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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01373567
Recruitment Status : Completed
First Posted : June 15, 2011
Last Update Posted : November 22, 2012
Information provided by (Responsible Party):
Piramal Enterprises Limited

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
Plaque Psoriasis Drug: TINEFCON Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 298 participants
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 : December 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: TINEFCON
Tablets of 700 mg.
Two 700 mg tablets of Tinefcon in the morning and evening to be taken orally.

Primary Outcome Measures :
  1. Change in Psoriasis area severity index score [ Time Frame: 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 [ Time Frame: At baseline and week 12 or early termination ]
  2. Physicians global assessment score [ Time Frame: At week 4, week 8 and week 12 / early termination visit ]
  3. Nail psoriasis severity index [ Time Frame: At baseline and at week 12 or early termination ]
  4. Psoritic arthritis evaluation [ Time Frame: At baseline and week 12 or early termination ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01373567

Show Show 23 study locations
Sponsors and Collaborators
Piramal Enterprises Limited
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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

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Responsible Party: Piramal Enterprises Limited Identifier: NCT01373567    
Other Study ID Numbers: TINEFCON/49/10
First Posted: June 15, 2011    Key Record Dates
Last Update Posted: November 22, 2012
Last Verified: November 2012
Keywords provided by Piramal Enterprises Limited:
Plaque Psoriasis
Additional relevant MeSH terms:
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Skin Diseases, Papulosquamous
Skin Diseases