Multiple Sclerosis Clinical Trial
Official title:
A Phase IIa, Randomized, Double-blind, Placebo-controlled, Exploratory, Dose-ranging Study to Evaluate the Safety, Effectiveness and Pharmacokinetics of Three Courses of DC-TAB Treatment in Patients With Multiple Sclerosis
The purpose of this study is to evaluate safety and clinical efficacy of DC-TAB in multiple sclerosis.
This study is a randomized, double-blind, placebo-controlled, exploratory, dose-ranging
Phase IIa study in multiple sclerosis patients to evaluate the safety, tolerability, T-cell
tolerance inducing effect, clinical effects and pharmacokinetics of intravenous DC-TAB, a
solution of recombinant human alpha B-crystallin.
At entry, patients were randomized to one of the treatments, placebo, 7.5 mg DC-TAB, 12.5 mg
DC-TAB or 17.5 mg DC-TAB in a 1:1:1:1 fashion. Patients received a single intravenous bolus
injection which was repeated twice with 2-month intervals during the 6-month monitoring
period. The goal of such injection was to induce antigen-specific T-cell tolerance. The
study consisted of two parts, a treatment period of 24 weeks, and a follow-up period of an
additional 24 weeks. Patients returned to the hospital weekly during the first month, and
monthly thereafter.
The primary analysis was performed on data collected in the treatment period, and was
performed after all patients had completed 24 weeks into the study. An additional analysis
was performed once all patients had completed the full 48 weeks of the study. Patients and
site study personnel remained blinded throughout the study.
After 12 and 24 patients completed 4 weeks into the study, and after 24 patients had
completed 12 weeks of follow-up, a partially blinded safety review was conducted by an
independent drug safety monitoring board to verify safety of the intervention in MS
patients.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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