A Phase 3 interventional study of tocilizumab and saline solution in Hand Osteoarthritis, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-07-30.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
Hand osteoarthritis (HOA) which affects the interphalangeal joints and the metacarpophalangeal of the thumb is a common disease, the prevalence of which being about 30 % of the population over than 70. Some forms of HOA are refractory to usual treatments (analgesics, NSAIDs, local injections) and can lead to a high disability. In vitro and in vivo studies showed that IL-6 is involved in the OA process. The aim of the present study is to assess the efficacy of an Interleukin-6-Receptor Inhibitor (tocilizumab) on pain and function in patients with refractory hand OA.
Patient is randomized to receive investigational product or placebo at week 0 and week 4 (1:1)
Follow-up visits are organized at week 6, and then week 8 and week 12.
Primary outcome is the pain as assessed with the VAS at week 6. Secondary outcomes include morning stiffness duration, patient and practitioner global assessments, functional indexes for hand OA, number of painful joints, number of swollen joints.
110 patients is expected to be randomized in 36 months. Each patient sign an informed consent before the beginning of the study.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 104 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
2 infusions four weeks apart
Drug: tocilizumab
2 infusions four weeks apart
Drug: saline solution
Le tocilizumab is administered by intravenous infusion at a dose of 8 mg / kg.
Also known as: ROACTEMRA®
La saline solution is administered by intravenous infusion.
Also known as: NaCl 0,9 %
Change of pain
Change of pain between the first infusion (week 0) and 2 weeks after the second infusion (week 6) as assessed on the VAS (0 -100 mm)
Time frame: 6 weeks
Change of pain
Change of pain between the first infusion (week 0) and 4, 8,12 weeks after the first infusion as assessed on the VAS (0 -100 mm)
Time frame: weeks 4, 8, 12
Number of painful joints
Time frame: weeks 4, 6, 8, 12
Number of swollen joints
Time frame: weeks 4, 6, 8, 12
Overall assessment of disability
Patient and practitioner global assessments
Time frame: weeks 4, 6, 8, 12
Morning stiffness duration
Time frame: weeks 4, 6, 8, 12
Evaluation of the function
Dreiser's algofunctional index + Functional Cochin hand index
Time frame: weeks 4, 6, 8, 12
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris