| CTRI Number |
CTRI/2024/04/065428 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
20/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Trial to test the effectiveness of biologic drug Inj. Adalimumab for the management of primary osteoarthritis of knee joint and to compare its effectiveness with Intra-articular Triamcinolone. |
|
Scientific Title of Study
|
An open label randomised controlled trial to compare the effectiveness of subcutaneous Injection Adalimumab with intra-articular triamcinolone in primary knee osteoarthritis. |
| Trial Acronym |
ADAKOA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Israrul Haque |
| Designation |
DM Post doctoral trainee |
| Affiliation |
IPGMER Kolkata West Bengal |
| Address |
Room no 508
Department of Clinical Immunology and Rheumatology
IPGMER AJC Bose road 700020
West Bengal
Kolkata
WEST BENGAL
700020
India |
| Phone |
7050112785 |
| Fax |
|
| Email |
haque257607@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Biswadip Ghosh |
| Designation |
Associate professor |
| Affiliation |
IPGME&R Kolkata |
| Address |
Room no 510
Department of Clinical Immunology and Rheumatology
IPGME&R AJC bose road Kolkata 700020 West Bengal
Kolkata
WEST BENGAL
700020
India |
| Phone |
9433272612 |
| Fax |
|
| Email |
drbiswadip@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Biswadip Ghosh |
| Designation |
Associate professor |
| Affiliation |
IPGME&R Kolkata |
| Address |
Room no 510
Department of Clinical Immunology and Rheumatology
IPGME&R AJC bose road Kolkata 70020
West Bengal
Kolkata
WEST BENGAL
700020
India |
| Phone |
9433272612 |
| Fax |
|
| Email |
drbiswadip@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Clinical Immunology and Rheumatology
IPGME&R and SSKM Kolkata
West Bengal |
|
|
Primary Sponsor
|
| Name |
IPGMER and SSKM hospital |
| Address |
AJC bose road
kolkata 700020
West Bengal |
| 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 Israrul Haque |
IPGME&R and SSKM |
Room no 508
Department of Clinical Immunology and Rheumatology
IPGME&R and SSKM hospital
244, A.J.C Bose Road 700020
Kolkata
WEST BENGAL |
7050112785
haque257607@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R Research oversight committee kolkata |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intra-articular Inj. Triamcinolone 40 mg |
patients satisfying inclusion and exclusion criteria and randomised to control arm will be given single dose of Inj. Triamcinolone in the more severely affected knee. |
| Intervention |
Subcutaneous Inj. Adalimumab 40 mg |
patients satisfying both inclusion and exclusion criteria and randomised to intervention arm will be given monthly subcutaneous Injection Adalimumab 40 mg for 3 months. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Satisfying ACR criteria for classification and reporting of osteoarthritis of knee joint, 1986
Age 40-75 years
Symptomatic for at-least 6 months
Radiographic Kellgren-Lawrence grade II (definite osteophyte and unimpaired joint space) or grade III (moderate multiple osteophytes, definite narrowing of joint space, some sclerosis and possible deformity of bone contour)
Visual analog score for knee pain at-least 40 or more on the scale of 0-100
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in WOMAC pain subscale score (0-100) at 12 weeks. |
Improvement in WOMAC pain subscale score (0-100) at 12 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| A) Percentage of patients achieving an Osteoarthritis Research Society International/Outcome Measure in Rheumatology Clinical trials (OARSI/OMERACT) response at week 12 |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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 3 |
|
Date of First Enrollment (India)
|
15/04/2024 |
| 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="6"
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
|
The proposed trial is phase 3 open label randomised control trial to compare the efficacy of subcutaneous inj. Adalimumab in comparison to an established therapy of intraarticular Inj. Triamcinolone for symptomatic primary Knee osteoarthritis with evidence of inflammation (clinical/biochemical/radiological). it is a superiority trial. The study will have two arms. each arm will have 37 patients each. after recruitment each patient will undergo contrast MRI of the involved joint to assess the baseline damage and activity in the involved joint. The intervention arm will receive monthly Inj. Adalimumab 40 mg for 3 months and the comparator arm will receive single dose of Intraarticular Triamcinolone. patients will be followed for primary outcome at 12 weeks. |