| CTRI Number |
CTRI/2024/04/066083 [Registered on: 22/04/2024] Trial Registered Prospectively |
| Last Modified On: |
07/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A CLINICAL TRIAL TO STUDY THE EFFECT OF TWO DRUGS JAK INHIBITORS (TOFACITINIB) AND
NSAIDS ON PATIENTS WITH AXIAL
SPONDYLOARTHROPATHIES
|
|
Scientific Title of Study
|
A COMPARATIVE STUDY BETWEEN OUTCOME OF JAK INHIBITORS (TOFACITINIB) AND NSAIDS ON PATIENTS WITH AXIAL SPONDYLOARTHROPATHIES |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Nilotpal Saikia |
| Designation |
Post graduate trainee student |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Orthopaedics
Gauhati Medical College and Hospital,
Bhangagarh Guwahati
Pin-781032 Department of Orthopaedics
Gauhati Medical College and Hospital,
Bhangagarh Guwahati
Pin-781032 Kamrup ASSAM 781032 India |
| Phone |
9101777281 |
| Fax |
|
| Email |
saikianilotpal12345@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Herman Conrad Frank |
| Designation |
Professor and Head of Department, Department of Orthopaedics |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Orthopaedics
Gauhati Medical College and Hospital,
Bhangagarh Guwahati
Pin-781032 Department of Orthopaedics
Gauhati Medical College and Hospital,
Bhangagarh Guwahati
Pin-781032 Kamrup ASSAM 781032 India |
| Phone |
9435032541 |
| Fax |
|
| Email |
herman32541@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr. Nilotpal Saikia |
| Designation |
Post graduate trainee student |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Orthopaedics
Gauhati Medical College and Hospital,
Bhangagarh Guwahati
Pin-781032 Department of Orthopaedics
Gauhati Medical College and Hospital,
Bhangagarh Guwahati
Pin-781032 Kamrup ASSAM 781032 India |
| Phone |
9101777281 |
| Fax |
|
| Email |
saikianilotpal12345@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR Nilotpal Saikia
Department of Orthopaedics
Gauhati Medical College and Hospital,Guwahati
Pin-781032 |
|
|
Primary Sponsor
|
| Name |
Dr Nilotpal Saikia |
| Address |
Department of Orthopaedics
Gauhati Medical College and Hospital,
Bhangagarh Guwahati
Pin-781032 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Nilotpal Saikia |
Gauhati Medical College and Hospital |
Gate No : 07,
Department of Orthopaedics
Bhangagarh Guwahati
Pin-781032
Kamrup ASSAM |
9101777281
saikianilotpal12345@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committe Gauhati medical college and Hospital |
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 |
Aceclofenac 100mg |
Aceclofenac 100mg twice daily after food for four weeks |
| Intervention |
Tofacitinib 5 mg |
Tofacitinib 5 mg twice daily after food for four weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed Cases of Ankylosing Spondylitis, 2. Patients with no Medical Contraindication, 3. Skeletally Mature Patients.
|
|
| ExclusionCriteria |
| Details |
1. Age less than 18 years, 2. Patients with active infections (tb & other viral and bacterial infection), 3. Pregnant, Lactating women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the clinical improvement between the two groups. |
To compare the clinical improvement between the two groups at 4 weeks, 8 weeks, 12 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the efficacy of the drugs between two groups.
2. To compare the incidence of side effects of the drugs between the two groups.
3. To compare the ASAS 20/ ASAS 40 response between the two groups.
4. To compare the improvement of ASDAS/BASDAI score between two groups. |
1. 4, 8, 12 weeks
2. 4, 8, 12 weeks
3. 4, 8, 12 weeks
4. 4, 8, 12 weeks |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/04/2024 |
| 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="0" Months="9" 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
|
Ankylosing spondylitis (AS), also called radiographic axial spondyloarthropathy is a chronic inflammatory disease of the axial skeleton that can result in serious impairment of spinal mobility and reduced quality of life. The incidence of AS is 0.4-15.0 per 100000 patient-years, varying by region. The Assessment of SpondyloArthritis international Society (ASAS)/European League Against Rheumatism and American College of Rheumatology/Spondylitis Association of America/ Spondyloarthritis Research and Treatment Network treatment guidelines recommend several pharmacological treatments for AS management as well as physical therapy. Non- steroidal anti-inflammatory drugs (NSAIDs) are recommended as first-line treatment, followed by biologic disease-modifying antirheumatic drugs (bDMARDs), such as tumour necrosis factor inhibitors (TNFi). No evidence exists to support the efficacy of conventional synthetic disease-modifying anti rheumatic drugs (csDMARDs) for treating purely axial disease. Therefore,treatment options are limited for patients with an inadequate response or intolerance (IR) to NSAIDs. Furthermore,given that bDMARDs are administered parenterally, there is an unmet need for oral therapies with alternative mechanisms of action to treat ASJanus kinase (JAK) inhibitors, also known as JAKi or JAKinibs, are the latest class of synthetic (non-biologic) disease-modifying anti-rheumatic drugs (DMARDs) that have been proven effective in clinical trials in the treatment of multiple forms of arthritis, including psoriatic arthritis (PsA) and ankylosing spondylitis These medications specially target the JAK family of enzymes, namely JAK1, JAK2, JAK3 and tyrosine kinase 2 (TYK2), each of which are involved in the initiation of the signal for a cell to make more than 60 different cytokines and growth factors. Unlike biologics, which inhibit the effects of one single cytokine, JAKi can block the effects of multiple cytokines that are implicated in the pathogenesis (development) of many immune-mediated rheumatic diseases, including AS. They have a shorter half-life compared to biologics, meaning they are active in the body for less time, which means if they are discontinued, any side effects will disappear in a swifter fashion.
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