A Phase IV Clinical Trial to Study the Safety, Tolerability and Efficacy of Tinefcon in Patients With Plaque Psoriasis

An Open Label, Non-comparative, Multicentre, Phase IV Study to Evaluate the Safety, Tolerability and Efficacy of Tinefcon in Patients With Plaque Psoriasis

Psoriasis is a chronic inflammatory hyperproliferative disease of the skin affecting approximately 2% of the world's population.This phase IV study is planned to monitor performance of Tinefcon in patients suffering from psoriasis under conditions of actual use and fulfill requirements to monitor all adverse drug reactions (ADRs) in psoriasis patients treated with Tinefcon. This study will add to literature on the risks and benefits of Tinefcon the novel oral TNF-alpha release inhibitor.

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: TINEFCON

• Study Type: Interventional
• Enrollment (Actual): 298
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Chandigarh, India
    • Postgraduate Institute of Medical Education and Research,Department of Dermatology ,Venerology & Leprology
  • Navi Mumbai, India
    • D.Y.Patil Medical college and Hospital, Dept. of Dermatology & STD,Sector-5, Nerul
  • New Delhi, India
    • Skin & Laser Center,F-12/10 Krishna Nagar,
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India
      • Durgabai Deshmukh Hospital & Research Center
  • Gujarat
    • Ahmedabad, Gujarat, India
      • Sheth VS General Hospital, Department of Dermatology
  • Karnataka
    • Bangalore, Karnataka, India
      • M.S. Diabetes and Shirdi Skin care centre
  • Madhtya Pradesh
    • Indore, Madhtya Pradesh, India, 452001
      • Bhatia Skin Center,124-128, Anand Bazar, Bima Nagar
  • Madhya Pradesh
    • Indore, Madhya Pradesh, India
      • Scheme No. 74, , Vijaynagar, ,
    • Indore, Madhya Pradesh, India
      • Swarnkar Superspeciality Centre,84,Shreenagar Main,Regency Avenue,Ground Floor, Near Anand Bazar
  • Maharashtra
    • Hyderabad, Maharashtra, India
      • Sai Skin Care Clinic
    • Mumbai, Maharashtra, India
      • Dr. Saple's clinic
    • Mumbai, Maharashtra, India
      • Lokmanya Tilak Municipal Medical College & General Hospital, Department of Dermatology, First Floor, College Building,Sion
    • Mumbai, Maharashtra, India
      • Seth GS Medical College &KEM Hospital,Department of Dermatology
    • Nagpur, Maharashtra, India
      • Dr.Vikrant Saoji,27, Navprabhat Chambers,Opp. Tarun Bharat,Central Bazar Road,Ramdaspeth
    • Nagpur, Maharashtra, India
      • NKP Salve Institute and Lata Mangeshkar Hospital
    • Nagpur, Maharashtra, India
      • Radiance Skin Care Clinic
    • Nagpur, Maharashtra, India
      • Skin Care Clinic, Consultant Dermatologist &Venerologist
    • Pune, Maharashtra, India
      • Medipoint Hospitals Pvt. Ltd
    • Thane, Maharashtra, India
      • Rajiv Gandhi Medical College
  • Punjab
    • Mohali, Punjab, India
      • Dr Walia'S Skin & Laser Clinic, Scf - 30, Phase- 3B-2, S.A.S. Nagar
  • Rajasthan
    • Jaipur, Rajasthan, India
      • Renova Skin & Laser Clinic,Sector 9, Shopping Centre,Opposite Meera Marg, Madhyam Marg
  • Tamilnadu
    • Coimbatore, Tamilnadu, India
      • PSG Hospital,Department of Skin & STD
  • Uttar pradesh
    • Lucknow, Uttar pradesh, India
      • Sri Skin Care & Laser Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects of at least 18 years of age with clinical diagnosis of plaque psoriasis
• Subject who understand and willing to sign informed consent document before start of any study specific assessment

Exclusion Criteria:

• Pregnant and lactating females
• Subject with active infection, acute or chronic due to bacteria, viruses, fungi or parasites (most notably tuberculosis, and chronic hepatitis B)
• Subject with heart failure (New York Heart Association class III or IV)
• Subject with demyelinating disease
• Subject with solid cancer or hematologic malignancy diagnosed within last 5 years with a potential for progression
• Women of childbearing potential [defined as a sexually mature woman who has not undergone hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e. who has had menses any time in the preceding 24 consecutive months)] and men, not agreeing to use adequate contraception (e.g., hormonal or barrier method of birth control or abstinence) after signing an informed consent document (ICD), during the duration of study participation and for at least 4 week after withdrawal from the study, unless they are surgically sterilized
• Subject with situations associated with a high risk of infection such as latent untreated tuberculosis, joint prosthesis infection within last 12 months, indwelling urinary catheter, uncontrolled diabetes, chronic obstructive pulmonary disease, skin ulcer
• Subject with known premalignant lesions (such as polyps in the colon or urinary bladder, cervical dysplasia and myelodysplasia)
• Subject known to be seropositive and/or clinically suspected to have the human immunodeficiency virus infection
• Subject with any condition that might make it difficult for the subject to participate in the study, at the discretion of the Investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TINEFCON; Tablets of 700 mg.	Drug: TINEFCON; Two 700 mg tablets of Tinefcon in the morning and evening to be taken orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Psoriasis area severity index score	Change from baseline at week 4, week 8 and week 12 or early termination	At week 4, week 8 and week 12 or early termination

Secondary Outcome Measures

Outcome Measure	Time Frame
Gene expression profiling and Immunohistochemistry	At baseline and week 12 or early termination
Physicians global assessment score	At week 4, week 8 and week 12 / early termination visit
Nail psoriasis severity index	At baseline and at week 12 or early termination
Psoritic arthritis evaluation	At baseline and week 12 or early termination

Collaborators and Investigators

• Sponsor: Piramal Enterprises Limited
• Investigators: Principal Investigator: Dr. Sharmila Patil, D.Y.Patil Medical college and Hospital, Dept. of Dermatology & STD,Sector-5, Nerul, Navi Mumbai; Principal Investigator: Dr. Jerajani, Lokmanya Tilak Municipal Medical College & General Hospital, Department of Dermatology, First Floor, College Building,Sion, Mumbai-400022 India; Principal Investigator: Dr. Saple, Dr. Saple's clinic, 88, 3rd Lane, Hindu Colony, Near Bhagini Samaj, Dadar (East), Mumbai-400014; Principal Investigator: Dr.Ranjan Rawal, Sheth VS General Hospital, Department of Dermatology, Ellis Bridge, Ahmedabad -380006, Gujrat, India; Principal Investigator: Dr Sudhakar Grandhi, Medipoint Hospitals Pvt. Ltd.,Pentagon Research Pvt. Ltd, 241/1, New DP Road, Aundh, Pune-411007, Maharashtra; Principal Investigator: Dr Sushil Pande, NKP Salve Institute and Lata Mangeshkar Hospital,Nagpur; Principal Investigator: Dr. Torsekar, Rajiv Gandhi Medical College & CSMH,Department of Dermatology, Kalwa, Thane; Principal Investigator: Dr. C.R. Srinivas, PSG Hospital,Department of Skin & STD,Avinashi Road, Peelamedu, Coimbatore, Tamilnadu-641004; Principal Investigator: Dr. DVS Pratap, Durgabai Deshmukh Hospital & Research Center, Andhramahila Sabha Road, Vidyanagar, University Road,Hyderabad; Principal Investigator: Dr. Aruna Samarth, Sai Skin Care Clinic, H.No.:2-1-409, Nallakunta, O.U.Road, Hyderabad; Principal Investigator: Dr. Kanwar, Postgraduate Institute of Medical Education and Research,Department of Dermatology ,Venerology & Leprology,Sector-12-Chandigarh; Principal Investigator: Dr. Meetesh Agarwal, 178/DH Sector, Scheme No. 74, Vijaynagar, Indore 452 2010; Principal Investigator: Dr. Kailash Bhatia, Bhatia Skin Center,124-128, Anand Bazar, Bima Nagar, Indore; Principal Investigator: Dr. Parmjit Singh Walia, DR WALIA'S SKIN & LASER CLINIC, SCF - 30, PHASE; Principal Investigator: Dr. Bhavesh Swarnkar, Swarnkar Superspeciality Centre,84,Shreenagar Main,Regency Avenue,Ground Floor, Near Anand Bazar,Indore; Principal Investigator: Dr. Sandesh Gupta, Skin & Laser Center,F-12/10 Krishna Nagar, New Delhi; Principal Investigator: Dr. Puneet Goyal, Renova Skin & Laser Clinic,Sector 9, Shopping Centre,Opposite Meera Marg, Madhyam Marg, Mansarovar, Jaipur; Principal Investigator: Dr.Rizwan Haq, Radiance Skin Care Clinic, Opp. Muslim Library,Tekdi Road, Sadar, Nagpur; Principal Investigator: Dr Vikrant Saoji, Navprabhat Chambers,Opp. Tarun Bharat,Central Bazar Road,Ramdaspeth, Nagpur; Principal Investigator: Dr.B. Leelavathy, M.S. Diabetes and Shirdi Skin care centre 6/1, 80 Feet Road, Opp. Krishna Sagar Hotel, Indiranagar, Bangalore; Principal Investigator: Dr Titarmare, Skin Care Clinic, Consultant Dermatologist &Venerologist,Akshay Towers(Basement), Umrer Road,Sakkardhara Square, Nagpur; Principal Investigator: Dr Shatrughan Sahay, Sri Skin Care & Laser Clinic,Netaji Subash Chandra Bose Complex, Tulsidas Marg (Opp. Charak Pathalogy) Chowk-Lucknow

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: December 7, 2010
• First Submitted That Met QC Criteria: June 13, 2011
• First Posted (Estimate): June 15, 2011

Study Record Updates

• Last Update Posted (Estimate): November 22, 2012
• Last Update Submitted That Met QC Criteria: November 21, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Plaque Psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: TINEFCON/49/10