- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01165008
Anakinra in Myositis
Anakinra in Patients With Refractory Idiopathic Inflammatory Myopathies
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Stockholm, Sweden, 17176
- Karolinska University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KS 01
- 03-144 (Other Identifier: Etikprovningsnamnden i Stockholm)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dermatomyositis
-
Istituto Giannina GasliniPediatric Rheumatology International Trials OrganizationCompletedJuvenile DermatomyositisItaly
-
The First Hospital of Jilin UniversityCompletedJuvenile Dermatomyositis
-
The Cleveland ClinicMallinckrodtCompletedDermatomyositis | Juvenile DermatomyositisUnited States
-
Biotech Pharmaceutical Co., Ltd.Not yet recruitingDermatomyositis, Adult Type
-
First Affiliated Hospital Xi'an Jiaotong UniversityRecruitingDermatomyositis, Adult TypeChina
-
Tulane UniversityCompletedDermatomyositis, Adult TypeUnited States
-
Assistance Publique - Hôpitaux de ParisRecruitingJuvenile DermatomyositisFrance
-
The Hospital for Sick ChildrenCompletedJuvenile DermatomyositisCanada
-
Second Affiliated Hospital, School of Medicine,...RecruitingGastric Mucosal Manifestations in Patients With DermatomyositisChina
-
MedImmune LLCCompletedDERMATOMYOSITIS OR POLYMYOSITISUnited States
Clinical Trials on Anakinra
-
University of AthensCompletedCoronary Artery Disease | Inflammation | Rheumatoid ArthritisGreece
-
Weill Medical College of Cornell UniversitySwedish Orphan BiovitrumWithdrawnCovid19 | Mechanical Ventilation Complication | Cytokine StormUnited States
-
University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)Withdrawn
-
Virginia Commonwealth UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedHeart FailureUnited States
-
Virginia Commonwealth UniversityAmerican Heart AssociationCompleted
-
University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)Withdrawn
-
National Institute of Neurological Disorders and...CompletedMultiple SclerosisUnited States
-
National Institute of Arthritis and Musculoskeletal...CompletedImmune System Diseases | Autoimmune Connective Tissue DisorderUnited States
-
National Institute of Allergy and Infectious Diseases...TerminatedEczema | Atopic Dermatitis | Allergic Disease | Anakinra | KineretUnited States