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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: July 25, 2007
Last Update Posted: July 25, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Federal University of São Paulo
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

Condition Intervention Phase
Rheumatoid Arthritis Drug: intraarticular injection Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Monoarticular Corticosteroid Injection Versus Systemic Administration in the Treatment of Rheumatoid Arthritis Patients: A Randomized Double-Blind Controlled Study

Resource links provided by NLM:

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • VAS for knee pain [ Time Frame: 12 weeks post intervention ]

Secondary Outcome Measures:
  • side and adverse effects, safety [ Time Frame: 12 weeks post intervention ]

Enrollment: 60
Study Start Date: July 2004
Study Completion Date: January 2006
Arms Assigned Interventions
Active Comparator: 1 Drug: intraarticular injection
Triamcinolone hexacetonide 60mg(3ml)by intraarticular injection Triamcinolone acetonide 60mg (3ml)by intramuscular administration
Other Names:
  • Triancil®
  • Theracort®

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.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00506896

Rheumatology Division, Federal University of Sao Paulo
Sao Paulo, Brazil, 04023-900
Sponsors and Collaborators
Federal University of São Paulo
Principal Investigator: Monique S Konai, MD Federal University of Sao Paulo
Study Director: Rita V Furtado, MD, PhD Federal University of Sao Paulo
Principal Investigator: Marla F Santos, MD Federal University of Sao Paulo
Study Chair: Jamil Natour, MD, PhD Federal University of Sao Paulo
  More Information

Additional Information:
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ClinicalTrials.gov Identifier: NCT00506896     History of Changes
Other Study ID Numbers: 0599/04
First Submitted: July 20, 2007
First Posted: July 25, 2007
Last Update Posted: July 25, 2007
Last Verified: July 2007

Keywords provided by Federal University of São Paulo:
Rheumatoid Arthritis
intraarticular injection

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

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