Effect of the Interleukin-6 Receptor Antagonist Tocilizumab in Patients With Hand Osteoarthritis (TIDOA)
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|ClinicalTrials.gov Identifier: NCT02477059|
Recruitment Status : Completed
First Posted : June 22, 2015
Last Update Posted : July 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hand Osteoarthritis||Drug: tocilizumab Drug: saline solution||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||November 20, 2015|
|Actual Primary Completion Date :||December 26, 2018|
|Actual Study Completion Date :||February 2019|
2 infusions four weeks apart
Le tocilizumab is administered by intravenous infusion at a dose of 8 mg / kg.
Other Name: ROACTEMRA®
Placebo Comparator: saline solution
2 infusions four weeks apart
Drug: saline solution
La saline solution is administered by intravenous infusion.
Other Name: NaCl 0,9 %
- Change of pain [ Time Frame: 6 weeks ]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)
- Change of pain [ Time Frame: weeks 4, 8, 12 ]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)
- 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 [ Time Frame: weeks 4, 6, 8, 12 ]Patient and practitioner global assessments
- Morning stiffness duration [ Time Frame: weeks 4, 6, 8, 12 ]
- Evaluation of the function [ Time Frame: weeks 4, 6, 8, 12 ]Dreiser's algofunctional index + Functional Cochin hand index
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02477059
|Rheumatology department Lariboisiere Hospital|
|Paris, Ile De France, France, 75010|
|Study Director:||Richette Pascal, MD, PhD||Rheumatology department, Lariboisière Hospital|