Treatment of painful knee osteoarthrosis with adalimumab (Humira (R)): Open-label study to evaluate safety and efficacy - HUM-OA

KAS Glostrup0 sites20 target enrollmentOctober 4, 2005

Overview

No summary available.

Registry

who.int

Start Date

October 4, 2005

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

KAS Glostrup

•\- Above 50 years of age
•\- Body mass index \< 35 kg/m2
•\- Diagnose of primary osteoarthritis in the femero\-tibiale region and in accordance with ACR combined clinical and radiographic criteria
•\- WOMAC\-pain score \> 40 mm despite treatment with NSAID and/or paracetamol
•\- 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

•\- Positive serology for hepatitis B or C indicating active infection
•\- History of positive HIV status
•\- History of tuberculosis, histoplasmosis or listeriosis
•\- Subjects with latent TB (positive PPD skin test and/or chest X\-ray indicative for TB) or having other risk factors for activation of latent TB must have TB prophylaxis starting four weeks prior to the first administration of study drug in accordance with local recommendations
•\- Persistent or recurrent infections or severe infections requiring hospitalisation or treatment with iv antibiotics within 30 days, or oral antibiotics within 14 days prior to enrolment
•\- History of cancer or lymphoproliferative disease other than a successfully and completely treated squamous cell or basal cell carcinoma or cervical dysplasia
•\- Co morbidities: 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
•\- Female subjects who are pregnant or breast –feeding
•\- Previous diagnosis or signs of central nervous system demyelinating diseases (e.g. optic neuritis, visual disturbance, gait disorder/ataxia, facial paresis, apraxia)