Be Part of Research - Trial Details - The use of anakinra in treating complex regional pain syndrome by blocking interleukin-1

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The aim of this study is to see if patients suffering from long-term complex regional pain syndrome can be helped with a drug called anakinra that suppresses part of the immune response that may contribute to this chronic painful condition.
Complex regional pain syndrome is a condition that results from trauma to an extremity that results in long-term pain that is disproportionate to the original injury and persists despite complete healing. It is a condition that is poorly responsive to treatments and often results in long-term physical disability and psychological distress.
We do not fully understand the reasons behind why complex regional pain syndrome occurs but laboratory studies suggest that these features are caused by abnormal activation in the immune system. One laboratory model of complex regional pain syndrome suggests that a specific component of the immune system plays a large contribution in perpetuating the ongoing pain and other abnormal physical features. In patients with complex regional pain syndrome, it is possible to take a sample of blood antibodies and administer these antibodies to mice. The mice then develop increased pain sensitivity when the antibodies are from patients with complex regional pain syndrome. This is highly suggestive that the immune system has an important contribution in how patients with complex regional pain syndrome have ongoing pain. In this model, a molecule called interleukin-1 which normally plays an important role in inflammation has a significant role in how the antibodies from patients with complex regional pain syndrome can increase pain and inflammation in mice.
Therefore, blocking interleukin-1 offers a potential way to treat patients with complex regional pain syndrome.
Anakinra is a drug in current medical use that blocks interleukin-1 activity and is used for medical conditions caused by abnormalities in the immune system. It has not been used in patients with complex regional pain syndrome. Blocking interleukin-1 by using anakinra may be useful in treating complex regional pain syndrome and the aim of this study is to administer it in 30 patients to check it is safe and well-tolerated before considering a larger trial to test for effectiveness.

Adult patients with long-term complex regional pain syndrome for 18 months to 10 years that has been resistant to conventional treatment. No restrictions on the upper age range or gender. Participants will have to be willing to comply with study requirements such as attendance and filling out questionnaires. The risk to pregnancy is unknown so participants must be using precautions against getting pregnant if this is a possibility. There will be a list of criteria to judge whether patients are able to participate.

You can take part if:

Current inclusion criteria as of 30/01/2024 (updated 13/02/2024):

1. A diagnosis of CRPS I or II according to the Budapest research criteria at the time of the assessment for this study
2. First documented diagnosis of Budapest CRPS by a healthcare professional not less than 18 months and not longer than 15 years before the screening assessment. A valid documented diagnosis must either include the term 'Budapest CRPS', or must include the term 'CRPS' and in addition documentation of the presence of signs and symptoms which allow making the Budapest diagnosis from the notes.
3. Pain intensity average 6 or greater on a 0-10-point numerical rating scale (NRS) over a minimum of seven consecutive daily entries prior to baseline (0 day) visit, with no single value below 5.
4. Completed a previous course of appropriate specialised physiotherapy
5. Poor response or intolerance to at least one anti-neuropathic pain medication such as tricyclic antidepressants or gabapentinoids.
6. If a woman of childbearing potential (WOCBP), to be willing to confirm the use of adequate birth control during the trial period unless pregnancy is impossible
7. Fertile male patients to be using contraception for the duration of therapy if sexually active with a female partner.
8. Age 18 years and over
9. Written and informed consent obtained from patient and agreement of patient to comply with the requ

You may not be able to take part if:

Current exclusion criteria as of 30/01/2024 (updated 13/02/2024):

1. Medical conditions that in the opinion of the study investigator would make it unsafe for participation or can adversely affect outcomes2. Co-existing pain that in the view of the study doctor may make assessment of outcomes related to refractory moderate to severe CRPS unreliable3. Ongoing relevant litigation where its conclusion is imminent during the course of the study4. Medical Contraindications to anakinra such as moderate/severe or progressive renal impairment (CLCR <60 ml/min or eGFR <60 ml/min/1.73m2 or end stage renal disease, including dialysis), or hepatic impairment (defined as any value of transaminases, γ-glutamyl transpeptidase, or bilirubin greater than2 times the upper normal limit) or hypersensitivity to anakinra or any of its excipients or to E.coli-derived proteins.5. Previous use of anakinra6. Current or recent (within 6 months) use of other immunosuppressants or biologics7. Neutropenia defined as Absolute Neutrophil Count< 1.5 x 109/L8. Requirement to receive a live vaccine during the trial duration.9. Active or latent Tuberculosis infection10. HIV, Hepatitis B or C carrier11. Brittle asthma12. Active malignancy or malignancy within 2 years13. Ongoing alcohol or drug misuse at registration14. Psychiatric or other mental health disorder which in the opinion of the study investigator may interfere with successful study participation15. Commencing new therapy for refractory moderate to severe CRPS that may alter the outcome of the trial drug; this includes new painmanagement program treatment. Equally patients who have completed a pain management program within the past 3 months16. Subject is pregnant or breastfeeding, inadequate birth control, or the possibility of pregnancy during the study.17. Patients who have a spinal cord or dorsal root ganglion stimulator whose average pain is less than 6 out of 10 when the stimulator is on.

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Previous exclusion criteria as of 07/03/2023:

1. Medical conditions that, in the opinion of the study investigator, would make it unsafe for participation or can adversely affect outcomes2. Co-existing pain that, in the view of the study doctor, may make an assessment of outcomes related to refractory moderate to severe CRPS unreliable3. Ongoing relevant litigation where its conclusion is imminent during the course of the study4. Medical Contraindications to anakinra such as moderate/severe or progressive renal impairment (eGFR<60ml/min/1.73m²), hepatic impairment (defined as any value of transaminases, γ-glutamyl transpeptidase, or bilirubin greater than 2 times the upper normal limit) or hypersensitivity to anakinra or any of its excipients or to E.coli-derived proteins.5. Previous use of anakinra6. Current or recent (within 6 months) use of other immunosuppressants or biologics7. Neutropenia defined as Absolute Neutrophil Count <1.5 x 10e9/l8. Requirement to receive a live vaccine during the trial duration9. Active or latent tuberculosis infection10. HIV, Hepatitis B or C carrier11. Brittle asthma12. Active malignancy or malignancy within 2 years13. Ongoing alcohol or drug misuse at registration14. Psychiatric or other mental health disorder which in the opinion of the study investigator may interfere with successful study participation15. Commencing new therapy for refractory moderate to severe CRPS that may alter the outcome of the trial drug; this includes new pain management program treatment. Equally patients who have completed a pain management program within the past 3 months16. Subject is pregnant or breastfeeding, inadequate birth control, or the possibility of pregnancy during the study17. Patients who have a spinal cord or dorsal root ganglion stimulator whose average pain is less than 6 out of 10 when the stimulator is on

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Previous exclusion criteria:

1. Medical conditions that, in the opinion of the study investigator, would make it unsafe for participation or can adversely affect outcomes2. Co-existing pain that, in the view of the study doctor, may make an assessment of outcomes related to refractory moderate to severe CRPS unreliable 3. Ongoing relevant litigation where its conclusion is imminent during the course of the study 4. Medical contraindications to anakinra such as moderate/severe or progressive renal (eGFR <60 ml/min/1.73 m²), hepatic impairment (defined as any value of transaminases, γ-glutamyl transpeptidase, or bilirubin greater than two times the upper normal limit) or hypersensitivity to anakinra or any of its excipients or to E. coli derived proteins5. Previous use of anakinra 6. Current or recent (within 6 months) use of other immunosuppressants or biologics 7. Neutropenia defined as Absolute Neutrophil Count <1.5 x 10e9/l 8. Requirement to receive a live vaccine during the trial duration9. Active or latent tuberculosis infection 10. HIV, Hepatitis B or C carrier11. Brittle asthma12. Active malignancy or malignancy within 2 years13. Ongoing alcohol or drug misuse14. Psychiatric or other mental health disorder which in the opinion of the study investigator may interfere with successful study participation15. Commencing new therapy for refractory moderate to severe CRPS that may alter the outcome of the trial drug; this includes new pain management program treatment. Equally patients who have completed a pain management program within the past 3 months16. Subject is pregnant or breastfeeding, inadequate birth control, or the possibility of pregnancy during the study17. Patients who have a spinal cord or dorsal root ganglion stimulator whose average pain is less than 6 out of 10 when the stimulator is on

The use of anakinra in treating complex regional pain syndrome by blocking interleukin-1

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The use of anakinra in treating complex regional pain syndrome by blocking interleukin-1

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Age: Adult

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