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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tocilizumab | Experimental | 2 infusions four weeks apart |
|
| saline solution | Placebo Comparator | 2 infusions four weeks apart |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tocilizumab | Drug | Le tocilizumab is administered by intravenous infusion at a dose of 8 mg / kg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | weeks 4, 8, 12 |
| Number of painful joints | weeks 4, 6, 8, 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richette Pascal, MD, PhD | Rheumatology department, Lariboisière Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheumatology department Lariboisiere Hospital | Paris | Île-de-France Region | 75010 | France |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| saline solution | Drug | La saline solution is administered by intravenous infusion. |
|
|
| Number of swollen joints | weeks 4, 6, 8, 12 |
| Overall assessment of disability | Patient and practitioner global assessments | weeks 4, 6, 8, 12 |
| Morning stiffness duration | weeks 4, 6, 8, 12 |
| Evaluation of the function | Dreiser's algofunctional index + Functional Cochin hand index | weeks 4, 6, 8, 12 |