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

Rheumatoid Arthritis Clinical Trial

Official title:

Monoarticular Corticosteroid Injection Versus Systemic Administration in the Treatment of Rheumatoid Arthritis Patients: A Randomized Double-Blind Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00506896
• Other study ID #: 0599/04
• Status: Completed
• Phase: Phase 2
• First received: July 20, 2007
• Last updated: July 20, 2007
• Start date: July 2004
• Est. completion date: January 2006

Study information

• Verified date: July 2007
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• intraarticular injection
Triamcinolone hexacetonide 60mg(3ml)by intraarticular injection Triamcinolone acetonide 60mg (3ml)by intramuscular administration

Locations

Country	Name	City	State
Brazil	Rheumatology Division, Federal University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (46)

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* Note: There are 46 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS for knee pain		12 weeks post intervention
Secondary	side and adverse effects, safety		12 weeks post intervention

External Links

•   Federal University of Sao Paulo