| CTRI Number |
CTRI/2011/07/001867 [Registered on: 07/07/2011] Trial Registered Prospectively |
| Last Modified On: |
02/12/2011 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Rheumatoid Arthritis Study in Patients |
|
Scientific Title of Study
|
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA) With or Without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| H9B-MC-BCDO |
Protocol Number |
| NCT01202760 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nishant Naniah |
| Designation |
Associate Clnical 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 |
| Affiliation |
Eli Lilly |
| Address |
Plot #92, Sector 32 Institutional Area
Gurgaon
HARYANA
122001
India |
| Phone |
0111242823099 |
| Fax |
0111244753012 |
| Email |
sethan@lilly.com |
|
Details of Contact Person
Public Query
|
| Name |
Anil Seth |
| Designation |
Director |
| Affiliation |
Eli Lilly |
| Address |
Plot #92, Sector 32 Institutional Area
Gurgaon
HARYANA
122001
India |
| Phone |
0111242823099 |
| Fax |
0111244753012 |
| Email |
sethan@lilly.com |
|
|
Source of Monetary or Material Support
|
| Eli Lilly and Company
Indianapolis, IN, USA 46285 |
|
|
Primary Sponsor
|
| Name |
Eli Lilly and Company |
| Address |
Indianapolis, IN, USA 46285 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
Modification(s)
|
Argentina
Australia
Bulgaria
Colombia
Croatia
Hungary
Japan
Lithuania
Malaysia
Mexico
New Zealand
Peru
Poland
Republic of Korea
Romania
Russian Federation
Slovakia
South Africa
Sri Lanka
Taiwan
Ukraine
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 20 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Balakrishna Gowda |
Apollo BGS Hospital |
Adichunchangari Road, Kuvempunaga
Mysore
KARNATAKA |
918212566666
918212460870
drtngkg@yahoo.com |
| Sarvajeet Pal |
Apollo Hospital |
Jubilee Hills
Hyderabad
ANDHRA PRADESH |
914023554720
914023543270
palsarvajeet@yahoo.com |
| Balagi Shrinivasan |
Apollo Hospital Chennai |
21 Greams Road
Chennai
TAMIL NADU |
914428294735
914428294449
baski4@yahoo.com |
| Gidaganti Mallinath |
BGS Global Hospital |
BGS Health Education City, #67 Uttarahalli Road, Kengeri
Bangalore
KARNATAKA |
08026255555
08028605642
mallinathortho@gmail.com |
| Balakondiah Koyagura |
Bollineni Superspeciality Hospital |
Dargamitta
Nellore
ANDHRA PRADESH |
918612349960
918612302164
bakolaxmi@rediffmail.com |
| Yadav Ajit |
Global Hospitals |
Lakdi Ka Pool, Near Hotel Dwaraka
Hyderabad
ANDHRA PRADESH |
0914444777000
0914422777100
drajityadav@globalhospital.net |
| Sundeep Upadhaya |
Indraprastha Apollo Hospital |
Sarita Vihar, Delhi Mathura Road
New Delhi
DELHI |
91911126925858
91911141677024
sundeepupadhaya@hotmail.com |
| Banwari Sharma |
Jaipur Hospital |
Lal Nothi, Near SMS Stadium
Jaipur
RAJASTHAN |
911419314627015
911412742472
sharmabanwari@hotmail.com |
| Bharat Jivani |
Jivani Orthopedic Hospital |
104 Ayush Doctor House, Near Poonam Doctor
Surat
GUJARAT |
91919805340772
914422265304
drjivani@yahoo.co.in |
| Ashok Patnala |
King George Hospital, Andhra Medical College |
S-5, Ortho Ward, Andhra Medical College
Visakhapatnam
ANDHRA PRADESH |
918912563344
918912563344
amcorthopaedics@hotmail.com |
| Sarath Chandra Veravalli |
Krishna Institute of Medical Sciences Ltd |
1-8-31/1, Minister Road
Hyderabad
ANDHRA PRADESH |
91914027725100
91914027840980
sarath10@hotmail.com |
| Sreenivasa Murthy |
Lifecare Clinic and Research Centre |
#2255, M.C.N. Complex, Kodigehalli Main Road, Sahakarnagar
Bangalore
KARNATAKA |
0919448051046
08023630055
drsreenivasamurthy@gmail.com |
| Naresh Shetty |
M S Ramaiah Medical College Hospital |
New Bel Road MSRIT Post
Bangalore
KARNATAKA |
91918023608888
91918025459164
nareshs8@hotmail.com |
| Bhagwan Bagaria |
Malpani Multispeciality Hospital |
Road No. 1, Vishwkarama Industrial Area, Sikar Road
Jaipur
RAJASTHAN |
0919460891205
0911412333886
dr.bagaria@yahoo.co.in |
| Talacheru Sreenivasulu |
Narayana Medical College |
Chinthareddypalem
Nellore
ANDHRA PRADESH |
0919703584153
0918612331763
drtsreenivasulu@gmail.com |
| Liza Rajasekara |
Nizams Institute of Medical Sciences |
Punjagutta
Hyderabad
ANDHRA PRADESH |
91914023320332
91914023310076
lizarajasekhar@gmail.com |
| Gaurav Rathi |
Rathi Orthopaedic and Research Centre |
Nr. Anupam Shopping Centre, Jodhpur Cross Roads, Satellite
Ahmadabad
GUJARAT |
919824015618
917926924812
drgjrathi@yahoo.co.in |
| Able Lawrence |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
Raebareli Road
Lucknow
UTTAR PRADESH |
91919984648333
915222668812
abledoc@gmail.com |
| Anil Gupta |
Somani Hospital |
277, Shri Gopal Nagar, 80 feet Rd., Gopalpura Bypass
Jaipur
RAJASTHAN |
919887501594
911412504110
drguptaanil2004@yahoo.co.in |
| Vineeta Shobha |
St. John Medical College |
Sarjapur Road
Bangalore
KARNATAKA |
91918022065345
91918025504593
vineeta_shobha@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 20 |
| Name of Committee |
Approval Status |
| Arogya Ethics Committee |
Approved |
| EC, Apollo Hospitals |
Approved |
| EC, Apollo Hospitals Enterprise Limited |
Approved |
| EC, M. S. Ramaiah Medical College and Teaching Hospital |
Approved |
| Ethical Committee on Clinical Trials, Indraprastha Apollo Hospitals |
Approved |
| IEC, Apollo BGS Hospital |
Approved |
| IEC, BGS Global Hospital |
Approved |
| IEC, Global Hospital and Health City |
Approved |
| IEC, King George Hospital |
Approved |
| IEC, Krishna Institute of Medical Sciences |
Approved |
| IEC, Krishna Institute of Medical Sciences (for Bollineni Hospital) |
Approved |
| IEC, Malpani Multispeciality Hospital |
Approved |
| IEC, Narayana Medical College Hospital |
Approved |
| IEC, Nizams Institute of Medical Sciences |
Approved |
| IEC, Sanjay Gandhi Post Graduate Institute of Medical Sciences |
Submittted/Under Review |
| IEC, St. Johns Medical College Hospital |
Approved |
| Rathi Ethics Committee |
Approved |
| Research Independent Ethics Committee |
Approved |
| SoMex Research and Health Ethics Committee, Jaipur |
Approved |
| The Lifecare 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 LY2127399 |
Given every 4 weeks for 24 weeks. Patients receive a 240mg loading dose when initiating treatment.
Administered subcutaneously.
During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.
After 16 weeks, non-responders will receive 90 mg every 2 weeks.
|
| Intervention |
90 mg LY2127399 |
Given every 2 weeks for 24 weeks. Patients receive a 180 mg loading dose when initiating treatment.
Administered subcutaneously.
After 16 weeks, non-responders will continue to receive 90 mg every 2 weeks.
|
| Comparator Agent |
Placebo |
Given every 2 weeks for 24 weeks.
Administered subcutaneously. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
-Diagnosis of Rheumatoid Arthritis (RA) of more than 6 months and less than 15 years
-Global Assessment of Disease Activity visual analog scale (VAS)greater than or equal to 20/100 mm
-If on one or more conventional DMARDs at randomization, must have been on a stable dose for at least 8 weeks prior to study start.
-Woman must not be pregnant, breastfeeding, or become pregnant during the study
-Age limit in India per Office of Drug Controller General India is 18 years to 65 years |
|
| ExclusionCriteria |
| Details |
-Use of unstable doses of non-steroidal inflammatory drugs (NSAIDS) in the past 6 weeks
-Steroid injection or intravenous (iv) infusion in the last 6 weeks
-Use of more than 10 mg/day of oral steroids in the last 6 weeks
-Use of biologic DMARD concurrently or recently
-History of a serious reaction to other biological DMARDs
-Use of an oral calcineurin inhibitor (e.g., cyclosporin or tacrolimus) in the last 8 weeks
-Surgery on a joint or other major surgery less than 2 months ago, or plans to have joint surgery or major surgery during the study
-Active fibromyalgia, juvenile chronic arthritis, spondyloarthropathy, Crohns disease, ulcerative colitis, psoriatic arthritis, or other systemic inflammatory condition except RA
-Cervical cancer or squamous skin cancer within the past 3 years, or other cancer within the past 5 years
-Received a live vaccine received within the past 12 weeks (for example, vaccines for measles, mumps, rubella, and chicken pox, and nasal-spray flu vaccines)
-Hepatitis or human immunodeficiency virus (HIV)
-A serious bacterial infection (for example, pneumonia or cellulitis) within 3 months or a serious bone or joint infection within 6 months
-Symptoms of herpes zoster or herpes simplex within the last month
-Active or latent tuberculosis (TB)
Current symptoms of a serious disorder or illness
-Use of an investigational drug within the last month |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of patients with American College of Rheumatology 20% response (ACR20) |
24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percentage of patients with American College of Rheumatology 50% (ACR50) and 70% (ACR70) response |
24 weeks |
| Mean percent improvement in ACR-N |
24 weeks |
| Change from baseline to 24 weeks in Tender Joint Count (68 joint count) |
baseline, 24 weeks |
| Change from baseline to 24 weeks in Swollen Joint Count (66 joint count) |
baseline, 24 weeks |
| Change from baseline to 24 weeks in Patients Assessment of Pain (VAS) |
baseline, 24 weeks |
| Change from baseline to 24 weeks in Patients Global Assessment of Disease Activity (VAS) |
baseline, 24 weeks |
| Change from baseline to 24 weeks in Physicians Global Assessment of Disease Activity (VAS) |
baseline, 24 weeks |
| Change from baseline to 24 weeks in Health Assessment Questionnaire-Disability Index (HAQ-DI) |
baseline, 24 weeks |
| Change from baseline to 24 weeks in Disease Activity Score-C-Reactive Protein (DAS28-CRP) |
baseline, 24 weeks |
| Percentage of patients with DAS28-Based European League Against Rheumatism (EULAR) response |
24 weeks |
| Change from baseline to 24 weeks in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) domain and summary scores |
baseline, 24 weeks |
| Time to ACR20 response |
baseline through 24 weeks |
| Change from baseline to 24 weeks in absolute B cell counts |
baseline, 24 weeks |
| Change from baseline to 24 weeks in serum immunoglobulin (Ig) levels |
baseline, 24 weeks |
| Population Pharmacokinetics (PK) |
baseline through 24 weeks |
| Percentage of patients developing anti-LY2127399 antibodies |
baseline through 24 Weeks |
| Change from baseline to 24 weeks in CRP |
baseline, 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="1002"
Sample Size from India="83"
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)
Modification(s)
|
25/10/2011 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
17/01/2011 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 in the treatmetn of rheumatoid arthritis while with or without background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy.
This study is comprised of 2 periods:
Period 1 - 24 week blinded treatment
Period 2 - 48 week post treatment follow up |