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

Piramal

Status and phase

Completed

Phase 4

Conditions

Plaque Psoriasis

Treatments

Drug: TINEFCON

Study type

Interventional

Funder types

Industry

Identifiers

NCT01373567

TINEFCON/49/10

Details and patient eligibility

About

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.

Enrollment

298 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.