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.

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,

OR
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,

OR
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)·
- Cutaneous signs of 2 at two consecutive visits,

OR
Patients 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:
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

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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