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

NCT ID: NCT00506896

Last Updated: 2007-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2006-01-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

intraarticular injection

Intervention Type DRUG

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

Interventions

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intraarticular injection

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

Intervention Type DRUG

Other Intervention Names

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Triancil® Theracort®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Principal Investigators

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Monique S Konai, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Rita V Furtado, MD, PhD

Role: STUDY_DIRECTOR

Federal University of São Paulo

Marla F Santos, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Jamil Natour, MD, PhD

Role: STUDY_CHAIR

Federal University of São Paulo

Locations

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Rheumatology Division, Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Gray RG, Gottlieb NL. Intra-articular corticosteroids. An updated assessment. Clin Orthop Relat Res. 1983 Jul-Aug;(177):235-63.

Reference Type BACKGROUND
PMID: 6345042 (View on PubMed)

Verstappen SM, Jacobs JW, Bijlsma JW; Utrecht Rheumatoid Arthritis Cohort Study Group. The Utrecht experience with different treatment strategies in early rheumatoid arthritis. Clin Exp Rheumatol. 2003 Sep-Oct;21(5 Suppl 31):S165-8.

Reference Type BACKGROUND
PMID: 14969070 (View on PubMed)

See Y. Intra-synovial corticosteroid injections in juvenile chronic arthritis--a review. Ann Acad Med Singap. 1998 Jan;27(1):105-11.

Reference Type BACKGROUND
PMID: 9588284 (View on PubMed)

Caldwell JR. Intra-articular corticosteroids. Guide to selection and indications for use. Drugs. 1996 Oct;52(4):507-14. doi: 10.2165/00003495-199652040-00004.

Reference Type BACKGROUND
PMID: 8891463 (View on PubMed)

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. doi: 10.1185/03007997709110154.

Reference Type BACKGROUND
PMID: 340129 (View on PubMed)

Marchesoni A, Sinigaglia L, Ranza R, Varenna M, Battafarano N, Tosi S. Rifamycin SV versus triamcinolone in local treatment of rheumatoid synovitis. Scand J Rheumatol. 1993;22(4):194-8. doi: 10.3109/03009749309099270.

Reference Type BACKGROUND
PMID: 8356413 (View on PubMed)

Stein A, Yassouridis A, Szopko C, Helmke K, Stein C. Intraarticular morphine versus dexamethasone in chronic arthritis. Pain. 1999 Dec;83(3):525-532. doi: 10.1016/S0304-3959(99)00156-6.

Reference Type BACKGROUND
PMID: 10568861 (View on PubMed)

Schatteman L, Gyselbrecht L, De Clercq L, Mielants H. Treatment of refractory inflammatory monoarthritis in ankylosing spondylitis by intraarticular injection of infliximab. J Rheumatol. 2006 Jan;33(1):82-5. Epub 2005 Nov 15.

Reference Type BACKGROUND
PMID: 16292792 (View on PubMed)

Bliddal H, Terslev L, Qvistgaard E, Konig M, Holm CC, Rogind H, Boesen M, Danneskiold-Samsoe 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. doi: 10.1080/03009740600844530.

Reference Type BACKGROUND
PMID: 17062431 (View on PubMed)

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. doi: 10.1093/rheumatology/37.7.770.

Reference Type BACKGROUND
PMID: 9714355 (View on PubMed)

Hollander JL. Intra-synovial corticosteroid therapy in rheumatoid arthritis. MD Med J 1970;19:62-66.

Reference Type BACKGROUND

MCCARTY DJ Jr, FAIRES JS. A comparison of the duration of local anti-inflammatory effect of several adrenocorticosteroid esters--a bioassay technique. Curr Ther Res Clin Exp. 1963 May;5:284-90. No abstract available.

Reference Type BACKGROUND
PMID: 13932060 (View on PubMed)

Derendorf H, Mollmann H, Gruner A, Haack D, Gyselby G. Pharmacokinetics and pharmacodynamics of glucocorticoid suspensions after intra-articular administration. Clin Pharmacol Ther. 1986 Mar;39(3):313-7. doi: 10.1038/clpt.1986.45.

Reference Type BACKGROUND
PMID: 3948470 (View on PubMed)

Bain LS, Balch HW, Wetherly JM, Yeadon A. Intraarticular triamcinolone hexacetonide: double-blind comparison with methylprednisolone. Br J Clin Pract. 1972 Dec;26(12):559-61. No abstract available.

Reference Type BACKGROUND
PMID: 4567862 (View on PubMed)

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. doi: 10.1136/ard.38.1.36.

Reference Type BACKGROUND
PMID: 373651 (View on PubMed)

Jalava S, Saario R. Treatment of finger joints with local steroids. A double-blind study. Scand J Rheumatol. 1983;12(1):12-4. doi: 10.3109/03009748309101996.

Reference Type BACKGROUND
PMID: 6836233 (View on PubMed)

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. doi: 10.1093/rheumatology/33.5.461.

Reference Type BACKGROUND
PMID: 8173851 (View on PubMed)

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. doi: 10.1093/rheumatology/keg358. Epub 2003 Jun 16.

Reference Type BACKGROUND
PMID: 12810938 (View on PubMed)

McCarty DJ. Treatment of rheumatoid joint inflammation with triamcinolone hexacetonide. Arthritis Rheum. 1972 Mar-Apr;15(2):157-73. doi: 10.1002/art.1780150205. No abstract available.

Reference Type BACKGROUND
PMID: 5027603 (View on PubMed)

HOLLANDER JL, BROWN EM Jr, JESSAR RA, BROWN CY. Hydrocortisone and cortisone injected into arthritic joints; comparative effects of and use of hydrocortisone as a local antiarthritic agent. J Am Med Assoc. 1951 Dec 22;147(17):1629-35. doi: 10.1001/jama.1951.03670340019005. No abstract available.

Reference Type BACKGROUND
PMID: 14880415 (View on PubMed)

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. doi: 10.1002/art.1780310302.

Reference Type BACKGROUND
PMID: 3358796 (View on PubMed)

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. doi: 10.1002/art.1780350502.

Reference Type BACKGROUND
PMID: 1575785 (View on PubMed)

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. doi: 10.1002/art.1780380602.

Reference Type BACKGROUND
PMID: 7779114 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2213777 (View on PubMed)

Lequesne MG. The algofunctional indices for hip and knee osteoarthritis. J Rheumatol. 1997 Apr;24(4):779-81.

Reference Type BACKGROUND
PMID: 9101517 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8523335 (View on PubMed)

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. doi: 10.1093/rheumatology/34.8.771.

Reference Type BACKGROUND
PMID: 7551664 (View on PubMed)

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. doi: 10.1136/ard.40.6.571.

Reference Type BACKGROUND
PMID: 7332377 (View on PubMed)

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. doi: 10.1136/ard.57.12.732.

Reference Type BACKGROUND
PMID: 10070273 (View on PubMed)

Weitoft T, Ronnblom L. Randomised controlled study of postinjection immobilisation after intra-articular glucocorticoid treatment for wrist synovitis. Ann Rheum Dis. 2003 Oct;62(10):1013-5. doi: 10.1136/ard.62.10.1013.

Reference Type BACKGROUND
PMID: 12972485 (View on PubMed)

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. doi: 10.1002/1529-0131(200008)43:83.0.CO;2-D.

Reference Type BACKGROUND
PMID: 10943871 (View on PubMed)

Hetland ML, Stengaard-Pedersen K, Junker P, Lottenburger T, Ellingsen T, Andersen LS, Hansen I, Skjodt H, Pedersen JK, Lauridsen UB, Svendsen A, Tarp U, Podenphant J, Hansen G, Lindegaard H, de Carvalho A, Ostergaard M, Horslev-Petersen K; CIMESTRA Study Group. Combination treatment with methotrexate, cyclosporine, and intraarticular betamethasone compared with methotrexate and intraarticular betamethasone in early active rheumatoid arthritis: an investigator-initiated, multicenter, randomized, double-blind, parallel-group, placebo-controlled study. Arthritis Rheum. 2006 May;54(5):1401-9. doi: 10.1002/art.21796.

Reference Type BACKGROUND
PMID: 16645967 (View on PubMed)

American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Guidelines for the management of rheumatoid arthritis: 2002 Update. Arthritis Rheum. 2002 Feb;46(2):328-46. doi: 10.1002/art.10148. No abstract available.

Reference Type BACKGROUND
PMID: 11840435 (View on PubMed)

Intra-articular radioactive yttrium and triamcinolone hexacetonide: an inconclusive trial. Arthritis and Rheumatism Council Multicentre Radiosynoviorthesis Trial Group. Ann Rheum Dis. 1984 Aug;43(4):620-3. doi: 10.1136/ard.43.4.620.

Reference Type BACKGROUND
PMID: 6383234 (View on PubMed)

Silverman E, Spiegel L, Hawkins D, Petty R, Goldsmith D, Schanberg L, Duffy C, Howard P, Strand V. Long-term open-label preliminary study of the safety and efficacy of leflunomide in patients with polyarticular-course juvenile rheumatoid arthritis. Arthritis Rheum. 2005 Feb;52(2):554-62. doi: 10.1002/art.20861.

Reference Type BACKGROUND
PMID: 15693001 (View on PubMed)

Neidel J, Boehnke M, Kuster RM. The efficacy and safety of intraarticular corticosteroid therapy for coxitis in juvenile rheumatoid arthritis. Arthritis Rheum. 2002 Jun;46(6):1620-8. doi: 10.1002/art.10313.

Reference Type BACKGROUND
PMID: 12115194 (View on PubMed)

Schumacher HR, Chen LX. Injectable corticosteroids in treatment of arthritis of the knee. Am J Med. 2005 Nov;118(11):1208-14. doi: 10.1016/j.amjmed.2005.05.003.

Reference Type BACKGROUND
PMID: 16271901 (View on PubMed)

Ostergaard M, Stoltenberg M, Gideon P, Sorensen 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.

Reference Type BACKGROUND
PMID: 8823685 (View on PubMed)

Weitoft T, Larsson A, Saxne T, Ronnblom 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. doi: 10.1136/ard.2004.035022. Epub 2005 Apr 20.

Reference Type BACKGROUND
PMID: 15843449 (View on PubMed)

Huppertz HI, Pfuller H. Transient suppression of endogenous cortisol production after intraarticular steroid therapy for chronic arthritis in children. J Rheumatol. 1997 Sep;24(9):1833-7.

Reference Type BACKGROUND
PMID: 9292813 (View on PubMed)

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. doi: 10.1056/NEJM199507203330302.

Reference Type BACKGROUND
PMID: 7791815 (View on PubMed)

Sholter DE, Armstrong PW. Adverse effects of corticosteroids on the cardiovascular system. Can J Cardiol. 2000 Apr;16(4):505-11.

Reference Type BACKGROUND
PMID: 10787466 (View on PubMed)

Reid IR. Glucocorticoid-induced osteoporosis. Baillieres Best Pract Res Clin Endocrinol Metab. 2000 Jun;14(2):279-98. doi: 10.1053/beem.2000.0074.

Reference Type BACKGROUND
PMID: 11035907 (View on PubMed)

Furtado RN, Oliveira LM, Natour J. Polyarticular corticosteroid injection versus systemic administration in treatment of rheumatoid arthritis patients: a randomized controlled study. J Rheumatol. 2005 Sep;32(9):1691-8.

Reference Type BACKGROUND
PMID: 16142862 (View on PubMed)

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. No abstract available. German.

Reference Type BACKGROUND
PMID: 5109272 (View on PubMed)

Adebajo AO, Nash P, Hazleman BL. A prospective double blind dummy placebo controlled study comparing triamcinolone hexacetonide injection with oral diclofenac 50 mg TDS in patients with rotator cuff tendinitis. J Rheumatol. 1990 Sep;17(9):1207-10.

Reference Type BACKGROUND
PMID: 2290163 (View on PubMed)

Related Links

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http://www.unifesp.br

Federal University of Sao Paulo

Other Identifiers

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0599/04

Identifier Type: -

Identifier Source: org_study_id