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

Sponsor
Piramal Enterprises Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT01373567
Collaborator
(none)
298
Enrollment
23
Locations
1
Arm
18
Duration (Months)
13
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
298 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Dec 1, 2010
Actual Primary Completion Date :
Feb 1, 2012
Actual Study Completion Date :
Jun 1, 2012

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Psoriasis area severity index score [At week 4, week 8 and week 12 or early termination]

    Change from baseline at week 4, week 8 and week 12 or early termination

Secondary Outcome Measures

  1. Gene expression profiling and Immunohistochemistry [At baseline and week 12 or early termination]

  2. Physicians global assessment score [At week 4, week 8 and week 12 / early termination visit]

  3. Nail psoriasis severity index [At baseline and at week 12 or early termination]

  4. Psoritic arthritis evaluation [At baseline and week 12 or early termination]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Durgabai Deshmukh Hospital & Research Center Hyderabad Andhra Pradesh India
2 Sheth VS General Hospital, Department of Dermatology Ahmedabad Gujarat India
3 M.S. Diabetes and Shirdi Skin care centre Bangalore Karnataka India
4 Bhatia Skin Center,124-128, Anand Bazar, Bima Nagar Indore Madhtya Pradesh India 452001
5 Scheme No. 74, , Vijaynagar, , Indore Madhya Pradesh India
6 Swarnkar Superspeciality Centre,84,Shreenagar Main,Regency Avenue,Ground Floor, Near Anand Bazar Indore Madhya Pradesh India
7 Sai Skin Care Clinic Hyderabad Maharashtra India
8 Dr. Saple's clinic Mumbai Maharashtra India
9 Lokmanya Tilak Municipal Medical College & General Hospital, Department of Dermatology, First Floor, College Building,Sion Mumbai Maharashtra India
10 Seth GS Medical College &KEM Hospital,Department of Dermatology Mumbai Maharashtra India
11 Dr.Vikrant Saoji,27, Navprabhat Chambers,Opp. Tarun Bharat,Central Bazar Road,Ramdaspeth Nagpur Maharashtra India
12 NKP Salve Institute and Lata Mangeshkar Hospital Nagpur Maharashtra India
13 Radiance Skin Care Clinic Nagpur Maharashtra India
14 Skin Care Clinic, Consultant Dermatologist &Venerologist Nagpur Maharashtra India
15 Medipoint Hospitals Pvt. Ltd Pune Maharashtra India
16 Rajiv Gandhi Medical College Thane Maharashtra India
17 Dr Walia'S Skin & Laser Clinic, Scf - 30, Phase- 3B-2, S.A.S. Nagar Mohali Punjab India
18 Renova Skin & Laser Clinic,Sector 9, Shopping Centre,Opposite Meera Marg, Madhyam Marg Jaipur Rajasthan India
19 PSG Hospital,Department of Skin & STD Coimbatore Tamilnadu India
20 Sri Skin Care & Laser Clinic Lucknow Uttar pradesh India
21 Postgraduate Institute of Medical Education and Research,Department of Dermatology ,Venerology & Leprology Chandigarh India
22 D.Y.Patil Medical college and Hospital, Dept. of Dermatology & STD,Sector-5, Nerul Navi Mumbai India
23 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Piramal Enterprises Limited
ClinicalTrials.gov Identifier:
NCT01373567
Other Study ID Numbers:
  • TINEFCON/49/10
First Posted:
Jun 15, 2011
Last Update Posted:
Nov 22, 2012
Last Verified:
Nov 1, 2012
Keywords provided by Piramal Enterprises Limited
Plaque Psoriasis
Additional relevant MeSH terms:
Psoriasis

Study Results

No Results Posted as of Nov 22, 2012