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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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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