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

Study Overview
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Brief Summary
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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.

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

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: TINEFCON


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TINEFCON<br>Tablets of 700 mg. | Drug: TINEFCON<br>* Two 700 mg tablets of Tinefcon in the morning and evening to be taken orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plaque Psoriasis