Clinical trial NCT01373567: A Phase IV Clinical Trial to Study the Safety, Tolerability and Efficacy of Tinefcon in Patients With Plaque Psoriasis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Plaque Psoriasis
Keywords: Plaque Psoriasis
Lead sponsor: Piramal Enterprises Limited
Sponsor class: INDUSTRY
First posted: 2011-06-15
Enrollment: 298
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in Psoriasis area severity index score
timeFrame: At week 4, week 8 and week 12 or early termination
Secondary outcomes:
measure: Gene expression profiling and Immunohistochemistry
timeFrame: At baseline and week 12 or early termination
measure: Physicians global assessment score
timeFrame: At week 4, week 8 and week 12 / early termination visit
measure: Nail psoriasis severity index
timeFrame: At baseline and at week 12 or early termination
measure: Psoritic arthritis evaluation
timeFrame: At baseline and week 12 or early termination
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Durgabai Deshmukh Hospital & Research Center
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Sheth VS General Hospital, Department of Dermatology
state: Gujarat
city: Bangalore
country: India
facility: M.S. Diabetes and Shirdi Skin care centre
state: Karnataka
city: Indore
country: India
facility: Bhatia Skin Center,124-128, Anand Bazar, Bima Nagar
state: Madhtya Pradesh
city: Indore
country: India
facility: Scheme No. 74, , Vijaynagar, ,
state: Madhya Pradesh
city: Indore
country: India
facility: Swarnkar Superspeciality Centre,84,Shreenagar Main,Regency Avenue,Ground Floor, Near Anand Bazar
state: Madhya Pradesh
city: Hyderabad
country: India
facility: Sai Skin Care Clinic
state: Maharashtra
city: Mumbai
country: India
facility: Dr. Saple's clinic
state: Maharashtra
city: Mumbai
country: India
facility: Lokmanya Tilak Municipal Medical College & General Hospital, Department of Dermatology, First Floor, College Building,Sion
state: Maharashtra
city: Mumbai
country: India
facility: Seth GS Medical College &KEM Hospital,Department of Dermatology
state: Maharashtra
city: Nagpur
country: India
facility: Dr.Vikrant Saoji,27, Navprabhat Chambers,Opp. Tarun Bharat,Central Bazar Road,Ramdaspeth
state: Maharashtra
city: Nagpur
country: India
facility: NKP Salve Institute and Lata Mangeshkar Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Radiance Skin Care Clinic
state: Maharashtra
city: Nagpur
country: India
facility: Skin Care Clinic, Consultant Dermatologist &Venerologist
state: Maharashtra
city: Pune
country: India
facility: Medipoint Hospitals Pvt. Ltd
state: Maharashtra
city: Thane
country: India
facility: Rajiv Gandhi Medical College
state: Maharashtra
city: Mohali
country: India
facility: Dr Walia'S Skin & Laser Clinic, Scf - 30, Phase- 3B-2, S.A.S. Nagar
state: Punjab
city: Jaipur
country: India
facility: Renova Skin & Laser Clinic,Sector 9, Shopping Centre,Opposite Meera Marg, Madhyam Marg
state: Rajasthan
city: Coimbatore
country: India
facility: PSG Hospital,Department of Skin & STD
state: Tamilnadu
city: Lucknow
country: India
facility: Sri Skin Care & Laser Clinic
state: Uttar pradesh
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education and Research,Department of Dermatology ,Venerology & Leprology
city: Navi Mumbai
country: India
facility: D.Y.Patil Medical college and Hospital, Dept. of Dermatology & STD,Sector-5, Nerul
city: New Delhi
country: India
facility: Skin & Laser Center,F-12/10 Krishna Nagar,
Study officials:
affiliation: D.Y.Patil Medical college and Hospital, Dept. of Dermatology & STD,Sector-5, Nerul, Navi Mumbai
name: Dr. Sharmila Patil
role: PRINCIPAL_INVESTIGATOR
affiliation: Lokmanya Tilak Municipal Medical College & General Hospital, Department of Dermatology, First Floor, College Building,Sion, Mumbai-400022 India
name: Dr. Jerajani
role: PRINCIPAL_INVESTIGATOR
affiliation: Dr. Saple's clinic, 88, 3rd Lane, Hindu Colony, Near Bhagini Samaj, Dadar (East), Mumbai-400014
name: Dr. Saple
role: PRINCIPAL_INVESTIGATOR
affiliation: Sheth VS General Hospital, Department of Dermatology, Ellis Bridge, Ahmedabad -380006, Gujrat, India
name: Dr.Ranjan Rawal
role: PRINCIPAL_INVESTIGATOR
affiliation: Medipoint Hospitals Pvt. Ltd.,Pentagon Research Pvt. Ltd, 241/1, New DP Road, Aundh, Pune-411007, Maharashtra
name: Dr Sudhakar Grandhi
role: PRINCIPAL_INVESTIGATOR
affiliation: NKP Salve Institute and Lata Mangeshkar Hospital,Nagpur
name: Dr Sushil Pande
role: PRINCIPAL_INVESTIGATOR
affiliation: Rajiv Gandhi Medical College & CSMH,Department of Dermatology, Kalwa, Thane
name: Dr. Torsekar
role: PRINCIPAL_INVESTIGATOR
affiliation: PSG Hospital,Department of Skin & STD,Avinashi Road, Peelamedu, Coimbatore, Tamilnadu-641004
name: Dr. C.R. Srinivas
role: PRINCIPAL_INVESTIGATOR
affiliation: Durgabai Deshmukh Hospital & Research Center, Andhramahila Sabha Road, Vidyanagar, University Road,Hyderabad
name: Dr. DVS Pratap
role: PRINCIPAL_INVESTIGATOR
affiliation: Sai Skin Care Clinic, H.No.:2-1-409, Nallakunta, O.U.Road, Hyderabad
name: Dr. Aruna Samarth
role: PRINCIPAL_INVESTIGATOR
affiliation: Postgraduate Institute of Medical Education and Research,Department of Dermatology ,Venerology & Leprology,Sector-12-Chandigarh
name: Dr. Kanwar
role: PRINCIPAL_INVESTIGATOR
affiliation: 178/DH Sector, Scheme No. 74, Vijaynagar, Indore 452 2010
name: Dr. Meetesh Agarwal
role: PRINCIPAL_INVESTIGATOR
affiliation: Bhatia Skin Center,124-128, Anand Bazar, Bima Nagar, Indore
name: Dr. Kailash Bhatia
role: PRINCIPAL_INVESTIGATOR
affiliation: DR WALIA'S SKIN & LASER CLINIC, SCF - 30, PHASE
name: Dr. Parmjit Singh Walia
role: PRINCIPAL_INVESTIGATOR
affiliation: Swarnkar Superspeciality Centre,84,Shreenagar Main,Regency Avenue,Ground Floor, Near Anand Bazar,Indore
name: Dr. Bhavesh Swarnkar
role: PRINCIPAL_INVESTIGATOR
affiliation: Skin & Laser Center,F-12/10 Krishna Nagar, New Delhi
name: Dr. Sandesh Gupta
role: PRINCIPAL_INVESTIGATOR
affiliation: Renova Skin & Laser Clinic,Sector 9, Shopping Centre,Opposite Meera Marg, Madhyam Marg, Mansarovar, Jaipur
name: Dr. Puneet Goyal
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiance Skin Care Clinic, Opp. Muslim Library,Tekdi Road, Sadar, Nagpur
name: Dr.Rizwan Haq
role: PRINCIPAL_INVESTIGATOR
affiliation: Navprabhat Chambers,Opp. Tarun Bharat,Central Bazar Road,Ramdaspeth, Nagpur
name: Dr Vikrant Saoji
role: PRINCIPAL_INVESTIGATOR
affiliation: M.S. Diabetes and Shirdi Skin care centre 6/1, 80 Feet Road, Opp. Krishna Sagar Hotel, Indiranagar, Bangalore
name: Dr.B. Leelavathy
role: PRINCIPAL_INVESTIGATOR
affiliation: Skin Care Clinic, Consultant Dermatologist &Venerologist,Akshay Towers(Basement), Umrer Road,Sakkardhara Square, Nagpur
name: Dr Titarmare
role: PRINCIPAL_INVESTIGATOR
affiliation: Sri Skin Care & Laser Clinic,Netaji Subash Chandra Bose Complex, Tulsidas Marg (Opp. Charak Pathalogy) Chowk-Lucknow
name: Dr Shatrughan Sahay
role: PRINCIPAL_INVESTIGATOR
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