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 Study
A randomized, double-blind, multicenter, phase 3 study to compare the efficacy and safety of BMO-2 (adalimumab) and Humira® (adalimumab) in patients with active rheumatoid arthritis
Rajiv Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital, Srikakulam
Rajiv Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital,Research Wing , Beside FM Ward, 2nd Floor , Srikakulam-532001 , A.P, India. Srikakulam ANDHRA PRADESH
9949900369
rimsresearch@gmail.com
Dr Ajit Nalawade
Ruby Hall Clinic,Pune
Ruby Hall Clinic, 40 Sassoon Road,Pune-411001, Maharashtra, India. Pune MAHARASHTRA
Ajanta Research Centre,
Ajanta Institute & IVF Centre,
No. 765, ABC Complex,
Kanpur Road, Near Krishna Cinema,
Alambagh, Lucknow-226005. Lucknow UTTAR PRADESH
9559782773
dr.rajeshkgmc@gmail.com
Dr Nishil Shah
Apple Hospital,Surat
Apple Hospital,
Udhna Dharwaja, Ring Road,
Surat - 345002
Gujarat - India Surat GUJARAT
9825634634 91-261-6696078 drnishil.shah@gmail.com
Dr Pramodini shankaran
Bhakti Vedanta Hospital and Research Institute,
Bhakti Vedanta Hospital and Research Institute,
Srishti Complex, BhaktiVedanta swami Marg,
Mira road east,
Thane, Maharastra-401107, India Thane MAHARASHTRA
Calicut Government Medical College,
Medical College PO
Calicut- 673008
Kerala- India Kozhikode KERALA
7411906179 4952355331 njayachandran9@gmail.com
Dr Chandrashekara Srikantiah
Chanre Rheumatology and Immunology Center and Research
Chanre Rheumatology and Immunology Center and Research #149,15th main , NHCS , water tank Road,4th Block, 3rd Stage, Basaveshwaranagar, Bangalore-560079 Bangalore KARNATAKA
080-42516699
chandrashekara_s@yahoo.com
Dr Krishnamurthy V
Chennai meenakshi multispeciality hospital, Chennai
Chennai Meenakshi MultiSpeciality Hospital, Chennai
Tamil Nadu- India Chennai TAMIL NADU
Chopda Medicare & Research Center Pvt, Ltd, Magnum Heart Institute,
Chopda Medicare & Research Center Pvt, Ltd, Magnum Heart Institute,
3/5 Patil lane no.1, Laxmi Nagar,
Near KBH Vidyalaya,Canada Corner,
Nashik-422005.Maharashtra, Inida Nashik MAHARASHTRA
9970222227
dr.naisar@yahoo.com
Dr Emil J Thachil
Elite Mission Hospital, Thrissur
Elite Mission Hospital
PB No 1414, Kookenchery,
Thrissur- 680007
Kerala- India Thrissur KERALA
0487-2436100 0487-2436167 eliteh.cr@gmail.com
Dr Sukhendu Sarkhel
Healthpoint, Kolkata
Healthpoint 21, Prannath Pandit Street, Opposite Lansdowne Paddapukur, Kolkata - 700025
West Bengal- India Kolkata WEST BENGAL
Rathi Hospital, Near Anupam Shopping Centre,
Opp Mahabaleshwar Society,
Jodhpur Cross Roads, Satellite, Ahmedabad-380015, India Ahmadabad GUJARAT
9824015618 079-26924812 drgjrathi@yahoo.co.in
Dr Sharad Purohith
Sanjivani Super Speciality Hospitals Private Limited
Sanjivani Super Speciality Hospitals Private Limited, 1, Uday Park Society, Vastrapur,Near Sunrise Park, Vastrapur-380051,Ahmadabad, GUJARAT, India Ahmadabad GUJARAT
9879007908
drsharad15@gmail.com
Dr Girish HR
Sapthagiri Hospital,
Sapthagiri Hospital, No. 15, Chikkasandra, Hesaraghatta Main Road, Bengaluru,560073 Karnataka, India Bangalore KARNATAKA
9900073260 080-22188737 girirudra@yahoo.co.in
DrAshish Pongde
Shree hospital & critical care center
Shree hospital & critical care center 799,
Nagar, opp.Tajshree building,
Sakkardara square, Nagpur – 440009,
Maharashtra, India Nagpur MAHARASHTRA
9326118869
drpongade@gmail.com
DrPSrinivas Raju Gupta
St. Theresa’s Hospital
St. Theresa’s Hospital, Sanathnagar,
Hyderabad-500018, Telangana State,
India Hyderabad ANDHRA PRADESH
9392491940
drpsrguptaa@gmail.com
Dr Hema
Stanley medical college
Stanley medical college,Old jail road, Royapuram,Chennai-600003. Chennai TAMIL NADU
9094821986
stanleyresearch@gmail.com
DrJadhav Meera Praveen
Sujata Birla Hospital & Research Center,
Sujata Birla Hospital & Research Center,
Opp Bytco College,Nasik Road,Nashik-422101,Maharashtra,India Nashik MAHARASHTRA
9822055612
drpraveenjadhav@rediffmail.com
Dr Vikram Muralidar Haridas
Sushruta Multispecialty Hospital and Research Centre
Sushruta Multispecialty Hospital and Research Centre Private Limited, P. B. Road, Vidyanagar, Hubli- 580021, Karnataka, India. Dharwad KARNATAKA
institutional Ethics committee, Om Surgical Center
Approved
Institutional Ethics Committee, Rajiv Gandhi Institute of Medical Science A.P.
Approved
institutional Ethics committee, Stanley Medical college Chennai
Approved
Instiutional Ethics Committee,KGH,Vishakhapatnam
Approved
Jasleen Hospitals Ethics committee, Nagpu
Approved
Magna Care Ethics Committee, Chopda Medicare & Research Centre Nasik
Approved
Noble hospital Institutional Ethics committee
Approved
Penta-Med Ethics Committee, Pune
Approved
Rathi Ethics Committee, Ahmedabad
Approved
Sanjivani hospital, Ethics committee, Ahmedabad
Approved
Sapthagiri Institute Of Medical Sciences and Research Center institutional ethics committee,Bangalore
Approved
Shree Hospital Ethics Committee,Nagpur
Approved
Sushruta Hospital Ethics Committee, Hubli
Approved
Yash Society Ethics Committee, Nasik
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
moderate to severely active rheumatoid arthritis patients ,
Intervention / Comparator Agent
Type
Name
Details
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
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 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.
ExclusionCriteria
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 Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
Proportion of patients achieving ACR 20 response at week 14.
ACR 20 response at week 14.
Secondary Outcome
Outcome
TimePoints
• Proportion of patients achieving ACR 20 response at week 24.
• Proportion of patients achieving ACR 50 and ACR 70 response at weeks 14 and 24.
•Change from baseline of the DAS 28-CRP at weeks 14 and 24.
•Change from baseline in physical function as 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.
•ACR 20 response at week 24.
•ACR 50 and ACR 70 response at weeks 14 and 24.
•DAS 28-CRP at weeks 14 and 24.
•HAQ-DI at weeks 14 and 24.
•Antidrug antibodies (binding and neutralizing) over 24 weeks.
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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.