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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 22, 2014