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1 Clinical Trial Details (PDF Generation Date :- Thu, 26 Jul :07:50 GMT) CTRI Number Last Modified On 28/10/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2013/10/ [Registered on: 01/10/2013] - Trial Registered Prospectively No Interventional Biological Randomized, Parallel Group, Active Controlled Trial A study to evaluate efficacy, tolerability and safety of Adalimumab (Zydus) and Adalimumab (Reference) in patients with Rheumatoid Arthritis. A multicentric, randomized, active controlled parallel group study to evaluate efficacy, tolerability and safety of Adalimumab (Zydus) and Adalimumab (Reference) in patients with 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) ADA PROT(Version -1.0 dated 27th April 2013) Designation Affiliation Protocol Number Details of Principal Investigator Dr R H jani Phone Fax Designation Affiliation Senior Vice president Cadila healthcare limited Zydus Cadila House,Plot no.360, TPS 5, Service road, Vile Parle (East) Mumbai, Mumbai rhjani@zyduscadila.com Details Contact Person (Scientific Query) Dr R H jani Senior Vice president Cadila healthcare limited Zydus Cadila House,Plot no.360, TPS 5, Service road, Vile Parle (East) Mumbai, Details Contact Person (Public Query) Phone Fax Designation Affiliation rhjani@zyduscadila.com Details Contact Person (Public Query) Dr R H jani Senior Vice president Cadila healthcare limited Zydus Cadila House,Plot no.360, TPS 5, Service road, Vile Parle (East) Mumbai, page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax > Cadila Healthcare Limited Type of Sponsor NA List of Countries of Principal Investigator Source of Monetary or Material Support Primary Sponsor Details Cadila Healthcare Limited Zydus Cadila House,2nd Floor,Plot No.360,T.P.S.5,service road,vile parle(e),mumbai Pharmaceutical industry-n of Site Site Phone/Fax/ Dr Uma Kumar AIIMS, Delhi Room No 4076, Department of Medicine, AIIMS, Ansari Nagar, South in Extension, New Delhi New Delhi DELHI Dr Girish Bartakke Dr Dinesh Jain B J Govt. Medical College,Pune Dayanand Medical College and Hospital Department of Orthopaedics, B J Govt. Medical College and a girishbartakke@rediffm Nursing -COllege and ail.com Sassoon Hospital. Near Pune Railway Station. Pune Pune Department of Medicine, Dayanand Medical College and Hospital,D.M.C.Road, Togore Nagar, Ludhiana Ludhiana PUNJAB Dr P Ashok Kumar King George Hospital Department of Orthopedics, Unit 2. King George Hospital, Visakhapatnam , AP, Visakhapatnam ANDHRA PRADESH Dr Rajiv Gupta Malpani Multispeciality hospital Malpani Multispeciality hospital, Road No-1, V K I, Jaipur Jaipur RAJASTHAN dineshdmc@gmail.com ashok_ortho59@rediffm ail.com drrajivg77@gmail.com page 2 / 6

3 Details of Ethics Committee Dr Girish Bhatia Golkuldas Dr Gaurav Rathi Dr Liyakat Ali Gauri Medipoint Hospitals Pvt. Ltd Rathi Orthopaedic & Research Centre S P Medical College and associated Group of Hospi Medipoint Hospitals Pvt. Ltd, 241/1, New D. P. Road, Aundh, Pune , Maharashtra, Pune Rathi Orthopaedic & Research Centre, Nr. Anupam Shopping Centre, Opp. Mahabaleshwar Socity, Jodhpur cross road, Satellite, Ahmedabad , Gujarat. Ahmadabad GUJARAT Dr Reena Sharma Shalby Hospital Shalby Hospitals, Opp. Karnavati Club, S. G. Highway, Ahmedabad Ahmadabad GUJARAT Dr Praveen Jadhav Dr Vikram Haridas Sujata Birla Hospital and Medical Research Center drbhatia.pentagon@gm ail.com drgjrathi@yahoo.co.in S P Medical College and associated Group of Hospital, Bikaner-334 drliyakatgauri@rediffma 001,Rajasthan il.com Bikaner RAJASTHAN Sujata Birla Hospital and Medical Research Center, Opp. Bytco College, Nashik Road, Nashik Nashik reena.sharma@shalby. org drpraveenj@sify.com Sushrusta Sushrusta Multispeciality Hospitals Multispeciality Hospitals & Research Centre & Research Centre Pvt Ltd. Vidyanagar,P. B Road, Hubli-Karnataka Belgaum KARNATAKA haridasvikram@yahoo. co.in of Committee Approval Status Date of Approval Is Independent Ethics Committee? Ethics Committee,S P Medical college and A G Hospitals,Bikaner Ethics Committee,Shalby Hospital Institute Ethics committee,all Institute of medical sciences Committe,King george hospital Vi Approved 26/08/2012 No Approved 21/09/2013 No Approved 08/01/2014 No Approved 25/11/2013 No page 3 / 6

4 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria committee Committee,Dayanand Medical college and hospital,ludhiana Committee,Malpani Multispeciality hospital Penta Med Ethics Committee Approved 10/02/2014 No Approved 01/11/2013 No Approved 29/09/2013 No Approved 19/09/2013 No Rathi Ethics Committee Approved 29/06/2013 No Sushruta Hospital Ethics Committee Yash Society Ethics Committe Status Approved 29/08/2013 No Approved 08/10/2013 No Date Approved/Obtained 04/09/2013 Health Type Patients Condition Rheumatoid arthritis. Type Details Intervention Adalimumab (Zydus) Route:-Subcutaneous Dose:-40mg Dosage:-subcutaneous injection every other week Duration:-3 months Comparator Agent Adalimumab (Abbott) Route:-Subcutaneous Dose:-40mg Dosage:-subcutaneous injection every other week Duration :-3 months Age From Age To Gender Year(s) Year(s) Both Inclusion Criteria Details 1. Adults subjects of either gender in age group of? 18 year and?65 years. 2. History of rheumatoid arthritis, as defined by the American College of Rheumatology (ACR) Classification1, for atleast 6 months. 3. Moderate to severe active seropositive disease. 4. History of treatment with Methotrexate (MTX) 10-25mg per week for atleast 12 weeks with last 4 weeks at the stable dose before screening. 5. If female and of childbearing potential, she shall have a negative pregnancy test at the time of screening and agrees to use adequate contraception throughout the study period. 6. Able and willing to give written informed consent and comply with the requirements of the study protocol. Exclusion Criteria Details Exclusion Criteria 1. Patients with significant systemic manifestations of RA. 2. Female nursing patients. 3. Rheumatic autoimmune disease other than RA. 4. History of diagnosis of juvenile idiopathic arthritis (JIA) (also page 4 / 6

5 Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Pre-numbered or coded identical Containers Participant and Investigator Blinded known as juvenile rheumatoid arthritis [JRA]) and/or RA before age History of inflammatory arthritis other than RA (e.g., inflammatory bowel disease (IBD), systemic lupus erythematosus (SLE), or psoriatic arthritis). 6. Any surgical procedure, including bone/joint surgery or planned surgery within 8 weeks prior to screening or during the study period. 7. Functional Class IV as defined by the American College of Rheumatology (ACR) classification of functional status in RA2. 8. History of use of disease-modifying anti-rheumatic drugs (DMARDs) other than MTX within 4 weeks prior to randomization (8 weeks prior for leflunomide). 9. Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer). 10. Preceding treatment with any tumor necrosis factor (TNF) antagonist, including adalimumab. 11. Use of intra-articular or parenteral corticosteroids within 4 weeks prior to screening visit. Inhaled corticosteroids for stable medical conditions are allowed. 12. Receipt of a vaccine within 4 weeks prior to enrolment visit. 13. History of severe allergic or anaphylactic reactions to latex 14. History of primary or secondary immunodeficiency. 15. Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, renal, hepatic, endocrine, gastrointestinal, or pulmonary disease, including any pulmonary or other condition that would preclude subject participation. 16. Known active bacterial, viral, fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds). 17. History of travel to areas endemic for mycoses, such as histoplasmosis, coccidioidomycosis or blastomycosis. 18. History of recurrent significant infection or any significant episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening. 19. History of cancer, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinoma of the skin that have been excised and cured). 20. Lack of peripheral venous access. 21. History of chronic daily use of narcotic analgesics. 22. History of alcohol, drug, or chemical abuse within 6 months prior to screening. 23. Positive Hepatitis B surface antigen or antibodies to Hepatitis C. 24. History of significant cytopenias or other bone marrow disorders. 25. Laboratory Exclusion Criteria: Patients may not participate in this study until any of the following that are present have resolved. a. Serum creatinine > 1.4 mg/dl for women or 1.6 mg/dl for men. b. AST or ALT > 2.5 times upper limit of normal (UNL). c. Platelet count d. Hemoglobin e. Neutrophil < /µL. Primary Outcome Outcome Timepoints 1) Pharmacodynamic (efficacy) of Adalimumab (Zydus) and Adalimumab (Abbott) in subjects with RA on Day 84 as compared to baseline Day 84 page 5 / 6

6 Powered by TCPDF ( PDF of Trial a) Proportion of patient with an ACR 20 response in both the treatment groups. Secondary Outcome Outcome Timepoints Pharmacodynamic (efficacy) of Adalimumab (Zydus) and Adalimumab (Abbott) in subjects with RA on Day 84 as compared to baseline:-change from baseline in Disease Activity Score 28 C-Reactive Protein (DAS 28-CRP),Proportion of patient with an ACR 50 response in both the treatment groups,proportion of patient with an ACR 70 response in both the treatment groups. Immunogenicity assessment: Percentage of subjects who develop detectable anti-drug antibodies Pharmacodynamic (efficacy) :-Day 84. Immunogenicity assessment:-day 1, Day 28 and Day 84 (Week 12). 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 Total Sample Size=120 Sample Size from =120 15/10/2013 No Date Specified Years=1 Months=6 Days=0 Not Applicable Completed NA This is a multicentric, randomized, active controlled parallel group study to evaluate efficacy, tolerability and safety of Adalimumab (Zydus) and Adalimumab (Reference) in patients with Rheumatoid Arthritis. The purpose of this study is to determine the efficacy, tolerability and safety of Adalimumab (Zydus) in patients with rheumatoid Th subjects from either gender in age group of? 18 to?65 years with History of rheumatoid arthritis, as defined by the American College of Rheumatology (ACR) Classification1, for at least 6 months, Moderate to severe active seropositive disease., History of treatment with Methotrexate (MTX) 10-25mg per week for atleast 12 weeks with last 4 weeks at the stable dose before screening will be invited to participate in this study. page 6 / 6