Text Size

Anakinra in Myositis

This study has been completed.
Sponsor:
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01165008
First received: July 16, 2010
Last updated: NA
Last verified: February 2005
History: No changes posted
  Purpose

To investigate the effect of the interleukin-1 (IL-1) blocking agent, anakinra, in patients with treatment-resistant inflammatory myopathies.

Patients and methods: Fifteen patients with refractory polymyositis (PM), dermatomyositis (DM), or inclusion body myositis (IBM) were treated with 100 mg anakinra subcutaneously per day during 12 months. Outcome measures included myositis disease activity score with improvement defined according to The International Myositis Assessment and Clinical Studies Group (IMACS) and for muscle performance the functional index of myositis (FI). In addition repeat muscle biopsies were performed


Condition Intervention Phase
Polymyositis
Dermatomyositis
Inclusion Body Myositis
 Drug: Anakinra
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: Anakinra in Patients With Refractory Idiopathic Inflammatory Myopathies

Resource links provided by NLM:

Drug Information available for: Anakinra
U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Study Start Date: September 2003
Study Completion Date: September 2008
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Men and women aged 18 to 80 years with diagnosis of PM, DM or IBM based Peter and Bohan's and Grigg's criteria. All patients had to be capable of giving informed consent. Other inclusion criteria were muscle strength and/or function reduced at least 20 % below predicted values as measured by functional index (FI) [45-47] and failure to respond to treatment with high-dose glucocorticoids (0.75 mg/kg/day for at least one month) in combination with azathioprine and/or methotrexate for at least two months.

-

Exclusion Criteria:

serious infections such as hepatitis, pneumonia, pyelonephritis in the previous 3 months; history of opportunistic infections such as tuberculosis, drug resistant atypical mycobacterium, active pneumocystis carinii, active cytomegalovirus infection; documented HIV infection; alcoholism, alcoholic liver disease or other chronic liver disease; chest x-ray suggestive of active tuberculosis; and pregnant, nursing mothers or patients with planned pregnancy within one and a half years of enrolment.

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01165008

Locations
Sweden
Karolinska University Hospital
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska Institutet
  More Information

No publications provided

Responsible Party: Ingrid Lundberg, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01165008     History of Changes
Other Study ID Numbers: KS 01, 03-144
Study First Received: July 16, 2010
Last Updated: July 16, 2010
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Polymyositis
Dermatomyositis
Myositis
Myositis, Inclusion Body
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
 Nervous System Diseases
Connective Tissue Diseases
Skin Diseases
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013