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A Study of the Safety and Efficacy of Ustekinumab in Adolescent Patients With Psoriasis (CADMUS)

2014-08-27 03:15:05 | BioPortfolio

Summary

This is a study of the safety and efficacy of ustekinumab (CNTO 1275) in adolescent patients with moderate to severe psoriasis.

Description

Ustekinumab is a drug that is being tested to see if it may be useful in treating adolescents with moderate to severe plaque-type psoriasis. This study will compare the effects (both good and bad) of ustekinumab to those of placebo. Placebo looks like the drug being studied but has no active ingredients. Ustekinumab (also known as Stelara) has been approved by the Food and Drug Administration, Health Canada, European and other global regulatory authorities for the treatment of patients with moderate to severe plaque-type psoriasis. Ustekinumab is being studied in several other illnesses. About 150 adolescents will take part in the study. Each patient who is allowed to join the study is put into a group by chance (randomly). There are 4 treatment groups in this study: GROUP 1: Ustekinumab low dose at weeks, 0, 4, 16, 28 & 40. Placebo injections at week 12. GROUP 2: Ustekinumab high dose at weeks 0, 4, 16, 28 & 40. Placebo injections at week 12. GROUP 3a : Placebo at Weeks 0 and 4, Ustekinumab low dose at Weeks 12 and 16, 28 & 40. GROUP 3b: Placebo at Weeks 0 and 4, Ustekinumab high dose at Weeks 12 and 16, 28 & 40. For dose description, please refer to Treatment Arm Section. Each patient will either receive ustekinumab or placebo, at the start of the study. By week 12 everyone will be receiving Ustekinumab. The dose of medication the patient will receive is based on his/her assigned group and the patient's weight. There are 2 dose groups - low dose and high dose. So that no one knows which dose any patient is receiving at one time - 2 injections will be given to each patient at each injection visit. While the study is ongoing, neither the patient nor the study doctor (or his/her staff) will know which treatment group the patient is in. Patients will be in the study approximately 60 weeks. Clinical safety will be assessed by the incidence and severity of adverse events, clinical laboratory tests, vital signs and physical examinations during the study period. There are 4 treatment groups in this study. Group 1 will receive Ustekinumab low dose at weeks, 0, 4, 16, 28 & 40. Placebo injections at week 12. Group 2: Ustekinumab high dose at weeks 0, 4, 16, 28 & 40. Placebo injections at week 12. Group 3a: Placebo at Weeks 0 and 4, Ustekinumab low dose at Weeks 12 and 16, 28 & 40 and GROUP 3b: Placebo at Weeks 0 and 4, Ustekinumab high dose at Weeks 12 and 16, 28 & 40.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Psoriasis

Intervention

ustekinumab/placebo, ustekinumab/placebo, ustekinumab/placebo

Location

Brussel
Alberta
Belgium

Status

Recruiting

Source

Centocor, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:05-0400

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Medical and Biotech [MESH] Definitions

A humanized monoclonal antibody that binds to IL-12 and IL-23 and is used as a DERMATOLOGIC AGENT in the treatment of patients with plaque PSORIASIS who have not responded to other therapies.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches. The lesions have a predilection for nails, scalp, genitalia, extensor surfaces, and the lumbosacral region. Accelerated epidermopoiesis is considered to be the fundamental pathologic feature in psoriasis.

A topical anti-inflammatory glucocorticoid used in DERMATOSES, skin allergies, PSORIASIS, etc.

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