Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM) - Rituximab in myositis

Karolinska University Hospital0 sites202 target enrollmentNovember 2, 2006

ConditionsAdult polymyositis or adult dermatomyositis or juvenile dermatomyositis MedDRA version: 8.1Level: LLTClassification code 10036102Term: Polymyositis

DrugsMabthera

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Adult polymyositis or adult dermatomyositis or juvenile dermatomyositis
Sponsor: Karolinska University Hospital
Enrollment: 202
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 2, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Karolinska University Hospital

Eligibility Criteria

Inclusion Criteria

•1\.Adults with definite or probable DM or PM and pediatric patients five years of age and over with definite or probable JDM. Patients without the rash of DM will require a muscle biopsy compatible with PM as determined by an experienced muscle pathologist. In order to be enrolled with a diagnosis of refractory PM, patients’ medical information will be reviewed and the diagnosis confirmed by a 3\-member Adjudication Committee. This adjudication process is necessary to exclude mimics of polymyositis.
•2\.A diagnosis of JDM based on an age of onset (i.e. first symptom of myositis or the rash of dermatomyositis) \< 18 years of age.
•3\.Refractory myositis as defined by the intolerance to or an inadequate response to corticosteroids plus an adequate regimen of at least one other IS agent .
•An adequate corticosteroid treatment trial is as follows:
•Adult IIM: prednisone (or an equivalent corticosteroid) at a dose of at least 60 mg/day for one month
•JDM: 1\.0mg/kg/day prednisone for at least one month
•4\.Baseline manual muscle testing which is based on a maximum MMT\-8 score of 150 (see Appendix D): Adult subjects with dermatomyositis (DM) or polymyositis (PM) must have a score that is no greater than 125/150 in conjunction with 2 other abnormal core set measures as listed below. Subjects with a diagnosis of Juvenile Dermatomyositis (JDM) must meet either of the following criteria:1\) An MMT 8 score that is no greater than 125/150 in conjunction with 2 other abnormal core set measures as listed below. OR 2\) If MMT score is greater than 125/150 the patient MUST meet at least 3 abnormal core set measures as listed below
•Patient/Parent global VAS with a minimum value of 2\.0cm on a 10cm scale
•MD global VAS with a minimum value of 2\.0cm on a 10cm scale
•CHAQ/HAQ disability index with a minimum value of 0\.25

Exclusion Criteria

•1\.Drug\-induced myositis (myositis in patients taking medications known to induce myositis\-like syndromes, including, but not limited to, statin agents, fibric acid derivatives, colchicine, and hydroxychloroquine).
•2\.Use of colchicine during study participation is not allowed.
•3\.Juvenile polymyositis; inclusion body myositis; cancer\-associated myositis, defined as the diagnosis of myositis within 2 years of the diagnosis of cancer except basal or squamous cell skin cancer or carcinoma in situ of the cervix if at least 5 years since excision
•4\.Myositis in overlap with another connective tissue disease (CTD) that precludes the accurate assessment of a treatment response (the 3\-member committee discussed under Inclusion Criteria \#1 above will also determine the eligibility of such patients with myositis and an associated CTD).
•5\.History of receiving a live vaccine 4 weeks prior to initiation of study treatment
•6\.Joint disease or other musculoskeletal condition, which precludes the ability to quantitate muscle strength.
•7\.Known hypersensitivity to murine proteins.
•8\.Concomitant illness that would prevent adequate patient assessment or in the investigators opinion pose an added risk for study participants. The clinical site investigator should consider further evaluation or consultation if clinically indicated prior to study enrollment
•recurrent or chronic infections, including HIV, hepatitis B and C
•known liver disease (i.e. cirrhosis or other conditions compromising the synthetic function of the liver)