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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Piramal Enterprises Limited
ClinicalTrials.gov Identifier:
NCT01373567
First received: December 7, 2010
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Plaque Psoriasis
Drug: TINEFCON
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Non-comparative, Multicentre, Phase IV Study to Evaluate the Safety, Tolerability and Efficacy of Tinefcon in Patients With Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by Piramal Enterprises Limited:

Primary Outcome Measures:
  • Change in Psoriasis area severity index score [ Time Frame: At week 4, week 8 and week 12 or early termination ] [ Designated as safety issue: No ]
    Change from baseline at week 4, week 8 and week 12 or early termination


Secondary Outcome Measures:
  • Gene expression profiling and Immunohistochemistry [ Time Frame: At baseline and week 12 or early termination ] [ Designated as safety issue: No ]
  • Physicians global assessment score [ Time Frame: At week 4, week 8 and week 12 / early termination visit ] [ Designated as safety issue: No ]
  • Nail psoriasis severity index [ Time Frame: At baseline and at week 12 or early termination ] [ Designated as safety issue: No ]
  • Psoritic arthritis evaluation [ Time Frame: At baseline and week 12 or early termination ] [ Designated as safety issue: No ]

Enrollment: 298
Study Start Date: December 2010
Study Completion Date: June 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TINEFCON
Tablets of 700 mg.
Drug: TINEFCON
Two 700 mg tablets of Tinefcon in the morning and evening to be taken orally.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01373567

Locations
India
Durgabai Deshmukh Hospital & Research Center
Hyderabad, Andhra Pradesh, India
Sheth VS General Hospital, Department of Dermatology
Ahmedabad, Gujarat, India
M.S. Diabetes and Shirdi Skin care centre
Bangalore, Karnataka, India
Bhatia Skin Center,124-128, Anand Bazar, Bima Nagar
Indore, Madhtya Pradesh, India, 452001
Scheme No. 74, , Vijaynagar, ,
Indore, Madhya Pradesh, India
Swarnkar Superspeciality Centre,84,Shreenagar Main,Regency Avenue,Ground Floor, Near Anand Bazar
Indore, Madhya Pradesh, India
Sai Skin Care Clinic
Hyderabad, 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
Mumbai, 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
Nagpur, Maharashtra, India
Medipoint Hospitals Pvt. Ltd
Pune, Maharashtra, India
Rajiv Gandhi Medical College
Thane, Maharashtra, India
Dr Walia'S Skin & Laser Clinic, Scf - 30, Phase- 3B-2, S.A.S. Nagar
Mohali, Punjab, India
Renova Skin & Laser Clinic,Sector 9, Shopping Centre,Opposite Meera Marg, Madhyam Marg
Jaipur, Rajasthan, India
PSG Hospital,Department of Skin & STD
Coimbatore, Tamilnadu, India
Sri Skin Care & Laser Clinic
Lucknow, Uttar pradesh, India
Postgraduate Institute of Medical Education and Research,Department of Dermatology ,Venerology & Leprology
Chandigarh, India
D.Y.Patil Medical college and Hospital, Dept. of Dermatology & STD,Sector-5, Nerul
Navi Mumbai, India
Skin & Laser Center,F-12/10 Krishna Nagar,
New Delhi, India
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Piramal Enterprises Limited
ClinicalTrials.gov Identifier: NCT01373567     History of Changes
Other Study ID Numbers: TINEFCON/49/10
Study First Received: December 7, 2010
Last Updated: November 21, 2012
Health Authority: India: Ministry of Health

Keywords provided by Piramal Enterprises Limited:
Plaque Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on November 20, 2014