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Clinical Trial Details (PDF Generation Date :- Sun, 26 Sep 2021 11:45:12 GMT)
CTRI Number CTRI/2016/02/006625 [Registered on: 11/02/2016] - Trial Registered Prospectively Last Modified On 18/11/2019 Post Graduate Thesis No Type of Trial Interventional Type of Study Biological Study Design Randomized, Parallel Group Trial Public Title of Study A clinical Trial to evaluate efficacy and safety of BMO-2 and Adalimumab in patient with active rheumatoid arthritis Scientific Title of A randomized, double-blind, multicenter, phase 3 study to compare the efficacy and safety of Study BMO-2 (adalimumab) and Humira® (adalimumab) in patients with active rheumatoid arthritis Secondary IDs if Any Secondary ID Identifier BMO-2-RA-03-I-01 Ver 3.0 19/10/2016 Protocol Number Details of Principal Details of Principal Investigator Investigator or overall Name Dr Subramanian L Trial Coordinator (multi-center study) Designation Chief Scientific Manager Affiliation Biocon Research Limited, Address Biocon House,Semicon Park, Electronic City Phase II, Bengaluru, Karnataka 560100 KARNATAKA,India Bangalore KARNATAKA 560100 India Phone 8067755305 Fax 080-28085323 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Subramanian L Query) Designation Chief Scientific Manager Affiliation Biocon Research Limited, Address Biocon House,Semicon Park, Electronic City Phase II, Bengaluru, Karnataka 560100 KARNATAKA,India Bangalore KARNATAKA 560100 India Phone 8067755305 Fax 080-28085323 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Ms Jayanti Panda Designation Scientific Manager Affiliation Biocon Research Limited Address Biocon Special Economic Zone, Plot no 2&3, Phase IV-B Bommasandra, Jigani Link Road Bangalore KARNATAKA 560099 India
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Phone 08067755304 Fax 08067755323 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Biocon Ltd. Primary Sponsor Primary Sponsor Details Name Biocon Research Limited Address Biocon Special Economic Zone, Plot no 2 and 3, Phase IV B Bommasandra, Jigani Link Road, Bangalore, KARNATAKA, 560099. Type of Sponsor Pharmaceutical industry-Indian Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator DrJugal Kishore Kadal Care Hospital Care Hospital, Road 9550601010 No:1, Banjara Hills Hyderabad-500034. [email protected] India Hyderabad ANDHRA PRADESH Dr P Ashok Kumar King George Hospital, King George Hospital, 9849123602 Visakhapatnam Medicine-New Block, 91-891-2704848 Beside Nizam?s Medic ashok_ortho59@rediffm als,Visakhapatnam ail.com 530002,Andhra Pradesh, India Visakhapatnam ANDHRA PRADESH DrSudheer Tulasi Rajiv Gandhi Institute Rajiv Gandhi Institute 9949900369 of Medical Sciences & of Medical Sciences & RIMS Govt. General RIMS Govt. General [email protected] Hospital, Srikakulam Hospital,Research m Wing , Beside FM Ward, 2nd Floor , Srikakulam-532001 , A.P, India. Srikakulam ANDHRA PRADESH Dr Ajit Nalawade Ruby Hall Clinic,Pune Ruby Hall Clinic, 40 9822027023 Sassoon 020-261164529 Road,Pune-411001, dr.ajitnalawade@gmail. Maharashtra, India. com Pune MAHARASHTRA Dr Rajesh Prajapati Ajanta Research Ajanta Research 9559782773 Centre,Lucknow Centre, Ajanta Institute & IVF Centre, No. 765, [email protected] ABC Complex, Kanpur om Road, Near Krishna Cinema, Alambagh, Lucknow-226005. Lucknow UTTAR PRADESH
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Dr Nishil Shah Apple Hospital,Surat Apple Hospital, Udhna 9825634634 Dharwaja, Ring Road, 91-261-6696078 Surat - 345002 Gujarat [email protected] - India m Surat GUJARAT Dr Pramodini Bhakti Vedanta Hospital Bhakti Vedanta Hospital 9820317030 shankaran and Research Institute, and Research Institute, 02228459885 Srishti Complex, shankarankrishnan@ya BhaktiVedanta swami hoo.com Marg, Mira road east, Thane, Maharastra-401107, India Thane MAHARASHTRA Dr NV Jayachandran Calicut medical college, Calicut Government 7411906179 Calicut Medical College, 4952355331 Medical College PO njayachandran9@gmail Calicut- 673008 Kerala- .com India Kozhikode KERALA Dr Chandrashekara Chanre Rheumatology Chanre Rheumatology 080-42516699 Srikantiah and Immunology Center and Immunology Center and Research and Research chandrashekara_s@ya #149,15th main , NHCS hoo.com , water tank Road,4th Block, 3rd Stage, Basaveshwaranagar, Bangalore-560079 Bangalore KARNATAKA Dr Krishnamurthy V Chennai meenakshi Chennai Meenakshi 04442938938 multispeciality hospital, MultiSpeciality Hospital, 044-24993282 Chennai Chennai Tamil Nadu- researchchennaimeena India [email protected] Chennai TAMIL NADU DrNaisar Dilip Nahar Chopda Medicare & Chopda Medicare & 9970222227 Research Center Pvt, Research Center Pvt, Ltd, Magnum Heart Ltd, Magnum Heart [email protected] Institute, Institute, 3/5 Patil lane no.1, Laxmi Nagar, Near KBH Vidyalaya,Canada Corner, Nashik-422005. Maharashtra, Inida Nashik MAHARASHTRA Dr Emil J Thachil Elite Mission Hospital, Elite Mission Hospital 0487-2436100 Thrissur PB No 1414, 0487-2436167 Kookenchery, Thrissur- [email protected] 680007 Kerala- India Thrissur KERALA Dr Sukhendu Sarkhel Healthpoint, Kolkata Healthpoint 21, 9831011878 Prannath Pandit Street, 3324559037 Opposite Lansdowne sukhendu.sarkhel@gm
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Paddapukur, Kolkata - ail.com 700025 West Bengal- India Kolkata WEST BENGAL Dr Smruti Ramteke Jasleen Hospital, Jasleen Hospital, 1st 9823514680 Nagpur floor, Opp. Big Bazar, 0712-2421209 Panchsheel Square, [email protected] Dhantoli, Wardha Road m Nagpur-440012,MAHA RASHTRA, Inida Nagpur MAHARASHTRA Dr Urmila Dhakad King George Medical King George Medical 9696349671 University University,Lal Bahadur Shastri drurmiladhakad@gmail. Bhawan,Lucknow com 226018 Lucknow UTTAR PRADESH Dr BR Bagaria Malpani Multispeciality Malpani Multispeciality 9460891205 Hospital Hospital, SP-6, Road 0141-2333886 no-1, V.K I Area, Sikar [email protected] Road, Jaipur-302013, Rajasthan, India Jaipur RAJASTHAN Dr Girish Gokuldas Medipoint Hospital Medipoint Hospital Pvt. 7387003636 Bhatia ,Pune Ltd, 241/1, New D.P 020-39841200 Road, Aundh, drbhatia.pentagon@gm Pune-411007, ail.com Maharashtra, India Pune MAHARASHTRA Dr Sachin Karkamkar Noble Hospital, Pune Noble Hospital,Dept. of 9225505582 Rheumatology 53, Magarpatta City [email protected] Road,Hadapsar, Pune, .in Maharashtra-411013,In dia Pune MAHARASHTRA DrAwadhesh Kumar Om Research Om Research 9415226817 Yadav Center,Om surgical Center,Om surgical centre & Maternity centre & Maternity omresearchcenter@gm Home Home SA-17/3,Sri ail.com Krishna Nagar,Paharia,Ghazipu r road, Varanasi-22100 7,UP,India Lucknow UTTAR PRADESH Dr Vijay Goni Post graduate institute PGIMER, Sector -12 , 9914209747 of medical research & Chandigarh -India 91-172-2744401 education Chandigarh [email protected] CHANDIGARH Dr Gaurav Rathi Rathi Rathi Hospital, Near 9824015618 Hospital,Ahmedabad Anupam Shopping 079-26924812 Centre, Opp [email protected]
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Mahabaleshwar Society, Jodhpur Cross Roads, Satellite, Ahmedabad-380015, India Ahmadabad GUJARAT Dr Sharad Purohith Sanjivani Super Sanjivani Super 9879007908 Speciality Hospitals Speciality Hospitals Private Limited Private Limited, 1, Uday [email protected] Park Society, Vastrapur,Near Sunrise Park, Vastrapur-380051 ,Ahmadabad, GUJARAT, India Ahmadabad GUJARAT Dr Girish HR Sapthagiri Hospital, Sapthagiri Hospital, 9900073260 No. 15, Chikkasandra, 080-22188737 Hesaraghatta Main [email protected] Road, Bengaluru,560073 Karnataka, India Bangalore KARNATAKA DrAshish Pongde Shree hospital & critical Shree hospital & critical 9326118869 care center care center 799, Nagar, opp.Tajshree building, [email protected] Sakkardara square, Nagpur – 440009, Maharashtra, India Nagpur MAHARASHTRA DrPSrinivas Raju Gupta St. Theresa’s Hospital St. Theresa’s Hospital, 9392491940 Sanathnagar, Hyderabad-500018, [email protected] Telangana State, India m Hyderabad ANDHRA PRADESH Dr Hema Stanley medical college Stanley medical 9094821986 college,Old jail road, Ro yapuram,Chennai-6000 stanleyresearch@gmail 03. .com Chennai TAMIL NADU DrJadhav Meera Sujata Birla Hospital & Sujata Birla Hospital & 9822055612 Praveen Research Center, Research Center, Opp Bytco College,Nasik Ro drpraveenjadhav@rediff ad,Nashik-422101,Mah mail.com arashtra,India Nashik MAHARASHTRA Dr Vikram Muralidar Sushruta Multispecialty Sushruta Multispecialty 9343649883 Haridas Hospital and Research Hospital and Research Centre Centre Private Limited, drvikramharidas@gmail P. B. Road, .com Vidyanagar, Hubli- 580021, Karnataka, India.
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Dharwad KARNATAKA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Apple hospital ethics Approved 23/11/2015 No committee,Surat Bhakti Vedanta Hospital Approved 22/12/2015 No Ethics Committee,Thane Chennai Meenakshi Approved 23/01/2016 No MultiSpeciality Hospital ethics committe, Ethics committee,St. Approved 12/01/2017 No Theresa Health point ethics Submittted/Under No Date Specified No committee, Kolkata Review Institutional Ethics Approved 10/11/2015 No Committee Elite Mission Hospital,Thrissur Institutional ethics Approved 01/11/2015 No committee Malpani Multispecialty Hospital,Jaipur Institutional Ethics Approved 04/12/2015 No Committee Poona Medical Research Foundation, Pune Institutional Ethics Submittted/Under No Date Specified No Committee Post Review Graduate Institute of medical education & research, Chandigarh institutional Ethics Approved 29/02/2016 No committee, Ajanta Hospital, Lucknow institutional Ethics Approved 06/03/2016 No committee, care hospital, Hydrabad institutional Ethics Approved 11/01/2017 No committee, Chanre Hospital, Bangalore institutional Ethics Approved 13/12/2016 No committee, GMC Kozhikode, Calicut institutional Ethics Approved 16/02/2016 No committee, KGMU, Lucknow institutional Ethics Approved 08/01/2017 No committee, Om Surgical Center Institutional Ethics Approved 05/01/2016 No Committee, Rajiv Gandhi Institute of Medical Science A.P. institutional Ethics Approved 04/02/2017 No
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committee, Stanley Medical college Chennai Instiutional Ethics Com Approved 01/12/2015 No mittee,KGH,Vishakhapa tnam Jasleen Hospitals Approved 31/10/2015 No Ethics committee, Nagpu Magna Care Ethics Approved 05/01/2017 No Committee, Chopda Medicare & Research Centre Nasik Noble hospital Approved 12/08/2016 No Institutional Ethics committee Penta-Med Ethics Approved 06/11/2015 No Committee, Pune Rathi Ethics Approved 25/11/2015 No Committee, Ahmedabad Sanjivani hospital, Approved 10/03/2016 No Ethics committee, Ahmedabad Sapthagiri Institute Of Approved 01/12/2015 No Medical Sciences and Research Center institutional ethics committee,Bangalore Shree Hospital Ethics Approved 20/12/2016 No Committee,Nagpur Sushruta Hospital Approved 11/01/2017 No Ethics Committee, Hubli Yash Society Ethics Approved 10/01/2017 No Committee, Nasik Regulatory Clearance Status Date Status from DCGI Approved/Obtained 18/01/2016 Health Condition / Health Type Condition Problems Studied Patients moderate to severely active rheumatoid arthritis patients Intervention / Type Name Details Comparator Agent Intervention BMO-2 (adalimumab) 40 mg SC (subcutaneous) administration every alternate week start from week 0 to week 22 Comparator Agent Humira® (adalimumab) 40 mg SC (subcutaneous) administration every alternate week start from week 0 to week 22 Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 65.00 Year(s) Gender Both Details 1. Adult male and female patients diagnosed with RA for at least 4
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months (as per 2010 ACR/EULAR criteria) and having a score ?6/10.
2. Patients with active RA defined as ?6 swollen (out of 66) and ?6 tender (out of 68) joint counts and CRP >8 mg/L despite taking MTX orally for ?12 weeks and at a stable weekly dose of ?12.5 mg (minimum of 10 mg if intolerant/contraindicated to further dose escalation) in the last 4 weeks prior to screening and plan to remain on stable dose throughout the study.
3. RA functional class I, II, or III.
Exclusion Criteria Exclusion Criteria Details 1. Rheumatoid arthritis with significant secondary involvement 2. Treatment with DMARDs other than MTX within 4 weeks prior to screening (8 weeks prior for leflunomide, and azathioprine). 3. Prior or current treatment with investigational or approved biologics for rheumatoid arthritis. 4. History of or current inflammatory joint disease other than RA or other systemic autoimmune disorder or diagnosis of JIA/JRA. 5. Any surgical procedure, including bone/joint surgery/synovectomy within 12 weeks prior to screening or planned during the study or history of infected joint prosthesis within 5 years. 6. Chronic or current infectious disease 7. Subjects with active or latent tuberculosis as evident from chest X ray and/or clinical signs and symptoms 8. Subjects with a positive test for TB (Mantoux/PPD test or Quantiferon TB Gold/IGRA test). 9. Evidence of significant uncontrolled concomitant diseases. 10. Known active infection of any kind or any episode of infection requiring hospitalization or treatment with anti-infective within 30 days of dosing. 11. Receipt of a live/attenuated vaccine within 28 days prior to randomization. 12. History of use of intra-articular or parenteral glucocorticoids within 4 weeks prior to screening.
Method of Generating Computer generated randomization Random Sequence Method of Centralized Concealment Blinding/Masking Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded Primary Outcome Outcome Timepoints Proportion of patients achieving ACR 20 ACR 20 response at week 14. response at week 14. Secondary Outcome Outcome Timepoints • Proportion of patients achieving ACR 20 •ACR 20 response at week 24. response at week 24. •ACR 50 and ACR 70 response at weeks 14 and • Proportion of patients achieving ACR 50 and 24. ACR 70 response at weeks 14 and 24. •DAS 28-CRP at weeks 14 and 24. •Change from baseline of the DAS 28-CRP at •HAQ-DI at weeks 14 and 24. weeks 14 and 24. •Antidrug antibodies (binding and neutralizing) •Change from baseline in physical function as over 24 weeks. assessed by HAQ-DI at weeks 14 and 24. •Nature, frequency and severity of adverse events (AEs). •Detection of antidrug antibodies (binding and neutralizing) over 24 weeks.
Target Sample Size Total Sample Size=220 Sample Size from India=220
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Final Enrollment numbers achieved (Total)=222 Final Enrollment numbers achieved (India)=222 Phase of Trial Phase 3 Date of First 09/08/2016 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=2 Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Completed Trial (India) Publication Details - Brief Summary This study is randomized, double-blind, multicenter, two-arm, parallel-group, phase 3 study to assess the efficacy and safety of BMO-2 and Humira® in combination with MTX in 140 patients with active rheumatoid arthritis. Patients will be randomized to receive either BMO-2 or Humira®, every other week until week 22, along with their background stable dose of MTX every week until week 24. End of trial safety follow up will be performed at week 30.
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