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

Primary Purpose

Plaque Psoriasis

Status

Completed

Phase

Phase 4

Locations

India

Study Type

Interventional

Intervention

TINEFCON

About this trial

This is an interventional treatment trial for Plaque Psoriasis focused on measuring Plaque Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Durgabai Deshmukh Hospital & Research Center
Sheth VS General Hospital, Department of Dermatology
M.S. Diabetes and Shirdi Skin care centre
Bhatia Skin Center,124-128, Anand Bazar, Bima Nagar
Scheme No. 74, , Vijaynagar, ,
Swarnkar Superspeciality Centre,84,Shreenagar Main,Regency Avenue,Ground Floor, Near Anand Bazar
Sai Skin Care Clinic
Dr. Saple's clinic
Lokmanya Tilak Municipal Medical College & General Hospital, Department of Dermatology, First Floor, College Building,Sion
Seth GS Medical College &KEM Hospital,Department of Dermatology
Dr.Vikrant Saoji,27, Navprabhat Chambers,Opp. Tarun Bharat,Central Bazar Road,Ramdaspeth
NKP Salve Institute and Lata Mangeshkar Hospital
Radiance Skin Care Clinic
Skin Care Clinic, Consultant Dermatologist &Venerologist
Medipoint Hospitals Pvt. Ltd
Rajiv Gandhi Medical College
Dr Walia'S Skin & Laser Clinic, Scf - 30, Phase- 3B-2, S.A.S. Nagar
Renova Skin & Laser Clinic,Sector 9, Shopping Centre,Opposite Meera Marg, Madhyam Marg
PSG Hospital,Department of Skin & STD
Sri Skin Care & Laser Clinic
Postgraduate Institute of Medical Education and Research,Department of Dermatology ,Venerology & Leprology
D.Y.Patil Medical college and Hospital, Dept. of Dermatology & STD,Sector-5, Nerul
Skin & Laser Center,F-12/10 Krishna Nagar,

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TINEFCON

Arm Description

Tablets of 700 mg.

Outcomes

Primary Outcome Measures

Change in Psoriasis area severity index score

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

Secondary Outcome Measures

Gene expression profiling and Immunohistochemistry

Physicians global assessment score

Nail psoriasis severity index

Psoritic arthritis evaluation

Full Information

NCT ID

NCT01373567

First Posted

December 7, 2010

Last Updated

November 21, 2012

Sponsor

Piramal Enterprises Limited

1. Study Identification

Unique Protocol Identification Number

NCT01373567

Brief Title

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

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Completed

Study Start Date

December 2010 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Piramal Enterprises Limited

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Plaque Psoriasis

Keywords

Plaque Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

298 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TINEFCON

Arm Type

Experimental

Arm Description

Tablets of 700 mg.

Intervention Type

Drug

Intervention Name(s)

TINEFCON

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Psoriasis area severity index score

Description

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

Time Frame

At week 4, week 8 and week 12 or early termination

Secondary Outcome Measure Information:

Title

Gene expression profiling and Immunohistochemistry

Time Frame

At baseline and week 12 or early termination

Title

Physicians global assessment score

Time Frame

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

Title

Nail psoriasis severity index

Time Frame

At baseline and at week 12 or early termination

Title

Psoritic arthritis evaluation

Time Frame

At baseline and week 12 or early termination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: