Effect of a treatment strategy of tight control for rheumatoid arthritis (the TICORA study): a single-blind randomised controlled trial - PubMed (original) (raw)
Clinical Trial
Effect of a treatment strategy of tight control for rheumatoid arthritis (the TICORA study): a single-blind randomised controlled trial
Catriona Grigor et al. Lancet. 2004 Jul.
Abstract
Background: Present treatment strategies for rheumatoid arthritis include use of disease-modifying antirheumatic drugs, but a minority of patients achieve a good response. We aimed to test the hypothesis that an improved outcome can be achieved by employing a strategy of intensive outpatient management of patients with rheumatoid arthritis--for sustained, tight control of disease activity--compared with routine outpatient care.
Methods: We designed a single-blind, randomised controlled trial in two teaching hospitals. We screened 183 patients for inclusion. 111 were randomly allocated either intensive management or routine care. Primary outcome measures were mean fall in disease activity score and proportion of patients with a good response (defined as a disease activity score <2.4 and a fall in this score from baseline by >1.2). Analysis was by intention-to-treat.
Findings: One patient withdrew after randomisation and seven dropped out during the study. Mean fall in disease activity score was greater in the intensive group than in the routine group (-3.5 vs -1.9, difference 1.6 [95% CI 1.1-2.1], p<0.0001). Compared with routine care, patients treated intensively were more likely to have a good response (definition, 45/55 [82%] vs 24/55 [44%], odds ratio 5.8 [95% CI 2.4-13.9], p<0.0001) or be in remission (disease activity score <1.6; 36/55 [65%] vs 9/55 [16%], 9.7 [3.9-23.9], p<0.0001). Three patients assigned routine care and one allocated intensive management died during the study; none was judged attributable to treatment.
Interpretation: A strategy of intensive outpatient management of rheumatoid arthritis substantially improves disease activity, radiographic disease progression, physical function, and quality of life at no additional cost.
Comment in
- Intensive management reduced disease activity in rheumatoid arthritis.
van der Heijde D. van der Heijde D. ACP J Club. 2004 Nov-Dec;141(3):70. ACP J Club. 2004. PMID: 15518454 No abstract available.
Similar articles
- Adalimumab added to a treat-to-target strategy with methotrexate and intra-articular triamcinolone in early rheumatoid arthritis increased remission rates, function and quality of life. The OPERA Study: an investigator-initiated, randomised, double-blind, parallel-group, placebo-controlled trial.
Hørslev-Petersen K, Hetland ML, Junker P, Pødenphant J, Ellingsen T, Ahlquist P, Lindegaard H, Linauskas A, Schlemmer A, Dam MY, Hansen I, Horn HC, Ammitzbøll CG, Jørgensen A, Krintel SB, Raun J, Johansen JS, Østergaard M, Stengaard-Pedersen K; OPERA Study-Group. Hørslev-Petersen K, et al. Ann Rheum Dis. 2014 Apr;73(4):654-61. doi: 10.1136/annrheumdis-2012-202735. Epub 2013 Feb 23. Ann Rheum Dis. 2014. PMID: 23434570 Clinical Trial. - Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double-blind randomised controlled trial.
Klareskog L, van der Heijde D, de Jager JP, Gough A, Kalden J, Malaise M, Martín Mola E, Pavelka K, Sany J, Settas L, Wajdula J, Pedersen R, Fatenejad S, Sanda M; TEMPO (Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes) study investigators. Klareskog L, et al. Lancet. 2004 Feb 28;363(9410):675-81. doi: 10.1016/S0140-6736(04)15640-7. Lancet. 2004. PMID: 15001324 Clinical Trial. - A treat-to-target strategy with methotrexate and intra-articular triamcinolone with or without adalimumab effectively reduces MRI synovitis, osteitis and tenosynovitis and halts structural damage progression in early rheumatoid arthritis: results from the OPERA randomised controlled trial.
Axelsen MB, Eshed I, Hørslev-Petersen K, Stengaard-Pedersen K, Hetland ML, Møller J, Junker P, Pødenphant J, Schlemmer A, Ellingsen T, Ahlquist P, Lindegaard H, Linauskas A, Dam MY, Hansen I, Horn HC, Ammitzbøll CG, Jørgensen A, Krintel SB, Raun J, Krogh NS, Johansen JS, Østergaard M; OPERA study group. Axelsen MB, et al. Ann Rheum Dis. 2015 May;74(5):867-75. doi: 10.1136/annrheumdis-2013-204537. Epub 2014 Jan 10. Ann Rheum Dis. 2015. PMID: 24412895 Clinical Trial. - Aspects of early arthritis. Definition of disease states in early arthritis: remission versus minimal disease activity.
van der Helm-van Mil AH, Breedveld FC, Huizinga TW. van der Helm-van Mil AH, et al. Arthritis Res Ther. 2006;8(4):216. doi: 10.1186/ar1983. Arthritis Res Ther. 2006. PMID: 16879719 Free PMC article. Review.
Cited by
- Management strategies in rheumatoid arthritis.
Konzett V, Aletaha D. Konzett V, et al. Nat Rev Rheumatol. 2024 Oct 24. doi: 10.1038/s41584-024-01169-7. Online ahead of print. Nat Rev Rheumatol. 2024. PMID: 39448800 Review. - Rotation or change of biotherapy after TNF blocker treatment failure for axial spondyloarthritis: the ROC-SpA study, a randomised controlled study protocol.
Dalix E, Marcelli C, Bejan-Angoulvant T, Finckh A, Rancon F, Akrour M, De Araujo L, Presles E, Marotte H; ROC-SpA study group. Dalix E, et al. BMJ Open. 2024 Sep 10;14(9):e087872. doi: 10.1136/bmjopen-2024-087872. BMJ Open. 2024. PMID: 39260856 Free PMC article. - Evolving Concepts in Treat-to-Target Strategies for Systemic Lupus Erythematosus.
Nikolopoulos D, Lourenço MH, Depascale R, Triantafyllias K, Parodis I. Nikolopoulos D, et al. Mediterr J Rheumatol. 2024 Jun 30;35(Suppl 2):328-341. doi: 10.31138/mjr.290424.eci. eCollection 2024 Jun. Mediterr J Rheumatol. 2024. PMID: 39193182 Free PMC article. Review. - External Validation of the Machine Learning-Based Thermographic Indices for Rheumatoid Arthritis: A Prospective Longitudinal Study.
Morales-Ivorra I, Taverner D, Codina O, Castell S, Fischer P, Onken D, Martínez-Osuna P, Battioui C, Marín-López MA. Morales-Ivorra I, et al. Diagnostics (Basel). 2024 Jun 30;14(13):1394. doi: 10.3390/diagnostics14131394. Diagnostics (Basel). 2024. PMID: 39001284 Free PMC article. - Long-term outcomes and predictive factors of achieving low disease activity status in childhood systemic lupus erythematosus: a Chinese bicentric retrospective registered study.
Yu XX, Deng J, Chen QX, Qiu SY, Jiang CH, Wu YQ, Yang Q, Zhang GF, Yang HP, Zhao F, Li Q, Zhang AH, Wang M. Yu XX, et al. Front Immunol. 2024 Jun 10;15:1369969. doi: 10.3389/fimmu.2024.1369969. eCollection 2024. Front Immunol. 2024. PMID: 38915395 Free PMC article.
Publication types
MeSH terms
Substances
LinkOut - more resources
Full Text Sources
Other Literature Sources
Medical