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

Phase 1

• Conditions: Osteoarthrosis

• Registration Number: EUCTR2005-004301-28-DK
• Lead Sponsor: KAS Glostrup

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-04
• Last Update Posted: 3 October 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

- 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
F.1.3.1 Number of subjects for this age range

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)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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<br>;Secondary Objective: - Changes at week 2, 6, 18 and 24 in WOMAC-pain score from baseline<br>- Changes at week 2, 6, 12, 18, and 24 in other WOMAC scores from baseline<br>- Changes at week 12 and 24 in quality of life (SF-36) from baseline<br>- Changes in concomittant medication ;Primary end point(s): Primary end points:<br>- Changes at week 12 in WOMAC-pain score from baseline<br>- Safety during 12 weeks treatment and 12 weeks follow-up