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CTRI Number  CTRI/2025/01/079331 [Registered on: 23/01/2025] Trial Registered Prospectively
Last Modified On: 22/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the efficacy and safety of Tofacitinib 5 mg once a day with that of 11 mg once a day in the treatment of Axial Spondyloarthritis 
Scientific Title of Study   Efficacy of half-dose Tofacitinib in Axial Spondyloarthritis- a double blind randomised controlled trial 
Trial Acronym  RADIATE 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bodhibrata Banerjee 
Designation  Senior Resident 
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh 
Address  Post Graduate Institute of Medical Education and Research, Chandigarh sector 12, Chandigarh
Post Graduate Institute of Medical Education and Research, Chandigarh sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  9748696900  
Fax    
Email  bodhibrata.sphs@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Varun Dhir 
Designation  Professor 
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh 
Address  Post Graduate Institute of Medical Education and Research, Chandigarh sector 12, Chandigarh
Post Graduate Institute of Medical Education and Research, Chandigarh sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  01722756670  
Fax    
Email  varundhir@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bodhibrata Banerjee 
Designation  Senior Resident  
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh 
Address  Post Graduate Institute of Medical Education and Research, Chandigarh sector 12, Chandigarh
Post Graduate Institute of Medical Education and Research, Chandigarh sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  9748696900  
Fax    
Email  bodhibrata.sphs@gmail.com  
 
Source of Monetary or Material Support  
IPCA Pharmaceuticals for Tofacitinib tablets 
 
Primary Sponsor  
Name  Post Graduate Institute of Medical Education and Research, Chandigarh 
Address  Department of Internal Medicine, 4th Floor, F block, Nehru Hospital, Post Graduate Institute of Medical Education and Research, Chandigarh 
Type of Sponsor  Research institution and hospital 
 
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 
Bodhibrata Banerjee  Post Graduate Institute of Medical Education and Research, Chandigarh  Department of Internal Medicine, 4th Floor, F block, Nehru Hospital, PGIMER, Chandigarh
Chandigarh
CHANDIGARH 		 9748696900

bodhibrata.sphs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, PGIMER  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  Tofacitinib 11 mg Extended Release once daily  Tofacitinib 11 mg Extended Release once daily will be continued from week 5 to week 20 after initial 4 weeks of Tofacitinib extended release 11 mg once daily 
Intervention  Tofacitinib 5 mg once daily  Tofacitinib 5 mg once daily will be given from week 5 to week 20 after initial 4 weeks of Tofacitinib extended release 11 mg once daily 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  The study recruits individuals aged 18-50 years who fulfill the ASAS classification criteria for Axial Spondyloarthritis. Patients should have active disease defined by BASDAI ≥ 4 but have inadequate response to NSAIDs, received at least one NSAIDs for a total duration of at least 4 weeks. They should not have any thrombotic risk factors 
 
ExclusionCriteria 
Details  Exclusion criteria include patients having access to anti-TNF or anti-IL17 biologics, those who are currently on JAK inhibitors or received them in the last 3 months, those who received anti-TNF or anti-IL17 in last 6 months, presence of uncontrolled or poorly controlled diabetes (HbA1c more than 7.0%) or hypertension (BP more than 160/100 mm Hg or requiring more than 2 antihypertensive drugs), prior major adverse cardiovascular events like myocardial infarction, stroke, angina, deep vein thrombosis or pulmonary thromboembolism, presence of active infection currently, malignancy in the past or currently,overt psoriasis or inflammatory bowel disease, chronic liver or kidney disease, those who are pregnant or planning for pregnancy in next 6 months, unwilling to participate in the study, cytopenia (Hemoglobin less than 7% and platelet less than 1 L per microlitre or WBC less than 4000 per microlitre, transaminitis (AST or ALT more than 50 IU/L), any other disease or past illness which is considered contraindication by the physician. 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
ASAS20 response  20 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. ASDAS major improvement at 20 weeks.
2. Other Secondary outcomes will include BASDAI-50, ASAS40, ASAS clinically
significant improvement all at 20 weeks.
3. Other outcomes will include delta-BASFI and delta-ASDAS at 4, 12 and 20 weeks. 		 20 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 4 
Date of First Enrollment (India)   14/02/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 study is a randomized double-blind active parallel group trial. The study duration is 20 weeks.100 patients fullfilling the ASAS classification criteria for  Axial Spondyloarthritis between ages 18-50 years who have active disease as defined by BASDAI > 4 will be recruited from outpatient department of Internal Medicine and Rheumatology clinic of Post Graduate Institute of Medical Education and Research, Chandigarh. All of them will get 11 mg of tablet Tofacitinib extended release preparation for initial 4 weeks. After that, following randomisation and concealment, 50 individuals (intervention arm) will get Tofacitinib 5 mg once daily and the other 50 (comparator arm) will be continued on Tofacitinib 11 mg extended release from week 5 to week 20 that is the rest of the study period. At the end of 20 weeks, achievement of ASAS20 in both the groups will be assessed. Key secondary outcome measure will include ASDAS major improvement at 20 weeks, BASDAI-50, ASAS40, ASAS clinically significant improvement all at 20 weeks delta-BASFI and delta-ASDAS at 4, 12 and 20 weeks. Tofacitinib tablets will be supplied to the patients free of cost by IPCA pharmaceuticals. 
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