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Treatment With TNF Blockade, Infliximab, in Patients With Myositis

Primary Purpose

Refractory Myositis

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Infliximab

About this trial

This is an interventional treatment trial for Refractory Myositis focused on measuring infliximab, polymyositis, dermatomyositis, inclusion body myositis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult patients.
Persisting muscle weakness defined as ≤ 80% of muscle strength as measured by functional index of myositis
Signs of disease activity defined as muscle edema observed by magnetic resonance imaging (MRI) or creatine kinase (CK) elevation, or inflammatory cell infiltrates on muscle biopsy, and failure to respond to treatment with glucocorticoids for a minimum of six months in combination with azathioprine or methotrexate.

Exclusion Criteria:

Pregnant women, nursing mothers or a planned pregnancy within one and a half years of enrolment.
Prior administration of infliximab or any other therapeutic agent targeted at reducing TNF (e.g., Etanercept, pentoxifylline, thalidomide or anti-CD4+ antibody) within the previous six months.
A history of known allergies to murine proteins.
Serious infections, such as hepatitis, pneumonia, pyelonephritis in the previous 3 months. Less serious infections in the previous 3 months, such as acute upper respiratory tract infection (colds) or uncomplicated urinary tract infection (colds) or uncomplicated urinary tract infection need not to considered exclusions at the discretion of the treating physician.
History of opportunistic infections such as herpes zoster within 2 months of screening. Evidence of active CMV, active pneumocystis carinii, drug resistant atypical mycobacterium, etc.
Documented HIV infection.
Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease.
Any currently known malignancy or pre-malignant lesions or any history of malignancy within the past five years.
Patients with alcoholism, alcoholic liver disease, or other chronic liver disease.
Patients with a positive PPD and chest X-Ray suggestive of active TB or a previous exposure to TB.

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00443222

First Posted

March 2, 2007

Last Updated

March 2, 2007

Sponsor

Karolinska Institutet

Collaborators

Schering-Plough, Medical Research Council

1. Study Identification

Unique Protocol Identification Number

NCT00443222

Brief Title

Treatment With TNF Blockade, Infliximab, in Patients With Myositis

Official Title

An Open Trial With TNF Blockade With Infliximab (Remicade®), in Patients With Chronic Inflammatory Myopathies

Study Type

Interventional

2. Study Status

Record Verification Date

March 2007

Overall Recruitment Status

Completed

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Karolinska Institutet

Collaborators

Schering-Plough, Medical Research Council

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a 4 month open trial with TNF-blockade using infliximab (an antibody that blocks TNF) in adult patients with chronic myositis (polymyositis, dermatomyositis, inclusion body myositis) who have persisting muscle weakness and inflammatory active disease despite adequate treatment with immunosuppressives either currently or previously. Infliximab is given as infusions, 5 mg/kg body weight, these infusions are repeated after 2, 6 and 14 weeks. The study involves 15 adult patients. Primary outcome measure is muscle function assessed by muscle function index score. Other outcome measures are Myositis Disease Activity core set: Patient's global assessment and physicians global assessment on visual analogue scales (VAS). Manual muscle test, Health assessment questionnaire (HAQ), serum levels of CPK, LD and extra muscular disease activity score. Muscle biopsy, Magnetic resonance imaging (MRI) of thigh muscles and Health related Quality of life, measured by SF-36.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Refractory Myositis

Keywords

infliximab, polymyositis, dermatomyositis, inclusion body myositis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Infliximab

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult patients. Persisting muscle weakness defined as ≤ 80% of muscle strength as measured by functional index of myositis Signs of disease activity defined as muscle edema observed by magnetic resonance imaging (MRI) or creatine kinase (CK) elevation, or inflammatory cell infiltrates on muscle biopsy, and failure to respond to treatment with glucocorticoids for a minimum of six months in combination with azathioprine or methotrexate. Exclusion Criteria: Pregnant women, nursing mothers or a planned pregnancy within one and a half years of enrolment. Prior administration of infliximab or any other therapeutic agent targeted at reducing TNF (e.g., Etanercept, pentoxifylline, thalidomide or anti-CD4+ antibody) within the previous six months. A history of known allergies to murine proteins. Serious infections, such as hepatitis, pneumonia, pyelonephritis in the previous 3 months. Less serious infections in the previous 3 months, such as acute upper respiratory tract infection (colds) or uncomplicated urinary tract infection (colds) or uncomplicated urinary tract infection need not to considered exclusions at the discretion of the treating physician. History of opportunistic infections such as herpes zoster within 2 months of screening. Evidence of active CMV, active pneumocystis carinii, drug resistant atypical mycobacterium, etc. Documented HIV infection. Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease. Any currently known malignancy or pre-malignant lesions or any history of malignancy within the past five years. Patients with alcoholism, alcoholic liver disease, or other chronic liver disease. Patients with a positive PPD and chest X-Ray suggestive of active TB or a previous exposure to TB.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ingrid E Lundberg, MD, PhD

Organizational Affiliation

Rheumatology Unit, Department of Medicine, Karolinska University Hospital, Solna, Karolinska Institutet, Stockholm, Sweden

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Treatment With TNF Blockade, Infliximab, in Patients With Myositis

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