| CTRI Number |
CTRI/2012/02/002423 [Registered on: 15/02/2012] Trial Registered Prospectively |
| Last Modified On: |
23/07/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Rheumatoid Arthritis study in patients
|
|
Scientific Title of Study
|
A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT01215942 |
ClinicalTrials.gov |
| Protocol No.H9B-MC-BCDP dated 21 Sep 2010 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nishant Naniah |
| Designation |
Associate Clinical Project Manager |
| Affiliation |
Quintiles Research Private Limited |
| Address |
Quintiles Research Private Limited Fourth Floor, Nitesh
Timessquare, NO 8 M.G. Road
Bangalore
KARNATAKA
560011
India |
| Phone |
919986660974 |
| Fax |
918066552018 |
| Email |
nishant.naniah@quintiles.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anil Seth |
| Designation |
Director-Clinical Research |
| Affiliation |
Eli Lilly and Company India Pvt. Ltd. |
| Address |
Eli Lilly and Company (India) Pvt. Ltd.
Plot No. 92, Sector – 32
Gurgaon
HARYANA
122001
India |
| Phone |
0124-4753000 |
| Fax |
0124-4753013 |
| Email |
seth_anil@lilly.com |
|
Details of Contact Person
Public Query
|
| Name |
Anil Seth |
| Designation |
Director-Clinical Research |
| Affiliation |
Eli Lilly and Company India Pvt. Ltd. |
| Address |
Eli Lilly and Company (India) Pvt. Ltd.
Plot No. 92, Sector – 32
Gurgaon
HARYANA
122001
India |
| Phone |
0124-4753000 |
| Fax |
0124-4753013 |
| Email |
seth_anil@lilly.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Eli Lilly and Company |
| Address |
Corporate Center, Indianapolis,IN 46285, USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Quintiles |
Quintiles Research (India) Pvt. Ltd.
4th Floor, Nitesh Times square,
No 8 M.G Road, Bangalore: 560 001
Karnataka, India
Ph: +9180 66552018
Fax: +9180 66552010 |
|
|
Countries of Recruitment
|
Argentina
Australia
Brazil
Bulgaria
Colombia
Croatia
France
Germany
Greece
Hungary
India
Italy
Japan
Lithuania
Malaysia
Mexico
New Zealand
Peru
Poland
Romania
Russian Federation
Slovakia
South Africa
Spain
Sri Lanka
Taiwan
Ukraine
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 18 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Balakrishna Gowda |
Apollo BGS Hospital |
Department of Rheumatology, Adichunchangari road, Kuvempunagar
Mysore
KARNATAKA |
09448054589
0821-2566665
drtnbkg@yahoo.com |
| Dr Sarvajeet Pal |
Apollo Hospital Educational and Research Foundation |
Department of Rheumatology, Apolllo Hospitals Complex, Jubilee Hills
Hyderabad
ANDHRA PRADESH |
040-23554720
040-23543270
drsarvajeetpal@gmail.com |
| Dr Balaji Shrinivasan |
Apollo Hospitals Educational & Research Foundation |
Department of Rheumatology, 21, Greams Lane of Greams Road
Chennai
TAMIL NADU |
044-28294735
044-28294449
drbalaji_s@apollohospitals.com |
| Dr G Mallinath |
BGS Global Hospital |
BGS Health Education City, #67 Uttarahalli Road, Kengeri
Bangalore
KARNATAKA |
080-26255555
080-28605642
mallinathortho@gmail.com |
| Dr Balakondiah Koyagura |
Bollineni Superspeciality Hospital |
Department of Rheumatology, Beside Ennar Cine Vilas Dargamitta
Nellore
ANDHRA PRADESH |
09440279700
0861-2302164
bakolaxmi@rediffmail.com |
| Dr Ajit Yadav |
Global Hospitals & Health City |
Department of Rheumatology, 439 Cheran Nagar, Perumbakkam
Chennai
TAMIL NADU |
044-44777000
044-22777100
drajityadav@globalhospital.net |
| Dr Sundeep Upadhyaya |
Indraprastha Apollo Hospitals |
Sarita Vihar, Delhi Mathura Road,
New Delhi
DELHI |
09818359408
011-41677024
sundeepupadhyaya@hotmail.com |
| Dr Banwari Sharma |
Jaipur Hospital |
Department of Rheumatology, Near SMS Stadium, Lal Kothi, Tonk Road
Jaipur
RAJASTHAN |
0141-2741619
0141-2742472
sharmabanwari@hotmail.com |
| Dr Bharat Jivani |
Jivani Orthopedic Hospital |
Department of Rheumatology, 104, Ayush Doctor House,
Near Poonam Doctor House Station to Lal Darwaja Road
Surat
GUJARAT |
09638077767
040-22265304
drbharatjivani@gmail.com |
| Dr Sarath Chandra Veeravalli |
Krishna Institute of Medical Sciences |
Department of Rheumatology, 1-8-31/1, Minister Road
Hyderabad
ANDHRA PRADESH |
09866000685
040-27840773
sarath10@hotmail.com |
| Dr L Sreenivasa Murthy |
Lifecare Clinic and Research Centre |
#2255, M. C. N. Complex, Kodigehalli Main Road, Sahakarnagar
Bangalore
KARNATAKA |
09448051046
080-23630055
drsreenivasamurthy@gmail.com |
| Dr Naresh Shetty |
M S Ramaiah Medical College and Hospital |
M. S. Ramaiah Medical College and Hospital ,New BEL Road, M. S. Ramaiah Nagar, MSRIT Post, Gokula Extension,
Bangalore
KARNATAKA |
098440502221
080-40528402
nareshs8@hotmail.com |
| Dr Bhagwan Bagaria |
Malpani Multispeciality Hospital |
Department of Rheumatology, Road No 1, Vishawakarma Industrial Area
Jaipur
RAJASTHAN |
09460891205
0141-2333886
dr.bagaria@yahoo.co.in |
| Dr Sreenivasulu Talacheru |
Narayana Medical College & Hospital |
Department of Rheumatology, Chinthareddypalem
Nellore
ANDHRA PRADESH |
0861-2317963
0861-2331763
drtsreenivasulu@gmail.com |
| Dr Liza Rajasekara |
Nizams Institute of Medical Sciences |
Department of Rheumatology,
Panjagutta
Hyderabad
ANDHRA PRADESH |
09319008618
040-66465086
lizarajasekhar@gmail.com |
| Dr Gaurav Rathi |
Rathi Orthopaedic & Research Centre |
Department of Rheumatology,Nr.Anupam Shopping Centre,Jodhpur Cross Roads, Satellite
Ahmadabad
GUJARAT |
09824015618
079-26300411
drgjrathi@yahoo.co.in |
| Dr Anil Kumar Gupta |
Somani Hospital |
Department of Rheumatology, 277, Shri Gopal Nagar 80 feet Road, Gopalpura Bypass
Jaipur
RAJASTHAN |
09887501594
0141-2770900
drguptaanil2004@yahoo.co.in |
| Dr Vineeta Shobha |
St. Johns Medical College Hospital |
Department of Medicine, Sarjapur Road, Koramangala
Bangalore
KARNATAKA |
09845021146
080-22065352
immunology_clinical_trials@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 18 |
| Name of Committee |
Approval Status |
| Arogya Ethics Committee |
Approved |
| Ethical Committee on Clincal Trials |
Approved |
| Ethical Review Board |
Approved |
| Ethics Commitee |
Approved |
| Ethics Committee |
Approved |
| Independent Ethics Commitee |
Approved |
| Institutional EC |
Approved |
| Institutional Ethcs Committee |
Approved |
| Institutional Ethical Review Board |
Approved |
| Institutional Ethics Comittee |
Approved |
| Institutional Ethics Commitee |
Approved |
| Institutional Ethics Committe |
Approved |
| Institutional Ethics Commttee |
Approved |
| Institutonal Ethics Committee |
Approved |
| Lifecare Ethics Committee |
Approved |
| Rathi Ethics Committee |
Approved |
| Research Independent Ethics Committee |
Approved |
| SoMex Research & Health Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Rheumatoid Arthritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
120 mg of LY2127399 |
Given every 4 weeks for 240 weeks for those patients from Study BCDO or Study BCDV. Patients who had been receiving placebo immediately prior to enrollment will receive a 240mg loading dose when initiating treatment.
Or
Given every 4 weeks for 168 weeks those patients from Study BCDM. |
| Intervention |
90 mg LY2127399 |
Given every 2 weeks for 240 weeks for those patients from Study BCDO or Study BCDV. Patients who had been receiving placebo immediately prior to enrollment will receive a 180mg loading dose when initiating treatment.
Or
Given every 2 weeks for 168 weeks those patients from Study BCDM. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
-Completion of 24 weeks of participation in Study H9B-MC-BCDO or Study H9B-MC-BCDV, or have completed 100 weeks of participation in Study H9B-MC-BCDM
-Woman must not be pregnant, breastfeeding, or become pregnant during the study |
|
| ExclusionCriteria |
| Details |
-Current symptoms of a serious disorder or illness
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
-Percentage of patients developing anti-LY2127399 antibodies
-Change from baseline in absolute B cell counts
-Change from baseline in serum immunoglobulin (Ig) levels |
Baseline through 240 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percentage of patients with American College of Rheumatology 20% (ACR20), 50% (ACR50) and 70% (ACR70) response |
Baseline through 240 weeks |
| Change from baseline in Disease Activity Score-C-Reactive Protein (DAS28-CRP) |
Baseline through 240 weeks |
| Percentage of patients with DAS28-Based European League Against Rheumatism |
Baseline through 240 weeks |
| Change from baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) domain scores and summary scores |
Baseline through 240 weeks |
| Change from baseline in Tender Joint Count (68 joint count) |
Baseline through 240 weeks |
| Change from baseline in Swollen Joint Count (66 joint count) |
Baseline through 240 weeks |
| Change from baseline in Patients Assessment of Pain (VAS) |
Baseline through 240 weeks |
| Change from baseline in Patients Global Assessment of Disease Activity (VAS) |
Baseline through 240 weeks |
| Change from baseline in Physicians Global Assessment of Disease Activity (VAS) |
Baseline through 240 weeks |
| Change from baseline in Health Assessment Questionnaire-Disability Index HAQ-DI |
Baseline through 240 weeks |
| Change from baseline in CRP |
Baseline through 240 weeks |
| Mean percent improvement in ACR-N |
Baseline through 240 weeks |
|
|
Target Sample Size
|
Total Sample Size="1505"
Sample Size from India="224"
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)
|
01/04/2012 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
11/07/2011 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="7"
Months="7"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The primary purpose of this study is to help answer if LY2127399 is safe and effective during long-term treatment in patients with Rheumatoid Arthritis.
This study is comprised of 2 periods:
Period 1 - unblinded treatment for up to 240 weeks for patients who enroll from Study H9B-MC-BCDO (BCDO) (NCT01202760) (CTRI/2011/07/001867) or Study H9B-MC-BCDV (BCDV) (NCT01202773) or up to 168 weeks for patients who enroll from Study H9B-MC-BCDM (BCDM) (NCT01198002) (CTRI/2011/07/001870)
Period 2 - 48 week post treatment follow up
|