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1 Clinical Trial Details (PDF Generation Date :- Fri, 08 Mar :58:25 GMT) CTRI Number CTRI/2009/091/ [Registered on: 17/11/2009] - Last Modified On 15/01/2015 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No Interventional Biological Single Arm Trial To determine the safety and efficacy of Etanercept for injection 25 mg in patients with moderate to severe active rheumatoid arthritis. An open label, prospective, non-comparative, multicentre study to assess the safety and efficacy of Etanercept for injection 25 mg in patients with moderate to severe active rheumatoid arthritis. 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) PRC/CRD/05/09, V-N0 4, September 04, 2009 Protocol Number Details of Principal Investigator Dr Sushrut Babhulkar Principal Investigator Phone Fax Sushrut Hospital and research Centre and Post Graduate institute of Orthopaedics, Central Bazar road, Ramdaspeth, Nagpur Maharashtra Sushrut Hospital and research Centre and Post Graduate institute of Orthopaedics, Central Bazar road, Ramdaspeth, Nagpur Maharashtra Nagpur sushrutdsurgeon@gmail.com Details Contact Person (Scientific Query) Dr Dhiraj Abhyankar Head Clinical Research Development Cipla Ltd., Phone Fax Cipla Ltd R and D 8th floor Vikhroli west Vikhroli West Dhiraj.Abhyankar@Cipla.com Details Contact Person (Public Query) Dr Sachin naik Medical And Safety Expert Cipla Ltd Cipla Ltd R and D 4th floor Vikhroli west Vikhroli West page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax Source of Monetary or Material Support > Cipla Ltd., Opp. Hotel Sahil, Central, Type of Sponsor Nil List of Countries of Principal Investigator Dr Pramodini Shankaran Dr Lata Bichile DrBGDharmanand Dr Yojana Gokhale Primary Sponsor Details Cipla Ltd R and D Centre LBS Marg Vikhroli W Cipla Ltd. Cipla R and D centre LBS Marg Vikhroli west Pharmaceutical industry-n of Site Site Phone/Fax/ Arthritis Clinic Centre for Arthritis & Rheumatic Diseases Department of Arthritis, Room No C/405, 4th floor,hetal Arch, Opp. Natraj Market,,S.V. Road, Malad (west) Department of Arthritis and Rheumatic disease Room no 106, Modi Chambers, 1st floor, French Bridge,,Opp. Opera House, CHANRE Department of Rheumatology & Rheumatology & Immunology Center and Immunology Research Centre,#149,15th Main,Water tank road,4th Block,3rd Stage,,Basaveshwara Nagar, Bangalore KARNATAKA Dr. Gokhales Clinic & Arthritis Center Department of Arthritis Centre, Ground floor, 5/33, Unnat Nagar-3,,MG road, Goregaon(w) DrShashank Akerkar Jivdaya Clinic Department of Arthritis,Jivdaya Lane,Dharmodaya,B Wing,1st Floor,Room No 1,Next to Ghatkopar Telephone Exchange,G shankarankrishnan@ya hoo.com lsbichile@rediffmail.co m chanrericr@yahoo.co.in yojana1962@gmail.co m shashank77_2000@ya hoo.com page 2 / 5

3 Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria DrSushrut Babhulkar Sushrut Hospital and Research Center and Post Graduate Institute of Orthopaedics hatkopar(w) Department of Research Centre,Sushrut Hospital sushrutdsurgeon@gmai and research Centre l.com and Post Graduate institute of Orthopaedics, Central Bazar road, Ramdaspeth, Nagpur Maharashtra Nagpur of Committee Approval Status Date of Approval Is Independent Ethics Committee? Institutional Ethics Committee, CHANRE Rheumatology & Immunology Centre and Research Banglore Karnataka Approved 04/01/2010 No Status Approved 04/11/2009 Yes Approved 04/05/2010 Yes Date Approved/Obtained 30/10/2009 Health Type Patients Condition Rheumatoid Arthritis Type Details Intervention Etanercept 25 mg twice weekly for 24 weeks Comparator Agent Nil Nil Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria 1. Written informed consent after being provided with detailed information about the nature, risks, and scope of the clinical trial as well as the expected desirable and adverse effects of the drug. 2. Male or female patients aged more than 18 to 70 years. 3. Definite diagnosis made in line with American College of Rheumatology (ACR) 1987 revised criteria. Diagnosis of rheumatoid arthritis meeting at least four of seven of the following criteria: A. Morning stiffness duration>1 hr lasting >6 weeks. B. Soft tissue swelling (arthritis) of 3 or more joint areas observed by page 3 / 5

4 a physician lasting > 6 weeks. C. Arthritis of hand joints; swelling of the proximal interphalangeal, metacarpophalangeal, or wrist joints lasting > 6 weeks. D. Symmetric swelling (arthritis) at least one area, lasting > 6 weeks. E. Rheumatoid nodules; as observed by a physician. F. Serum rheumatoid factor; as assessed by a method positive. G. Radiographic changes; erosions and/or periarticular osteopenia in hand and/or wrist joints. 4. Patients having inadequate response to at least one but not more than four disease-modifying antirheumatic drugs (DMARDs) e.g. hydroxychloroquine, Sulfasalazine, oral or injectable gold, D-penicillamine, including methotrexate. 5. Patients willing to continue the appropriate dose of Methotrexate and discontinuing other DMARDs for rest of the study duration if the patient is found maintaining on DMARDs during screening. 6. ESR (Westergren)?28mm/h 7. Stabilizing the dosage at least for 4 weeks before the enrolment if the patient was found taking oral NSAIDs during screening. 8. Stabilizing the dosage of oral glucocorticosteroids at least for 4 weeks (?10 mg/day equivalent to prednisone) if the patient was found taking oral glucocorticosteroids during the screening. 9. Able to self administer the injection or with the help of an assistant and store the investigational medicinal product (IMP) at 2-80C. Exclusion Criteria Details Exclusion Criteria 1. Patients with history or presence of cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, metabolic, dermatologic, neurological, psychiatric or other immunologic disease which is considered as significant at the discretion of Principal Investigator. 2. Patients currently suffering from acute or chronic infections or history of recurring and chronic infections or active and inactive/latent tuberculosis (i.e. Mantoux Tuberculosis Skin test; Induration of?10 mm) or sepsis or risk of sepsis. 3. Patients who have: Haemoglobin Clinically significant out of range values of AST(SGOT), ALT(SGPT) (i.e. more than 1.5 times the upper limit of normal values) Any other clinically significant abnormal lab values at the discretion of investigator. 4. Malignancies or susceptible population of family history. 5. Patients at risk of Hepatitis B virus. 6. Patients who are on live vaccinations. 7. Patients who have a previous history of blood dyscrasias. 8. Patients previously treatment with Etanercept or other bio-tech products within 6 months from screening. 9. Patients who have received Leflunomide treatment within 4 weeks of screening. 10. Patients who have received glucocorticosteroids treatment in joint cavities within 4 weeks of screening. 11. Known hypersensitivity to Etanercept or any of the components of study medication. 12. Patients with history of alcohol, drug or chemical abuse which is considered as significant at the discretion of Principal Investigator. 13. Pregnancy, lactation period or females of child-bearing age unwilling to take adequate contraceptive precautions. 14. Treatment with any other investigational drug in a clinical trial in the last 3 months before initiation of this trial. 15. Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible page 4 / 5

5 Powered by TCPDF ( consequences of the study. 16. In the investigator s opinion, patients unlikely to comply with study procedures. 17. Patients previously enrolled into this study. Method of Generating Random Sequence Method of Concealment Blinding/Masking Primary Outcome Outcome Timepoints ACR 20% improvement 24 weeks from baseline Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 3 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 1. Rate and amount of NSAIDs used. 2. ACR 50% improvement Total Sample Size=100 Sample Size from =100 30/12/2009 No Date Specified Years=1 Months=0 Days=0 Completed 24 weeks from baseline Safety and Efficacy of Biosimilar Etanercept in Moderate to Severe Active Rheumatoid Arthritis: Phase IIIstudy Dr. Chachad Siddarth, 1Mr. Phatak Mukul, 1Mr. Salvi Amit, 1Dr. Purandare Shrinivas, 2Dr. Dharmanand B.G., 3Dr. Bichile Lata, 4Dr. Akerkar S. M., 5Dr. Gokhale Yojana, 6Dr. Babhulkar Sushrut, 7Dr. Shankaran Pramodini, The study is non comparative study to evaluate the efficacy and safety of Etanercept powder for solution for injection 25 mg/ml in moderate to severe active rheumatoid arthritis patients. Enrolled patients will be treated with Etanercept 25 mg twice weekly for 24 weeks. Efficacy and safety will be evaluated at the end of 24 weeks in terms of ACR 20% and ACR50% criteria. Total of 100 patients are planned to be recruited for the study. The recruitment HAS started from 30th December page 5 / 5