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OpenTrials
Completed

NCT Number: NCT00506896

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rheumatology Division, Federal University of Sao Paulo

São Paulo, 04023-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intraarticular injection

Drug

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

Other names: Triancil®, Theracort®

Primary outcomes

  1. VAS for knee pain

    Time frame: 12 weeks post intervention

Secondary outcomes

  1. side and adverse effects, safety

    Time frame: 12 weeks post intervention

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2006
First posted
Jul 25, 2007
Registry last updated
Jul 25, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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