| CTRI Number |
CTRI/2009/091/000832 [Registered on: 26/10/2009] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
|
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Type of Study
|
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| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical Trial to Study the Efficacy and Safety of Rilonacept for the Prophylaxis of Gout Flares During the Initiation of Allopurinol Therapy |
|
Scientific Title of Study
|
A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Rilonacept for the Prophylaxis of Gout Flares During the Initiation of Allopurinol Therapy |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IL1T-GA-0816 |
ClinicalTrials.gov |
| NCT00958438 |
ClinicalTrials.gov |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sheetal Telang |
| Designation |
|
| Affiliation |
|
| Address |
Quintiles Research India Pvt Limited
301- A Leela Business Park, Andheri (E),
Mumbai
MAHARASHTRA
400 059
India |
| Phone |
+91-22-6677 4213 |
| Fax |
91-22-6677 4343 |
| Email |
sheetal.telang@quintiles.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanghamitra Patnaik |
| Designation |
|
| Affiliation |
Director Regulatory Affairs |
| Address |
Quintiles Research India Pvt Limited
B 101-106, Shapath IV, S G Road,
Ahmadabad
GUJARAT
380051,
India |
| Phone |
+91-79-6630 3340 |
| Fax |
+91-79-6652 7272 |
| Email |
sanghamitra.patnaik@quintiles.com |
|
Details of Contact Person
Public Query
|
| Name |
Suneela Thatte |
| Designation |
|
| Affiliation |
|
| Address |
Quintiles Research India Pvt Limited
301- A Leela Business Park, Andheri (E),
Mumbai
MAHARASHTRA
400 059
India |
| Phone |
+91-22-6677 4242 |
| Fax |
+91-22-6677 4343 |
| Email |
suneela.thatte@quintiles.com |
|
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Source of Monetary or Material Support
|
| Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, NY 10591
|
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Primary Sponsor
|
| Name |
Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, NY 10591
Telephone: +914 345 7400
Fax : +914 347 2847
|
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
|
| Name |
Address |
| Quintiles Research (India) Pvt. Limited
8, M.G. Road, 4th Floor, Nitesh Time Square, Bangalore 560001
Telephone: +91-80 4138 4900
Fax : +91-22-80 4116255
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Countries of Recruitment
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Indonesia
India |
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Sites of Study
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Syamasis Bandyopadhyay |
Apollo Gleneagles Hospitals Ltd. |
58,,Canal Circular Road-700054
|
+91 33 23203040
+91 33 23201739
sambando@yahoo.co.uk |
| Dr Sarvajeet Pal |
Apollo Hospital educational and Research Foundation |
Apolllo Hospitals, ,Jubilee Hills, -500033
Hyderabad
ANDHRA PRADESH |
+91 40 23307432
+91 40 23608050
hydaherf@gmail.com |
| Dr Maulik Patwa |
Apollo Hospital International Limited |
Block A, Village Bhat, Plot 1A, ,GIDC Estate, -382428
|
+91 79 66701802
+91 79 66701843
aherf@ Dr Maulik Patwa apolloahd.com |
| Dr Chandrashekara |
Chanre Rheumatology Immunology Center and Research |
#123, 13th Cross,3rd Main Margosa Road Malleswaram, -560 003
Bangalore
KARNATAKA |
+ 91 09 845071151
+ 91 80 23368029
chanrericr@gmail.com |
| Dr Surendra Kamath |
Kasturba Medical College & Hospital |
Attavar,,-575001
Bangalore
KARNATAKA |
+ 91 82 42445858
+ 91 82 42428379
skamath3@hotmail.com |
| Dr Sarath Chandra Veeravalli |
Krishna Institute of Medical Sciences |
1-8-31/1, ,Minister Road -500 003
|
+ 91 09 866000685
+ 91 40 27840980
sarath10@hotmail.com |
| Dr DC Sundaresh |
M. S. Ramaiah Medical College and Teaching Hospital |
New BEL Road,,M S Ramaiah nagar, MSRIT Post, -560054
Bangalore
KARNATAKA |
+ 91 80 40528403
+ 91 80 40528402
dabris@hotmail.com |
| Dr Amit Mehrotra |
Naman Hospital |
38 ,Bhagwan Das Nagar Sigra, Varanasi,-221001
|
+91 09 839049357
+91 05 422226973
dramitvns@gmail.com |
| Dr Prasanna |
Pristine Hospital and Research Centre Pvt Ltd |
877, Modi Hospital Road ,West of Chord Road IInd stage,-560086
Bangalore
KARNATAKA |
+ 91 80 41354444
+ 91 80 41354455
hmprasanna@rediffmail.com |
| Dr Rajesh Parasnis |
Ruby Hall Clinic |
40, ,Sasoon Road, -411 001
Pune
MAHARASHTRA |
+ 91 20 26123391
+91 20 26121185
rajeshparasnis@rediffmail.com |
| Dr Joe Joseph Cherian |
St.Johns Medical College and Hospital |
John Nagar,Sarjapur Road-560034
Bangalore
KARNATAKA |
+ 91 80 25633087
Fax-91 80 25630603
cherianjoe@msn.com |
| Dr Sapan Pandya |
Vedanta Institute of Medical Sciences |
Near Samved Hospital,Commerce College Road Navarangpura, -380009
Ahmadabad
GUJARAT |
+ 91 79 40042223
+ 91 79 40042225
sapancpandya@yahoo.com |
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Details of Ethics Committee
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| DHMC Ethics Committee, Varanasi, Naman Hospital |
Approved |
| Ethical Review Board, M. S. Ramaiah Medical College and Teaching Hospital |
Approved |
| Ethics Committee , Vedanta Institute of Medical Sciences |
Approved |
| Ethics Committee Pristine Hospital and Research Centre Pvt Ltd |
Approved |
| Ethics Committee, Apollo Hospitals |
Approved |
| Ethics Committee- Apollo Hospitals, Apollo Hospital International Limited |
Approved |
| Institutional Ethics Committee, Apollo Gleneagles Hospitals Ltd. |
Approved |
| Institutional Ethics Committee, Chanre Rheumatology Immunology Center and Research |
Submittted/Under Review |
| Institutional Ethics Committee, Kasturba Medical College & Hospital |
Approved |
| Institutional Ethics Committee, Krishna Institute of Medical Sciences |
Approved |
| Institutional Ethics Review Board, St.John s Medical College and Hospital |
Approved |
| Poona Medical Research Foundation, Ruby Hall Clinic |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Gout, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Allopurinol |
100 mg and 300 mg tablets |
| Intervention |
Matching Placebo |
Matching |
| Intervention |
Rilonacept |
160 mg and 80mg s.c. |
|
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Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
Male or female 18 to 80 years of age
Previously met the preliminary criteria of the ARA for the classification of the acute arthritis of primary gout
At least 2 gout flares in the year prior to the Screening Visit
Serum uric acid greater than or equal to 7.5 mg/dL at the Screening Visit
|
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| ExclusionCriteria |
| Details |
Acute gout flare within 2 weeks of the Screening Visit or during Screening
Persistent chronic or active infections
History of an allergic reaction to allopurinol
History or presence of cancer within 5 years of the Screening Visit
Previous exposure to rilonacept
Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 3 months prior to 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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Centralized |
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Blinding/Masking
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Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| The number of gout flares per subject assessed from Day 1 to Week 16. |
number of gout flares |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| The number of gout flares per subject from Day 1 to Week 16. The proportion of subjects with at least one flare from Day 1 to Week 16 The proportion of subjects with at least two flares from Day 1 to Week 16 The mean number of gout flare days per subject assessed from Day 1 to Week 16 The mean number of days with the subjects pain score of 5 or more (daily diary) per subject from Day 1 to Week 16 |
number of days with the subjects pain score of 5 or more |
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Target Sample Size
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Total Sample Size="80"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 3 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/07/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This is a randomized, double blind, placebo-controlled, multi-center, parallel group Phase III study.
In this study two rilonacept doses will be evaluated; a 320 mg loading dose followed by a weekly 160 mg maintenance dose, and a 160 mg loading dose followed by a 80 mg weekly maintenance dose. This study will be conducted in 240 patients across 85 sites in 5 countries including India. This study would be conducted at 12 Indian sites and will enroll 80 subjects in India. It is hypothesized that in subjects with hyperuricemia and gout who are initiating therapy with allopurinol, the mean number of gout flares from Day 1 to Week 16 in subjects randomized to rilonacept 80 mg or 160 mg weekly will be less than the mean number of Gout flares from Day 1 to Week 16 in subjects randomized to placebo.
The primary end points will be the number of gout flares per subject assessed from Day 1 to Week 16.
Number of patients to be enrolled in India: 80
Total Number of sites: 12
Anticipated date of enrollment: November 15, 2009 |