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Stopping Aminosalicylate Therapy in Inactive Crohn's Disease (STATIC)

Primary Purpose

Crohn Disease, Remission

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
5-ASA Withdrawal
Sponsored by
Alimentiv Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Crohn Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Documented diagnosis of CD at least 3 months prior to enrollment
  • Taking any brand or dosage of an oral aminosalicylate for at least 6 months
  • Subject-confirmed compliance with current aminosalicylate therapy (taking at least 75% of prescribed doses)
  • CD currently in clinical remission

Exclusion Criteria:

  • A current diagnosis of UC, indeterminate colitis, microscopic colitis, or diverticular disease-associated colitis
  • A diagnosis of short-bowel syndrome
  • Active perianal disease
  • Active fistulizing disease
  • A flare of CD within 3 months prior to enrollment requiring initiation/escalation of medical therapy or surgery
  • Use of systemic corticosteroids for CD (2 continuous weeks or more) within 3 months prior to enrollment
  • Any major resective bowel surgery for CD (ileal resection, ileocecal resection, proctocolectomy, colectomy, enterectomy, ostomy formation and repair, anastomosis/reanastomosis) within 6 months prior to enrollment
  • Unwillingness to stop taking aminosalicylates for the duration of the trial
  • Untreated bile salt malabsorption that, in the opinion of the investigator, may interfere with accurate study HBI assessment
  • Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the subject's ability to participate fully in the study
  • History of active alcohol or drug abuse that, in the opinion of the investigator, may interfere with the subject's ability to comply with the study procedures

Sites / Locations

  • University of CalgaryRecruiting
  • University of AlbertaRecruiting
  • Dr. Jesse Siffledeen Professional Medical CorporationRecruiting
  • (G.I.R.I.) GI Research InstituteRecruiting
  • Discovery Clinical Services Ltd.
  • PerCuro Clinical Research Ltd.
  • University of Manitoba - Health Sciences Centre
  • McMaster University
  • London Health Sciences Centre - University HospitalRecruiting
  • Scott Shulman Medical Professional Corporation
  • Taunton Surgical CenterRecruiting
  • Mount Sinai Hospital
  • Dr. O. Tarabain Medicine Professional CorporationRecruiting
  • McGill University HealthcareRecruiting
  • IRCCS Policlinico San DonatoRecruiting
  • UOC Gastroenterologic UOS Malattie Infiammatorie Intestinali, OspedaliRecruiting
  • IRCCA De BellisRecruiting
  • Luigi Vanvitelli of CampaniaRecruiting
  • Intituto Clinico HumanitasRecruiting
  • Azienda Ospedale-Universita Padova
  • Campus Bio-Medico University of RomeRecruiting
  • BYK - KyivRecruiting
  • Danylo Halytsky Lviv National Medical University
  • Odesa Regional Clinical HospitalRecruiting
  • Ternopil University HospitalRecruiting
  • Vinnytsia Nation Medical University N.I. Pirogov
  • Warrington and Halton Hospitals NHS Foundation TrustRecruiting
  • Darlington Memorial HospitalRecruiting
  • Basildon and Thurrock University Hospitals NHS Foundation TrustRecruiting
  • Royal Blackburn Hospital
  • St. Marks HospitalRecruiting
  • Sherwood Forest Hospitals NHS Foundation Trust - Kings Mill HospitalRecruiting
  • Barnsley Hospital NHS TrustRecruiting
  • Bedford Hospital NHS TrustRecruiting
  • West Suffolk Hospital
  • Northern Care Alliance NHS Group - Fairfield General HospitalRecruiting
  • Addenbrooke's NHS
  • Royal Devon and Exeter NHS Foundation TrustRecruiting
  • Royal Free HospitalRecruiting
  • Guy's and St. Thomas' Hospitals NHS TrustRecruiting
  • Luton and Dustable Hospital Foundation TrustRecruiting
  • Nottingham University Hospitals NHS Trust and University of NottinghamRecruiting
  • Royal Berkshire NHS Foundation TrustRecruiting
  • Salford Ryal NHS Foundation TrustRecruiting
  • Airedale NHS Foundation TrustRecruiting
  • Royal Hampshire County Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

5-ASA Continuation

5-ASA Withdrawal

Arm Description

Half of the subjects will continue on aminosalicylate therapy using the same dose and brand for the duration of the study

Half of the subjects will discontinue their aminosalicylate therapy

Outcomes

Primary Outcome Measures

CD-related complications at 2 years
CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication

Secondary Outcome Measures

CD-related complications at 1 year
CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication
CD-related or CD-treatment related surgeries at 1 year
CD-related or CD-treatment related surgeries at 2 years
CD-related or CD-treatment related hospitalizations at 1 year
CD-related or CD-treatment related hospitalizations at 2 years
Other CD-related or CD-treatment related complications at 1 year
Other complication excludes surgeries or hospitalizations
Other CD-related or CD-treatment related complications at 2 years
Other complication excludes surgeries or hospitalizations
Proportion of patients who require the use of systemic corticosteroids for treatment of CD flares at 1 year
Proportion of patients who require the use of systemic corticosteroids for treatment of CD flares at 2 years
Time to first CD-related complication
CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication
Change in disease activity at 6 months
Disease activity assessed by HBI score
Change in disease activity at 12 months
Disease activity assessed by HBI score
Change in disease activity at 24 months
Disease activity assessed by HBI score
Change in self-assessed quality of life at 6 months
Quality of life assessed with the Crohn's and Ulcerative Colitis Questionnaire 32-item
Change in self-assessed quality of life at 1 year
Quality of life assessed with the Crohn's and Ulcerative Colitis Questionnaire 32-item
Change in self-assessed quality of life at 2 years
Quality of life assessed with the Crohn's and Ulcerative Colitis Questionnaire 32-item
Change in C-reactive protein concentration at 6 months
Change in C-reactive protein concentration at 1 year
Change in C-reactive protein concentration at 2 years
Change in fecal calprotectin concentration at 1 year
Change in fecal calprotectin concentration at 2 years
Change in CD-related drug treatment costs at 2 years
Estimated drug treatment costs before and after enrollment
Change in CD-related and total healthcare costs at 2 years
Estimated costs before and after enrollment

Full Information

First Posted
August 22, 2017
Last Updated
February 6, 2023
Sponsor
Alimentiv Inc.
Collaborators
Academic Medical Organization of Southwestern Ontario
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1. Study Identification

Unique Protocol Identification Number
NCT03261206
Brief Title
Stopping Aminosalicylate Therapy in Inactive Crohn's Disease
Acronym
STATIC
Official Title
Stopping Aminosalicylate Therapy in Inactive Crohn's Disease (STATIC) Study: A Randomized, Open-label, Non-inferiority Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 20, 2017 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alimentiv Inc.
Collaborators
Academic Medical Organization of Southwestern Ontario

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess whether withdrawal of aminosalicylate (5-ASA) is non-inferior to continuation of 5-ASA therapy in Crohn's disease (CD) subjects in remission.
Detailed Description
Aminosalicylate (5-ASA) agents have proven effective for inducing and maintaining remission in mild to moderate ulcerative colitis (UC) and thus are commonly used as first-line agents for patients with Crohn's disease (CD) in remission. However, there is uncertainty regarding their effectiveness for CD. In this open-label, randomized study, participants with CD in remission will be allocated to either continue their 5-ASA therapy or withdraw their 5-ASA. The purpose is to investigate if withdrawal of 5-ASA therapy is not unacceptably less effective than continuing on 5-ASA in maintaining CD remission over a 24 month period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease, Remission

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1580 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
5-ASA Continuation
Arm Type
No Intervention
Arm Description
Half of the subjects will continue on aminosalicylate therapy using the same dose and brand for the duration of the study
Arm Title
5-ASA Withdrawal
Arm Type
Experimental
Arm Description
Half of the subjects will discontinue their aminosalicylate therapy
Intervention Type
Other
Intervention Name(s)
5-ASA Withdrawal
Intervention Description
Withdrawal of 5-ASA therapy
Primary Outcome Measure Information:
Title
CD-related complications at 2 years
Description
CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication
Time Frame
24 months
Secondary Outcome Measure Information:
Title
CD-related complications at 1 year
Description
CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication
Time Frame
12 months
Title
CD-related or CD-treatment related surgeries at 1 year
Time Frame
12 months
Title
CD-related or CD-treatment related surgeries at 2 years
Time Frame
24 months
Title
CD-related or CD-treatment related hospitalizations at 1 year
Time Frame
12 months
Title
CD-related or CD-treatment related hospitalizations at 2 years
Time Frame
24 months
Title
Other CD-related or CD-treatment related complications at 1 year
Description
Other complication excludes surgeries or hospitalizations
Time Frame
12 months
Title
Other CD-related or CD-treatment related complications at 2 years
Description
Other complication excludes surgeries or hospitalizations
Time Frame
24 months
Title
Proportion of patients who require the use of systemic corticosteroids for treatment of CD flares at 1 year
Time Frame
12 months
Title
Proportion of patients who require the use of systemic corticosteroids for treatment of CD flares at 2 years
Time Frame
24 months
Title
Time to first CD-related complication
Description
CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication
Time Frame
up to 24 months
Title
Change in disease activity at 6 months
Description
Disease activity assessed by HBI score
Time Frame
6 months
Title
Change in disease activity at 12 months
Description
Disease activity assessed by HBI score
Time Frame
12 months
Title
Change in disease activity at 24 months
Description
Disease activity assessed by HBI score
Time Frame
24 months
Title
Change in self-assessed quality of life at 6 months
Description
Quality of life assessed with the Crohn's and Ulcerative Colitis Questionnaire 32-item
Time Frame
Base line and 6 months
Title
Change in self-assessed quality of life at 1 year
Description
Quality of life assessed with the Crohn's and Ulcerative Colitis Questionnaire 32-item
Time Frame
Base line and 12 months
Title
Change in self-assessed quality of life at 2 years
Description
Quality of life assessed with the Crohn's and Ulcerative Colitis Questionnaire 32-item
Time Frame
Base line and 24 months
Title
Change in C-reactive protein concentration at 6 months
Time Frame
Base line and 6 months
Title
Change in C-reactive protein concentration at 1 year
Time Frame
Base line and 12 months
Title
Change in C-reactive protein concentration at 2 years
Time Frame
Base line and 24 months
Title
Change in fecal calprotectin concentration at 1 year
Time Frame
Base line and 12 months
Title
Change in fecal calprotectin concentration at 2 years
Time Frame
Base line and 24 months
Title
Change in CD-related drug treatment costs at 2 years
Description
Estimated drug treatment costs before and after enrollment
Time Frame
12 months prior to enrollment and 24 months after enrollment
Title
Change in CD-related and total healthcare costs at 2 years
Description
Estimated costs before and after enrollment
Time Frame
12 months prior to enrollment and 24 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented diagnosis of CD at least 3 months prior to enrollment Taking any brand or dosage of an oral aminosalicylate for at least 6 months Subject-confirmed compliance with current aminosalicylate therapy (taking at least 75% of prescribed doses) CD currently in clinical remission Able to participate fully in all aspects of the clinical trial Written informed consent obtained and documented Exclusion Criteria: A current diagnosis of UC, indeterminate colitis, microscopic colitis, or diverticular disease-associated colitis A diagnosis of short-bowel syndrome Active perianal disease Active fistulizing disease A flare of CD within 3 months prior to enrollment requiring initiation/escalation of medical therapy or surgery Use of systemic corticosteroids for CD (2 continuous weeks or more) within 3 months prior to enrollment Any major resective bowel surgery for CD (ileal resection, ileocecal resection, proctocolectomy, colectomy, enterectomy, ostomy formation and repair, anastomosis/reanastomosis) within 6 months prior to enrollment Unwillingness to stop taking aminosalicylates for the duration of the trial Untreated bile salt malabsorption that, in the opinion of the investigator, may interfere with accurate study HBI assessment Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the subject's ability to participate fully in the study History of active alcohol or drug abuse that, in the opinion of the investigator, may interfere with the subject's ability to comply with the study procedures Currently participating in another interventional trial, or previous participation within the last 3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heather MacAulay
Phone
226-270-7683
Email
heather.macaulay@alimentiv.com
First Name & Middle Initial & Last Name or Official Title & Degree
Vipul Jairath, MD
Phone
(226) 270-7683
Ext
1027
Email
vipul.jairath@robartsinc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vipul Jairath, MD
Organizational Affiliation
Western University; London Health Sciences Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gordon Moran, MD
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nima Hamidi
Email
nima.hamidi@ucalgary.ca
First Name & Middle Initial & Last Name & Degree
Heather Baylis
Email
hbaylis@ucalgary.ca
First Name & Middle Initial & Last Name & Degree
Remo Panaccione, MD
First Name & Middle Initial & Last Name & Degree
Christopher Ma, MD
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Miller
Phone
780-248-1035
Email
rebecca.gildr@ualberta.ca
First Name & Middle Initial & Last Name & Degree
Brendan Philip Halloran, MD
Facility Name
Dr. Jesse Siffledeen Professional Medical Corporation
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6L 6K3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christie Cor
Email
christie.cor@sedmgastro.ca
First Name & Middle Initial & Last Name & Degree
Jesse Sifledden, MD
Facility Name
(G.I.R.I.) GI Research Institute
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 2K5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Schmidt
Email
maria.a.schmit@gmail.com
First Name & Middle Initial & Last Name & Degree
Gregory Rosenfeld, MD
Facility Name
Discovery Clinical Services Ltd.
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8T 5G4
Country
Canada
Individual Site Status
Completed
Facility Name
PerCuro Clinical Research Ltd.
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3M9
Country
Canada
Individual Site Status
Withdrawn
Facility Name
University of Manitoba - Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Individual Site Status
Completed
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
Individual Site Status
Withdrawn
Facility Name
London Health Sciences Centre - University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Prins
Phone
519-685-8500
Ext
33344
Email
heather.prins@lhsc.on.ca
First Name & Middle Initial & Last Name & Degree
Tricia Leavens
Phone
519-685-8500
Ext
35992
Email
tricia.leavens@lhsc.ca
First Name & Middle Initial & Last Name & Degree
Melanie Beaton, MD
Facility Name
Scott Shulman Medical Professional Corporation
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B2H3
Country
Canada
Individual Site Status
Completed
Facility Name
Taunton Surgical Center
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1H 7K4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alana Carter
Email
alanacarter01@gmail.com
First Name & Middle Initial & Last Name & Degree
Daniel M. Green
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3L9
Country
Canada
Individual Site Status
Completed
Facility Name
Dr. O. Tarabain Medicine Professional Corporation
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 1E6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Marcon
Phone
519-915-4456
Email
ml.marcon@hotmail.com
First Name & Middle Initial & Last Name & Degree
Osman Tarabain, MD
Facility Name
McGill University Healthcare
City
Montréal
State/Province
Quebec
ZIP/Postal Code
N6A 5B6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Laneuville
Email
jennifer.laneuville@muhc.mcgill.ca
First Name & Middle Initial & Last Name & Degree
Carolyne Lemieux
Email
carolune.lemieux@muhc.mcgill.ca
First Name & Middle Initial & Last Name & Degree
Talat Bessissow
Facility Name
IRCCS Policlinico San Donato
City
San Donato Milanese
State/Province
Milan Italy
ZIP/Postal Code
20097
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Laura Annuziata, MD
Facility Name
UOC Gastroenterologic UOS Malattie Infiammatorie Intestinali, Ospedali
City
Roma
State/Province
Rome
ZIP/Postal Code
00135
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stafano Festa, MD
Facility Name
IRCCA De Bellis
City
Castellana Grotte
State/Province
Via Turi
ZIP/Postal Code
27-70013
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mauro Mastronardi, MD
Facility Name
Luigi Vanvitelli of Campania
City
Catania
ZIP/Postal Code
95123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnese Miranda, MD
Facility Name
Intituto Clinico Humanitas
City
Milano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvio Danese, MD
Facility Name
Azienda Ospedale-Universita Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabiana Zingone, MD
Facility Name
Campus Bio-Medico University of Rome
City
Roma
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paola Balestrieri, MD
Facility Name
BYK - Kyiv
City
Kyiv
ZIP/Postal Code
01030
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andriy E Dorofyeyev, MD
Facility Name
Danylo Halytsky Lviv National Medical University
City
Lviv
ZIP/Postal Code
79059
Country
Ukraine
Individual Site Status
Completed
Facility Name
Odesa Regional Clinical Hospital
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olena Levchenko, MD
Facility Name
Ternopil University Hospital
City
Ternopil
ZIP/Postal Code
46002
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ihor Hospodarsky, MD
Facility Name
Vinnytsia Nation Medical University N.I. Pirogov
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mykola Stanislavchuk, MD
Facility Name
Warrington and Halton Hospitals NHS Foundation Trust
City
Warrington
State/Province
Cheshire
ZIP/Postal Code
WA5 1QG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nemonie Marriott
Phone
1925 275513
Email
Nemonie.marriott@nhs.net
First Name & Middle Initial & Last Name & Degree
Subramaniam Ramakrishnan
Facility Name
Darlington Memorial Hospital
City
Darlington
State/Province
Durham
ZIP/Postal Code
DL3 6HX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellen Brown
Phone
325743376
Email
ellen.brown2@nhs.net
First Name & Middle Initial & Last Name & Degree
Anjan Dhar
Facility Name
Basildon and Thurrock University Hospitals NHS Foundation Trust
City
Basildon
State/Province
Essex
ZIP/Postal Code
SS16 5NL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Nicholson
Phone
1268524900
Ext
3599
First Name & Middle Initial & Last Name & Degree
Mark Jarvis
Facility Name
Royal Blackburn Hospital
City
Blackburn
State/Province
Lancashire
ZIP/Postal Code
BB2 3HH
Country
United Kingdom
Individual Site Status
Completed
Facility Name
St. Marks Hospital
City
Harrow
State/Province
Middlesex
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teena Varghese
Phone
44 20 8869 5804
First Name & Middle Initial & Last Name & Degree
Sheena Quaid
Phone
44 20 8967 5000
Ext
3466
First Name & Middle Initial & Last Name & Degree
Nalia Arebi
Facility Name
Sherwood Forest Hospitals NHS Foundation Trust - Kings Mill Hospital
City
Sutton In Ashfield
State/Province
Nottinghamshire
ZIP/Postal Code
NG17 4JL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynne Allsop
Phone
1623622515
Ext
3313
Email
lynne.allsop1@nhs.net
First Name & Middle Initial & Last Name & Degree
Stephen Foley
Facility Name
Barnsley Hospital NHS Trust
City
Barnsley
State/Province
Yorkshire
ZIP/Postal Code
S75 2EP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mishell Cunningham
Phone
004 41 22 643 2096
Email
mishellcunningham@nhs.net
First Name & Middle Initial & Last Name & Degree
Robert Atkinson
Facility Name
Bedford Hospital NHS Trust
City
Bedford
ZIP/Postal Code
MK42 9DJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carina Gapin
Phone
44 123455122
Ext
5965
Email
carina.galpin@bedfordhospital.nhs.uk
First Name & Middle Initial & Last Name & Degree
Babur Javaid
Facility Name
West Suffolk Hospital
City
Bury St Edmunds
ZIP/Postal Code
IP33 2QZ
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Northern Care Alliance NHS Group - Fairfield General Hospital
City
Bury
ZIP/Postal Code
BL9 7TD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruth Craddock
Phone
0161 788 8720
Email
ruth.craddock@pat.nhs.uk
First Name & Middle Initial & Last Name & Degree
Jimmy K Limdi, MD
Facility Name
Addenbrooke's NHS
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
Royal Devon and Exeter NHS Foundation Trust
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzie Marriott
Email
suzie.marriott@nhs.net
First Name & Middle Initial & Last Name & Degree
Tariq Ahmad, MD
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
Nw3 2QG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Witele
Phone
0207 794 0500
Email
eric.witele@nhs.net
First Name & Middle Initial & Last Name & Degree
Charles Murray
Facility Name
Guy's and St. Thomas' Hospitals NHS Trust
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Namoi Hare
Phone
7918 338590
Email
naomi.hare@gstt.nhs.uk
First Name & Middle Initial & Last Name & Degree
Peter Irving
Facility Name
Luton and Dustable Hospital Foundation Trust
City
Luton
ZIP/Postal Code
LU4 0DZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kabiru Kasamu
Email
Kasamu.Kabiru@ldh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Matthew Johnson, MD
Facility Name
Nottingham University Hospitals NHS Trust and University of Nottingham
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shellie Radford, RN
Phone
0115 9249924
Ext
60604
Email
Shellie.Radford@nuh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Gordon Moran, MD
Facility Name
Royal Berkshire NHS Foundation Trust
City
Reading
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susanna Malkakorpi
Phone
118 322 6973
Email
susanna.malkakorpi@royalberkshire.nhs.uk
First Name & Middle Initial & Last Name & Degree
Aminda De Silva, MD
Facility Name
Salford Ryal NHS Foundation Trust
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Taylor
Phone
1612065116
Email
melanie.taylor@srft.nhs.uk
First Name & Middle Initial & Last Name & Degree
Arash Assadsangabi
Facility Name
Airedale NHS Foundation Trust
City
Steeton
ZIP/Postal Code
BD20 6TD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Dooks
Phone
01535 292279
Email
Emma.Dooks@anhst.nhs.uk
First Name & Middle Initial & Last Name & Degree
Richard Shenderey, MD
Facility Name
Royal Hampshire County Hospital
City
Winchester
ZIP/Postal Code
SO22 5DG
Country
United Kingdom
Individual Site Status
Withdrawn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Stopping Aminosalicylate Therapy in Inactive Crohn's Disease

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