TNF-blockade for the treatment of erosive osteoarthritis (OA) of interphalangeal finger joints. Randomized, double blind, placebo-controlled study to evaluate the efficacy of adalimumab 40 mg sc every other week in patients with erosive osteoarthritis of the interphalangeal finger joints

• Conditions: Erosive interphalangeal osteoarthritis

• Registration Number: EUCTR2006-000925-71-BE
• Lead Sponsor: niversity Hospital Ghent

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-01
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Males and females > or = 18 years of age.
• Subjects with hand OA showing or having suffered from transient inflammatory attacks of the interphalangeal finger joints characteristic for what has been termed ‘inflammatory’ or ‘erosive’ hand OA.
• Subjects with hand OA in which at least 1 interphalangeal finger joint has the typical appearance on the roentgenpicture of an ‘E’ phase joint as defined by the criteria mentioned above.
• Able and willing to self-administer sc injections or have available a suitable person to administer sc injections
• Able and willing to give written informed consent and to comply with the requirements of the study protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Prior treatment with any investigational agent within 30 days, or five half lives of the product, whichever is longer.
• Patients suffering from chronic inflammatory rheumatic disease (e.g. rheumatoid arthritis, spondylarthropathy, Psoriatic arthritis, gout, chondrocalcinosis or other auto-immune diseases
• Prior use of any chondroprotective drug within 90 days e.g.. chondroitin sulfate, glucosamine, avocado-soybean unsaponifiables, tetracyclins, corticosteroids.
• Prior use of any immunomodulating drug with possible effects on proinflammatory cytokine metabolism within 90 days a.o. corticosteroids, methotrexate, sulfasalazine, leflunomide, D-Penicilamin, anti-malarials, cytotoxic drugs, TNF blocking agents
• Patient who is pregnant; if the patient is of child-bearing age, he/she must use effective means of contraception during the study.
• Patient who has a known blood coagulation disorder
• History of cancer or lymphoproliferative disease other than a successfully and completely treated squamous cell or basal cell carcinoma of the skin or cervical dysplasia, with no recurrence within the last two years
• Comorbidities: uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure (NYHA III, IV), active inflammatory bowel disease, recent stroke (within three months), chronic leg ulcer and any other condition (e.g,. indwelling urinary catheter) which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.
• Positive serology for hepatitis B or C indicating active infection.
• History of positive HIV status.
• Persistent or recurrent infections or severe infections requiring hospitalization or treatment with iv antibiotics within 30 days, or oral antibiotics within 14 days prior to enrollment.
• Female subjects who are pregnant or breast-feeding.
• History of clinically significant drug or alcohol abuse in the last year.
• Previous diagnosis or signs of central nervous system demyelinating diseases (e.g., optic neuritis, visual disturbance, gait disorder/ataxia, facial paresis, apraxia).
• Medical history of systemic lupus erythematosus
• Evolutive tuberculosis or other severe infections like sepsis and opportunistic infections
• Patients with latent TB (positive PPD skin and/or chest X-ray indicative for TB) or having other risk factors for activation of latent TB, e.g. previous exposure to TB, who have not initiated a TB prophylaxis prior to the first adalimumab treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified