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

November 21, 2012 updated by: Piramal Enterprises Limited

An Open Label, Non-comparative, Multicentre, Phase IV Study to Evaluate the Safety, Tolerability and Efficacy of Tinefcon in Patients With Plaque Psoriasis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
298

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Chandigarh, India
        • Postgraduate Institute of Medical Education and Research,Department of Dermatology ,Venerology & Leprology
      • Navi Mumbai, India
        • D.Y.Patil Medical college and Hospital, Dept. of Dermatology & STD,Sector-5, Nerul
      • New Delhi, India
        • Skin & Laser Center,F-12/10 Krishna Nagar,
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India
        • Durgabai Deshmukh Hospital & Research Center
    • Gujarat
      • Ahmedabad, Gujarat, India
        • Sheth VS General Hospital, Department of Dermatology
    • Karnataka
      • Bangalore, Karnataka, India
        • M.S. Diabetes and Shirdi Skin care centre
    • Madhtya Pradesh
      • Indore, Madhtya Pradesh, India, 452001
        • Bhatia Skin Center,124-128, Anand Bazar, Bima Nagar
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India
        • Scheme No. 74, , Vijaynagar, ,
      • Indore, Madhya Pradesh, India
        • Swarnkar Superspeciality Centre,84,Shreenagar Main,Regency Avenue,Ground Floor, Near Anand Bazar
    • Maharashtra
      • Hyderabad, Maharashtra, India
        • Sai Skin Care Clinic
      • Mumbai, Maharashtra, 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
      • Nagpur, 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
      • Pune, Maharashtra, India
        • Medipoint Hospitals Pvt. Ltd
      • Thane, Maharashtra, India
        • Rajiv Gandhi Medical College
    • Punjab
      • Mohali, Punjab, India
        • Dr Walia'S Skin & Laser Clinic, Scf - 30, Phase- 3B-2, S.A.S. Nagar
    • Rajasthan
      • Jaipur, Rajasthan, India
        • Renova Skin & Laser Clinic,Sector 9, Shopping Centre,Opposite Meera Marg, Madhyam Marg
    • Tamilnadu
      • Coimbatore, Tamilnadu, India
        • PSG Hospital,Department of Skin & STD
    • Uttar pradesh
      • Lucknow, Uttar pradesh, India
        • Sri Skin Care & Laser Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TINEFCON
Tablets of 700 mg.
Drug: TINEFCON
Two 700 mg tablets of Tinefcon in the morning and evening to be taken orally.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
At week 4, week 8 and week 12 or early termination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Gene expression profiling and Immunohistochemistry
Time Frame: At baseline and week 12 or early termination
At baseline and week 12 or early termination
Physicians global assessment score
Time Frame: At week 4, week 8 and week 12 / early termination visit
At week 4, week 8 and week 12 / early termination visit
Nail psoriasis severity index
Time Frame: At baseline and at week 12 or early termination
At baseline and at week 12 or early termination
Psoritic arthritis evaluation
Time Frame: At baseline and week 12 or early termination
At baseline and week 12 or early termination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Piramal Enterprises Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TINEFCON/49/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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