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CTRI Number  CTRI/2014/09/005044 [Registered on: 23/09/2014] Trial Registered Prospectively
Last Modified On: 16/12/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   multicenter, randomized, double-blind, controlled, Phase 2b/3 study to compare efficacy and safety of AB1010 at 3 and 6 mg/kg/day in treatment of patients which active rheumatoid arthritis 
Scientific Title of Study   A 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 3-parallel groups, Phase 2b/3 study to compare efficacy and safety of masitinib at 3 and 4.5 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
2010-020992-21  EudraCT 
AB06012, Version 9.0 dated 7th August 2013  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sudhir Kumar 
Designation  Head Clinical Operations  
Affiliation  Maya Clinicals Drug Development Pvt Ltd. 
Address  H-No 6-3-252-1-7-1 Plot- 545 APM Square Erramanzil Opposite IIPM Krishna Oberoi Road Banjara Hills

Hyderabad
ANDHRA PRADESH
500082
India 
Phone  9866193953  
Fax  040-233003277  
Email  drsudhirkumar@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sudhir Kumar 
Designation  Head Clinical Operations  
Affiliation  Maya Clinicals Drug Development Pvt Ltd. 
Address  H-No 6-3-252-1-7-1 Plot- 545 APM Square Erramanzil Opposite IIPM Krishna Oberoi Road Banjara Hills

Hyderabad
ANDHRA PRADESH
500082
India 
Phone  9866193953  
Fax  040-233003277  
Email  drsudhirkumar@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Jhansi Reddy 
Designation  CEO  
Affiliation  Maya Clinicals Drug Development Pvt Ltd. 
Address  H-No 6-3-252-1-7-1 Plot- 545 APM Square Erramanzil Opposite IIPM Krishna Oberoi Road Banjara Hills

Hyderabad
ANDHRA PRADESH
500082
India 
Phone  9177000930  
Fax  040-233003277  
Email  jhansi@mayaclinicals.com  
 
Source of Monetary or Material Support  
AB SCIENCE 
 
Primary Sponsor  
Name  AB SCIENCE 
Address  3 Avenue George V 75008 PARIS FRANCE 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Maya Clinicals  H-No 6-3-252-1-7-1 Plot- 545 APM Square Erramanzil Opposite IIPM Krishna Oberoi Road Banjara Hills 
 
Countries of Recruitment     Czech Republic
France
Germany
India
Poland
Romania
Slovakia
Spain
Thailand
United States of America
Greece  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashok Kumar  King George Hospital  Research Room,Medicine New Block, Beside Nizams Medicals,King George Hospital
Visakhapatnam
ANDHRA PRADESH 		 9849123602

ashok_ortho59@rediffmail.com 
Dr T Sudheer  Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital  Research Wing, 2nd Floor ,Beside Female Medical Ward,Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital
Srikakulam
ANDHRA PRADESH 		 9912320517

sudheer_mbbs@hotmail.com 
Dr TH Prakashappa  Sri Venkateshwra Hospital  Orthopedic Department,#86, Hosur Mian Road, Madiwala, Bangalore-560068.
Bangalore
KARNATAKA 		 9739908969

drprakashth@gmail.com 
Dr Arun Harwani  Sujan Surgical Cancer Hospital And Amravati Cancer foundation  Department of Rhemutology,52/B shankar Nagar main road Amravati 444606
Amravati
MAHARASHTRA 		 9881260388
0721-2578568
arunharwani@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Amravati ethics committee  Approved 
Institutional Ethics Committe  Approved 
Institutional Ethics Committee, King George Hospital  Approved 
Sri Venkateshwara Hosptial Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients with active rheumatoid arthritis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AB1010  patient will receive a total daily dose of 3 mg/kg/day of masitinib/placebo in addition to methotrexate/placebo. Patients will be treated for 24 weeks (with possible treatment extension) 
Intervention  AB1010  patient will receive a total daily dose of 4.5 mg/kg/day of masitinib/placebo in addition to methotrexate/placebo.Patients will be treated for 24 weeks (with possible treatment extension) 
Comparator Agent  METHOTREXATE  Methotrexate or a matching placebo to be taken during meals at the dose of 15 or 20 mg per week according to single or divided oral administration schedule.Methotrexate / 15 and 20 mg weekly  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patient with rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria for at least 6 months.
2. Patient with ACR functional class I-III.
3. Patient who have active RA.
4. Patient who failed (defined as active RA with stable dose during 3 months) methotrexate at a dose ≥ 15 mg/week or any DMARD including biologics drugs if patients previously failed methotrexate at a dose ≥ 15 mg/week or methotrexate at a dose ≥ 15 mg/week in combination with any DMARD including biologics drugs (Biologic drugs being defined as any of the following therapies: anti-TNFα, Anti-CD20, Anti-IL1, Anti-IL6, CTLA4).
5. Patient with a disease onset at > 16 years of age.
 
 
ExclusionCriteria 
Details  A patient must not be enrolled if he/she fulfills one of the following exclusion criteria:
1. Patient from whom the use of methotrexate is contraindicated as per its SPC (i.e. patient with severe renal or liver failure, patient with pre-existing blood dyscrasia, patient with alcohol abuse, patient with acute or chronic infection, patient with methotrexate intolerance, patient being treated with live attenuated vaccine)
2. Patient with documented fibromyalgia
3. Patient who have had a major surgery within 2 weeks prior to study entry
4. Patient with lactose intolerance
5. Patient presenting with cardiac disorders defined by at least one of the following conditions:
• Patient with recent cardiac history (within 6 months) of:
- Acute coronary syndrome
- Acute heart failure (class III or IV of the NYHA classification)
- Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death)
• Patient with cardiac failure class III or IV of the NYHA classification
• Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block)
• Syncope without known aetiology within 3 months
• Uncontrolled severe hypertension, according to judgment of the investigator, or symptomatic hypertension
6. Patient with history of primary malignancy < 5 years; except treated basal cell skin cancer or cervical carcinoma in situ
7. Patient with a severe and/or uncontrolled medical condition
8. Pregnant or lactating woman
9. Patient with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent.
10. Patient who were treated with methotrexate >20 mg cannot be included in the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Cumulative response on ACR20 (ie. response from week 8 to week 24).  Cumulative response on ACR20 (ie. response from week 8 to week 24). 
 
Secondary Outcome  
Outcome  TimePoints 
Cumulative response on ACR50 (ie. response from week 8 to week 24),
Cumulative response on ACR70 (ie. response from week 8 to week 24),
Cumulative response on ACR90 (ie. response from week 8 to week 24) 		 Cumulative response on ACR50, 70, 90 (ie. response from week 8 to week 24). 
 
Target Sample Size   Total Sample Size="450"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   30/09/2014 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/07/2011 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Other (Terminated) 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
Any formal presentation or publication of data collected from this study will be considered as a joint publication by the investigator(s) and the appropriate personnel of AB Science. For this multicentre study, it is mandatory that the first publication is based on data from all centres, analyzed as stipulated in the protocol by AB Science statisticians, and not by the investigators themselves. Investigators agree not to present data gathered from one centre or a small group of centres before the full, initial publication, unless formally agreed to by all other investigators and AB Science.
 
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