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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00506896
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
  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
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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


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:
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See Y. Intra-synovial corticosteroid injections in juvenile chronic arthritis--a review. Ann Acad Med Singapore. 1998 Jan;27(1):105-11. Review.
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Bird HA, Ring EF, Daniel R, Bacon PA. Comparison of intra-articular methotrexate with intra-articular triamcinolone hexacetonide by thermography. Curr Med Res Opin. 1977;5(2):141-6.
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Bliddal H, Terslev L, Qvistgaard E, Konig M, Holm CC, Rogind H, Boesen M, Danneskiold-Samsøe B, Torp-Pedersen S. A randomized, controlled study of a single intra-articular injection of etanercept or glucocorticosteroids in patients with rheumatoid arthritis. Scand J Rheumatol. 2006 Sep-Oct;35(5):341-5.
Blyth T, Stirling A, Coote J, Land D, Hunter JA. Injection of the rheumatoid knee: does intra-articular methotrexate or rifampicin add to the benefits of triamcinolone hexacetonide? Br J Rheumatol. 1998 Jul;37(7):770-2.
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Bird HA, Ring EF, Bacon PA. A thermographic and clinical comparison of three intra-articular steroid preparations in rheumatoid arthritis. Ann Rheum Dis. 1979 Feb;38(1):36-9.
Jalava S, Saario R. Treatment of finger joints with local steroids. A double-blind study. Scand J Rheumatol. 1983;12(1):12-4.
Blyth T, Hunter JA, Stirling A. Pain relief in the rheumatoid knee after steroid injection. A single-blind comparison of hydrocortisone succinate, and triamcinolone acetonide or hexacetonide. Br J Rheumatol. 1994 May;33(5):461-3.
Zulian F, Martini G, Gobber D, Agosto C, Gigante C, Zacchello F. Comparison of intra-articular triamcinolone hexacetonide and triamcinolone acetonide in oligoarticular juvenile idiopathic arthritis. Rheumatology (Oxford). 2003 Oct;42(10):1254-9. Epub 2003 Jun 16.
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Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, Healey LA, Kaplan SR, Liang MH, Luthra HS, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum. 1988 Mar;31(3):315-24.
Hochberg MC, Chang RW, Dwosh I, Lindsey S, Pincus T, Wolfe F. The American College of Rheumatology 1991 revised criteria for the classification of global functional status in rheumatoid arthritis. Arthritis Rheum. 1992 May;35(5):498-502.
Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, Katz LM, Lightfoot R Jr, Paulus H, Strand V, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995 Jun;38(6):727-35.
Ferraz MB, Quaresma MR, Aquino LR, Atra E, Tugwell P, Goldsmith CH. Reliability of pain scales in the assessment of literate and illiterate patients with rheumatoid arthritis. J Rheumatol. 1990 Aug;17(8):1022-4.
Lequesne MG. The algofunctional indices for hip and knee osteoarthritis. J Rheumatol. 1997 Apr;24(4):779-81.
McCarty DJ, Harman JG, Grassanovich JL, Qian C. Treatment of rheumatoid joint inflammation with intrasynovial triamcinolone hexacetonide. J Rheumatol. 1995 Sep;22(9):1631-5.
Srinivasan A, Amos M, Webley M. The effects of joint washout and steroid injection compared with either joint washout or steroid injection alone in rheumatoid knee effusion. Br J Rheumatol. 1995 Aug;34(8):771-3.
Armstrong RD, English J, Gibson T, Chakraborty J, Marks V. Serum methylprednisolone levels following intra-articular injection of methylprednisolone acetate. Ann Rheum Dis. 1981 Dec;40(6):571-4.
Steer JH, Ma DT, Dusci L, Garas G, Pedersen KE, Joyce DA. Altered leucocyte trafficking and suppressed tumour necrosis factor alpha release from peripheral blood monocytes after intra-articular glucocorticoid treatment. Ann Rheum Dis. 1998 Dec;57(12):732-7.
Weitoft T, Rönnblom L. Randomised controlled study of postinjection immobilisation after intra-articular glucocorticoid treatment for wrist synovitis. Ann Rheum Dis. 2003 Oct;62(10):1013-5.
Proudman SM, Conaghan PG, Richardson C, Griffiths B, Green MJ, McGonagle D, Wakefield RJ, Reece RJ, Miles S, Adebajo A, Gough A, Helliwell P, Martin M, Huston G, Pease C, Veale DJ, Isaacs J, van der Heijde DM, Emery P. Treatment of poor-prognosis early rheumatoid arthritis. A randomized study of treatment with methotrexate, cyclosporin A, and intraarticular corticosteroids compared with sulfasalazine alone. Arthritis Rheum. 2000 Aug;43(8):1809-19.
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Ostergaard M, Stoltenberg M, Gideon P, Sørensen K, Henriksen O, Lorenzen I. Changes in synovial membrane and joint effusion volumes after intraarticular methylprednisolone. Quantitative assessment of inflammatory and destructive changes in arthritis by MRI. J Rheumatol. 1996 Jul;23(7):1151-61.
Weitoft T, Larsson A, Saxne T, Rönnblom L. Changes of cartilage and bone markers after intra-articular glucocorticoid treatment with and without postinjection rest in patients with rheumatoid arthritis. Ann Rheum Dis. 2005 Dec;64(12):1750-3. Epub 2005 Apr 20.
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Kirwan JR. The effect of glucocorticoids on joint destruction in rheumatoid arthritis. The Arthritis and Rheumatism Council Low-Dose Glucocorticoid Study Group. N Engl J Med. 1995 Jul 20;333(3):142-6.
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Rausch-Stroomann JG, Petry R, Brandt T, Thomas E. [Comparative study on intramuscular and intraarticular administration of the depot steroid Triamcinolone acetonide]. Arzneimittelforschung. 1971 Jun;21(6):836-40. German.
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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
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


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