| CTRI Number |
CTRI/2011/05/001734 [Registered on: 13/05/2011] Trial Registered Prospectively |
| Last Modified On: |
22/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy and Safety of Hydroxychloroquine and Methotrexate Combination in Treatment of Juvenile Rheumatoid Arthritis |
|
Scientific Title of Study
|
Efficacy and Safety of Hydroxychloroquine and Methotrexate Combination in Treatment of Juvenile Rheumatoid Arthritis: A Double Blind, Randomized Comparison with Methotrexate alone |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Ipca/HQMT/PIII-10 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Anil Pareek |
| Designation |
President Medical Affairs and Clinical Research |
| Affiliation |
|
| Address |
Ipca Laboratories Ltd; Mumbai
142,AB,Kandivli Industrial Estate, Kandivli W
Mumbai
MAHARASHTRA
400067
India |
| Phone |
022-66474641 |
| Fax |
022-66474416 |
| Email |
anil.pareek@ipca.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Mr Nitin Chandurkar |
| Designation |
Deputy General Manager Clinical Research Department |
| Affiliation |
|
| Address |
Ipca Laboratories Ltd; Mumbai
48, International House, Kandivli Industrial Estate, Kandivli W
Mumbai
MAHARASHTRA
400067
India |
| Phone |
022-61113165 |
| Fax |
022-61113150 |
| Email |
nitin.chandurkar@ipca.com |
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
Ipca Laboratories Ltd Mumbai |
| Address |
KANDIVILI INDUSTRIAL ESTATE |
| Type of Sponsor |
Pharmaceutical industry-Indian |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSara Subodh Dhanwade |
Bharati Vidyapeeth Deemed University Medical College & Hospital |
Wanlesswadi Sangli Miraj Road Sangli – 416414
Sangli
MAHARASHTRA |
9890936995
sarasubodh@hotmail.com |
| Dr Chandrashekara S |
Chare Rheumatology & Immunology Research & Centre |
#149,15thMain,NHCLwatertankroad,4thBlock,3rdstage,Basaveswarnagar, Bangalore 560079
Bangalore
KARNATAKA |
9845071151
chandrashekara_s@yahoo.com |
| Dr Sathish Kumar |
Christian Medical College |
Vellore
Vellore
TAMIL NADU |
9488469989
sathishkumar_cmc@yahoo.com |
| Dr Vijaya Shenoy |
K. S. Hedge Medical Academy |
Deralakatte Mangalore- 575 018
Bangalore
KARNATAKA |
9241070047
vijayapaed@yahoo.com |
| Dr Nalini Bhaskaranand |
Kasturba Hospital |
Kasturba Hospital
Post Box No 7,
Manipal 576104
Udupi
KARNATAKA |
08202922759
08202922209
dr_nalinib@yahoo.co.in |
| Dr Nutan Kamath |
Kasturba Medical College |
Light House Hill Road
Mangalore 575 001
Bangalore
KARNATAKA |
9448147687
nutankamath@yahoo.com |
| Dr Sciddhartha Koonwar |
M. V. Hospital & Research Centre |
314/30 Mirza Mandi Chowk Lucknow- 226 003
Lucknow
UTTAR PRADESH |
9415102691
dr_sciddhartha@indiatimes.com |
| Dr Rukmangatharajan |
Madras Medica College & GGH, Chennai |
Rheumatology Dept. Room No. 169A Tower Block 1, 6th floore, ,Madras MEdical College & GGH, Chennai -600003
Chennai
TAMIL NADU |
044-25500400
drsrukmangatharrajane@yahoo.co.in |
| Dr. Sharad Agarkhedkar |
Padmashri Dr. DY Patil Medical College, Pimpri |
Department of Pediatrics ,Dr. DY Patil Medical College & Research Center, Sant Tukaram Nagar, Pimpri-411018
Pune
MAHARASHTRA |
020-27420605
020-27420439
ashalaka@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Central Ethics Committee, Nitte University |
Approved |
| Institutional Ethical Committee, Madras Medical College, Chennai |
Approved |
| Institutional Ethics Committe Kasturba Hospital Manipal |
Approved |
| Institutional Ethics Committe, Lucknow (U.P) |
Approved |
| Institutional Ethics Committee, Padmashri Dr. DY Patil Medical College, Pimpri, Pune |
Approved |
| Institutional Ethics Committee,Bharati, Vidhyapeeth deemed University Medical College and Hospital , Sangli |
Approved |
| Institutional Ethics Committee,Christian Medical College, Vellore |
Approved |
| Institutional Ethics Committee,CRICR,BANGALORE- 560079 |
Approved |
| University Ethics Committee, Manipal |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Juvenile Rheumatoid Arthritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hydroxychloroquine |
100mg/Day oral for 24 weeks |
| Comparator Agent |
Methotrexate 2.5, 5.7,5 or 10 mg |
Methotrexate oral weekly for 24 weeks |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
-Male and female subjects in the age range of 4 to 16 years (both inclusive).
-Subjects who have a diagnosis of JRA according to the ACR (American College of Rheumatology) criteria for JRA.
-Active pauciarticular (i.e. inflammation in fewer than 5 joints) or polyarticular JRA (i.e. equal to or greater than 5 swollen joint or equal to or greater than 3 joint with limitation of movement accompanied by either pain on motion or tenderness or both which could be of the same joint and rheumatoid factor positive or negative) without systemic onset that persists for at least 6 weeks and inadequately controlled by NSAIDs plus any DMARDs.
-Ready to give consent/assesnt
|
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| ExclusionCriteria |
| Details |
-Subjects having active systemic course of JRA(i.e. persistent intermittent fever with or without erythematosus rash, hepatosplenomegally , lymphadenopathy , serositis or other organ involvement)
-Current inflammatory diseases or history of diseases other than juvenile rheumatoid arthritis (like lupus erythematosus, vasculitis, dermatomyositis, scleroderma, rheumatic fever, anterior uveitis, fibromyalgia, SLE infectious arthritis, psoriasis or ankylosing spondylitis, sacroiliitis with inflammatory bowel disease).
-Subjects who had undergone joint surgery within the preceding two months of the screening visit |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Pre-numbered or coded identical Containers |
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Blinding/Masking
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Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
Patients with a 30 percent improvement from baseline in at least 3 of the 6 following variables with no more than one of the remaining variables worsening by more than 30percent The core set are;
1.Physician’s global assessment of disease activity
2.Parent’s/patient’s (if appropriate in age) global assessment of overall well-being
3.Functional ability by CHAQ Disability Index
4.Number of joints with active arthritis
5.Number of joints with limited range of motion; and
6.ESR.
|
Week 0, 4,8,12,16,20 and 24 [Delete]
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| ACR Pedi 50, ACR Pedi 70, JAFAR-C, JAFAR-P |
ACR Pedi 50, ACR Pedi 70: Week 0, 4,8,12,16,20 and 24
JAFAR-C, JAFAR-P: Week 0 and Week 24 |
|
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Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
Final Enrollment numbers achieved (Total)= "77"
Final Enrollment numbers achieved (India)="77" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/05/2011 |
| Date of Study Completion (India) |
03/04/2014 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This is a double blind, randomized, parallel group, comparative, multicentric study of 24 weeks. This will be an outpatient study. The study will be initiated only after obtaining necessary approval from DCGI and hospitals ethics committees. At screening after successful fulfillment of informed consent and assent procedures, patients satisfying screening criteria have to undergo 7 days placebo washout period. At baseline visit, the patients satisfying all the entry criteria will be randomized 1:1 in two treatment arms for 24 weeks.During ht estudy patients will be evaluated for ACR Pedi 30 as a primary efficacy endpoint. |