Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-30 @ 12:20 AM
Study NCT ID:
NCT02477059
Status:
COMPLETED
Last Update Posted:
2019-07-30
First Post:
2015-06-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of the Interleukin-6 Receptor Antagonist Tocilizumab in Patients With Hand Osteoarthritis
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Double-blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Two Infusions Four Weeks Apart of Interleukin-6-Receptor Inhibitor (Tocilizumab) on Pain Relief in Patients With Severe Osteoarthritis of the Hand Refractory to Usual Treatment
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TIDOA
Brief Summary:
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.
Detailed Description:
Patient is randomized to receive investigational product or placebo at week 0 and week 4 (1:1)
* arm 1: 2 infusions four weeks apart of tocilizumab 8mg/kg
* arm 2: 2 infusions four weeks apart of saline solution
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.
* arm 1: 2 infusions four weeks apart of tocilizumab 8mg/kg
* arm 2: 2 infusions four weeks apart of saline solution
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: