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Lessons learnt from a discontinued randomised controlled trial : adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica (Subcutaneous Injection of Adalimumab Trial compared with Control: SCIATiC)

Williams, Nefyn H.; Jenkins, Alison; Goulden, Nia; Hoare, Zoe; Hughes, Dyfrig A.; Wood, Eifiona; Foster, Nadine E.; Walsh, David; Carnes, Dawn; Sparkes, Valerie; Hay, Elaine M.; Isaacs, John; Konstantinou, Kika; Morrissey, Dylan; Karppinen, Jaro; Genevay, Stephane; Wilkinson, Clare (2018-07-31)

 
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URL:
https://doi.org/10.1186/s13063-018-2801-6

Williams, Nefyn H.
Jenkins, Alison
Goulden, Nia
Hoare, Zoe
Hughes, Dyfrig A.
Wood, Eifiona
Foster, Nadine E.
Walsh, David
Carnes, Dawn
Sparkes, Valerie
Hay, Elaine M.
Isaacs, John
Konstantinou, Kika
Morrissey, Dylan
Karppinen, Jaro
Genevay, Stephane
Wilkinson, Clare
Springer Nature
31.07.2018

Williams, N., Jenkins, A., Goulden, N., Hoare, Z., Hughes, D., Wood, E., Foster, N., Walsh, D., Carnes, D., Sparkes, V., Hay, E., Isaacs, J., Konstantinou, K., Morrissey, D., Karppinen, J., Genevay, S., Wilkinson, C. (2018) Lessons learnt from a discontinued randomised controlled trial: adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica (Subcutaneous Injection of Adalimumab Trial compared with Control: SCIATiC). Trials, 19:408. doi:10.1186/s13063-018-2801-6

https://rightsstatements.org/vocab/InC/1.0/
© The Author(s). 2018. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
https://rightsstatements.org/vocab/InC/1.0/
doi:https://doi.org/10.1186/s13063-018-2801-6
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Julkaisun pysyvä osoite on
https://urn.fi/URN:NBN:fi-fe2018100537583
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Abstract

Background: Adalimumab, a biological treatment targeting tumour necrosis factor α, might be useful in sciatica. This paper describes the challenges faced when developing a new treatment pathway for a randomised controlled trial of adalimumab for people with sciatica, as well as the reasons why the trial discussed was stopped early.

Methods: A pragmatic, parallel group, randomised controlled trial with blinded (masked) participants, clinicians, outcome assessment and statistical analysis was conducted in six UK sites. Participants were identified and recruited from general practices, musculoskeletal services and outpatient physiotherapy clinics. They were adults with persistent symptoms of sciatica of 1 to 6 months’ duration with moderate to high level of disability. Eligibility was assessed by research physiotherapists according to clinical criteria, and participants were randomised to receive two doses of adalimumab (80 mg then 40 mg 2 weeks later) or saline placebo subcutaneous injections in the posterior lateral thigh. Both groups were referred for a course of physiotherapy. Outcomes were measured at baseline, 6-week, 6-month and 12-month follow-up. The main outcome measure was disability measured using the Oswestry Disability Index. The planned sample size was 332, with the first 50 in an internal pilot phase.

Results: The internal pilot phase was discontinued after 10 months from opening owing to low recruitment (two of the six sites active, eight participants recruited). There were several challenges: contractual delays; one site did not complete contract negotiations, and two sites signed contracts shortly before trial closure; site withdrawal owing to patient safety concerns; difficulties obtaining excess treatment costs; and in the two sites that did recruit, recruitment was slower than planned because of operational issues and low uptake by potential participants.

Conclusions: Improved patient care requires robust clinical research within contexts in which treatments can realistically be provided. Step changes in treatment, such as the introduction of biologic treatments for severe sciatica, raise complex issues that can delay trial initiation and retard recruitment. Additional preparatory work might be required before testing novel treatments. A randomised controlled trial of tumour necrosis factor-α blockade is still needed to determine its cost-effectiveness in severe sciatica.

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