Monoarticular Corticosteroid Injection Versus Systemic Administration in the Treatment of Rheumatoid Arthritis Patients

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: intraarticular injection

• Registration Number: NCT00506896
• Lead Sponsor: Federal University of São Paulo

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2004-07
• Study Completion: 2006-01
• Status Verified: 2007-07
• Study First Submitted: 2007-07-20
• Study First Submitted QC: 2007-07-20
• Last Update Submitted: 2007-07-20
• Study First Posted: 2007-07-25
• Last Update Posted: 2007-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Rheumatoid Arthritis diagnosed for more than 6 months
• 18 and 65 years
• Functional class II or III according to the ACR criteria
• VAS for knee pain higher than 5
• Use of stable doses of oral corticosteroid for the last 30 days
• Use of stable doses of DMARDs for the last 3 months
• Active synovitis at least in one knee for at least the 30 days

Exclusion Criteria

• Non-controlled diabetes mellitus or hypertension
• Bacterial infection of any site
• Blood coagulation disorders
• Skin lesion on the affected knee
• History of previous surgical procedure in the knee
• Use of intra-muscular glucocorticoid in the last 30 days
• Intra-articular injection in the last 3 months
• Knee injection in the last 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	intraarticular injection	-

Primary Outcome Measures

Name	Time	Method
VAS for knee pain	12 weeks post intervention

Secondary Outcome Measures

Name	Time	Method
side and adverse effects, safety	12 weeks post intervention

Trial Locations

Locations (1)

Rheumatology Division, Federal University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil