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

NCT00506896 | Completed Phase 2 DMC

• 1 other identifier: 0599/04
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; glucocorticoid; intraarticular injection; arthritis

Outcome Measures

Primary Outcomes (1)

• VAS for knee pain

  12 weeks post intervention

Secondary Outcomes (1)

• side and adverse effects, safety

  12 weeks post intervention

Study Arms (1)

1

ACTIVE COMPARATOR

Drug: intraarticular injection

Interventions

intraarticular injection DRUG

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

Also known as: Triancil®, Theracort®

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Rheumatoid Arthritis diagnosed for more than 6 months
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Rheumatology Division, Federal University of Sao Paulo

São Paulo, São Paulo, 04023-900, Brazil

Location

Related Publications (46)

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

  PMID: 6345042 BACKGROUND

• 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.

  PMID: 14969070 BACKGROUND

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

  PMID: 9588284 BACKGROUND

• 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.

  PMID: 8891463 BACKGROUND

• 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.

  PMID: 340129 BACKGROUND

• 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.

  PMID: 8356413 BACKGROUND

• 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.

  PMID: 10568861 BACKGROUND

• 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.

  PMID: 16292792 BACKGROUND

• 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.

  PMID: 17062431 BACKGROUND

• 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.

  PMID: 9714355 BACKGROUND

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

  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.

  PMID: 13932060 BACKGROUND

• 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.

  PMID: 3948470 BACKGROUND

• 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.

  PMID: 4567862 BACKGROUND

• 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.

  PMID: 373651 BACKGROUND

• 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.

  PMID: 6836233 BACKGROUND

• 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.

  PMID: 8173851 BACKGROUND

• 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.

  PMID: 12810938 BACKGROUND

• 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.

  PMID: 5027603 BACKGROUND

• 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.

  PMID: 14880415 BACKGROUND

• 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.

  PMID: 3358796 BACKGROUND

• 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.

  PMID: 1575785 BACKGROUND

• 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.

  PMID: 7779114 BACKGROUND

• 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.

  PMID: 2213777 BACKGROUND

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

  PMID: 9101517 BACKGROUND

• 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.

  PMID: 8523335 BACKGROUND

• 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.

  PMID: 7551664 BACKGROUND

• 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.

  PMID: 7332377 BACKGROUND

• 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.

  PMID: 10070273 BACKGROUND

• 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.

  PMID: 12972485 BACKGROUND

• 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.

  PMID: 10943871 BACKGROUND

• 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.

  PMID: 16645967 BACKGROUND

• 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.

  PMID: 11840435 BACKGROUND

• 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.

  PMID: 6383234 BACKGROUND

• 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.

  PMID: 15693001 BACKGROUND

• 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.

  PMID: 12115194 BACKGROUND

• 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.

  PMID: 16271901 BACKGROUND

• 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.

  PMID: 8823685 BACKGROUND

• 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.

  PMID: 15843449 BACKGROUND

• 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.

  PMID: 9292813 BACKGROUND

• 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.

  PMID: 7791815 BACKGROUND

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

  PMID: 10787466 BACKGROUND

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

  PMID: 11035907 BACKGROUND

• 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.

  PMID: 16142862 BACKGROUND

• 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.

  PMID: 5109272 BACKGROUND

• 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.

  PMID: 2290163 BACKGROUND

Related Links

• Federal University of Sao Paulo

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis

Interventions

Injections, Intra-Articular

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Monique S Konai, MD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

• Rita V Furtado, MD, PhD

  Federal University of São Paulo

  STUDY DIRECTOR

• Marla F Santos, MD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

• Jamil Natour, MD, PhD

  Federal University of São Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 20, 2007
• First Posted: July 25, 2007
• Study Start: July 1, 2004
• Study Completion: January 1, 2006
• Last Updated: July 25, 2007

Record last verified: 2007-07

Locations

BR (1)