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

Karolinska University Hospital0 sites202 target enrollmentOctober 18, 2007

ConditionsAdult polymyositis or adult dermatomyositis or juvenile dermatomyositis.MedDRA version: 9.1Level: LLTClassification code 10036102Term: Polymyositis

DrugsMabthera

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Adult polymyositis or adult dermatomyositis or juvenile dermatomyositis.
Sponsor: Karolinska University Hospital
Enrollment: 202
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 18, 2007

End Date

TBD

Last Updated

last year

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 by the criteria of Bohan and Peter. Patients without the rash of DM will require a muscle biopsy (not necessarily done at the enrollement) compatible with PM as determined by an experienced 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 consisiting of 3 Steering Committee members/investigators. This adjudication process is necessary to exclude mimics of polyomyositis including but not limited to inclusion body myositis, toxic or metabolic myopathies and adult onset muscular dystrophies.
•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\. Disease duration \> 6 months from diagnosis of myositis.
•4\. 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 such as azathioprine, methotrexate, IVIg, mycophenolate mofetil, cyclophosphamide, tacrolimus or cyclosporine A. The definition of intolerance is: side effects that require discontinuation of the medication or an underlying condition that precludes the further use of the medication. An adequate corticosteroid treatment trial is as follows:
•\- Adult IIM: prednisone (or an equivalent corticosteroid) at a dose of at least 60mg/day for one month
•\- JDM: 1\.0mg/kg/day prednisone for at least one month
•5\. Baseline manual muscle testing which is based on a maximum MMT\-8 score of 150\. Subjects must have a score that is no greater than 125/150 in conjunction with 2 other abnormal core set measures include the following:
•\- Patient/Parent global VAS with a minimum value of 2\.0 cm on a 10 cm scale
•\- MD Global VAS with a minimum value of 2\.0 cm on a 10 cm scale
•\- CHAQ/HAQ disability index witha minimum value of 0\.25

Exclusion Criteria

•1\. Drug induced myositis (myositis in patients taking medication known to induce myositis\-like syndromes, including but not limited to statin agents, fibric acid derivates, 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 inder Inclusion Criteria 1 above will also determine the eligibility of such patients with myositis and an associated CTD).
•5\. History of receiving live vaccination 4 weeks prior to initiation of study treatment.
•6\. Joint disease or other musculoskeletal condition, which precludes the ability to quantitative muscle strength
•7\. Known hypersensitivity to murine proteins
•8\. Concomitant illness that would prevent adequate patient assessment or pose an added risk for study paticipants:
•\-reccurent 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)