A multicenter study to evaluate safety and efficacy of GP2017 comparing to Humira in patients with long term plaque-type psoriasis.

Phase 3

• Conditions: Chronic Plaque-type Psoriasis

• Registration Number: CTRI/2015/06/005941
• Lead Sponsor: Novartis Healthcare Private Limited

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-15
• Last Update Posted: 2016-06-24

Recruitment & Eligibility

• Status: Other
• Sex: All
• Target Recruitment: 448

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is the PASI 75 response rate.	The primary outcome measure is the PASI 75 response rate. | [Designated as safety issue: No]
[Designated as safety issue: No]	The primary outcome measure is the PASI 75 response rate. | [Designated as safety issue: No]

Secondary Outcome Measures

Name	Time	Method
2. Change from baseline in IGA	[Designated as safety issue: No]
3. Patient health related quality of life (HRQoL)	[Designated as safety issue: No]
1. PASI response rates	[Designated as safety issue: No]

Trial Locations

Locations (9)

BYL Nair Ch Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

CARE Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Father Muller Medical College and Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Kempegowda Insitute of Medical Sciences; 🇮🇳 Bangalore, KARNATAKA, India

King George Hospital; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

Medipoint Hospitals Pvt. Ltd.; 🇮🇳 Pune, MAHARASHTRA, India

Osmania General Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Sri Venkateshwara Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Sujata Birla Hospital & Medical Research Centre; 🇮🇳 Nashik, MAHARASHTRA, India

BYL Nair Ch Hospital

🇮🇳Mumbai, MAHARASHTRA, India

Dr Chitra Nayak

Principal investigator

22-23027640

chitra212@hotmail.com