Patients will be randomly assigned to treatment groups, and they and study personnel will not know the identity of the treatments given. Some patients will receive a placebo, which resembles a medication, but does not contain an active substance. This helps to determine if the study agent is effective. Patients will receive placebo or sirukumab by injection under the skin. The expected duration of the study is 120 weeks, which includes 104 weeks of treatment. Upon completion of participation through Week 104, patients will be eligible to enroll in a long-term safety and efficacy study. If they choose not to participate in the long-term study, they will continue into the safety follow-up for approximately 16 weeks. The placebo-controlled portion of the study is through Week 52, when placebo patients will cross over to one of two sirukumab dose regimens. Patient safety will be monitored throughout the study.
Read more: http://www.clinicaltrials.gov/ct2/show/NCT01604343?cond=%22Arthritis%22&lup_s=10/31/2013&lup_d=30