| CTRI Number |
CTRI/2024/09/073987 [Registered on: 17/09/2024] Trial Registered Prospectively |
| Last Modified On: |
12/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
A real world evidence study |
| Study Design |
Other |
|
Public Title of Study
|
A prospective study across 10 centers to evaluate persistence on treatment with advanced therapies in rheumatoid arthritis management in routine clinical practice. |
|
Scientific Title of Study
|
A multicenter evaluation of the treatment persistence of advanced therapies (Biological disease-modifying agents and Targeted synthetic Disease Modifying Anti-Rheumatic Drugs) in the treatment of rheumatoid arthritis (RA): A Real World Evidence (RWE) study from India. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| A3921433, Version 2.0 Dated 26 January 2024. |
Protocol Number |
| EUPAS103727 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amod Tilak |
| Designation |
Medical Advisor |
| Affiliation |
Pfizer Limited |
| Address |
The Capital
Plot No. C, The Capital, 1802, 18th Floor, 70, G Block Rd, Bandra Kurla Complex, Bandra East,
Mumbai
MAHARASHTRA
400051
India |
| Phone |
|
| Fax |
|
| Email |
amodmadhav.tilak@pfizer.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amod Tilak |
| Designation |
Medical Advisor |
| Affiliation |
Pfizer Limited |
| Address |
The Capital
Plot No. C, The Capital, 1802, 18th Floor, 70, G Block Rd, Bandra Kurla Complex, Bandra East,
Mumbai
MAHARASHTRA
400051
India |
| Phone |
18008793477 |
| Fax |
|
| Email |
amodmadhav.tilak@pfizer.com |
|
Details of Contact Person
Public Query
|
| Name |
Amod Tilak |
| Designation |
Medical Advisor |
| Affiliation |
Pfizer Limited |
| Address |
The Capital
Plot No. C, The Capital, 1802, 18th Floor, 70, G Block Rd, Bandra Kurla Complex, Bandra East,
MAHARASHTRA
400051
India |
| Phone |
18008793477 |
| Fax |
|
| Email |
amodmadhav.tilak@pfizer.com |
|
|
Source of Monetary or Material Support
|
| Pfizer Limited,
The Capital
Address: Plot No. C, The Capital, 1802, 18th Floor, 70, G Block Rd, Bandra Kurla Complex, Bandra East, Mumbai, Maharashtra 400051 |
|
|
Primary Sponsor
|
| Name |
Pfizer Limited |
| Address |
The Capital
Address: Plot No. C, The Capital, 1802, 18th Floor, 70, G Block Rd, Bandra Kurla Complex, Bandra East, Mumbai, Maharashtra 400051 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arghya Chattopadhyaya |
Asian Institute of Immunology and Rheumatology |
111, PRE. NO-4, Smart Workspace, CBD, 0378, Action Area, New Town, 700156
Kolkata
WEST BENGAL |
8777485459
dr.a.chattopadhyay@gmail.com |
| Dr Arvind Chopra |
Center for Rheumatic Diseases |
Hermes Doctor House, Center for Rheumatic Diseases, 11 Hermes Elegance, 1988, Convent Street, Camp, 411001
Pune
MAHARASHTRA |
9822039297
arvindchopra60@hotmail.com |
| Dr A K Khan |
Centre for Rheumatic Diseases and Regenerative Clinical Medicine |
Arthritis and rheumatology Clinic, Prime Clinics, Gole Market, Shergarhi, Karan Nagar,190010
Srinagar
JAMMU & KASHMIR |
9419000636
akkhan1234@yahoo.com |
| Dr Atanu Pal |
Institute Of Post Graduate Medical Education & Research, SSKM Hospital |
Department of Nephrology, Institute Of Post Graduate Medical Education & Research, SSKM Hospital, Bhowanipore,700020
Kolkata
WEST BENGAL |
9433121697
dratanupal@gmail.com |
| Dr Sakir Ahmed |
Kalinga Institute of Medical Sciences |
Dept of Clinical Immunology and Rheumatology, Kalinga Institute of Medical Sciences, KIIT road, Bhubaneswar, 751024
Khordha
ORISSA |
9706023644
sakir005@gmail.com |
| Dr Shashank Akerkar |
Mumbai Arthritis Clinic and Research Center |
Shop 15-16, Mayuresh Srishti Complex, Bhandup, Rajiv Gandhi Nagar
Mumbai
MAHARASHTRA |
9987027842
mumbaiarthritisclinic@gmail.com |
| Dr Firdous Fathima |
Olive Hospital- Hyderabad, TG, AB Rheumatology centre |
5-9-1032/2, Bhartiya Vidya Bhavan Road Gun Foundry, Bhasheer Bagh, mosque Lane, Behind Bahar café, Hyderguda,500029
Hyderabad
TELANGANA |
7794848588
firdaus674@yahoo.com |
| Dr Sharath Kumar |
Optima Arthritis and rheumatology clinic |
No. 9, 187, 1st Main Rd, behind Mahalakshmi METRO station, Mahalakshmipuram Layout, Mahalakshmi Layout,560086
Bangalore
KARNATAKA |
9663654655
arthritisdoctor.in@gmail.com |
| Dr Deepti Challa |
Sri Deepti Rheumatology Center |
6-2-45/8, P & T Officers Colony, Chintal, 500004Â
Hyderabad
TELANGANA |
7794848588
dipsrao@gmail.com |
| Dr M Hema |
Stanley Medical College |
Department of Rheumatology, 6th Floor, Stanley Medical College, Chennai, Tamilnadu, No.1, Old Jail Road,600 001
Chennai
TAMIL NADU |
9094827988
drhema.28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Centre for Rheumatic Diseases and Regenerative Clinical Medicine |
Submittted/Under Review |
| CLINIMED INDEPENDENT ETHICS COMMITTEE |
Approved |
| CLINIMED INDEPENDENT ETHICS COMMITTEE |
Approved |
| Ethics Committee Inamdar Multispeciality Hospital |
Submittted/Under Review |
| Gurushree Hitech multispeciality hospital |
Approved |
| Independent Ethics Committee - Shubhdisha Business Solutions |
Approved |
| Independent Ethics Committee -Â Shubhdisha Business Solutions |
Approved |
| Kalinga Institute of Medical Sciences |
Approved |
| Stanley Medical College |
Submittted/Under Review |
| Suraksha Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M069||Rheumatoid arthritis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NON-INTERVENTIONAL STUDY |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 18 years and over diagnosed with RA eligible for treatment with advanced therapies (bDMARDs as well as tsDMARDs)
2. Agree to a minimum of 3 follow up visits with the rheumatologist.
3. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. |
|
| ExclusionCriteria |
| Details |
1. Patients not willing to sign the informed consent document
2. Patients not willing to follow up for a duration of 1 year
3. Participation in a clinical trial during the past 6 months before enrolment into the study
4. Patients on therapy with bDMARDs/tsDMARDs for over 3 months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluate the treatment persistence/drug survival in patients on the advanced therapies
for rheumatoid arthritis. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the effectiveness parameters as per the routine clinical practice and understand the real-world practice towards management of rheumatological disorders (DAS 28 scores, HAQ-DI scores or any other routine parameters evaluated).
Record the adverse events including serious adverse events, non-serious adverse events while on treatment during the study inclusion.
To study patient factors, disease factors or other determinants for treatment switch and time to first and subsequent switch to advanced therapies.
Understand the use of branded and generic Tofacitinib in treatment of RA and persistence on the innovator versus the generic brands of Tofacitinib in India.
Evaluation of the reduction in the need for concomitant therapies like NSAIDs, corticosteroids.
Demographic characteristics of patients enrolled in the study. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="225"
Sample Size from India="225"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of this study is to define treatment persistence, the parameters to change the therapy, the prescribing patterns of advanced therapies and to evaluate the effectiveness and safety of persistence of these therapies in the management of rheumatoid arthritis in a real world setting. |