Immune Tolerance Network   

A clinical research consortium sponsored by NIAID


About the PAUSE study

PAUSE is a clinical trial testing the effectiveness of ustekinumab (STELARA ®) followed by an investigational drug, abatacept, for the treatment of psoriasis. After receiving two doses of ustekinumab (STELARA ®), study participants will be randomly assigned to different treatments based on chance, and neither the study participant nor the physician will know whether medication or placebo is being taken (a placebo is an inactive substance).

The main goal of the PAUSE study is to determine the efficacy of abatacept to induce prolonged remission of psoriasis following stopping all study medication. The study participation duration will be up to 100 weeks, which includes a treatment period of 39 weeks, an observation up to 49 weeks, and one follow-up visit 12 weeks after the observation period is complete. Up to one hundred forty participants will receive physical examinations, clinical laboratory assessment, skin biopsies, and psoriasis assessments throughout the study duration.  All study-related care and treatments are provided at no cost.  Participants may be reimbursed for travel expenses and may receive compensation for some study visits during the course of the trial.

Drugs being tested in the PAUSE study  

STELARA® is a prescription medicine approved by the Food and Drug Administration (FDA) to treat adults 18 years and older with moderate or severe plaque psoriasis that involves large areas or many areas of their body, who may benefit from taking injections.  While abatacept (ORENCIA®) is FDA approved to treat rheumatoid arthritis, it is considered an experimental therapy for psoriasis.

As with any medication, there is a risk of developing side effects. Depending on the person, side effects can vary in both type and severity. Before you decide if you would like to participate, the PAUSE study doctor will discuss all potential risks and benefits.