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Sponsored by: |
Institut National de la Santé Et de la Recherche Médicale, France |
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Information provided by: | Institut National de la Santé Et de la Recherche Médicale, France |
ClinicalTrials.gov Identifier: | NCT00339157 |
Condition | Intervention | Phase |
---|---|---|
Systemic-Onset Juvenile Idiopathic Arthritis |
Drug: Anakinra Biological: Pneumo23 |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | ANAkinra in Severe Juvenile Idiopathic Arthritis of Systemic Onset (ANAJIS) |
Estimated Enrollment: | 24 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | July 2008 |
Ages Eligible for Study: | 2 Years to 20 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
Pediatric Immuno-Hematology and Rheumatology Unit, Necker-Enfants Malades Hospital, 149 rue de Sevres | |
Paris, France, 75015 | |
Hopital Lyon Edouard Herriot | |
Lyon, France, 69437 | |
Kremlin-Bicetre Hospital | |
Kremlin-Bicetre, France, 94270 | |
Nancy Hopital d'Enfants | |
Nancy, France, 54511 | |
Bordeaux CHU | |
Bordeaux, France, 33000 | |
Robert Debre Hospital | |
Paris, France, 75019 |
Principal Investigator: | Pierre Quartier-dit-Maire, MD | Pediatric Immuno-Hematology and Rheumatology Unit, Necker-Enfants Malades Hospital, 149 rue de Sevre, 75015 Paris, France |
Study ID Numbers: | C05-40 |
Study First Received: | June 16, 2006 |
Last Updated: | April 23, 2007 |
ClinicalTrials.gov Identifier: | NCT00339157 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
IDIOPATHIC JUVENILE ARTHRITIS PEDIATRICS ORPHAN DISEASE |
INTERLEUKIN - 1 RECEPTORS , INTERLEUKINS ANTAGONISTS |
Autoimmune Diseases Arthritis, Juvenile Rheumatoid Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Interleukin 1 Receptor Antagonist Protein Rheumatic Diseases |
Immune System Diseases Therapeutic Uses Antirheumatic Agents Pharmacologic Actions |