Subcutaneous administration of polymerized-type I collagen for the treatment of @entity1 with XXXX . An open-label pilot trial.

@entity1 @entity12468 @entity4280 @entity1500 @entity158 @entity2693 @entity1499 @entity309 @entity1851
OBJECTIVE: To determine the efficacy, tolerance and safety of subcutaneous injections of porcine type I collagen- @entity4280 ( @entity12468 ) in @entity1 with @entity309 ( @entity309 ). METHODS: Eleven @entity1 with active @entity309 on stable therapy with @entity1499 ( @entity1500 ) were enrolled in a 3 month prospective and longitudinal study. @entity1 were treated weekly with subcutaneous injections of 0.2 ml of collagen- @entity12468 (1.7 mg of collagen) in the 8 most @entity158 . The primary endpoints included the Ritchie index (RI), swollen joint count, disease activity score (DAS), erythrocyte sedimentation rate (ESR), and @entity1851 (CRP). The secondary endpoints included morning @entity2693 , @entity158 intensity on a visual analog scale (VAS), and the Spanish-Health Assessment Questionnaire Disability Index (HAQ-DI). Improvement was determined using American College of Rheumatology (ACR) response criteria. RESULTS: Collagen- @entity12468 was safe and well-tolerated and there were no adverse events. @entity1 had a statistically significant improvement (p < 0.05) in basal versus 3 month's treatment in morning @entity2693 (Delta -32.3, -68.6%), RI (Delta -10.2, -46.4%), swollen joint count (Delta -10.7, -71.8%), VAS (Delta -39.9, -63.8%), HAQ-DI (Delta -0.5, -48.5%), DAS (Delta -1.35, -70.5%) and ACR20, 50, and 70 (80.0%; 60.0% and 20.0% respectively). We found no differences in serologic or hematologic variables. CONCLUSION: Collagen- @entity12468 was a safe and well-tolerated drug for the short term treatment of @entity309 . The combination of collagen- @entity12468 plus @entity1500 was more efficacious than @entity1500 alone. However, double-blind placebo-controlled phase II and III clinical trials are necessary to determine whether this drug could be useful in the longterm treatment of @entity309 .
