Efficacy, Safety, and Tolerability Study of Infliximab in Juvenile Spondyloarthropathies
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|ClinicalTrials.gov Identifier: NCT00591201|
Recruitment Status : Completed
First Posted : January 11, 2008
Last Update Posted : January 17, 2008
Tumor necrosis factor (TNF) alpha is a pro-inflammatory cytokine playing a significant role in the pathogenesis of the spondyloarthropathies (SpA). Infliximab is a TNF alpha blocking monoclonal antibody efficacious and safe as treatment of adult-onset SpA.
In this study we will try to demonstrate that infliximab administered at 5mg/kg to patients with juvenile onset SpA over a period of 12 weeks will have more efficacy than placebo and that it will be well tolerated. At the end of this phase, patients will go into a 52-week open extension to demonstrate sustained efficacy, safety, and tolerability of infliximab We will include 34 patients with juvenile onset SpA unresponsive to standard treatment. Efficacy will be assessed by counting the number of actively inflamed joints and a number of other parameters.
|Condition or disease||Intervention/treatment||Phase|
|Spondylarthropathies||Drug: infliximab Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy, Safety, and Tolerability of Infliximab (Remicade; Schering-Plough) in Juvenile Spondyloarthropathies: a Three-Month, Randomized, Double-Blind, Placebo-Controlled Trial and 52-Week Open Extension.|
|Study Start Date :||June 2002|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||September 2007|
Infliximab 5mg/kg diluted in 250 ml of isotonic solution of sodium chloride will be administered by the intravenous route on weeks 0, 2, 6, 12, 18, 24, 30, 36, 42, and 48.
Other Name: remicade
Placebo Comparator: B
Placebo -powder diluted in 250 ml of isotonic solution of sodium chloride- will be administered on weeks 0, 2 and 6.
- Number of joints with active arthritis. [ Time Frame: 12 weeks ]
- Number of tender entheses; patient assessment of pain; patient/parent assessment of well being; investigator assessments of disease activity and health status; childhood health assessment questionnaire; and C reactive protein. Safety issues [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00591201
|Servicio de Reumatología, Hospital General de México|
|México City, DF, Mexico, 06720|
|Principal Investigator:||Rubén Burgos-Vargas, MD||Rheumatologist, Hospital General de México/Professor of Medicine, Universidad Nacional Autónoma de México|