| CTRI Number |
CTRI/2024/04/065955 [Registered on: 19/04/2024] Trial Registered Prospectively |
| Last Modified On: |
19/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to compare the effect of two drugs, Tofacitinib and Adalimumab in axial spondyloarthritis patients |
|
Scientific Title of Study
|
A Comparative study to evaluate the efficacy of Tofacitinib and Adalimumab in treating axial spondyloarthritis: An open label randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Monika G |
| Designation |
Post doctoral trainee |
| Affiliation |
IPGMER and SSKM hospital |
| Address |
Room number 510, Department of Clinical immunology and Rheumatology, IPGMER, Kolkata, West Bengal
Kolkata
WEST BENGAL
700020
India |
| Phone |
9738052459 |
| Fax |
|
| Email |
dr.monikagajendrakumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pradyut Sinhamahapatra |
| Designation |
Associate Professor |
| Affiliation |
IPGMER and SSKM hospital |
| Address |
Room number 510, Department of Clinical immunology and Rheumatology, IPGMER, Kolkata, West Bengal
Kolkata
WEST BENGAL
700025
India |
| Phone |
8017391868 |
| Fax |
|
| Email |
sinhamahapatra@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Monika G |
| Designation |
Post doctoral trainee |
| Affiliation |
IPGMER and SSKM hospital |
| Address |
Room number 510, Department of Clinical immunology and Rheumatology, IPGMER, Kolkata, West Bengal
Kolkata
WEST BENGAL
700020
India |
| Phone |
9738052459 |
| Fax |
|
| Email |
dr.monikagajendrakumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of post graduate medical education and research, Kolkata, West Bengal, India 700020 |
|
|
Primary Sponsor
|
| Name |
Institute of post graduate graduate medical education and research |
| Address |
AJC Bose road, Kolkata, West Bengal, 700020 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Monika G |
SSKM Hospital |
Room number 510, Department of clinical immunology and rheumatology, IPGMER, AJC Bose Road, Kolkata, West Bengal, 700020
Kolkata
WEST BENGAL |
9738052459
dr.monikagajendrakumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe,IPGMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M450||Ankylosing spondylitis of multiplesites in spine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injection Adalimumab |
40mg subcutaneously every 2 weekly for 4 weeks |
| Intervention |
Oral Tablet Tofacitinib |
5mg twice daily for 4 months |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the ASAS classification criteria for axial SpA including both non radiographic axial spondyloarthritis (nr-AxSpA) and ankylosing spondylitis (AS)
Patients with BASDAI ≥4 or ASDAS-CRP≥2.1.
Biologic DMARD (b DMARD) and targeted synthetic DMARD (ts DMARD) naïve patients who have undergone a trial of at least 2 courses of NSAIDs with optimum doses for at least 1 month without response or with partial response.
Patients with prior b DMARD and ts DMARD permitted if discontinued for ≥4 weeks or ≥5 half-lives (whichever was longer) before randomization.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ASAS20 response |
ASAS20 response |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ASAS20 response |
4, 8, 12 and 16 weeks |
| ASAS40 response |
4,8, 12 and 16 weeks |
| Change in ASADASCRP |
4,8,12 and 16 weeks |
| Change in hsCRP |
4,8,12 and 16 weeks |
| Change in BASDAI |
4,8,12 and 16 weeks |
| ASAS 5/6 response |
4,8,12 and 16 weeks |
| Change in BASMI |
16 weeks |
| Change in BASFI |
16 weeks |
| Change in ASQoL |
16 weeks |
| Change in patient global assessment |
4,8,12 and 16 weeks |
| Incident and severity of adverse effects |
4,8,12 and 16 weeks |
| Change in MASES |
4,8,12 and 16 weeks |
| Change in swollen joint count |
4,8,12 and 16 weeks |
| NSAID use |
4,8,12 and 16 weeks |
| BASDAI50 response |
4,8,12 and 16 weeks |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 3 |
|
Date of First Enrollment (India)
|
06/05/2024 |
| 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="1"
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
|
This is a randomized, open label, parallel group, single center trial comparing the efficacy of Tofacitinib 5mg twice daily and Adalimumab 40mg subcutaneous 2 weekly for a duration of 16 weeks. Primary outcome will measure ASAS20 response at 16 weeks. Secondary outcomes will be ASAS20, ASAS40, ASAS 5/6, change in CRP, ASDASCRP, BASDAI, MASES, PGA at 4 weekly interval and change in BASFI,BASMI, ASQoL at 16weeks along with NSAID use. |