This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Hypothesis: Cytokine blockade with a human TNF-a monoclonal antibody (Adalimumab) is safe in the treatment of, and can improve the signs and symptoms of, inflammatory osteoarthritis (OA) of the hands. This will be a Phase II open-label pilot study of 12 patients with active erosive OA receiving Adalimumab 40 mg every other week for twelve weeks. Prior to study enrollment, each patient identified will have a clinical evaluation including medical history, physical examination, laboratory studies, vital signs (blood pressure, pulse, respiration, and oral temperature), PPD skin test, and a detailed list of concurrent medications. Results of laboratory tests required for eligibility will be reviewed and approved by a physician with inclusion/exclusion criteria met before patient receives study drug. Investigational drug will be supplied by Abbott Laboratories. The study drug will be provided as an injection solution in 1-mL pre-filled syringes containing 40 mg Adalimumab/0.8 mL (50 mg/mL concentration). Endpoints: The primary endpoint is the safety of treatment with Adalimumab in subjects with inflammatory OA following SC injections of 40 mg Adalimumab every other week for 12 weeks. To investigate the clinical efficacy of treatment with Adalimumab, co-primary endpoints will be observed: ACR20 at Week 12 and improvement in joint severity (inflammation and tenderness) at Week 12. The ACR 20 is defined by at least a 20% improvement from baseline in the number of tender and swollen joints and at least a 20% improvement in three of the five following domains: pain [based on visual analogue scale (VAS)], patient global assessment (PTGA), physician global assessment (MDGA), erythrocyte sedimentation rate, and Health Assessment Questionnaire disability index (HAQ-DI).

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000070-44
Application #
7375300
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2005-12-01
Project End
2006-11-30
Budget Start
2005-12-01
Budget End
2006-11-30
Support Year
44
Fiscal Year
2006
Total Cost
$19,571
Indirect Cost
Name
Stanford University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
009214214
City
Stanford
State
CA
Country
United States
Zip Code
94305
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