Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00443222
Status:
COMPLETED
Last Update Posted:
2007-03-05
First Post:
2007-03-02
Brief Title:
Treatment With TNF Blockade Infliximab in Patients With Myositis
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
An Open Trial With TNF Blockade With Infliximab Remicade in Patients With Chronic Inflammatory Myopathies
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgkg 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 Patients 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
Infliximab is given as infusions 5 mgkg 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 Patients 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None