fficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM)

• Conditions: Idiopathic dermatomyositis and polymyositis with insufficiently improved muscle strength under conventional therapy (glucocorticosteroids associated with immunosuppressors).; MedDRA version: 14.1Level: HLTClassification code 10003821Term: Muscular autoimmune disordersSystem Organ Class: 100000004870; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2005-002463-88-IT
• Lead Sponsor: ORFAGE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-21
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

- 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, OR Patients with a contra-indication or a major side-effect to prednisone or methotrexate / other IS,ORPatients 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,ORDM 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)`· Cutaneous signs of 2 at two consecutive visits, ORPatients under bitherapy (prednisone and MTX / other IS) with an onset of visceral involvement (e.g. pharyngeal, pulmonary, cardiac).- Patients with no significant improvement of muscle strength under conventional therapy, as follows:`· Less of 8 points if BMRC score over 56 at the beginning of the run-in period `· Less of 12 points if BMRC score between 40.5 and 56 at the beginning of the run-in period `· Less of 18 points if BMRC score below 40.5 at the beginning of the run-in period.- Patients with BMRC index between 24 and 72 at baseline.- For French centres, patients affiliated to the French Security System.- Patients able to follow instructions.- Written informed consent from the patients.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- 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- Patients with an BMRC index of less than 24 or more than 72.- Patients having received a bolus of methylprednisone within 3 weeks prior to study entry.- Patients with a known allergy to one of the ingredients of the IVIg test product.- Patients with decompensated cardiac insufficiency or any other intercurrent condition that may alter the study conduct.- Patients with positive Coomb`s test at baseline.- Patients who refuse to participate in the study.- Patients who are not able to follow instructions.- Patients who are protected by the law (guardianship, trusteeship).- Patients who have participated in a study within the 3 months prior to study run-in period.- Patients who refuse to give written informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified