Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of the Interleukin-6 Receptor Antagonist Tocilizumab in Patients With Hand Osteoarthritis (TIDOA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02477059
Recruitment Status : Completed
First Posted : June 22, 2015
Last Update Posted : July 30, 2019
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Hand Osteoarthritis Drug: tocilizumab Drug: saline solution Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: tocilizumab
2 infusions four weeks apart
Drug: tocilizumab
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 %




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. Number of painful joints [ Time Frame: weeks 4, 6, 8, 12 ]
  3. Number of swollen joints [ Time Frame: weeks 4, 6, 8, 12 ]
  4. Overall assessment of disability [ Time Frame: weeks 4, 6, 8, 12 ]
    Patient and practitioner global assessments

  5. Morning stiffness duration [ Time Frame: weeks 4, 6, 8, 12 ]
  6. Evaluation of the function [ Time Frame: weeks 4, 6, 8, 12 ]
    Dreiser's algofunctional index + Functional Cochin hand index



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 40-85
  • Hand OA according to the ACR criteria (with recent X-rays of the hands - less than 6 months )
  • Symptomatic hand OA lasting more than 3 months (DIP or PIP) despite analgesics and NSAIDs
  • OA affecting more than three finger joints (DIP or PIP) (Kellgren and Lawrence equal or more than 2)
  • Pain intensity superior to 40 (VAS 0-100 mm) in the last 24 hours
  • Not breastfeeding throughout the study and for 150 days after the last infusion
  • Negative pregnancy test or effective contraception for women of childbearing age throughout the study and for 150 days after the last infusion or postmenopausal or surgically sterile
  • Written informed consent
  • Affiliated to health system

Exclusion Criteria:

  • Patients having already been treated with an anti-TNF alpha within 6 months
  • Patients having already been treated with an Interleukin-6-Receptor Inhibitor
  • Hand OA secondary to inflammatory rheumatism
  • Existence of painful syndrome of upper limbs likely to interfere with the monitoring of pain (cervicobrachial neuralgia, incapacitating carpal tunnel syndrome, joint disorders of the elbow or shoulder)
  • Inflammatory rheumatism
  • Psoriasis
  • Contraindications to Interleukin-6-Receptor Inhibitor
  • Contraindications to acetaminophen
  • Anticoagulant (oral) or treatment with heparin at a curative dose
  • Surgery scheduled within 6 months following recruitment
  • Local injection of a corticosteroid in a symptomatic finger joint during the previous month
  • Local injection of hyaluronic acid in a symptomatic finger joint during the prior 6 months
  • Treatment with a slow-acting anti-osteoarthritis agent initiated within the previous 3 months
  • Treatment with methotrexate, hydrochloroquine, sulfasalazine, colchicine within the last month
  • History of symptomatics sigmoiditis or intestinal ulceration
  • Oral corticosteroid within 3 days for hydrocortisone or cortisone, within 8 days for prednisone, prednisolone, methylprednisolone or triamcinolone, and within 12 days for betamethasone or dexamethasone
  • Psychiatric illness
  • Antidepressants initiated or modified within previous month
  • Non-controlled diabetes "mellitus"
  • Known viral hepatitis B or C, HIV infection
  • Current infectious (active or latent tuberculosis)
  • Excessive drinking
  • Participation in another search
  • Lidocain plasters on digital joint within two months

Information from the National Library of Medicine

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


Locations
Layout table for location information
France
Rheumatology department Lariboisiere Hospital
Paris, Ile De France, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Hoffmann-La Roche
Investigators
Layout table for investigator information
Study Director: Richette Pascal, MD, PhD Rheumatology department, Lariboisière Hospital
Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02477059    
Other Study ID Numbers: P120206
First Posted: June 22, 2015    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Hand OA
Tocilizumab
Osteoarthritis
Interleukin-6
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases