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

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00506896
First received: July 20, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00506896

Locations
Brazil
Rheumatology Division, Federal University of Sao Paulo
Sao Paulo, Brazil, 04023-900
Sponsors and Collaborators
Federal University of São Paulo
Investigators
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:
Federal University of Sao Paulo  This link exits the ClinicalTrials.gov site

Publications:
Hollander JL. Intra-synovial corticosteroid therapy in rheumatoid arthritis. MD Med J 1970;19:62-66.
American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Guidelines for the management of rheumatoid arthritis – 2002 Update. Arthritis Rheum 2002;46:328-346.
Reid IR. Glucocorticoid-induced osteoporosis. Baillieres Best Pract Res Clin Endocrinol Metab 2000;14(2):279-98.

ClinicalTrials.gov Identifier: NCT00506896     History of Changes
Other Study ID Numbers: 0599/04
Study First Received: July 20, 2007
Last Updated: July 20, 2007
Health Authority: Brazil: National Committee of Ethics in Research

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

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

ClinicalTrials.gov processed this record on May 23, 2013