Protocol A Proof-of-concept Study to Evaluate the Efficacy and Safety of Rozanolixizumab to Treat [Adults] With Severe Fibromyalgia Syndrome, 2022-4, UK

https://classic.clinicaltrials.gov/...df&type=Intr&cond=Fibromyalgia&draw=3&rank=11

Recruitment Status : Recruiting
Actual Study Start Date : December 21, 2022
Estimated Primary Completion Date : September 11, 2024
Estimated Study Completion Date : September 11, 2024

Experimental: Treatment sequence 1
Study participants on Treatment sequence 1 will receive rozanolixizumab and Placebo during the dosing period at pre-specified timepoints.
Experimental: Treatment sequence 2
Study participants on Treatment sequence 2 will receive rozanolixizumab and Placebo during the dosing period at pre-specified timepoints.
Placebo Comparator: Treatment sequence 3
Study participants on Treatment sequence 3 will receive Placebo during the dosing period at pre-specified timepoints.

Primary Outcome Measures :

1. Brief Pain Inventory short form (BPI-SF) average interference score after 12 weeks of treatment [ Time Frame: After 12 weeks of treatment ]
   The short form of the BPI is a self-administered questionnaire used to evaluate the severity of a study participant's pain and the impact of this pain on the study participant's daily functioning. The BPI-SF assesses for the location of pain, pain intensity and functional interference from pain. The 7 BPI-SF interference items include: general activity, mood, walking ability, normal work (including housework), relations with other people, sleep, and enjoyment of life. Each item is rated on a 0 (does not interfere) to 10 (completely interferes) scale with a recall period of 24 hours. The arithmetic mean of the 7 interference items can be used as a measure of pain interference.

Locations
United Kingdom: Recruiting in Blackpool, Liverpool, Manchester, Stockton-on-tees, Tankersley,
Sponsors and Collaborators
UCB Biopharma SRL
Investigators
Study Director: UCB Cares

 

60 participant; quadruple blinding

Secondary outcomes

I don't fully understand the rationale of the primary outcome. It's just seven questions on how much pain interferes with function, taken out of a larger questionnaire (the Brief Pain Inventory) that includes questions specifically on pain, at 12 weeks. If this was a BPS study, I would understand the rationale, as the idea would be that it doesn't matter if the person still thinks they have pain, what's important is to what extent they can ignore it in order to function. But here, it seems an odd measure to focus on. There is a secondary measure that looks at pain, but it is taken at 10 weeks. There is a Fibromyalgia Impact Questionnaire with 21 questions covering function, overall impact and symptoms which sounds good, but that is only a secondary outcome, measured at 10 weeks.

In terms of longer term effect, again it's just the pain interference measure at 24 weeks.

There aren't any objective measures, which seems surprising and provides no protection against the possibility that the nature of the treatment will make it easy for the blinding to be broken. I would have thought there would be regular blood tests, maybe to track levels of the antibodies, maybe to check for liver damage or something. I suppose not having any blood testing keeps costs down.