A Phase 2 interventional study of intraarticular injection in Rheumatoid Arthritis, sponsored by Federal University of São Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2007-07-25.
Sponsored by Federal University of São Paulo · Phase 2, Interventional, and Treatment
The purpose of this study is to compare the efficacy and safety of intra-articular glucocorticoid injection to its systemic use for treatment of knee synovitis in patients with Rheumatoid Arthritis
A randomized double-blind controlled study was conducted including 60 patients with RA. Patients were randomized to receive either a single intra-articular knee injection with triamcinolone hexacetonide 60 mg and xylocaine chloride 2% (1 mL) associated to a single intramuscular injection of 1 mL of xylocaine chloride 2% (IAI group) or 1 mL of xylocaine chloride 2% by intra-articular injection and a intramuscular injection of triamcinolone acetonide 60 mg and xylocaine chloride 2% (1 mL) (IM group). Evaluations were performed at baseline and 1, 4, 8 and 12 weeks post-intervention. The following instruments were used: the ACR 20%, 50 and 70% improvement criteria; VAS for knee morning stiffness, pain and edema; knee circumference and goniometry; Likert's scale of improvement (IVAS); daily use of oral glucocorticoid and NSAIDs, blood pressure and adverse effects.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 60 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.
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Drug: intraarticular injection
Triamcinolone hexacetonide 60mg(3ml)by intraarticular injection Triamcinolone acetonide 60mg (3ml)by intramuscular administration
Also known as: Triancil®, Theracort®
VAS for knee pain
Time frame: 12 weeks post intervention
side and adverse effects, safety
Time frame: 12 weeks post intervention
This study is completed, as verified in Jul 2007. You cannot join it, but the record below documents what was studied.
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Federal University of São Paulo