| CTRI Number |
CTRI/2015/06/005941 [Registered on: 22/06/2015] Terminated Trial Registered |
| Last Modified On: |
24/06/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A multicenter study to evaluate safety and efficacy of GP2017 comparing to Humira in patients with long term plaque-type psoriasis. |
|
Scientific Title of Study
|
A randomized, double-blind, multicenter study to demonstrate equivalent efficacy and to compare safety and immunogenicity of a biosimilar adalimumab (GP2017) and Humira® in patients with moderate to severe chronic plaque-type psoriasis. |
| Trial Acronym |
ADACESS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GP17-301, Original Protocol, dated 22-May-2013 |
Protocol Number |
| NCT02016105 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Murugananthan K |
| Designation |
Head-Clinical Development |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited, Medical
Department, Sandoz House, Shiv Sagar Estate, Dr.
Annie Besant Road, Worli, Mumbai.
Mumbai
MAHARASHTRA
400018
India |
| Phone |
022-24958545 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Murugananthan K |
| Designation |
Head-Clinical Development |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited, Medical
Department, Sandoz House, Shiv Sagar Estate, Dr.
Annie Besant Road, Worli, Mumbai.
MAHARASHTRA
400018
India |
| Phone |
022-24958545 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
Details of Contact Person
Public Query
|
| Name |
Murugananthan K |
| Designation |
Head-Clinical Development |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited, Medical
Department, Sandoz House, Shiv Sagar Estate, Dr.
Annie Besant Road, Worli, Mumbai.
MAHARASHTRA
400018
India |
| Phone |
022-24958545 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
|
Source of Monetary or Material Support
|
| Hexal AG, a Sandoz Company [a member of Novartis Co.] |
|
|
Primary Sponsor
|
| Name |
Novartis Healthcare Private Limited |
| Address |
Medical Department, Sandoz House, Shiv Sagar Estate,
Dr. Annie Besant Road, Worli, Mumbai – 400018. |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bulgaria
France
Germany
India
Russian Federation
Spain
United States of America |
|
Sites of Study
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chitra Nayak |
BYL Nair Ch Hospital |
Dept of Dermatology, BYL Nair Ch Hospital & TN Medical College, Dr. AL Nair Road, Mumbai Central, Mumbai-400008.
Mumbai
MAHARASHTRA |
91-22-23027640
chitra212@hotmail.com |
| Dr Mir Mubashir Ali |
CARE Hospital |
Department of Clinical Research, CARE Hospital, Nampally, Hyderabad - 500001
Hyderabad
ANDHRA PRADESH |
91-9866338629
mir.ali.dr@gmail.com |
| Dr Ramesh Bhat |
Father Muller Medical College and Hospital |
Dept. of dermatology, Father Muller Medical College and Hospital, Father  Muller Road, Kankanady, Mangalore 575002
Bangalore
KARNATAKA |
91-9845084224
rameshderma@yahoo.com |
| Dr M G Gopal |
Kempegowda Insitute of Medical Sciences |
Dept of dermatology, Kempegowda Insitute of medical sciences, Department of Skin, No.10, KIMS Hospital, V V Puram, KR Road, Bangalore-560004.
Bangalore
KARNATAKA |
91-9845010455
gopalamg@yahoo.co.in |
| Dr P Guru Prasad |
King George Hospital |
Department of Dermatology, King George Hospital, Maharanipeta, Visakhapatnam – 530002.
Visakhapatnam
ANDHRA PRADESH |
91-9848022615
gppatnala@yahoo.co.in |
| Dr Sudhakarrao Grandhi |
Medipoint Hospitals Pvt. Ltd. |
Medipoint Hospitals Pvt. Ltd., 241/1, New D. P. Road, Aundh, Pune – 411007.
Pune
MAHARASHTRA |
91-2027298081
sudhakargrandhi.pentagon@gmail.com |
| Dr Putta Srinivas |
Osmania General Hospital |
Department of Dermatology, 1st Floor, Osmania General Hospital, Afzalgunj, Hyderabad – 500012.
Hyderabad
ANDHRA PRADESH |
91-9848079603
puttasrinivasderma@gmail.com |
| Dr B Leelavathy |
Sri Venkateshwara Hospital |
Sri Venkateshwara Hospital, #86, Hosur Main road, Madiwala, Bangalore-560068
Bangalore
KARNATAKA |
91-9590271453
drleelaskincare@rediffmail.com |
| Dr Suneel C Vartak |
Sujata Birla Hospital & Medical Research Centre |
Sujata Birla Hospital & Medical Research Centre, Opp. Bytco College, Nashik-Pune Road, Nashik Road, Nashik-422006.
Nashik
MAHARASHTRA |
91-9373901829
suneel.vartak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Ethics Committee, Osmania Medical College |
Submittted/Under Review |
| Father Muller Institutional Ethics Committee, Father Muller Hospital |
Submittted/Under Review |
| Institutional Ethics Committee, BYL Nair Ch Hospital & TN Medical College |
Submittted/Under Review |
| Institutional Ethics Committee, CARE Hospital |
Approved |
| Institutional Ethics Committee, Kempegowda Institute of Medical Sciences |
Submittted/Under Review |
| Institutional Ethics Committee, King George Hospital |
Submittted/Under Review |
| Penta-Med Ethics Committee, Medipoint Hospitals Pvt. Ltd. |
Submittted/Under Review |
| Sri Venkateshwara Hospital Ethics Committee, Sri Vankateshwara Hospital |
Approved |
| Yash Society Ethics Committee (YSEC), Sujata Birla Hospital and Medical Research Centre |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic Plaque-type Psoriasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GP2017 Adalimumab |
Study arm with intervention being studied in the protocol.
Adalimumab Solution for subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 33.
Duration: 7 and Half months. |
| Comparator Agent |
Humira® Adalimumab |
Humira® Adalimumab as a subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 33.
Duration: 7 and Half months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
>> Men or women at least 18 years of age at time of screening
>> Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization
>> Moderate to severe psoriasis as defined at baseline by:
>> PASI score of 12 or greater
>> Investigator´s Global Assessment score of 3 or greater (based on a scale of 0 - 4) and,
>> Body Surface Area affected by plaque-type psoriasis of 10% or greater
>> Chronic plaque-type psoriasis patients who have previously received phototherapy or systemic psoriasis therapy at least once or who are candidates for such therapies in the opinion of the investigator.
|
|
| ExclusionCriteria |
| Details |
1. Forms of psoriasis other than chronic plaque-type
2. Drug-induced psoriasis
3. Ongoing use of prohibited psoriasis treatments
4. Previous exposure to adalimumab
5. Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of treatment with etanercept.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome measure is the PASI 75 response rate.
[Designated as safety issue: No] |
The primary outcome measure is the PASI 75 response rate.
[Designated as safety issue: No] |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. PASI response rates
[Designated as safety issue: No]
PASI 50, 75, 90 and 100 will be assessed.
|
Time Frame: Weeks 1,3,5,7,9,11,13, 15,16,17 |
2. Change from baseline in IGA
[Designated as safety issue: No]
|
Time Frame: Weeks 1, 3, 5, 7, 9, 11, 13, 15, 16 and 17. |
3. Patient health related quality of life (HRQoL)
[Designated as safety issue: No]
|
Time Frame: Week 11 and 16. |
|
|
Target Sample Size
|
Total Sample Size="448"
Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
15/07/2014 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/12/2013 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
No Publications Provided. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
i] Purpose of the Trial - The aim of the study is to demonstrate equivalent efficacy and similarity in the safety profile of GP2017 and Humira® in patients with moderate to severe chronic plaque-type psoriasis. ii] FPFV for India -17th March, 2014. iii] Target Sample Size for India - 100 iv] Reason for withdrawal: Reason for Withdrawal of Trial: The Sponsor of the study (Sandoz) decided to withdraw the study from India due to administrative reasons.Enrollment did not start in India. |