| CTRI Number |
CTRI/2011/12/002247 [Registered on: 16/12/2011] Trial Registered Prospectively |
| Last Modified On: |
07/12/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug
Biological |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFα Agents |
|
Scientific Title of Study
|
A Randomized, Double-blind, Placebo-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 2 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFα Agents |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CAIN457F2302 (Version 00; Date-11-May-2011 |
Protocol Number |
| NCT01365455 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Murugananthan K |
| Designation |
Head- Cinical Development |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited,
Medical Department,
Sandoz House,
Shiv Sagar Estate,
Dr. Annie Besant Road,
Worli, Mumbai � 400 018
Maharashtra
Mumbai
MAHARASHTRA
400 018
India |
| Phone |
022-24958545 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Murugananthan K |
| Designation |
Head- Cinical Development |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited,
Medical Department,
Sandoz House,
Shiv Sagar Estate,
Dr. Annie Besant Road,
Worli, Mumbai � 400 018
Maharashtra
Mumbai
MAHARASHTRA
400 018
India |
| Phone |
022-24958545 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
Details of Contact Person
Public Query
|
| Name |
Murugananthan K |
| Designation |
Head- Cinical Development |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited,
Medical Department,
Sandoz House,
Shiv Sagar Estate,
Dr. Annie Besant Road,
Worli, Mumbai � 400 018
Maharashtra
Mumbai
MAHARASHTRA
400 018
India |
| Phone |
022-24958545 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
|
Source of Monetary or Material Support
|
| Novartis Pharma AG, Basel, Switzerland |
|
|
Primary Sponsor
|
| Name |
Novartis Healthcare Pvt Ltd |
| Address |
Medical Dept, Sandoz House, Shiv Sagar Estate, dr A. B. road, Worli Mumbai |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Belgium
Canada
Colombia
Guatemala
Hungary
India
Italy
Japan
Panama
Romania
Thailand
Turkey
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 14 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrDineshS |
Asha Health Pit |
Department of Rheumatoid Arthritis,Stop, No:1 CC, 201, 3rd Floor, 2nd Main, Kasturi Nagar, Bangalore-560043, Karnataka, India.
Bangalore
KARNATAKA |
919886125229
bhaktha.dinesh@gmail.com |
| DrChandrashekaraS |
Chanre Rheumatology & Immunology Centre & Research (CRIC&R) |
Department of Rheumatoid Arthritis, 123 Margosa Road Malleswaram, Opp 13th Cross Bus Stop, Bangalore 560003
Bangalore
KARNATAKA |
919845041151
chandrashekara_s@yahoo.com |
| DrBharat Jivani |
Jivani Orthopedic, Arthosccopy and Joint Replacement Center |
Department of Rheumatoid Arthritis,104, Aayush Hospital, Station – Lal Darwaja Road, Surat –395 003
Surat
GUJARAT |
912612402435
drbharatjivani@gmail.com |
| Dr Jyotsna Oak |
Kokilaben Dhirubhai Ambani Hospital |
Department of Rheumatoid Arthritis,Four Bunglows, Andheri (W), Mumbai – 400 053
Mumbai
MAHARASHTRA |
919324717618
Jyotsna.Oak@relianceada.com |
| DrSarathchandra Mouli Veeravalli |
Krishna Institute of Medical Sciences |
Department of Rheumatoid Arthritis,1-8-31/1, Minister Road, Secunderabad 500003
Hyderabad
ANDHRA PRADESH |
919866000685
sarath10@hotmail.com |
| DrBagaria Bhagwan |
Malpani Multispeciality Hospital |
Dept of Rheumatoid Arthritis, VKI,Sikar Road, Jaipur-302013, Rajasthan
Jaipur
RAJASTHAN |
919460891205
dr.bagaria@yahoo.co.in |
| DrHarish Mathur |
Mavens Hospitals |
Department of Rheumatoid Arthritis,N37, Lane near Reliance Fresh, Vaishali Nagar, Ajmer-305001(Raj.)
Ajmer
RAJASTHAN |
919829279052
drharishmathur@yahoo.com |
| DrGurumallapa Prasad |
Pace Clinical Research Centre |
Department of Rheumatoid Arthritis,C/o. Pranav Diabetes Centre,No. 53, Nanda Complex,Ramamurthy Nagar Main Road.Banaswadi. Bangalore 560 043
Bangalore
KARNATAKA |
919731911630
drgmprasad@gmail.com |
| Dr Girish Bhatia |
Pentagon Research Pvt. Ltd |
Swar Vishwa Bunglow, Near Siddharth Residency, Ekdant Vihar Co-operative Society, New D.P. Road, Aundh
Pune
MAHARASHTRA |
917387003636
drbhatia.pentagon@gmail.com |
| DrReena Sharma |
Shalby Hospital |
Department of Rheumatoid Arthritis,Opp. Karnavati Club,
S.G. Highway,
Ahmedabad - 380 015
Ahmadabad
GUJARAT |
917940203000
research1@shalby.org |
| Dr Manoj Kumar Venkataiya Honnakere |
Shirdi Sai Hospital |
Department of Rheumatoid Arthritis,2nd Main, Nethravathi Street, New BEL Road Devasandra Bangalore -560054
Bangalore
KARNATAKA |
919844021930
orthomanoj@gmail.com |
| DrLalit Duggal |
Sir Ganga Ram Hospital |
Department of Rheumatoid Arthritis,R.No.2208A,Rajinder Nagar, New Delhi-110060
New Delhi
DELHI |
01142252226
lduggal@gmail.com |
| DrURK Rao |
Sri Deepti Rheumatology Center |
Department of Rheumatoid Arthritis,Centre‎ – Shop No. 6-2-45/8, Lakdikapool, Hyderabad, Andhra Pradesh 500004‎
Hyderabad
ANDHRA PRADESH |
919849160640
urkrao@yahoo.com |
| DrArun Harwani |
Sujan Surgical Cancer Hospital and Amravati Cancer Foundation |
Department of Rheumatoid Arthritis,52/B, Shankar Nagar Main Road, Amravati-444606
Amravati
MAHARASHTRA |
9823170639
drarunharwani@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 14 |
| Name of Committee |
Approval Status |
| ACE Ethics,Bangalore,Dr.G.Prasad |
Approved |
| Amravati Ethics Committee,Amravati,Dr.Arun Harwani |
Approved |
| CLINICOM,Bangalore,Dr. Manoj Kumar Venkataiya Honnakere |
Approved |
| Ethical Committee Sri Deepti Rheumatology, Sri Deepti Rheumatology Center |
Approved |
| Ethics Committee , Shalby Hospitals, Shalby Hospitals |
Approved |
| Ethics Committee Sir Gangaram Hospital, Sir Gangaram Hospital |
Approved |
| Ethics Committee- ACE Ethics, Bangalore,Dr. S.Dinesh |
Approved |
| Human Ethics Committee-Bhavnagar,Dr.Bharat Jivani |
Approved |
| Independent Ethics Committee,Ajmer,Dr.Harish Mathur |
Approved |
| Independent Ethics Committee,Jaipur, Dr B R Bagaria |
Approved |
| Institutional Ethics Committee, Krishna Institute of Medical Sciences,Secunderabad |
Approved |
| Institutional Ethics Committee-CRICR,Dr.Chandrashekara.S |
Submittted/Under Review |
| Institutional Scientific and Ethics Board (ISEB),Kokilaben Dhirubhai Ambani Hospital |
Approved |
| Penta-Med Ethics Committee, Pentagon Research Pvt Ltd |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Rheumatoid Arthritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
secukinumab 150 mg |
Secukinumab 150 mg intra veinous infusion given on week 2nd, 4th and5th.
Secukinumab 150 mg injected sub-cutaneously from week 6 to week 29. |
| Comparator Agent |
Secukinumab placebo 150 mg |
regime matching to the Intervention. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Male or non-pregnant, non-lactating female patients
Presence of RA classified by American College of Rheumatology (ACR) 2010 revised criteria for at least 3 months before screening
At Baseline: Disease activity criteria defined by ≥ 6 tender joints out of 68 and ≥6 swollen joints out of 66 with at least 1 of the following at screening:
Anti-Cyclic Citrullinated Peptide (CCP) antibodies positive OR
Rheumatoid Factor positive and with at least 1 of the following at screening:
High sensitivity C-reactive protein (hsCRP) ≥ 10 mg/L OR Erythrocyte sedimentation rate (ESR) ≥ 28 mm/1st hr
Patients must have been taking at least one anti-TNF-α agent given at an approved dose for at least 3 months before randomization and have experienced an inadequate response to treatment or have been intolerant to at least one administration of an anti-TNF-α agent
Patients must be taking MTX for at least 3 months before randomization and have to be on a stable dose at least 4 weeks before randomization (7.5 to 25 mg/week For Japan only: 6 to 25 mg/week)
|
|
| ExclusionCriteria |
| Details |
Chest x-ray with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician RA patients functional status class IV according to the ACR 1991 revised criteria
Patients who have ever received biologic immunomodulating agents except for those targeting TNFα
Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19)
Other protocol-defined inclusion/exclusion criteria may apply.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| efficacy (proportion of patients achieving an ACR20 response) at 75 mg or 150 mg of secukinumab (AIN457) compared to placebo as add-on therapy in patients with active RA despite stable treatment with methotrexate (MTX) |
Time Frame:24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.improvement (change) of the Health Assessment Questionnaire - Disability Index (HAQ-DI) from baseline on secukinumab 75 mg or 150 mg compared to placebo
2.change of the van der Heijde total modified Sharp score on secukinumab 75 mg or 150 mg or both secukinumab doses is superior to placebo
3.proportion of patients achieving major clinical response (continuous six-month period of ACR70 response) on secukinumab 75 mg or 150 mg compared to placebo (as originally randomized) |
1.Time Frame: 24 weeks
2.Time Frame: 24 weeks
3.Time Frame: 1 year |
|
|
Target Sample Size
|
Total Sample Size="630"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
29/12/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
15/06/2011 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
No publications provided |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Purpose of study:
This study will assess the safety and efficacy of secukinumab when added to a background therapy in patients with active rheumatoid arthritis (RA) who are intolerant to or have had an inadequate response to anti-tumor necrosis factor (TNF)-α agents.
FPFV:29-Dec -2011
Enrolment target for India:50 |