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CTRI Number  CTRI/2018/09/015662 [Registered on: 08/09/2018] Trial Registered Prospectively
Last Modified On: 04/07/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of Effect of Adalimumab versus Hyaluronic Acid in Knee Osteoarthritis 
Scientific Title of Study   A Randomized Controlled Trial to Compare the Effect of Intra -Articular Adalimumab Versus Intra - Articular Hyaluronic Acid in Primary Osteoarthritis of the Knee  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhimanyu Vasudeva 
Designation  Senior Resident 
Affiliation  AIIMS, New Delhi 
Address  Room Number 10, Department of Physical Medicine and Rehabilitation, AIIMS, New Delhi

South West
DELHI
110029
India 
Phone  9910185126  
Fax    
Email  abhimanyu.vmmc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr S L Yadav 
Designation  Professor 
Affiliation  AIIMS, New Delhi 
Address  Room Number 3, Department of Physical Medicine and Rehabilitation, AIIMS, New Delhi

South West
DELHI
110029
India 
Phone  9560678577   
Fax    
Email  slyaiims@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Abhimanyu Vasudeva 
Designation  Senior Resident 
Affiliation  AIIMS, New Delhi 
Address  Room Number 10, Department of Physical Medicine and Rehabilitation, AIIMS, New Delhi

South West
DELHI
110029
India 
Phone  9910185126  
Fax    
Email  abhimanyu.vmmc@gmail.com  
 
Source of Monetary or Material Support  
The Social Worker (MSSO) in our Department shall ensure that no patient would need to spend on any investigations or drugs for the purpose of this study 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  Ansari Nagar, New Delhi 
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 
Dr Abhimanyu Vasudeva  AIIMS, New Delhi  Room Number 10, Department of Physical Medicine and Rehabilitation,
South West
DELHI 		 9910185126

abhimanyu.vmmc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for Post Graduate Research All India Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Primary Osteoarthritis of the Knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Adalimumab  10 mg of Ultrasound Guided Adalimumab + Quadriceps Strengthening Exercises + Hamstring Stretching Exercises + Joint Protection Techniques + ADL Modifications 
Comparator Agent  Hyaluronic Acid   90mg/3ml of Ultrasound Guided Hyaluronic Acid + Quadriceps Strengthening Exercises + Hamstring Stretching Exercises + Joint Protection Techniques + ADL Modifications 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Diagnosis of Knee OA as per 2016 ACR Revised Criteria for Early Diagnosis of Knee OA
2. Unilateral Primary OA of Grade 2 or Grade 3 on Kellgren Lawrence Scale
3. Pain Score >4 on VAS( Visual Analogue Scale) within the past one month
4. Lack of efficacy of previous treatment with Diclofenac at a dose of 75mg/day 
 
ExclusionCriteria 
Details  1. Previous treatment with TNF inhibitors
2. Previous Intra - Articular treatment within 3 months
3.Previous Knee Surgery
4. History of tumor or serious Infection
5. Pregnancy
6. Lactation
7. Cognitive Impairment
8. Previous history of trauma to the knee 
 
Method of Generating Random Sequence
Modification(s)  		 Computer generated randomization 
Method of Concealment
Modification(s)  		 On-site computer system 
Blinding/Masking
Modification(s)  		 Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To Compare the Effect of a Single Ultrasound - Guided Intra - Articular Injection of Adalirec) mumab with a Single Ultrasound Guided Intra -Articular Injection of Hyaluronic Acid on Pain using VAS  4 weeks and 12 weeks post injection 
 
Secondary Outcome  
Outcome  TimePoints 
To Compare the Effect of a Single Ultrasound - Guided Intra - Articular Injection of Adalimumab with a Single Ultrasound Guided Intra -Articular Injection of Hyaluronic Acid on Pain, other Symptoms, Function in Daily Living(ADL), Function in Sport and Recreation(Sport/Rec) using KOOS Scale  4 weeks and 12 weeks post injection 
 
Target Sample Size   Total Sample Size="19"
Sample Size from India="19" 
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
Modification(s)  		 Phase 4 
Date of First Enrollment (India)   17/09/2018 
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="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Publication is planned after the completion of this study. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Although an Intra - Articular Injection of Hyaluronic Acid is commonly used for the treatment of Osteoarthritis of the knee, Adalimumab owing to its ability to downregulate the expression of pro - inflammatory cytokines and rate of synthesis of metalloproteinases has shown good results in inflammatory conditions. However, few attempts have been made to improve the treatment of patients with Knee OA by Intra -Articular Adalimumab.  
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