Efficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled study

Orfagen0 sites44 target enrollmentDecember 28, 2005

Overview

No summary available.

Registry

who.int

Start Date

December 28, 2005

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\-Male or female patients of at least 18 years of age
•\-Patients fulfilling the diagnostic criteria (definite or probable) of the European Neuro\-Muscular Committee (ENMC) for idiopathic DM and PM.
•\-Patients with an active DM or PM disease who received conventional therapies for at least 14 weeks: prospective or clearly\-documented retrospective administration of oral prednisone 1mg/Kg per day for at least 4 weeks, with or without IS, followed by IS at stable dose (methotrexate MTX 15\-50 mg per week, or other IS) and prednisone for at least 10 weeks,
•Patients with a contra\-indication or a major side\-effect to prednisone or methotrexate / other IS,
•Patients under bitherapy (prednisone and MTX / other IS) with a documented deterioration of their BMRC score, as follows:·
•\- Of at least 18 points if BMRC at the beginning of the run\-in period over 56·
•\- Of at least 12 points if BMRC at the beginning of the run\-in period between 40\.5 and 56 included·
•\- Of at least 8 points if BMRC at the beginning of the run\-in period below 40\.5,
•DM patients under bitherapy (prednisone and MTX / other IS) having a documented deterioration of their cutaneous signs, as follows:
•\- Cutaneous signs aggravated (score from 0 or 1 to 2\)·

•\- Pregnant women, nursing mothers and women of childbearing potential with no reliable contraception.
•\- Patients who do not fulfill the ENMC diagnostic criteria (definite or probable) of idiopathic DM and PM.
•\- Patients with a diagnosis of paraneoplasic DM or PM.
•\- Juvenile DM and PM (age less than 18 years).
•\- DM patients with no muscle involvement.
•\- Patients with life expectancy of less than 3 months.
•\- Patients whose muscle strength is responsive to conventional therapy, i.e. with the following BMRC improvement of at least:
•· 18 points of their BMRC index at baseline compared to the beginning of the run\-in period if BMRC below 40,5 at first run\-in period assessment
•· 12 points of their BMRC index at baseline compared to the beginning of the run\-in period if BMRC between 40\.5 and 56 included at first run\-in period assessment
•· 8 points of their BMRC index at baseline compared to the beginning of the run\-in period if BMRC over 56 at first run\-in period assessment