection; Drug dose level 1 delivered SC, 3 doses separated by 4 weeks; Drug: PF-00547659 SC injection; Drug dose level 2 delivered SC, 3 doses separated by 4 weeks; Drug: PF-00547659 SC injection; Drug dose level 3 delivered SC, 3 doses separated by 4 weeks
Experimental: Drug Dose level 2-SC injection; Drug dose level 2 delievered SC, 3 doses separated by 4 weeks.	Drug: PF-00547659 SC injection; Placebo delivered SC, 3 doses separated by 4 weeks; Drug: PF-00547659 SC injection; Drug dose level 1 delivered SC, 3 doses separated by 4 weeks; Drug: PF-00547659 SC injection; Drug dose level 2 delivered SC, 3 doses separated by 4 weeks; Drug: PF-00547659 SC injection; Drug dose level 3 delivered SC, 3 doses separated by 4 weeks
Experimental: Drug Dose level 3- SC injection; Drug dose level 3 delivered SC, 3 doses separated by 4 weeks.	Drug: PF-00547659 SC injection; Placebo delivered SC, 3 doses separated by 4 weeks; Drug: PF-00547659 SC injection; Drug dose level 1 delivered SC, 3 doses separated by 4 weeks; Drug: PF-00547659 SC injection; Drug dose level 2 delivered SC, 3 doses separated by 4 weeks; Drug: PF-00547659 SC injection; Drug dose level 3 delivered SC, 3 doses separated by 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Shire

Publications and helpful links

General Publications

• Saruta M, Park DI, Kim YH, Yang SK, Jang BI, Cheon JH, Im JP, Kanai T, Katsuno T, Ishiguro Y, Nagaoka M, Isogawa N, Li Y, Banerjee A, Ahmad A, Hassan-Zahraee M, Clare R, Gorelick KJ, Cataldi F, Watanabe M, Hibi T. Anti-MAdCAM-1 antibody (PF-00547659) for active refractory Crohn's disease in Japanese and Korean patients: the OPERA study. Intest Res. 2020 Jan;18(1):45-55. doi: 10.5217/ir.2019.00039. Epub 2020 Jan 30.
• Sandborn WJ, Lee SD, Tarabar D, Louis E, Klopocka M, Klaus J, Reinisch W, Hebuterne X, Park DI, Schreiber S, Nayak S, Ahmad A, Banerjee A, Brown LS, Cataldi F, Gorelick KJ, Cheng JB, Hassan-Zahraee M, Clare R, D'Haens GR. Phase II evaluation of anti-MAdCAM antibody PF-00547659 in the treatment of Crohn's disease: report of the OPERA study. Gut. 2018 Oct;67(10):1824-1835. doi: 10.1136/gutjnl-2016-313457. Epub 2017 Oct 5.
• Hassan-Zahraee M, Banerjee A, Cheng JB, Zhang W, Ahmad A, Page K, von Schack D, Zhang B, Martin SW, Nayak S, Reddy P, Xi L, Neubert H, Fernandez Ocana M, Gorelick K, Clare R, Vincent M, Cataldi F, Hung K. Anti-MAdCAM Antibody Increases ss7+ T Cells and CCR9 Gene Expression in the Peripheral Blood of Patients With Crohn's Disease. J Crohns Colitis. 2018 Jan 5;12(1):77-86. doi: 10.1093/ecco-jcc/jjx121.

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2011
• Primary Completion (Actual): February 7, 2014
• Study Completion (Actual): October 9, 2015

Study Registration Dates

• First Submitted: January 12, 2011
• First Submitted That Met QC Criteria: January 12, 2011
• First Posted (Estimate): January 13, 2011

Study Record Updates

• Last Update Posted (Actual): June 3, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Crohn's disease Safety Efficacy Pharmacokinetics Pharmacodynamics Crohn's Disease Activity Index (CDAI)
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: A7281006; 2010-023437-30 (EudraCT Number); OPERA (Alias Study Number)