The main aim of this study is to assess the efficacy of Tofacitinib in moderate to severe Ulcerative Colitis patients
Design
One arm, non blinded, clinical trial
40 ulcerative colitis patients who have respond to induction therapy to Tofacitinib, ill be enrolled for continuation of therapy. these patients will recieve Tofacitinib (10 mg/ day) for another 10 months and clinical response to maintenance therapy to Tofacitinib will be assessed in these patients
Settings and conduct
This clinical trial is consisted of only one intervention group. The patients will be drawn from a list of Ulcerative Colitis patients referring to Gastrointestinal out patient clinic of Shariati hospital affiliated with Tehran University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age> 18 years old
Known case of Ulcerative Colitis
Mayo score ≥6 in last 4 months
No clinical response or clinical remission (failed treatment) after anti TNF being used for at least 12- 14 weeks or Azathioporin used for at least 8-10 weeks
Unacceptable side effects after Corticostroid, Azathioprine, Mercaptopurine, Infliximab, or Adalimumab therapy
Being enrolled in phase 1 of study (induction therapy with Tofacitinib)
Clinical response to induction therapy ( 2 months treatment duration) with Tofacitinib
Intervention groups
There is one intervention group in this study which would be selected based on inclusion and exclusion criteria. The included patients will orally receive 2 tablets of Tofacitinib (10mg/ day) for 10 months.
Main outcome variables
Mayo score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181217042020N2
Registration date:2019-03-12, 1397/12/21
Registration timing:registered_while_recruiting
Last update:2019-03-12, 1397/12/21
Update count:0
Registration date
2019-03-12, 1397/12/21
Registrant information
Name
Ali Reza Sima
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8241 5238
Email address
a-sima@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-11, 1397/12/20
Expected recruitment end date
2020-03-10, 1398/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of Tofacitinib in maintenance therapy of patients with ulcerative colitis
Public title
Effects of Tofacitinib on Ulcerative Colitis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age> 18 years old
Known case of Ulcerative Colitis
Mayo score ≥6 in last 4 months
No clinical response or clinical remission (failed treatment) after ant TNF being used for at least 12- 14 weeks or Azathioporin used for at least 8-10 weeks
Unacceptable side effects after Corticostroid, Azathioprine, Mercaptopurine, Infliximab, or Adalimumab therapy
Being enrolled in phase 1 of study (induction therapy with Tofacitinib)
Clinical response to induction therapy ( 2 months treatment duration) with Tofacitinib
Exclusion criteria:
Abnormal chest x ray
pregnant women or women who plan to become pregnant
Acute infection
GFR< 60 ml/ min
Known case of cancer
positive TB test (PPD/ or IGRA test)
Being positive for tests: HBV, HCV, HIV, CMV
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
This study is designed as the second phase of study entitled " Evaluation of Tofacitinib efficacy for induction therapy in patients with Ulcerative Colitis ". In that study, 50 patients aged 18 years and older who had moderate- to severe Ulcerative Colitis and didnot clinically respond to conventional therapy (didnot enter in clinical response or clinical remission phase) will recieve 20 mg / day Tofacitinib (Fanavaran Rojan Mohaghegh darou Co. ) for 2 months. Patients who clinically respond to Tofacitinib (assessed by biochemical and clinical assessment) will enter into second phase which is the present study.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Digestive Disease Research Institute of Tehran University of Medical Sciences
Street address
Digestive Disease Research Institute, Shariati hospital, North Kargar street,
City
Tehran
Province
Tehran
Postal code
1411713135
Approval date
2018-11-03, 1397/08/12
Ethics committee reference number
IR.TUMS.DDRI.REC.1397.016
Health conditions studied
1
Description of health condition studied
Ulcerative Colitis
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis
Primary outcomes
1
Description
Mayo score
Timepoint
At the beginning, 3 months and 9 months after entering this phase of study
Method of measurement
Colonoscopy
Secondary outcomes
1
Description
Lipid profile
Timepoint
At the beginning, 3 months and 9 months after entering this phase of study
Method of measurement
Enzymatic method
2
Description
Liver function test
Timepoint
At the beginning, 3 months and 9 months after entering this phase of study
Method of measurement
Autoanalyser
3
Description
ESR
Timepoint
At the beginning, 3 months and 9 months after entering this phase of study
Method of measurement
Autoanalyser
Intervention groups
1
Description
Intervention group: Medication: Tofacitinib 5 mg; Dose: 10 mg/day (2 tablets); frequency: 2 times per day (1 tablet in the morning; 1 tablet in the evening); Duration: 10 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Digestive Disease Research Institute
Full name of responsible person
Dr. Homayoun Vahedi
Street address
Digestive Disease Research Institute, Shariati hospital, North Kargar street,
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8241 5000
Email
info@ddri.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Digestive Disease Research Institute of Tehran University of Medical Sciences
Full name of responsible person
Dr. Reza Malekzadeh
Street address
Digestive Disease Research Institute, Shariati hospital, North Kargar street
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8241 5000
Fax
+98 21 8241 5400
Email
info@ddri.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Digestive Disease Research Institute of Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Digestive Disease Research Institute
Full name of responsible person
Sudabeh Alatab
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Genetics
Street address
Digestive Disease Research Institute, Shariati hospital, North Kargar street,
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8241 5000
Fax
+98 21 8241 5400
Email
sudabehalatab@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Digestive Disease Research Institute of Tehran University of Medical Sciences
Full name of responsible person
Dr. Homayoun Vahedi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gasteroenterologist
Street address
Digestive Disease Research Institute, Shariati hospital, North Kargar street,
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8241 5000
Email
homayoonvahedi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Digestive Disease Research Institute of Tehran University of Medical Sciences
Full name of responsible person
Sudabeh Alatab
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Genetics
Street address
Digestive Disease Research Institute, Shariati hospital, North Kargar street,
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8241 5000
Email
sudabehalatab@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Data of participants: at the end of study and after publication of results, the file of the primary and secondary outcomes as well as demographic and past medical history of participants could be shared. the consent form: the approved consent form could be shared
When the data will become available and for how long
Start date of sharing:Three months after publication of results End date of sharing: Nine months after publication of results
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
In case academic researchers are interested in obtaining these data, they should contact (by official academic email) the scientific responsible of this study and ask for data. the data can not be used for publishing the paper
From where data/document is obtainable
For requesting the data, thee academic researcher should contact by academic email the scientific responsible of the study Dr. Homayoun Vahedi dr_vahedi@yahoo.com
What processes are involved for a request to access data/document
The reason for requesting the data and type of use should be mentioned in request. if the conditions are satisfactory for the scientific responsible of study and other collaborators of the study, then the requested data will be shared. This process might take up to one month.