Abstract
Randomized controlled trials are commonly designed to compare the effectiveness of treatments in rheumatoid arthritis (RA). In a clinical trial (intervention study), researchers apply interventions or preventive services to patients and examine outcomes. Clinical trial design consists of the following categories: choice of intervention and control, selection of patients, informed consent, baseline measurement, bank specimens, randomized allocation and blinding, and outcome measurements. Here, we discuss the design of clinical trials for RA.
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References
Cummings SR, Grady D, Hulley SB (2013) Designing a randomized blinding trial. In: Hulley SB, Cummings SR, Browner WS, Grady DG, Newman TB (eds) Designing clinical research, 4th edn. Lippincott Williams & Wilkins/Wolters Kluwer Health, Philadelphia
den Broeder AA, Verhoef LM, Fransen J et al (2017) Ultra-low dose of rituximab in rheumatoid arthritis: study protocol for a randomised controlled trial. Trials 18:403
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (2016) Guideline for good clinical practice E6 (R2). ICH harmonized tripartite guideline. ICH, Geneva
Karsh J, Keystone EC, Haraoui B et al (2011) Canadian recommendations for clinical trials of pharmacologic interventions in rheumatoid arthritis: inclusion criteria and study design. J Rheumatol 38:2095–2104
Aletaha D, Neogi T, Silman AJ et al (2010) 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum 62:2569–2581
Borm GF, Fransen J, Lemmens WA (2007) A simple sample size formula for analysis of covariance in randomized clinical trials. J Clin Epidemiol 60:1234–1238
Teerenstra S, Eldridge S, Graff M et al (2012) A simple sample size formula for analysis of covariance in cluster randomized trials. Stat Med 31:2169–2178
Mathieu E, Herbert RD, McGeechan K et al (2014) A theoretical analysis showed that blinding cannot eliminate potential for bias associated with beliefs about allocation in randomized clinical trials. J Clin Epidemiol 67:667–671
Tugwell P, Boers M (1993) OMERACT conference on outcome measures in rheumatoid arthritis clinical trials: introduction. J Rheumatol 20:528–530
Mack ME, Hsia E, Aletaha D (2017) Comparative assessment of the different American College of Rheumatology/European League Against Rheumatism remission definitions for rheumatoid arthritis for their use as clinical trial end points. Arthritis Rheumatol 69:518–528
Kirkham JJ, Boers M, Tugwell P et al (2013) Outcome measures in rheumatoid arthritis randomised trials over the last 50 years. Trials 14:324
Aletaha D, Landewe R, Karonitsch T et al (2008) Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations. Ann Rheum Dis 67:1360–1364
Schwieterman WD (2008) Issues in the design of new clinical trials for rheumatoid arthritis therapeutics. Nat Clin Pract Rheumatol 4:641–648
Felson DT, Anderson JJ, Boers M et al (1995) American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum 38:727–735
Prevoo ML, van ‘t Hof MA, Kuper HH et al (1995) Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum 38:44–48
Smolen JS, Breedveld FC, Schiff MH et al (2003) A simplified disease activity index for rheumatoid arthritis for use in clinical practice. Rheumatology (Oxford) 42:244–257
Aletaha D, Nell VP, Stamm T et al (2005) Acute phase reactants add little to composite disease activity indices for rheumatoid arthritis: validation of a clinical activity score. Arthritis Res Ther 7:R796–R806
Felson DT, Smolen JS, Wells G et al (2011) American College of Rheumatology/European League against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials. Ann Rheum Dis 70:404–413
Studenic P, Aletaha D, de Wit M et al (2023) American College of Rheumatology/EULAR remission criteria for rheumatoid arthritis: 2022 revision. Arthritis Rheumatol 82:74–80
Van der Heijde DM (1996) Plain x-rays in rheumatoid arthritis: overview of scoring methods, their reliability and applicability. Baillieres Clin Rheumatol 10:435–453
Larsen A, Dale K, Eek M (1977) Radiographic evaluation of rheumatoid arthritis and related conditions by standard reference films. Acta Radiol Diagn (Stockh) 18:481–491
Fries JF, Spitz PW, Young DY (1982) The dimensions of health outcomes: the health assessment questionnaire, disability and pain scales. J Rheumatol 9:789–793
Ware JE Jr, Sherbourne CD (1992) The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 30:473–483
Herdman M, Gudex C, Lloyd A et al (2011) Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res 20:1727–1736
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Ishizaki, J., Hasegawa, H. (2024). Design an Intervention Study. In: Liu, S. (eds) Rheumatoid Arthritis. Methods in Molecular Biology, vol 2766. Humana, New York, NY. https://doi.org/10.1007/978-1-0716-3682-4_32
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DOI: https://doi.org/10.1007/978-1-0716-3682-4_32
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