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

Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01373567
• Other study ID #: TINEFCON/49/10
• Status: Completed
• Phase: Phase 4
• First received: December 7, 2010
• Last updated: November 21, 2012
• Start date: December 2010
• Est. completion date: June 2012

Study information

• Verified date: November 2012
• Source: Piramal Enterprises Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 298
• Est. completion date: June 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• TINEFCON
Two 700 mg tablets of Tinefcon in the morning and evening to be taken orally.

Locations

Country	Name	City	State
India	Sheth VS General Hospital, Department of Dermatology	Ahmedabad	Gujarat
India	M.S. Diabetes and Shirdi Skin care centre	Bangalore	Karnataka
India	Postgraduate Institute of Medical Education and Research,Department of Dermatology ,Venerology & Leprology	Chandigarh
India	PSG Hospital,Department of Skin & STD	Coimbatore	Tamilnadu
India	Durgabai Deshmukh Hospital & Research Center	Hyderabad	Andhra Pradesh
India	Sai Skin Care Clinic	Hyderabad	Maharashtra
India	Bhatia Skin Center,124-128, Anand Bazar, Bima Nagar	Indore	Madhtya Pradesh
India	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	Renova Skin & Laser Clinic,Sector 9, Shopping Centre,Opposite Meera Marg, Madhyam Marg	Jaipur	Rajasthan
India	Sri Skin Care & Laser Clinic	Lucknow	Uttar pradesh
India	Dr Walia'S Skin & Laser Clinic, Scf - 30, Phase- 3B-2, S.A.S. Nagar	Mohali	Punjab
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	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	Medipoint Hospitals Pvt. Ltd	Pune	Maharashtra
India	Rajiv Gandhi Medical College	Thane	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Piramal Enterprises Limited

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Gene expression profiling and Immunohistochemistry		At baseline and week 12 or early termination	No
Secondary	Physicians global assessment score		At week 4, week 8 and week 12 / early termination visit	No
Secondary	Nail psoriasis severity index		At baseline and at week 12 or early termination	No
Secondary	Psoritic arthritis evaluation		At baseline and week 12 or early termination	No