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CTRI Number  CTRI/2022/05/042887 [Registered on: 27/05/2022] Trial Registered Prospectively
Last Modified On: 26/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To look the effectiveness of the tablet "Tofacitinib" in a disease causing back pain "Ankylosing spondylitis" and its correlation with blood test markers causing this disease. 
Scientific Title of Study   Efficacy and safety of Tofacitinib in Ankylosing Spondylitis and its correlation with Serum Cytokines- A randomized, double- blind, placebo controlled trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  HARISH BV 
Designation  PG Student 
Affiliation  IMS and SUM Hospital 
Address  Room 77, Department of Clinical Immunology and rheumatology, IMS and SUM Hospital

Khordha
ORISSA
751003
India 
Phone  9036888895  
Fax    
Email  drharishmedico@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Pradeepta Sekhar Patro 
Designation  Professor 
Affiliation  IMS and SUM Hospital 
Address  Room 77, Department of Clinical Immunology and Rheumatology, IMS and SUM Hospital

Khordha
ORISSA
751003
India 
Phone  9721799997  
Fax    
Email  drpradeepta07@gmail.com  
 
Details of Contact Person
Public Query  
Name  HARISH BV 
Designation  PG Student 
Affiliation  IMS and SUM Hospital 
Address  Room 77, Department of Clinical Immunology and Rheumatology, IMS and SUM Hospital

Khordha
ORISSA
751003
India 
Phone  9036888895  
Fax    
Email  drharishmedico@gmail.com  
 
Source of Monetary or Material Support  
IMS and SUM Hospital 
 
Primary Sponsor  
Name  none 
Address  none 
Type of Sponsor  Other [] 
 
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 
HARISH BV  SUM Hospital  Room 77, Department of Clinical Immunology and Rheumatology
Khordha
ORISSA 		 9036888895

drharishmedico@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee IMS and SUM 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  Placebo  Identical looking multivitamin, 1 tablet twice daily per oral for 12 weeks  
Intervention  Tofacitinib  Tofacitinib 5mg, 1 tablet twice daily per oral for 12 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Age ≥ 18 years and < 60 years satisfying presence of Ankylosing Spondylitis based on the Modified New York Criteria for Ankylosing Spondylitis (1984).
2. Has active disease on screening at baseline defined by BASDAI ≥ 4 and Back pain score (BASDAI Question 2) of 4.
3. Inadequate response to NSAID- Has received at least two NSAIDs for a total duration of at least 4 weeks and lack of sufficient clinical response based on clinical judgement.
4. Patients having intolerance to atleast two different oral NSAIDs.
5. Patient not affording for biologicals like TNF inhibitors or IL-17 inhibitors recommended for treatment of ankylosing spondylitis.
 
 
ExclusionCriteria 
Details  1. Subjects that have been exposed to or are currently receiving JAK inhibitors or biological DMARDS
2. Blood dyscrasias at screening
2.1 Hemoglobin <10 g/dL
2.2 Absolute white blood cell count (WBC) <3.0 x 109/L (<3000 mm3)
2.3 Absolute neutrophil count (ANC) <1.5 x 109/L (<1500 mm3)
2.4 Absolute lymphocyte count <1.0 x 109/L (<1000/mm3)
2.5 Platelet count <100 x 109/L (<100,000/mm3)
3. Estimated Creatinine Clearance <40 mL/min based on Cockcroft Gault equation at Screening
4. Total bilirubin, AST or ALT more than 1.5 times the upper limit of normal (ULN) at screening
5. History of any other autoimmune rheumatic disease.
6. History of known or suspected complete ankylosis of the spine.
7. Patients having active tuberculosis or positive for latent tuberculosis as tested by QuantiFERON-TB Gold In Tube (QFT Gold test) or Montoux skin Test
8. History of recurrent herpes zoster or herpes simplex.
9. History of severe infection requiring hospitalization or parenteral antimicrobial therapy
10. History of lymphoproliferative disorder, such as Epstein Barr Virus related lymphoproliferative disease (EBV-LPD), history of lymphoma, leukemia
11. Patient with increased risk for GI perforation
12. Present malignancy or with a history of malignancy, with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
13. Pregnant female or breast feeding mothers.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the response of Assessment of SpondyloArthritis international Society ≥20% improvement (ASAS20) at week 12 and its correlation with serum TNF-α and IL-17 levels.  12 WEEKS 
 
Secondary Outcome  
Outcome  TimePoints 
To assess ASDAS-CRP, BASDAI, BASMI, BASFI   12 weeks 
To assess ESR and CRP  12 weeks 
To assess side effect profile   12 weeks 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/06/2022 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Axial spondyloarthropathies (axSpA) are a spectrum of chronic inflammatory diseases affecting primarily the axial skeleton (sacroiliac joints and spine). The first line treatment for ankylosing spondylitis recommended is non-steroidal anti-inflammatory drugs (NSAIDs) and non-pharmacological approaches such as education and physiotherapy. In patients whose disease is still active or by reasons are intolerant to or contraindicated for NSAIDs, tumour necrosis factor (TNF) α inhibitors or IL-17 inhibitors are recommended

Tofacitinib is a JAK inhibitor approved for the treatment of many rheumatology rheumatological diseases like Rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, polyarticular course juvenile idiopathic arthritis. Here in this study we attempt to look for the safety and efficacy of tofacitinib in the management of NSAID refractory, biologicals non affording patients with active ankylosing spondylitis and its correlation with serum cytokine levels.


 
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