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1 Clinical Trial Details (PDF Generation Date :- Sun, 20 Jan :39:27 GMT) CTRI Number CTRI/2009/091/ [Registered on: 11/01/2010] - Last Modified On Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study Randomized, Parallel Group, Placebo Controlled Trial A Study in Patients With Rheumatoid Arthritis A Phase 2 Dose-Ranging Study of Multiple Subcutaneous Doses of LY (an Anti-IL-17 Antibody) in Patients With Active Rheumatoid Arthritis on Concomitant DMARD Therapy Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) I1F-MC-RHAK NCT Designation Affiliation Protocol Number ClinicalTrials.gov Details of Principal Investigator Dr. Sumit Arora Phone Fax Designation Affiliation Parexel International Synchron Pvt. Ltd., MFAR Silver Line Tech Park Plot #180, 3rd floor, EPIP II Phase, Whitefield Bangalore KARNATAKA sumit.arora@parexel.com Details Contact Person (Scientific Query) Anil Seth Phone Fax Designation Affiliation Plot #92, Sector 32 Institutional Area Gurgaon HARYANA sethan@lilly.com Details Contact Person (Public Query) Anil Seth Phone Fax Plot #92, Sector 32 Institutional Area Gurgaon HARYANA page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee > Eli Lilly Type of Sponsor Nil List of Countries of Principal Investigator Source of Monetary or Material Support Eli Lilly Primary Sponsor Details of Site Site Phone/Fax/ Sarvajeet Pal Apollo Hospital Jubilee Hills, Hyderabad ANDHRA PRADESH Srikantiah Chandrashekhar Sarath Chandra Mouli Veeravalli Jugalkishore Kadel Bhagwana Bagaria Chanre Rheumatology and Immunology Center and Research Krishna Institutes of Medical Sciences Mahavir Hospital and Research Center Malpani Multispeciality Hospital 123, 13th Cross, 3rd Main Margosa Road,Ma lleswaram Bangalore KARNATAKA /1,,Minister Road Not Applicable N/A Ground Floor, AC Guard, Hyderabad ANDHRA PRADESH Road No 1, Vishwkarama Industrial Area,Sikar Road Jaipur RAJASTHAN Somnath Mitra Manipal Hospital 98, Rustom Bagh,Airport Road Bangalore KARNATAKA Gumdal Narsimulu Nizam's Institute of Medical Sciences Punjagutta, Hyderabad ANDHRA PRADESH m hoo.com n com mail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? EC of Manipal Hospital Approved No Date Specified Not Available IEC Approved No Date Specified Not Available IEC, Apollo Hospitals Approved No Date Specified Not Available IEC, Chanre Approved No Date Specified Not Available Rheumatology Immunology Center and page 2 / 6

3 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Research IEC, Krishna Institutes of Medical Sciences IEC, Mahavir Hospital and Research Center IEC, Nizam's Institute of Medical Sciences Status Approved/Obtained Health Type Approved No Date Specified Not Available Approved No Date Specified Not Available Approved No Date Specified Not Available Date No Date Specified Condition Rheumatoid Arthritis Type Details Intervention LY to 180 mg, subcutaneous at weeks 0, 1, 2, 4, 6, 8 10 (bdmard-naive population) mg, subcutaneous at weeks 0, 1, 2, 4, 6, 8, 10 (TNFa-IR population) Both populations can receive 160 mg in optional Part B, subcutaneous at weeks 16, 18, 20 and every 4 weeks thereafter until week 60. Comparator Agent Placebo Weeks 0, 1, 2, 4, 6, 8 and 10 Age From Age To Gender Details Details Inclusion Criteria You must be between the ages of 18 and 75 You must have active RA Qualifications Specific to the bdmard-naive Population: You must be regularly using methotrexate (MTX) for at least 12 weeks before your participation in this study Qualifications Specific to the TNFα-IR Population: You must have been treated with at least 1 biologic TNFα inhibitor therapy and either had an insufficient response to at least 3 months of treatment OR have been intolerant of such treatment You must be regularly using at least 1 conventional DMARD in a stable treatment regimen Exclusion Criteria You are concomitantly using non-steroidal anti-inflammatory drugs (NSAIDS), unless you are on a stable dose within the last 2 weeks You are a woman who is lactating or breast feeding You have donated more than 300 ml of blood within the last month You have received glucocorticoid administered by intra-articular, intramuscular, or intravenous (IV) injection or oral corticosteroids at an average daily dose of greater than 10 mg per day of prednisone or its equivalent within the last 4 weeks You had surgery on a joint that is to be assessed in the study within 2 months of study enrollment, or will require such during the study You have another serious disorder or illness You suffered a serious bacterial infection (for example, pneumonia, cellulitis, or bone or joint infections) within the last 3 months You have a history of uncontrolled high blood pressure You have clinical laboratory test results at entry that are outside the normal reference range You are an employee of the clinic or you are an immediate family member of an employee of the clinic. Immediate family member is defined as a spouse, parent, child, or sibling, page 3 / 6

4 Method of Generating Random Sequence Method of Concealment Blinding/Masking whether biological or legally adopted You are currently participating in or were discontinued within the last 30 days from another clinical trial involving an investigational drug If you are a woman and you could become pregnant during this study, you must talk to the study doctor about the birth control that you will use to avoid getting pregnant during the study. If you are a post menopausal woman, you must be at least 45 years of age and have not menstruated for the last 12 months If you are a woman between 40 and 45 years of age, test negative for pregnancy, and have not menstruated during the last 12 months only, you must have an additional blood test to see if you can participate. If you are male, you must agree to reduce the risk of your female partner becoming pregnant during the study. Exclusions Specific to the bdmard-naive Population: You have received any prior biologic DMARD therapy such as TNFα, IL-1, IL-6, T-cell, or B-cell targeted therapies You have had an inadequate response to a minimum of 3 months of treatment with 5 or more conventional DMARDs (such as leflunomide, azathioprine, cyclosporine, etc) You have used DMARDs other than MTX, hydroxychloroquine, or sulfasalazine within the last 8 weeks You have used leflunomide within the last 12 weeks and have not received cholestyramine to speed up the elimination of leflunomide from your body. Exclusions Specific to the TNFα-IR Population: You are currently using or recently used a biologic DMARD or a biologic TNFα inhibitor therapy within specified periods You have had a serious reaction to other biologic DMARDs that, in the study doctor's opinion, puts you at serious risk You have used cyclosporine or any other immunosuppressive in the 8 weeks before your participation in this study Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded Primary Outcome Outcome Timepoints Dose-response relationship measured by the week 12 proportion of American College of Rheumatology (ACR) 20 responders; Biologic disease modifying anti-rheumatic drug-naive population (bdmard-naive) only Secondary Outcome Outcome Timepoints Proportion of American College of Rheumatology (ACR) 20 responders; Tumor Necrosis Factor alpha - inadequate responder population (TNFa-IR) only Smallest doses that achieve 10%, 50%, and 90% of the maximum American College of Rheumatology (ACR) 20 response; Biologic disease modifying anti-rheumatic drug-naive population (bdmard-naive) Smallest doses that achieve 10%, 50%, and 90% of the maximum Disease Activity Score (DAS) 28 response; Biologic disease modifying anti-rheumatic drug-naive population (bdmard-naive) only Smallest doses that achieve 10%, 50%, and 90% of the maximum American College of Rheumatology (ACR) 50 response; Biologic disease modifying anti-rheumatic drug-naive week 12 Week 12 Week 12 Week 12 page 4 / 6

5 Target Sample Size Phase of Trial Phase 2 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary population (bdmard-naive) only Change from baseline in Disease Activity Score (DAS28 Proportion of American College of Rheumatology (ACR) 20/50/70 responders Change from baseline in individual components of the American College of Rheumatology (ACR) core set Proportion of patients in European League Against Rheumatism Responder Index (EULAR28) Actual value of American College of Rheumatology (ACR)-N Change from baseline in duration of morning stiffness (minutes) Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relationship between exposure and response of individual components of the American College of Rheumatology (ACR) core set Relationship between exposure and response of American College of Rheumatology (ACR) 20/50/70/N Relationship between exposure and response of Disease Activity Score (DAS) 28 Relationship between exposure and response of European League Against Rheumatism (EULAR) 28 Pharmacokinetics Cmax anti-ly antibodies Total Sample Size=372 Sample Size from = No Date Specified 25/08/2009 Years= Months=0 Days=0 Completed Study I1F-MC-RHAK is a multicenter study in patients with active rheumatoid arthritis on concomitant conventional disease modifying anti-rheumatic drug (DMARD) therapy. The study is a Phase 2 study with 2 parts. Part A is a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging design and Part B is an optional, open-label extension design. Two patient populations will be evaluated in this study: biologic disease modifying anti-rheumatic drug [bdmard]-naive patients and tumor necrosis factor alpha-inadequate responder [TNFα-IR] patients. Patients in Part A receive multiple subcutaneous (SC) injections of LY page 5 / 6

6 Powered by TCPDF ( PDF of Trial (bdmard-naive patients: 0 [placebo], 3, 10, 30, 80, or 180 mg; TNFα-IR patients: 0 [placebo], 80 or 180 mg) at Weeks 0, 1, 2, 4, 6, 8, and 10. Patients in Part B receive SC injections of LY mg at Weeks 16, 18, and 20, and every 4 weeks thereafter through Week 60. Patients who complete both Part A and B have a total study participation of up to approximately 72 to 84 weeks. The number of participants expected to enroll in is 32. The expected study start date in is 17Dec09. page 6 / 6