Clinical trial · Interventional
Efficacy Study of an Anti-Tumor Necrosis Factor (TNF) Alpha Agent in Patients With Hand Osteoarthritis
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hand Osteoarthritis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adalimumab (Humira®) | Other | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- 2 injections of Adalimumab (Humira®)
- interventionNames
- Other: Adalimumab (Humira®)
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- 2 injection of Placebo
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Level of Pain on visual analogue scale
- timeFrame
- 4 weeks following the last injection
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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) * No contraindication to anti-TNF alpha treatments * No digital osteoarthritis surgery scheduled within the next 2 months * Written informed consent Exclusion Criteria: * 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) * 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
References
Publications (1)
- DERIVEDChevalier 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. PMID 24817417