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Hand OsteoarthritisPhase 3DORANCT00597623

Efficacy Study of an Anti-Tumor Necrosis Factor (TNF) Alpha Agent in Patients With Hand Osteoarthritis

A Phase 3 study testing Adalimumab (Humira®) in people with Hand Osteoarthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Digital osteoarthritis (DO) which affects the interphalangeal joints and the Metacarpophalangeal (MCP) of the thumb is a common disease, the prevalence of which increases with age (36% of the population aged over 70). Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Hand Osteoarthritis
What is being tested?
Adalimumab (Humira®)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
84 participants
Where
1 siteFrance
Study dates
Jan 2008to Dec 2010
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 40-80
  • Men or women
  • Digital osteoarthritis (DIP and PIP) according to ACR criteria (with recent X-ray, dating from less than 6 months, of the hands showing radiological signs of digital osteoarthritis)
  • Symptomatic digital osteoarthritis for more than 3 months (at least every other day) despite taking analgesics and NSAIDs (except when there are contraindications to the latter therapeutic group)
  • Osteoarthritis affecting more than three finger joints
  • Pain more than 40 mm as evaluated by pain VAS (0-100 mm)
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  • No contraindication to anti-TNF alpha treatments
  • No digital osteoarthritis surgery scheduled within the next 2 months
  • Written informed consent

Who cannot join

  • Pregnant women or women of reproductive potential without effective contraception
  • Known hypersensitivity
  • Patients having already been treated with an anti-TNF alpha
  • Finger osteoarthritis secondary to inflammatory rheumatism
  • Psoriasis
  • 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)
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  • Inflammatory rheumatism
  • Contraindications to anti-TNF alpha agents: patients with suspected reactivation of tuberculosis (phlyctenular IDR, past history of tuberculosis, chest X-ray deemed suspect) or known leukopenia (< 3500 leukocytes), known hepatic cytolysis (transaminases more than twice normal), a history of serious allergy, concomitant infection, past history of serious systemic infection (septicemia), a history of known cancer within the past 5 years, history of multiple sclerosis
  • Skin disease incompatible with subcutaneous injection
  • Anticoagulant (oral) or treatment with heparin at a curative dose
  • Surgery scheduled within the coming 2 months
  • Finger surgery scheduled within the coming 6 months
  • 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 3 months
  • Treatment with a slow-acting anti-osteoarthritis agent initiated and colchicine (amendment 26/06/2008) within the previous 3 months
  • Oral corticosteroids
  • Psychiatric illness
  • Non-controlled diabetes "mellitus"
  • Known viral hepatitis B or C, HIV infection

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU Henri Mondor

    Créteil, 94000

Other trials in France

About this study

Official title: Randomized Double Blind Placebo-controlled Trial of the Efficacy of an Anti-TNF Alpha Agent (Adalimumab, Humira®) in Patients With Incapacitating Hand Osteoarthritis Refractory to Usual Treatment

Digital osteoarthritis (DO) which affects the interphalangeal joints and the Metacarpophalangeal (MCP) of the thumb is a common disease, the prevalence of which increases with age (36% of the population aged over 70). Certain forms of DO with clinical manifestations involving inflammatory features are particularly refractory to usual treatments (analgesics, NSAIDs, braces and local injections). The mechanism of osteoarthritis involves two major cytokines: interleukin-1 beta and tumor necrosis factor alpha. TNF alpha is particularly involved in the inflammation process.

The aim of the present study is to study the efficacy of TNF alpha blockers (2 injections of adalimumab compared to placebo injections in patients with severe and refractory hand osteoarthritis.

We hope that such new therapeutic option may induce substantial pain relief.

Read the detailed description

Objective: To demonstrate the efficacy of two subcutaneous injections of anti-TNF alpha (adalimumab) in patients with DO refractory to usual treatments (NSAIDs - analgesics).

Design: Randomized placebo-controlled multicenter (20 sites (amendment 18/12/2008)) trial

Trial duration: 6 months follow-up per patient, total trial duration: 12 months

Number of patients: 84(up)

Dose of administration: Two subcutaneous injections separated by a 2-week interval of either adalimumab or placebo. Therapeutic precautions inherent to the prescription of anti-TNF alpha are based upon those recommended in rheumatoid arthritis. With only two injections of anti-TNF alpha, the risk of complications (infectious in particular) inherent to the anti-TNF alpha appears to be extremely slight.

Patient selection: Patients with digital osteoarthritis (DIP and PIP) according to American College of Rheumatology (ACR) criteria (with a recent X-ray, less than 6 months, of the hands, showing signs of digital osteoarthritis), symptomatic for more than 3 months (at least three finger joints) and scored more than 40 mm on a pain visual analog scale (VAS) despite use of a level 1 analgesic (acetaminophen: 4 g daily) andNSAIDs. Main Exclusion criteria are contraindications to anti-TNF alpha according to international guidelines.

Methods: Patients will be seen at a screening visit, then during treatment administration (W0 and W2) and at follow-up visits: W6, 10, 14 and 26. NSAIDs will be stopped at the time of screening.

Efficacy evaluation: The efficacy endpoint is improvement in pain on a pain VAS at different times of assessment (primary endpoint at W6). A more than 50% improvement, in comparison with baseline, will be considered to be significant. Secondary endpoints are: number of tender joints, number of swollen joints, morning stiffness, global assessment of handicap by patient, global assessment of handicap by physician, the DREISER'S algofunctional index, Cochin hand index, weekly evolution of pain ( patient record), and recording of analgesic use (acetaminophen or NSAIDs).

Statistical data: Statistical analysis will be performed on the inter-group difference in the intention-to-treat population. khi-2 will be used only for criteria number 1.

Anticipated result: Significant superiority of adalimumab over placebo which would provide a therapeutic solution in difficult-to-treat patients with hand OA.

Being tested
Adalimumab (Humira®), Placebo
Keywords
Osteoarthritis, Hand, Tumor Necrosis Factor-alpha inhibitors, Biological Therapy
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adalimumab (Humira®)Other

    syringes for injections under cutaneous dose = 40mg vol = 0.8 ml

  • PlaceboOther

    syringes under cutaneous vol = 8 ml

Study groups in NCT00597623
Study groupRoleWhat they receive
1Experimental2 injections of Adalimumab (Humira®)
Receives: Other: Adalimumab (Humira®)
2Placebo comparator2 injection of Placebo
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Level of Pain on visual analogue scale

    Measured: 4 weeks following the last injection

Secondary outcomes (9)

  1. Number of tender joints

    Measured: at weeks 4, 6, 10, 14, 26

  2. Number of swollen joints

    Measured: at weeks 4, 6, 10, 14, 26

  3. Global assessment of handicap by patient

    Measured: at weeks 4, 6, 10, 14, 26

  4. Global assessment of handicap by physician

    Measured: at weeks 4, 6, 10, 14, 26

  5. Duration of morning stiffness

    Measured: at weeks 4, 6, 10, 14, 26

  6. DREISER'S algofunctional index

    Measured: at weeks 4, 6, 10, 14, 26

  7. Cochin hand index

    Measured: at weeks 4, 6, 10, 14, 26

  8. Weekly pain recording, and recording of analgesic use (acetaminophen)

    Measured: at weeks 4, 6, 10, 14, 26

  9. Percentage of non responders according to the number of patients requiring NSAIDS intake during the trial and/or rule out for lack of efficacy

    Measured: from week 0 until week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionJun 2010
  4. Study completionDec 2010

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00597623
Sponsor's protocol ID
P 051007
Acronym
DORA
Status last verified
May 2012
First submitted
15 Jan 2008
Last updated
26 Jul 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Chevalier X, Ravaud P, Maheu E, Baron G, Rialland A, Vergnaud P, Roux C, Maugars Y, Mulleman D, Lukas C, Wendling D, Lafforgue P, Loeuille D, Foltz V, Richette P; French section of osteoarthritis. Adalimumab in patients with hand osteoarthritis refractory to analgesics and NSAIDs: a randomised, multicentre, double-blind, placebo-controlled trial. Ann Rheum Dis. 2015 Sep;74(9):1697-705. doi: 10.1136/annrheumdis-2014-205348. Epub 2014 May 9.

    PubMed 24817417

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adalimumab (Humira®) 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 19 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 26 Jul 2012. 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?

Level of Pain on visual analogue scale (time frame: 4 weeks following the last injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00597623, which also lists 1 linked publication.

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 26 Jul 2012.

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