CTRI/2024/07/071353 [Registered on: 25/07/2024] Trial Registered Prospectively
Last Modified On:
11/09/2024
Post Graduate Thesis
No
Type of Trial
PMS
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
Tofacitinib Tablets in the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis, and Ulcerative Colitis
Scientific Title of Study
A Multi-Centric, Active Post Marketing Surveillance Study to Assess the Safety and Efficacy of Tofacitinib Extended Release Tablets 11 mg for the Treatment of Adult Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Ulcerative Colitis
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
ICR/22/PMS/001_Version No. 1.0_Dated 20/JUL/2022
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Pravin Ghadge
Designation
AVP and Head – India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun Pharma Laboratories Limited Sun house, Plot No. 201, B/1,
Western Express Highway, Goregaon east.
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
Email
pravin.ghadge@sunpharma.com
Details of Contact Person Scientific Query
Name
Dr Dipesh Sonawane
Designation
DGM – India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun Pharma Laboratories Limited Sun house, Plot No. 201, B/1,
Western Express Highway, Goregaon east.
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
Email
Dipesh.Sonawane@sunpharma.com
Details of Contact Person Public Query
Name
Dr Rajiv Yadav
Designation
Senior Manager-India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun Pharma Laboratories Limited Sun house, Plot No. 201, B/1,
Western Express Highway, Goregaon east.
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
Email
Rajiv.Yadav1@sunpharma.com
Source of Monetary or Material Support
Sun Pharmaceutical Industries Limited (SPIL)
Sun House, Plot No. 201 B/1, Western Express Highway,
Goregaon (E), Mumbai 400 063, Maharashtra, India
Primary Sponsor
Name
Sun Pharmaceutical Industries Limited (SPIL)
Address
Sun House, Plot No. 201 B/1, Western Express Highway,
Goregaon (E), Mumbai 400 063, Maharashtra, India
Institutional Ethics Committee, MLN Medical College
Submittted/Under Review
Institutional Ethics Committee, MLN Medical College
Approved
Institutional Ethics Committee, Osmania General Hospital
Submittted/Under Review
IPGME&R and Research Oversight Committee
Submittted/Under Review
J.K. Orthopaedic Hospital Ethics Committee
Approved
Medilink Ethics Committee
Approved
Ojas Multispeciality Hospital Ethics Committee
Submittted/Under Review
Suraksha Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: M059||Rheumatoid arthritis with rheumatoid factor, unspecified,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
NA
NA
Intervention
Tofacitinib Extended Release Tablets 11 mg
One tablet should be taken orally once daily with or without food from Day 1 to Day 84
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Patients of either gender, aged between greater than or equal to 18 years to lesser than or equal to 65 years
2. Patient with moderately to severely active Rheumatoid Arthritis, OR active Psoriatic Arthritis, OR moderately to severely Ulcerative Colitis, as per the treating physician’s clinical judgment (Physician Global Assessment)
3. Patients who are willing to provide informed consent to collect the surveillance data
ExclusionCriteria
Details
1. Patients with history of intolerance or hypersensitivity to any of the Tofacitinib including its components
2. Patient with any clinically significant disorder that, in the opinion of the treating physician would result in jeopardizing patient safety and his/ her inability to understand and comply with the requirements of the surveillance
3. Pregnant women and nursing mothers
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Proportion of patients with TEAEs
Proportion of patients with TEAEs
Secondary Outcome
Outcome
TimePoints
Percentage of patients with PGA response
Day 28, 56 and 84
Target Sample Size
Total Sample Size="268" Sample Size from India="268" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This will be a
multi-centric, active post marketing surveillance to assess the safety and
efficacy of Tofacitinib Extended Release Tablets 11 mg for treatment of
Rheumatoid Arthritis, Psoriatic Arthritis, and Ulcerative Colitis in Indian
adults. Approximately, 268 adult patients will be enrolled in the surveillance.
Treatment will be administered as per treating physician’s discretion based on prescribing
information. Surveillance duration of all patients will be 12 weeks and
surveillance data on safety and efficacy will be collected for a duration of 12
weeks.