Rheumatoid Arthritis Clinical Trial
Official title:
Monoarticular Corticosteroid Injection Versus Systemic Administration in the Treatment of Rheumatoid Arthritis Patients: A Randomized Double-Blind Controlled Study
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
Status | Completed |
Enrollment | 60 |
Est. completion date | January 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Rheumatology Division, Federal University of Sao Paulo | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Federal University of São Paulo |
Brazil,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Caldwell JR. Intra-articular corticosteroids. Guide to selection and indications for use. Drugs. 1996 Oct;52(4):507-14. Review. — View Citation
Derendorf H, Möllmann H, Grüner A, Haack D, Gyselby G. Pharmacokinetics and pharmacodynamics of glucocorticoid suspensions after intra-articular administration. Clin Pharmacol Ther. 1986 Mar;39(3):313-7. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Gray RG, Gottlieb NL. Intra-articular corticosteroids. An updated assessment. Clin Orthop Relat Res. 1983 Jul-Aug;(177):235-63. Review. — View Citation
Hetland ML, Stengaard-Pedersen K, Junker P, Lottenburger T, Ellingsen T, Andersen LS, Hansen I, Skjødt H, Pedersen JK, Lauridsen UB, Svendsen A, Tarp U, Pødenphant J, Hansen G, Lindegaard H, de Carvalho A, Østergaard M, Hørslev-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. — View Citation
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. — View Citation
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. — View Citation
Hollander JL. Intrasynovial corticosteroid therapy in arthritis. Md State Med J. 1970 Mar;19(3):62-6. — View Citation
Huppertz HI, Pfüller H. Transient suppression of endogenous cortisol production after intraarticular steroid therapy for chronic arthritis in children. J Rheumatol. 1997 Sep;24(9):1833-7. — View Citation
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. — View Citation
Jalava S, Saario R. Treatment of finger joints with local steroids. A double-blind study. Scand J Rheumatol. 1983;12(1):12-4. — View Citation
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. — View Citation
Lequesne MG. The algofunctional indices for hip and knee osteoarthritis. J Rheumatol. 1997 Apr;24(4):779-81. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
McCarty DJ. Treatment of rheumatoid joint inflammation with triamcinolone hexacetonide. Arthritis Rheum. 1972 Mar-Apr;15(2):157-73. — View Citation
Neidel J, Boehnke M, Küster RM. The efficacy and safety of intraarticular corticosteroid therapy for coxitis in juvenile rheumatoid arthritis. Arthritis Rheum. 2002 Jun;46(6):1620-8. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Reid IR. Glucocorticoid-induced osteoporosis. Baillieres Best Pract Res Clin Endocrinol Metab. 2000 Jun;14(2):279-98. Review. — View Citation
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. — View Citation
Schumacher HR, Chen LX. Injectable corticosteroids in treatment of arthritis of the knee. Am J Med. 2005 Nov;118(11):1208-14. Review. — View Citation
See Y. Intra-synovial corticosteroid injections in juvenile chronic arthritis--a review. Ann Acad Med Singapore. 1998 Jan;27(1):105-11. Review. — View Citation
Sholter DE, Armstrong PW. Adverse effects of corticosteroids on the cardiovascular system. Can J Cardiol. 2000 Apr;16(4):505-11. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Stein A, Yassouridis A, Szopko C, Helmke K, Stein C. Intraarticular morphine versus dexamethasone in chronic arthritis. Pain. 1999 Dec;83(3):525-32. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 46 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | VAS for knee pain | 12 weeks post intervention | ||
Secondary | side and adverse effects, safety | 12 weeks post intervention |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04226131 -
MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics
|
N/A | |
Completed |
NCT04171414 -
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT02833350 -
Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)
|
Phase 2 | |
Completed |
NCT04255134 -
Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)
|
Phase 4 | |
Recruiting |
NCT05615246 -
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
|
||
Completed |
NCT03248518 -
Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases
|
N/A | |
Completed |
NCT03514355 -
MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms
|
N/A | |
Recruiting |
NCT06005220 -
SBD121, a Synbiotic Medical Food for RA Management
|
N/A | |
Recruiting |
NCT05451615 -
Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT05054920 -
Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT02037737 -
Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting
|
N/A | |
Recruiting |
NCT04079374 -
Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel
|
Phase 3 | |
Completed |
NCT02504268 -
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
|
Phase 3 | |
Recruiting |
NCT05496855 -
Remote Care in People With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
Recruiting |
NCT06103773 -
A Study of Single and Multiple Oral Doses of TollB-001
|
Phase 1 | |
Recruiting |
NCT06031415 -
Study of GS-0272 in Participants With Rheumatoid Arthritis
|
Phase 1 | |
Completed |
NCT05999266 -
The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
|
||
Recruiting |
NCT05302934 -
Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
|
||
Recruiting |
NCT04169100 -
Novel Form of Acquired Long QT Syndrome
|
Phase 4 |