Treatment With TNF Blockade, Infliximab, in Patients With Myositis

This study has been completed.
Sponsor:
Collaborators:
Schering-Plough
Medical Research Council
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00443222
First received: March 2, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Refractory Myositis
Drug: Infliximab
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Trial With TNF Blockade With Infliximab (Remicade®), in Patients With Chronic Inflammatory Myopathies

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00443222

Sponsors and Collaborators
Karolinska Institutet
Schering-Plough
Medical Research Council
Investigators
Principal Investigator: Ingrid E Lundberg, MD, PhD Rheumatology Unit, Department of Medicine, Karolinska University Hospital, Solna, Karolinska Institutet, Stockholm, Sweden
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00443222     History of Changes
Other Study ID Numbers: Remicade myositis
Study First Received: March 2, 2007
Last Updated: March 2, 2007
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:
infliximab
polymyositis
dermatomyositis
inclusion body myositis

Additional relevant MeSH terms:
Myositis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Infliximab
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014