| CTRI Number |
CTRI/2025/07/091428 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to evaluate the safety and efficacy of Guselkumab injected Subcutaneously in Indian
Participants for treatment in Psoriatic Arthritis (PsA) |
|
Scientific Title of Study
|
A Phase IV, Multicenter, Non Comparative, Open Label Study Evaluating the Safety and Efficacy of Guselkumab Administered Subcutaneously in the Treatment of Indian Patients with Psoriatic Arthritis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CNTO1959PSA4018 Version No 1 dated 26 August 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanish Davis |
| Designation |
R and D Director GCO India |
| Affiliation |
Johnson and Johnson Pvt Ltd |
| Address |
Arena Space, Behind Majas Bus Depot, Off J.V. Link Road,
Jogeshwari east
Mumbai
MAHARASHTRA
400060
India |
| Phone |
919820958943 |
| Fax |
|
| Email |
sdavis20@its.jnj.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanish Davis |
| Designation |
R and D Director GCO India |
| Affiliation |
Johnson and Johnson Pvt Ltd |
| Address |
Arena Space, Behind Majas Bus Depot, Off J.V. Link Road,
Jogeshwari east
Mumbai
MAHARASHTRA
400060
India |
| Phone |
919820958943 |
| Fax |
|
| Email |
sdavis20@its.jnj.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanish Davis |
| Designation |
R and D Director GCO India |
| Affiliation |
Johnson and Johnson Pvt Ltd |
| Address |
Arena Space, Behind Majas Bus Depot, Off J.V. Link Road,
Jogeshwari east
Mumbai
MAHARASHTRA
400060
India |
| Phone |
919820958943 |
| Fax |
|
| Email |
sdavis20@its.jnj.com |
|
|
Source of Monetary or Material Support
|
| Johnson and Johnson Private Limited, Arena Space, Behind Majas Bus Depot, OffJ.V. Link Road, Jogeshwari East, Mumbai, MAHARASHTRA |
|
|
Primary Sponsor
|
| Name |
Johnson and Johnson Private Limited |
| Address |
LBS Marg Mulund West, Maharashtra India 400080 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Johnson and Johnson Private Limited |
LBS Marg Mulund West, Maharashtra India 400080 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Uma Kumar |
All India Institute Of Medical Sciences |
Department of Rheumatology
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029, India
South
DELHI |
9868217040
umaakumar@yahoo.co.in |
| Dr Syamasis Bandopadhyay |
Apollo Multispeciality Hospitals Limited |
Department of Rhematology,
58, Canal Circular Rd, Kadapara,
Kolkata
West Bengal - 700054
Kolkata
WEST BENGAL |
8777464768
sambando@yahoo.co.uk |
| Dr Krishnamurthy Venkataraman |
Chennai Meenakshi Multi-speciality Hospital |
Department of Rheumatology
Clinical research Department
Basement
New No 70, old no 149,
Luz church road, Mylapore
Chennai 600004. Tamil Nadu
Chennai
TAMIL NADU |
044 42938938
cmmhospitals@gmail.com |
| Dr Vijaya Prasanna |
ESIC medical college and super speciality hospital |
OPD block, Department of Immunology and Rhematology 4th floor Room No.407
7-1-634, Survey No.121/1 & 121/2, National Highway 65 Sanjeeva Reddy Nagar, Sanath Nagar, Hyderabad, Telangana 500038
Hyderabad
TELANGANA |
98491 45372
prasanna.parimi.vijaya@gmail.com |
| Dr Nachiket Kulkarni |
Jehangir Clinical Development Center |
Department of Rheumatology
Jehangi Hospital Premises, Bund Garden Rd, Sangamvadi, Pune, Maharashtra 411001, India
Raigarh
MAHARASHTRA |
9923243860
drnachiketkulkarni@gmail.com |
| Dr Reena Sharma |
Marengo CIMS Hospital |
2nd floor, Research Department, West wing, KP Area,
Plot no 67/1,Opp.Panchamrut Bunglows, Near Shukan Mall,
Off. Science city Road, Sola, Ahmedabad, Gujarat, India,380060
Ahmadabad
GUJARAT |
914023307432
reena141@gmail.com |
| Dr Meghna Gawali |
Nizams Institute of Medical Sciences |
Department of Rheumatology,
Punjagutta Rd, Punjagutta Market, Punjagutta, Hyderabad, Telangana 500082, India
Hyderabad
TELANGANA |
8143484350
lizarajasekhar@gmail.com |
| Dr Sandeep Yadav |
P. D. Hinduja Hospital and Medical Research Centre |
21st Floor, Department of Rheumatology, Lalita Girdhar Tower 2 (S2 Building),
PD Hinduja Hospital & MRC, Veer Savarkar Road,
Mahim West, Mumbai- 400016
Mumbai
MAHARASHTRA |
9920818270
dr_sandeep.yadav@hindujahospital.com |
| Dr Atul Kakar |
Sir Ganga Ram Hospital |
Department of Rhematology
5th floor by Lift No 12
Clinical Research Room
SGRH Marg, Rajinder Nagar, New Delhi-11006, India
Central
DELHI |
9811110802
atulkakar@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Chennai Meenakshi Multispeciality Hospital Ethics Committee CMMHEC |
Approved |
| Ethics Committee Jehangir Clinical Development Centre Pvt Ltd. |
Approved |
| Ethics Committee of CIMS |
Approved |
| Institute Ethics Committee, AIIMS Delhi |
Submittted/Under Review |
| Institutional Ethics Committee |
Submittted/Under Review |
| Institutional Ethics Committee |
Submittted/Under Review |
| Institutional Ethics Committee |
Submittted/Under Review |
| NIMS Institutional Ethics Committee |
Submittted/Under Review |
| Sir Ganga Ram Hospital Ethics Committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Guselkumab or Tremfya |
Participants will receive subcutaneous injections of
guselkumab at Weeks 0, 4, 12, and 20. |
| Comparator Agent |
Not Applicable |
Not Applicable. This is a single arm study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants who have definite diagnosis of active psoriatic arthritis (PsA) (according to the Classification criteria for Psoriatic Arthritis [CASPAR]) prior to the first administration of study drug and have at least 1 of the PsA. subsets: distal interphalangeal joint arthritis, polyarticular arthritis with the absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis.
2. Participants who are negative for rheumatoid factors
3. Participants having inadequate response (defined by presence of active arthritis [presence of any swollen or any tender joint]) to standard therapies for 3 months at the highest recommended dose (e.g., conventional disease-modifying antirheumatic drugs [DMARDs] including methotrexate, apremilast, or nonsteroidal anti-inflammatory drugs [NSAIDs]), including biologics naïve patient or have failed, or were intolerant to one or more biological treatments [anti-TNF/IL-17i]
4. Participants are considered eligible per the following Tuberculosis (TB) screening criteria:
4a. Have no history of TB prior to screening AND
4b. Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination AND
4c. Have had no recent close contact with a person with active TB, or if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study drug AND
4d. Within 6 weeks prior to the first administration of study drug, have a negative QuantiFERON- TB Gold and a negative tuberculin skin test result, OR have a newly identified positive QuantiFERON-TB Gold or tuberculin skin test result during screening in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study drug AND
4e. Have a chest radiograph (both posterior-anterior and lateral views), taken within 3 months prior to the first administration of study drug and read by a qualified radiologist, with no evidence of current active TB or old inactive TB
5. Medically stable on the basis of physical examination, medical history, vital signs, and 12-lead ECG
6. A woman of childbearing potential must have a negative highly sensitive serum beta-hCG at screening visit |
|
| ExclusionCriteria |
| Details |
1. History of latent or active granulomatous infection prior to screening
2. Have a known clinically significant hypersensitivity to guselkumab or to any of the excipients
3. Have had a serious infection, or have been hospitalized for an infection, or have been treated with intravenous (IV) antibiotics for an infection within 2 months prior to first administration of study intervention
4. Has any known malignancy or has a history of malignancy, or a history of lymphoproliferative disease
5. Have received, or are expected to receive, any live virus or bacterial vaccination within 3 months before the first administration of study intervention, during the study, or within 6 months after the last administration of study intervention |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily
have a causal relationship with the pharmaceutical/biological agent under study.
2. Number of Participants With Serious Adverse Events (SAEs)
A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient
hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is
a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important. |
Up to 32 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percentage of Participants Who Achieve an American College of Rheumatology (ACR) 20 Response at Week 12. |
Week 12 |
| Percentage of Participants Who Achieve an ACR 20 Response at Week 24 |
Week 24 |
| Change From Baseline in Analytic Marker of Inflammation (CRP Levels) at Weeks 12 and 24. CRP levels that is the analytic markers of inflammation will be assessed. |
Week 12 and Week 24 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
02/08/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 purpose of this study is to evaluate the safety and how well guselkumab treatment works (efficacy) in participants with psoriatic arthritis (PsA; a chronic, autoimmune form of arthritis that causes joint inflammation) who had inadequate response to standard therapies. |