Acthar Gel for Active Systemic Lupus Erythematosus (SLE)

Status

Completed

Phase

Phase 4

Enrollment

172 participants (actual)

Sponsor

Mallinckrodt · Industry

Design

Randomized · Double masking

Countries

5 countries

United States, Argentina, Chile, Mexico, Peru

Start

16 Dec 2016

Primary completion

31 Jul 2019

Completion

25 Oct 2019

First posted

3 Nov 2016 (estimated)

Last update posted

20 Aug 2020

Conditions

Lupus Erythematosus, Systemic

This trial is to study Acthar Gel in participants with active systemic lupus erythematosus (SLE). The doctor will assign eligible patients to one of two groups (like flipping a coin). Participants will receive the treatment assigned to their group for 24 weeks: * Acthar Gel * Placebo Gel, which looks like Acthar Gel, but has no medicine in it. The doctor or his staff will take measurements and ask questions to: * see how well the gel is working * see how safe it is for patients with SLE

• Experimental

  Acthar Gel

  Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks

• Placebo comparator

  Placebo Gel

  Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks

1. Physician's Global Assessment (PGA)

   Time frame · Baseline, Week 16, Week 24

   Registry description

   PGA is a 100 mm visual analogue scale where higher scores indicate more severe disease activity. Lower scores indicate improvement.

2. British Isles Lupus Assessment Group 2004 (BILAG 2004)

   Time frame · Baseline, Week 16, Week 24

   Registry description

   BILAG records disease activity occurring over the past 4 weeks, and is used to determine whether different course of treatment is required. The BILAG-2004 index covers 97 signs/symptoms across 9 organ systems. Each question is answered as 0-not present, 1-improving, 2-same, 3-worse, or 4-new. The BILAG-2004 index categorizes disease activity in each organ system into five different levels from A to E. Grade A represents very active disease, Grade B represents moderate disease activity, Grade C indicates mild stable disease, and grade D implies no disease activity, but suggests the organ system had previously been affected. Grade E indicates no current or previous disease activity. A score is applied to each grade of each organ system using coding scheme of A=12, B=8, C=1, and D/E=0 and is summarized as a total score ranging 0-108. Higher scores indicate more severe disease activity.

3. Number of Participants With at Least a 4 Point Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K)

   Time frame · Week 16, Week 24

   Registry description

   The SLEDAI-2K is a modified version of a composite score based on the presence or absence of clinical signs, clinical symptoms, and immunologic laboratory results taken within 10 days of the evaluations. Each of the descriptors has a weighted score and the total score of SLEDAI-2K is the sum of all 24 descriptor scores. The total SLEDAI-2K score falls between 0 and 105, with higher scores representing higher disease activity. Decrease from baseline indicates improvement.