Osteoarthrosis
Conditions
Sponsors
KAS Glostrup
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Above 50 years of age - Body mass index 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 F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish whether patients with primary OA confined to the knee with symptomatic disease experience pain-relief during treatment with 40 mg adalimumab (Humira) sc. every other week for 12-weeks ;Secondary Objective: - Changes at week 2, 6, 18 and 24 in WOMAC-pain score from baseline - Changes at week 2, 6, 12, 18, and 24 in other WOMAC scores from baseline - Changes at week 12 and 24 in quality of life (SF-36) from baseline - Changes in concomittant medication ;Primary end point(s): Primary end points: - Changes at week 12 in WOMAC-pain score from baseline - Safety during 12 weeks treatment and 12 weeks follow-up | — |
Countries
Denmark
Outcome results
None listed