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

NCT00597623 | Completed Phase 3 DMC

• 1 other identifier: P 051007
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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). 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

Hand Osteoarthritis

Keywords

Osteoarthritis; Hand; Tumor Necrosis Factor-alpha inhibitors; Biological Therapy

Outcome Measures

Primary Outcomes (1)

• Level of Pain on visual analogue scale

  4 weeks following the last injection

Secondary Outcomes (9)

• Number of tender joints

  at weeks 4, 6, 10, 14, 26

• Number of swollen joints

  at weeks 4, 6, 10, 14, 26

• Global assessment of handicap by patient

  at weeks 4, 6, 10, 14, 26

• Global assessment of handicap by physician

  at weeks 4, 6, 10, 14, 26

• Duration of morning stiffness

  at weeks 4, 6, 10, 14, 26

Study Arms (2)

1

EXPERIMENTAL

2 injections of Adalimumab (Humira®)

Other: Adalimumab (Humira®)

2

PLACEBO COMPARATOR

2 injection of Placebo

Other: Placebo

Interventions

Adalimumab (Humira®) OTHER

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

1

Placebo OTHER

syringes under cutaneous vol = 8 ml

2

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Abbott: collaborator

Study Sites (1)

CHU Henri Mondor

Créteil, 94000, France

Location

Related Publications (1)

• 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.

  PMID: 24817417 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Xavier Chevalier, PU-PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2008
• First Posted: January 18, 2008
• Study Start: January 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 26, 2012

Record last verified: 2012-05

Locations

FR (1)