NCT02477059

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2015

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 22, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

November 20, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

July 30, 2019

Status Verified

July 1, 2019

Enrollment Period

3.1 years

First QC Date

June 10, 2015

Last Update Submit

July 29, 2019

Conditions

Hand Osteoarthritis

Keywords

Hand OATocilizumabOsteoarthritisInterleukin-6

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Change of pain

    weeks 4, 8, 12

  • Number of painful joints

    weeks 4, 6, 8, 12

  • Number of swollen joints

    weeks 4, 6, 8, 12

  • Overall assessment of disability

    weeks 4, 6, 8, 12

  • Morning stiffness duration

    weeks 4, 6, 8, 12

  • +1 more secondary outcomes

Study Arms (2)

tocilizumab

EXPERIMENTAL

2 infusions four weeks apart

Drug: tocilizumab

saline solution

PLACEBO COMPARATOR

2 infusions four weeks apart

Drug: saline solution

Interventions

tocilizumabDRUG

Le tocilizumab is administered by intravenous infusion at a dose of 8 mg / kg.

Also known as: ROACTEMRA®
tocilizumab
saline solutionDRUG

La saline solution is administered by intravenous infusion.

Also known as: NaCl 0,9 %
saline solution

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rheumatology department Lariboisiere Hospital

Paris, Île-de-France Region, 75010, France

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

tocilizumabSaline Solution

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Richette Pascal, MD, PhD

    Rheumatology department, Lariboisière Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2015

First Posted

June 22, 2015

Study Start

November 20, 2015

Primary Completion

December 26, 2018

Study Completion

February 1, 2019

Last Updated

July 30, 2019

Record last verified: 2019-07

Locations

FR(1)