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CTRI Number  CTRI/2011/07/001870 [Registered on: 08/07/2011] Trial Registered Prospectively
Last Modified On: 01/12/2011
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 on a Background Treatment of Methotrexate 
Scientific Title of Study   A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis (RA) Who Had an Inadequate Response to Methotrexate Therapy  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
H9B-MC-BCDM   Protocol Number 
NCT01198002  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nishant Naniah 
Designation  Associate Clinical Team Lead 
Affiliation   
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 46285 
 
Primary Sponsor  
Name  Eli Lilly and Company 
Address  Indianapolis, IN USA 46285 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment
Modification(s)  		   Argentina
Australia
Brazil
Bulgaria
Colombia
Croatia
Hungary
India
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 = 19  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Balakrishna Gowda  Apollo BGS Hospital  Adichunchangari Road, Kuvempunaga
Mysore
KARNATAKA 		 9182125666665
9182125666665
drtnbkg@yahoo.com 
Sarvajeet Pal  Apollo Hospital  AHERF, Apollo Health City, Jubilee Hills
Hyderabad
ANDHRA PRADESH 		 914023554720
91402353270
palsarvajeet@yahoo.com 
Balaji Shrinivasan  Apollo Hospitals Chennai  21 Greams Road
Chennai
TAMIL NADU 		 9104428211111
9104428294429
baski4@yahoo.com 
Gidaganti Mallinath  BGS Global Hospital  BGS Health Education City #67, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA 		 08026255555
08026255555
mallinath45@yahoo.com 
Balakondiah Koyagura  Bollineni Superspeciality Hospital  Dargamitta
Nellore
ANDHRA PRADESH 		 91919440279700
9108612302164
bakolaxmi@rediffmail.com 
Ajit Yadav  Global Hospitals  439, Cheran Nagar, Perumbakkam
Chennai
TAMIL NADU 		 914422777000
914422777100
gcrschennai@gcrs-online.com 
Sundeep Upadhaya  Indraprastha Apollo Hospital  Sarita Vihar, Delhi Mathura Road
New Delhi
DELHI 		 91919818359408
9101141677024
sundeepupadhyaya@hotmail.com 
Banwari Sharma  Jaipur Hospital  Lal Nothi, Near SMS Stadium
Jaipur
RAJASTHAN 		 911412741619
911412742472
sharmabanwari@hotmail.com 
Bharat Jivani  Jivani Orthopedic Hospital  104 Ayush Doctor House, Near Poonam Doctor
Surat
GUJARAT 		 91919440279700
9104422265304
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 Veravalli  Krishna Institute of Medical Sciences Ltd  1-8-31/1, Minister Road
Hyderabad
ANDHRA PRADESH 		 9104044885074
9104027840773
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 		 9108040528411
9108040528402
nareshs8@hotmail.com 
Sreenivasulu Talacheru  Naryana Medical College and Hospital  Chinthareddypalem
Nellore
ANDHRA PRADESH 		 918612317963
918612331763
drtsreenivasulu@gmail.com 
Liza Rajasekara  Nizams Institute of Medical Science  Punjagutta
Hyderabad
ANDHRA PRADESH 		 9104023489412
9104066465086
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 		 915229984648333
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 		 91919845021146
9108022065352
immunology_clinical_trials@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 19  
Name of Committee  Approval Status 
Aroyga Ethics Committee  Approved 
BGS Global Hospital Institutional Ethics Committee  Approved 
EC, Apollo Hospitals  Approved 
EC, Apollo Hospitals Enterprise Limited  Approved 
EC, Krishna Institute of Medical Sciences (for Bollineni Hospital)  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, Global Hospitals and Health City  Approved 
IEC, King George Hospital  Approved 
IEC, Krishna Institute of Medical Sciences  Approved 
IEC, Narayana Medical College and 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  Approved 
Lifecare Ethics Committee  Approved 
Rathi Ethics Committee  Approved 
Research Independent Ethics Committee, Surat  Approved 
SoMex Research and Health Ethics Committee, Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
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 100 weeks. Patients receive a 240mg loading dose when initiating treatment. 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 100 weeks. Patients receive a 180 mg loading dose when initiating treatment. After 16 weeks, non-responders will continue to receive 90 mg every 2 weeks.  
Comparator Agent  placebo  Given every 2 weeks for 52 weeks, and then patients are randomized to receive one of the 2 doses of LY2127399. After 16 weeks, non-responders will receive 90 mg every 2 weeks.  
 
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
-Regular use of methotrexate (MTX) in the past 12 weeks, with the dose being stable during the past 8 weeks
-At least 8 tender and swollen joints
-At least one erosion of a hand or foot joint observed on an X-ray
-An abnormally high C-reactive protein (CRP) level or erythrocyte sedimentation rate (ESR)
-Positive for Rheumatoid Factor (RF) or Anti-cyclic citrullinated peptide (CCP) antibody
-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
-History of an inadequate response to a biologic disease-modifying anti-rheumatic drug (DMARD)
-History of a serious reaction to other biological DMARDs
-History of the use of rituximab or other B cell therapy
-Use of DMARDS other than MTX, hydroxychloroquine, or sulfasalazine within the last 8 weeks
-Use of leflunomide within the last 12 weeks (unless cholestyramine was used to speed up the elimination of leflunomide)
-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 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) at Week 24

Change from baseline to Week 52 in van der Heijde modified Total Sharp Score (mTSS)

Change from baseline to Week 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI) 		 24 weeks

Baseline, 52 weeks

Baseline, 24 weeks

 
 
Secondary Outcome  
Outcome  TimePoints 
Percentage of patients with American College of Rheumatology 50% (ACR50) and 70% (ACR70) response  24 weeks, 52 weeks 
Change from baseline in Disease Activity Score C-Reactive Protein (DAS28-CRP)  Baseline, 24 weeks, 52 weeks 
Percentage of patients with DAS28-Based European League Against Rheumatism (EULAR) response  24 weeks, 52 weeks 
Change from baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) domain scores and summary scores  Baseline, 24 weeks, 52 weeks 
Change from baseline in Brief Fatigue Inventory (BFI) individual items and impact score  Baseline, 24 weeks, 52 weeks 
Change from baseline in duration of morning stiffness (minutes)  Baseline, 24 weeks, 52 weeks 
Percentage of patients with Major Clinical Response (MCR) during 52 weeks  Baseline through 52 weeks 
Percentage of patients with change from baseline in mTSS less than or equal to 0  24 weeks, 52 weeks, 100 weeks 
Change from baseline in B cell subset counts  Baseline, 24 weeks, 52 weeks 
Population Pharmacokinetics (PK)  Baseline through 52 weeks 
Percentage of patients developing anti-LY2127399 antibodies  Baseline through 100 weeks 
Change from baseline in Brief Pain Inventory Short Form (BPI-sf) individual items and interference scores  Baseline, 24 weeks, 52 weeks 
Percentage of patients with structural inhibition at Week 52  52 weeks 
Change from baseline in mTSS  Baseline, 24 weeks, 100 weeks 
Change from baseline in serum immunoglobulin (Ig) levels  Baseline, 24 weeks, 52 weeks, 100 weeks 
Change from baseline in joint space narrowing score and bone erosions score (components of mTSS)  Baseline, 24 weeks, 52 weeks, 100 weeks 
Mean percent improvement in ACR N  24 weeks, 52 weeks 
Change from baseline in Tender Joint Count (68 joint count)  Baseline, 24 weeks, 52 weeks 
Change from baseline in Swollen Joint Count (66 joint count)  Baseline, 24 weeks, 52 weeks 
Change from baseline in Patients Assessment of Pain (VAS)  Baseline, 24 weeks, 52 weeks 
Change from baseline in Patients Global Assessment of Disease Activity (VAS)  Baseline, 24 weeks, 52 weeks 
Change from baseline in Physicians Global Assessment of Disease Activity (VAS)  Baseline, 24 weeks, 52 weeks 
Change from baseline to Week 52 in HAQ-DI  Baseline, 52 weeks 
Change from baseline in absolute B cell counts  Baseline, 24 weeks, 52 weeks, 100 weeks 
Percentage of patients with ACR20 at Week 52  52 weeks 
Time to ACR20 response  Baseline through 24 and 52 weeks 
Change from baseline in CRP  Baseline, 24 weeks, 52 weeks 
 
Target Sample Size   Total Sample Size="990"
Sample Size from India="238" 
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)  		 10/11/2011 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  02/12/2010 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="4"
Months="7"
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 treatment of rheumatoid arthritis while on a background treatment of methotrexate.

This study is comprised of three periods:

Period 1 - 52 week blinded treatment

Period 2 - additional 48 week unblinded treatment

Period 3 - 48 week post treatment follow up

H9B-MC_BCDM(1): this addendum is to be performed in countries participating in the vaccine addendum in addition to all procedures required by the protocol H9B-MC-BCDM or any subsequent amendments to that protocol.

 
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