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

Phase 4

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: TINEFCON

• Registration Number: NCT01373567
• Lead Sponsor: Piramal Enterprises Limited

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-07
• Study First Submitted QC: 2011-06-13
• Study First Posted: 2011-06-15
• Primary Completion: 2012-02
• Study Completion: 2012-06
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-21
• Last Update Posted: 2012-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 298

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TINEFCON	TINEFCON	Tablets of 700 mg.

Primary Outcome Measures

Name	Time	Method
Change in Psoriasis area severity index score	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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (23)

Durgabai Deshmukh Hospital & Research Center; 🇮🇳 Hyderabad, Andhra Pradesh, India

Sheth VS General Hospital, Department of Dermatology; 🇮🇳 Ahmedabad, Gujarat, India

M.S. Diabetes and Shirdi Skin care centre; 🇮🇳 Bangalore, Karnataka, India

Bhatia Skin Center,124-128, Anand Bazar, Bima Nagar; 🇮🇳 Indore, Madhtya Pradesh, India

Scheme No. 74, , Vijaynagar, ,; 🇮🇳 Indore, Madhya Pradesh, India

Swarnkar Superspeciality Centre,84,Shreenagar Main,Regency Avenue,Ground Floor, Near Anand Bazar; 🇮🇳 Indore, Madhya Pradesh, India

Sai Skin Care Clinic; 🇮🇳 Hyderabad, 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; 🇮🇳 Mumbai, Maharashtra, India

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