Plaque PsoriasisPhase 4NCT01373567
A Phase IV Clinical Trial to Study the Safety, Tolerability and Efficacy of Tinefcon in Patients With Plaque Psoriasis
A Phase 4 study testing TINEFCON in people with Plaque Psoriasis, run by Piramal Enterprises Limited at 23 sites in India.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- TINEFCON
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 298 participants
- Where
- 23 sitesIndia
- Study dates
- Dec 2010to Jun 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
India23 sites
Sheth VS General Hospital, Department of Dermatology
Ahmedabad, Gujarat
M.S. Diabetes and Shirdi Skin care centre
Bangalore, Karnataka
Postgraduate Institute of Medical Education and Research,Department of Dermatology ,Venerology & Leprology
Chandigarh, Chandigarh
PSG Hospital,Department of Skin & STD
Coimbatore, Tamil Nadu
Durgabai Deshmukh Hospital & Research Center
Hyderabad, Andhra Pradesh
Sai Skin Care Clinic
Hyderabad, Maharashtra
Bhatia Skin Center,124-128, Anand Bazar, Bima Nagar
Indore, Madhtya Pradesh, 452001
Scheme No. 74, , Vijaynagar, ,
Indore, Madhya Pradesh
Swarnkar Superspeciality Centre,84,Shreenagar Main,Regency Avenue,Ground Floor, Near Anand Bazar
Indore, Madhya Pradesh
Renova Skin & Laser Clinic,Sector 9, Shopping Centre,Opposite Meera Marg, Madhyam Marg
Jaipur, Rajasthan
Sri Skin Care & Laser Clinic
Lucknow, Uttar Pradesh
Dr Walia'S Skin & Laser Clinic, Scf - 30, Phase- 3B-2, S.A.S. Nagar
Mohali, Punjab
Dr. Saple's clinic
Mumbai, Maharashtra
Lokmanya Tilak Municipal Medical College & General Hospital, Department of Dermatology, First Floor, College Building,Sion
Mumbai, Maharashtra
Seth GS Medical College &KEM Hospital,Department of Dermatology
Mumbai, Maharashtra
Dr.Vikrant Saoji,27, Navprabhat Chambers,Opp. Tarun Bharat,Central Bazar Road,Ramdaspeth
Nagpur, Maharashtra
NKP Salve Institute and Lata Mangeshkar Hospital
Nagpur, Maharashtra
Radiance Skin Care Clinic
Nagpur, Maharashtra
Skin Care Clinic, Consultant Dermatologist &Venerologist
Nagpur, Maharashtra
D.Y.Patil Medical college and Hospital, Dept. of Dermatology & STD,Sector-5, Nerul
Navi Mumbai
Skin & Laser Center,F-12/10 Krishna Nagar,
New Delhi, New Delhi
Medipoint Hospitals Pvt. Ltd
Pune, Maharashtra
Rajiv Gandhi Medical College
Thane, Maharashtra
About this study
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
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
- Being tested
- TINEFCON
- Keywords
- Plaque Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TINEFCONDrug
Two 700 mg tablets of Tinefcon in the morning and evening to be taken orally.
| Study group | Role | What they receive |
|---|---|---|
| TINEFCON | Experimental | Tablets of 700 mg. Receives: Drug: TINEFCON |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Psoriasis area severity index score
Change from baseline at week 4, week 8 and week 12 or early termination
Measured: At week 4, week 8 and week 12 or early termination
Secondary outcomes (4)
Gene expression profiling and Immunohistochemistry
Measured: At baseline and week 12 or early termination
Physicians global assessment score
Measured: At week 4, week 8 and week 12 / early termination visit
Nail psoriasis severity index
Measured: At baseline and at week 12 or early termination
Psoritic arthritis evaluation
Measured: At baseline and week 12 or early termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study startDec 2010
- Primary completionFeb 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piramal Enterprises Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Sharmila Patil, Principal investigator, D.Y.Patil Medical college and Hospital, Dept. of Dermatology & STD,Sector-5, Nerul, Navi MumbaiDr. Jerajani, Principal investigator, Lokmanya Tilak Municipal Medical College & General Hospital, Department of Dermatology, First Floor, College Building,Sion, Mumbai-400022 IndiaDr. Saple, Principal investigator, Dr. Saple's clinic, 88, 3rd Lane, Hindu Colony, Near Bhagini Samaj, Dadar (East), Mumbai-400014Dr.Ranjan Rawal, Principal investigator, Sheth VS General Hospital, Department of Dermatology, Ellis Bridge, Ahmedabad -380006, Gujrat, IndiaDr Sudhakar Grandhi, Principal investigator, Medipoint Hospitals Pvt. Ltd.,Pentagon Research Pvt. Ltd, 241/1, New DP Road, Aundh, Pune-411007, MaharashtraDr Sushil Pande, Principal investigator, NKP Salve Institute and Lata Mangeshkar Hospital,NagpurDr. Torsekar, Principal investigator, Rajiv Gandhi Medical College & CSMH,Department of Dermatology, Kalwa, ThaneDr. C.R. Srinivas, Principal investigator, PSG Hospital,Department of Skin & STD,Avinashi Road, Peelamedu, Coimbatore, Tamilnadu-641004
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373567
- Sponsor's protocol ID
- TINEFCON/49/10
- Status last verified
- Nov 2012
- First submitted
- 7 Dec 2010
- Last updated
- 22 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01373567
- Acronym / sponsor ID
- TINEFCON/49/10
- Conditions
- Plaque Psoriasis
- Keywords
- Plaque Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- Piramal Enterprises LimitedIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 15 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TINEFCON | Experimental | Drug: TINEFCONTablets of 700 mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TINEFCONTwo 700 mg tablets of Tinefcon in the morning and evening to be taken orally. | Drug | TINEFCON |
Primary outcome
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
4 secondary outcomes
Gene expression profiling and Immunohistochemistry
Time frame: 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
Nail psoriasis severity index
Time frame: At baseline and at week 12 or early termination
Psoritic arthritis evaluation
Time frame: At baseline and week 12 or early termination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Sharmila Patil principal investigator
D.Y.Patil Medical college and Hospital, Dept. of Dermatology & STD,Sector-5, Nerul, Navi Mumbai
Dr. Jerajani principal investigator
Lokmanya Tilak Municipal Medical College & General Hospital, Department of Dermatology, First Floor, College Building,Sion, Mumbai-400022 India
Dr. Saple principal investigator
Dr. Saple's clinic, 88, 3rd Lane, Hindu Colony, Near Bhagini Samaj, Dadar (East), Mumbai-400014
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TINEFCON in people with Plaque Psoriasis, run by Piramal Enterprises Limited at 23 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Psoriasis area severity index score (time frame: At week 4, week 8 and week 12 or early termination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2012.