Clinical Trial: Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (Idiopathic Inflammatory Myopathy)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Prospective, Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis ("ProDERM Stu

Brief Summary: Prospective, Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis ("ProDERM study")

Detailed Summary:
Sponsor: Octapharma

Current Primary Outcome: Measure the number of patients who had an increase of ≥20 points on the Total Improvement Score (TIS) [ Time Frame: At week 16 ]

Proportion of responders in the 2.0 g/kg Octagam 10% and placebo arms at Week 16 relative to baseline (Week 0). A responder being defined as a patient with an increase of ≥20 points on the Total Improvement Score (TIS, a scale from 0 to 100; 20-39 points being minimal improvement, 40-59 points being moderate improvement, and ≥60 points being major improvement


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mean change from baseline (Week 0) to end of first period (Week 16) in: Total Improvement Score (TIS) [ Time Frame: First 16 weeks ]
  • Mean change from baseline (Week 0) to Week 40 in: Total Improvement Score (TIS) [ Time Frame: First 40 weeks ]
  • Mean change from baseline (Week 0) to end of first period (Week 16) in the modified: Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) [ Time Frame: First 16 weeks ]
  • Mean change from end of first period (Week 16) to end of extension period (Week 40) in: Total Improvement Score (TIS) [ Time Frame: From week 16 to Week 40 ]
  • Mean change from end of first period (Week 16) to end of extension period (Week 40) in the modified: Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) [ Time Frame: From week 16 to Week 40 ]
  • Mean change from baseline (Week 0) to end of first period (Week 16) and extension period (Week 40) in: SF-36v2 Health Survey [ Time Frame: From start of the trial till Week 40 ]
  • Mean change from baseline (Week 0) to end of first period (Week 16) and extension period (Week 40) in: Individual six core set measures (CSM) from Total Improvement Score (TIS) [ Time Frame: From start of the trial till Week 40 ]
  • Proportion of Total Improvement Score (TIS) responders at the end of the extension period (Week 40) relative to Week 16 or Week 0 [ Time Frame: Week 40 only ]


Original Secondary Outcome:

  • Mean change from baseline (Week 0) to end of first period (Week 16) in: Total Improvement Score (TIS) [ Time Frame: First 16 weeks ]
  • Mean change from baseline (Week 0) to end of first period (Week 16) in: Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) [ Time Frame: First 16 weeks ]
  • Mean change from end of first period (Week 16) to end of extension period (Week 40) in: Total Improvement Score (TIS) [ Time Frame: From week 16 to Week 40 ]
  • Mean change from end of first period (Week 16) to end of extension period (Week 40) in: Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) [ Time Frame: From week 16 to Week 40 ]
  • Mean change from baseline (Week 0) to end of first period (Week 16) and extension period (Week 40) in: SF-36v2 Health Survey [ Time Frame: From start of the trial till Week 40 ]
  • Mean change from baseline (Week 0) to end of first period (Week 16) and extension period (Week 40) in: Individual six core set measures (CSM) from Total Improvement Score (TIS) [ Time Frame: From start of the trial till Week 40 ]
  • Proportion of Total Improvement Score (TIS) responders at the end of the extension period (Week 40) relative to Week 16 or Week 0 [ Time Frame: Week 40 only ]


Information By: Octapharma

Dates:
Date Received: March 11, 2016
Date Started: February 27, 2017
Date Completion: March 2019
Last Updated: May 15, 2017
Last Verified: May 2017