Hand OsteoarthritisPhase 3TIDOANCT02477059
Effect of the Interleukin-6 Receptor Antagonist Tocilizumab in Patients With Hand Osteoarthritis
A Phase 3 study testing tocilizumab and saline solution in people with Hand Osteoarthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Hand Osteoarthritis
- What is being tested?
- tocilizumab and saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteFrance
- Study dates
- 20 Nov 2015to Feb 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Rheumatology department Lariboisiere Hospital
Paris, Île-de-France Region, 75010
About this study
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
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.
Read the 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.
- Conditions
- Hand Osteoarthritis
- Being tested
- tocilizumab, saline solution
- Keywords
- Hand OA, Tocilizumab, Osteoarthritis, Interleukin-6
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tocilizumabDrug
Also called ROACTEMRA®
Le tocilizumab is administered by intravenous infusion at a dose of 8 mg / kg.
saline solutionDrug
Also called NaCl 0,9 %
La saline solution is administered by intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| tocilizumab | Experimental | 2 infusions four weeks apart Receives: Drug: tocilizumab |
| saline solution | Placebo comparator | 2 infusions four weeks apart Receives: Drug: saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 weeks
Secondary outcomes (6)
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)
Measured: weeks 4, 8, 12
Number of painful joints
Measured: weeks 4, 6, 8, 12
Number of swollen joints
Measured: weeks 4, 6, 8, 12
Overall assessment of disability
Patient and practitioner global assessments
Measured: weeks 4, 6, 8, 12
Morning stiffness duration
Measured: weeks 4, 6, 8, 12
Evaluation of the function
Dreiser's algofunctional index + Functional Cochin hand index
Measured: weeks 4, 6, 8, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2015 (estimated)
- Study start20 Nov 2015
- Primary completion26 Dec 2018
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Richette Pascal, MD, PhD, Study director, Rheumatology department, Lariboisière Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02477059
- Sponsor's protocol ID
- P120206
- Acronym
- TIDOA
- Status last verified
- Jul 2019
- First submitted
- 10 Jun 2015
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02477059
- Acronym / sponsor ID
- TIDOA / P120206
- Conditions
- Hand Osteoarthritis
- Keywords
- Hand OA, Tocilizumab, Osteoarthritis, Interleukin-6
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- 20 Nov 2015 (actual)
- Primary completion
- 26 Dec 2018 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 22 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tocilizumab | Experimental | Drug: tocilizumab2 infusions four weeks apart |
| saline solution | Placebo comparator | Drug: saline solution2 infusions four weeks apart |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tocilizumabAlso: ROACTEMRA®Le tocilizumab is administered by intravenous infusion at a dose of 8 mg / kg. | Drug | tocilizumab |
| saline solutionAlso: NaCl 0,9 %La saline solution is administered by intravenous infusion. | Drug | saline solution |
Primary outcome
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)
6 secondary outcomes
Change of pain
Time frame: weeks 4, 8, 12
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
Morning stiffness duration
Time frame: weeks 4, 6, 8, 12
Evaluation of the function
Time frame: weeks 4, 6, 8, 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
Related trials for Hand Osteoarthritis
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Balneotherapy in Hand Osteoarthritis
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Methotrexate in Erosive Inflammatory Hand Osteoarthritis
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Recruiting
Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
Thumb Osteoarthritis, Thumb Carpometacarpal Joint Osteoarthritis
Active, not recruitingPhase 2
Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of STT Osteoarthritis
Osteoarthritis Hand
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richette Pascal, MD, PhD study director
Rheumatology department, Lariboisière Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tocilizumab and saline solution in people with Hand Osteoarthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of pain (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2019.