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1 Clinical Trial Details (PDF Generation Date :- Wed, 12 Sep :18:27 GMT) CTRI Number Last Modified On 04/07/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2013/05/ [Registered on: 27/05/2013] - Trial Registered Retrospectively No Interventional Biological Randomized, Parallel Group, Active Controlled Trial to evaluate pharmacokinetic, pharmacodynamic (efficacy) and safety of Rituximab (Zydus) and Rituximab (Roche) in patients with Rheumatoid Arthritis. A randomized controlled study to evaluate pharmacokinetic, pharmacodynamic (efficacy) and safety of Rituximab (Zydus) and Rituximab (Roche) 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) Details Contact Person (Public Query) RIT PROT,version 1.1,dated 06th November 2012 Designation Affiliation Protocol Number Details of Principal Investigator Dr R H Jani Phone Fax Designation Affiliation Senior Vice president (E) Mumbai Mumbai rhjani@zyduscadila.com Details Contact Person (Scientific Query) Dr R H Jani Phone Fax Designation Affiliation Senior Vice president (E) Mumbai Mumbai rhjani@zyduscadila.com Details Contact Person (Public Query) Dr R H Jani Senior Vice president (E) Mumbai Mumbai 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 Phone Fax > NA Type of Sponsor NIL List of Countries of Principal Investigator Source of Monetary or Material Support Primary Sponsor Details (E) Mumbai Pharmaceutical industry-n NIL of Site Site Phone/Fax/ DrAtchuta Ramaiah Andhra Hospital Department of Orthopaedics,Andhra Hospitals,CVR Complex,Prakasam Road,Vijaywada Hyderabad ANDHRA PRADESH DrRamchandra Kamath Kasturba Medical College Hospital Dr Praveen Jadhav Dr Gaurav Rathi Omkar Heart Institute and nursing home and rheumatology Clinic Rathi Orthopedic & Research Centre Dr. Ramachandra Kamath. K., Associate Professor Dept. of Orthopaedics Kasturba Medical College Hospital Attavar, Mangalore Karnataka, Bangalore KARNATAKA Omkar Heart Institute and nursing home and rheumatology Clinic, Behind Regimental Plaza, Gaikwad Mala, Nashik Road, Nashik Nashik Rathi Orthopedic & Research Centre, Nr. Anupam Shopping Centre, Jodhpur Crossroads, Satellite, Ahmedabad Ahmadabad GUJARAT veluriatchuta@rediffmai l.com drkrk_ortho@yahoo.co.i n drpraveenj@sify.com drgjrathi@yahoo.co.in of Approval Status Date of Approval Is Independent Ethics? Bezwada Central Ethics Approved 04/01/2013 Yes page 2 / 6

3 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Dr. Praveen Jadhav,Yash Society Ethics Dr.Ramchandra Kamath,Manipal University Ethics Approved 22/04/2013 Yes Approved 10/01/2013 Yes Rathi Ethics Approved 27/06/2013 No Status Date Approved/Obtained 21/03/2013 Health Type Patients Condition Rheumatoid Arthritis Type Details Intervention Rituximab (Zydus) Dose-1000mg Route-Intravenous Frequency-2 infusion 2 weeks apart. Duration of therapy -04 months Comparator Agent Rituximab (Roche) Dose-1000mg Route-Intravenous Frequency-2 infusion 2 weeks apart. Duration of therapy:04 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?70 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 at least 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. 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 (also known as juvenile rheumatoid arthritis) and/or RA before age History of inflammatory arthritis other than RA (e.g., inflammatory bowel disease, 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 infliximab, adalimumab, or leflunomide). 9. Treatment with any investigational agent within 4 weeks of page 3 / 6

4 Method of Generating Random Sequence Method of Concealment Blinding/Masking Other Other Open Label screening or 5 half-lives of the investigational drug (whichever is longer). 10. Previous treatment with Rituximab. 11. Previous treatment with any cell-depleting therapies, including investigational agents. 12. Treatment with IV gamma-globulin or plasma filtering device like Prosorba (R) Column within the previous 6 months. 13. Receipt of a vaccine within 4 weeks prior to Day 1 infusion. 14. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies. 15. History of primary or secondary immunodeficiency 16. 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. 17. Known active bacterial, viral, fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds). 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. Neutrophils < /µL. Primary Outcome Outcome Timepoints 1) Compare pharmacokinetics (PK- Cmax, AUC0-t)of rituximab following IV infusions of rituximab (Zydus) and Rituximab (Roche) Day 15 Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 1 Date of First 25/04/2013 1) Pharmacodynamic parameters: Assessment of CD19 level in RA patients on Day 15 as compared to baseline in both the treatment groups. 2) Immunogenicity assessment: Percentage of subjects who develop detectable anti-drug antibodies Total Sample Size=24 Sample Size from =24 Day 15 page 4 / 6

5 Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary No Date Specified Years=0 Months=6 Days=0 Not Applicable Open to Recruitment This is a multicentric, randomized, open label, parallel arm study to evaluate the pharmacokinetics, pharmacodynamics (efficacy) and safety of Rituximab (Zydus) as compared to Rituximab (Reference, Roche) in patients with Rheumatoid Arthritis (RA). Patients suffering from RA since the last 6 months and having mild- to moderate disease activity, as assessed by Disease Activity Score-28 (DAS-28) will be invited for participation in the screening program of the study. Such a patient will be required to sign an Informed Consent Form after understanding the informed consent document before any trial related activity. If the patient satisfies all the inclusion-exclusion criteria, the subject will be eligible for randomization into the study. The study is divided into 2 parts: Part A This study is a single dose PK/PD study (advised by DCGI) wherein Rituximab 1000 mg via IV infusion will be given to the eligible subjects who satisfy the inclusion-exclusion criteria on the day of enrolment (Day1). This study is of 15 days duration and will assess the single dose pharmacokinetics, pharmacodynamics of Rituximab (Zydus) as compared to Rituximab (Roche). The scheduled visits include Visit 1 - Day 1 Visit 2 - Day 3±1 Visit 3 - Day 7±1 Visit 4 - Day 15±1 Visit 2 and Visit 3 will be home visits wherein a lab personnel appointed by the sponsor will go to the patient s home and collect pharmacokinetic samples. Visit 1 and Visit 4 will be visits in the hospital wherein the Principal Investigator (PI) will assess the patient clinically (physical- vitals, general and systemic examination). The PI will also assess the tender joint and swollen joint count by counting the number of joints which are tender or swollen, along with pain assessment and global health assessment performed by the patient and the treating physician. Rituximab infusion will be given on Day 1 (Visit1) after collection of baseline blood samples. Prior to infusion, premedication with analgesics, antipyretics and antihistamine is necessary. Methylprednisolone 100mg IV is recommended 30 minutes prior to infusion of Rituximab to decrease the rate and severity of infusion reactions. The infusion of Rituximab will be given under the supervision of a physician and will follow the general instructions which have been mentioned in the package insert of the originator. For pharmacokinetics, blood sample will be collected at the following time points. a) Part A Day 1 0 hrs and end of infusion Day 3 Day 7 Day 15 0 hrs The study will also assess pharmacodynamics. For this, quantitative assessment of CD19 cell count will be done by the flow cytometry at the Central Laboratory, Ahmedabad. CD19 is a biomarker for efficacy analysis of Rituximab. Immunogenicity assessment will also be carried out at baseline (predose) and Day 15 (0hours). This will involve the detection of anti-drug antibodies to Rituximab. page 5 / 6

6 Powered by TCPDF ( PDF of Trial Part B As per the package insert of the originator, one complete course of Rituximab includes 2 infusions of 1000mg each given via IV infusion on Day 1 and Day 15. This complete course ensures that the patient remains symptom free for a minimum of months. The benefits may last for 1-2 years as well. In view of the same, the sponsor believes that the second dose should be given to the patient for compassionate use on ethical considerations. The subject s participation in receiving the second dose is completely non-obligatory. However, if they wish to receive the second dose of Rituximab they would be required to sign another Informed Consent Form (ICD Part B), confirming their participation in receiving the second dose of Rituximab. However, this would also mean that they are willing to provide additional blood samples for pharmacokinetic, pharmacodynamic and immunogenicity assessment. page 6 / 6

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