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| Sponsor: | MedImmune LLC |
|---|---|
| Collaborator: |
PPD |
| Information provided by (Responsible Party): | MedImmune LLC |
| ClinicalTrials.gov Identifier: | NCT00979654 |
Purpose
The objective of this study is to assess the safety and tolerability of sifalimumab in adult subjects with active systemic Lupus Erythematosus (SLE) or active dermatomyositis (DM) or polymyositis (PM) who participated in the following clinical studies: MI-CP151, MI-CP152, or MICP179.
| Condition | Intervention | Phase |
|---|---|---|
|
Systemic Lupus Erythematosus |
Drug: Sifalimumab |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2 Open-label Study to Evaluate the Long-term Safety of Sifalimumab in Adult Subjects With Systemic Lupus Erythematosus or Myositis |
| Estimated Enrollment: | 260 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | July 2015 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Open-Label
Sifalimumab
|
Drug: Sifalimumab
IV-600 mg
|
The primary objective of this study is to evaluate the long-term safety and tolerability of multiple intravenous (IV) doses of sifalimumab in adult subjects with active systemic Lupus Erythematosus (SLE) or active dermatomyositis (DM) or polymyositis (PM) who were previously treated with investigational product(sifalimumab or placebo) in one of the following sifalimumab clinical studies: MI-CP151, MI-CP152, or MICP179.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must meet all of the following criteria:
Exclusion Criteria:
Any of the following would exclude the subject from participation in the study:
For subjects with SLE:
For subjects with DM or PM:
· Inclusion body myositis, cancer-associated myositis, myositis associated with another connective tissue disease, environmentally-associated myositis, or drug-related myopathy, a history of or a family history of non-inflammatory myopathy, scapular winging, atrophy, or hypertrophy of the calf muscles
Any of the following within 28 days before entry into the study:
Any of the following medications within 6 months before entry into the study:
Any of the following medications within 28 days before entry into the study:
Nonstable doses of one or more of the following medications within 28 days before entry into the study:
At screening blood tests (within 28 days before entry into the study), any of the following:
Contacts and Locations
Show 54 Study Locations| Study Director: | Warren Greth, MD | MedImmune LLC |
More Information
| Responsible Party: | MedImmune LLC |
| ClinicalTrials.gov Identifier: | NCT00979654 History of Changes |
| Other Study ID Numbers: | MI-CP212 |
| Study First Received: | September 17, 2009 |
| Last Updated: | January 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Lupus Erythematosus, Systemic Myositis Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases Nervous System Diseases |