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

NCT01373567 | Completed Phase 4

• 1 other identifier: TINEFCON/49/10
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 23

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.

Conditions

Plaque Psoriasis

Keywords

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Gene expression profiling and Immunohistochemistry

  At baseline and week 12 or early termination

• Physicians global assessment score

  At week 4, week 8 and week 12 / early termination visit

• Nail psoriasis severity index

  At baseline and at week 12 or early termination

• Psoritic arthritis evaluation

  At baseline and week 12 or early termination

Study Arms (1)

TINEFCON

EXPERIMENTAL

Tablets of 700 mg.

Drug: TINEFCON

Interventions

TINEFCON DRUG

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

TINEFCON

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Piramal Enterprises Limited: lead

Study Sites (23)

Durgabai Deshmukh Hospital & Research Center

Hyderabad, Andhra Pradesh, India

Location

Postgraduate Institute of Medical Education and Research,Department of Dermatology ,Venerology & Leprology

Chandigarh, Chandigarh, India

Location

Sheth VS General Hospital, Department of Dermatology

Ahmedabad, Gujarat, India

Location

M.S. Diabetes and Shirdi Skin care centre

Bangalore, Karnataka, India

Location

Bhatia Skin Center,124-128, Anand Bazar, Bima Nagar

Indore, Madhtya Pradesh, 452001, India

Location

Scheme No. 74, , Vijaynagar, ,

Indore, Madhya Pradesh, India

Location

Swarnkar Superspeciality Centre,84,Shreenagar Main,Regency Avenue,Ground Floor, Near Anand Bazar

Indore, Madhya Pradesh, India

Location

Sai Skin Care Clinic

Hyderabad, Maharashtra, India

Location

Dr. Saple's clinic

Mumbai, Maharashtra, India

Location

Lokmanya Tilak Municipal Medical College & General Hospital, Department of Dermatology, First Floor, College Building,Sion

Mumbai, Maharashtra, India

Location

Seth GS Medical College &KEM Hospital,Department of Dermatology

Mumbai, Maharashtra, India

Location

Dr.Vikrant Saoji,27, Navprabhat Chambers,Opp. Tarun Bharat,Central Bazar Road,Ramdaspeth

Nagpur, Maharashtra, India

Location

NKP Salve Institute and Lata Mangeshkar Hospital

Nagpur, Maharashtra, India

Location

Radiance Skin Care Clinic

Nagpur, Maharashtra, India

Location

Skin Care Clinic, Consultant Dermatologist &Venerologist

Nagpur, Maharashtra, India

Location

Medipoint Hospitals Pvt. Ltd

Pune, Maharashtra, India

Location

Rajiv Gandhi Medical College

Thane, Maharashtra, India

Location

Skin & Laser Center,F-12/10 Krishna Nagar,

New Delhi, New Delhi, India

Location

Dr Walia'S Skin & Laser Clinic, Scf - 30, Phase- 3B-2, S.A.S. Nagar

Mohali, Punjab, India

Location

Renova Skin & Laser Clinic,Sector 9, Shopping Centre,Opposite Meera Marg, Madhyam Marg

Jaipur, Rajasthan, India

Location

PSG Hospital,Department of Skin & STD

Coimbatore, Tamil Nadu, India

Location

Sri Skin Care & Laser Clinic

Lucknow, Uttar Pradesh, India

Location

D.Y.Patil Medical college and Hospital, Dept. of Dermatology & STD,Sector-5, Nerul

Navi Mumbai, India

Location

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2010
• First Posted: June 15, 2011
• Study Start: December 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 22, 2012

Record last verified: 2012-11

Locations

IN (23)