A phase II study of ARA 290 as therapeutic strategy in rheumatoid arthritis

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 14

Inclusion Criteria

Patients with active rheumatoid arthritis, classified by the ARA criteria (1987) aged 18+

Exclusion Criteria

•Current treatment with biological agent or treatment with biological in the 2 months before inculsion.
•Clinically relevant abnormal laboratory results, ECG, vital signs, or physical findings other than conditions related to rheumatoid arthritis (as judged by the investigator)
•Pregnancy or wish to become pregnant during the study, or childbearing potential without adequate contraception
•Participation in an investigational drug trial, current or in the 3 months prior to administration of the initial dose of study drug or more than 4 times per year
•Use of erythropoietin
•Inability to follow the protocol and to comply with the follow up requirements
•Clinically relevant abnormal history of physical and mental health other than conditions related to rheumatoid arthritis, as determined by medical history taking (as judged by the investigator) or any other condition that in the opinion of the investigator would complicate or compromise the well being of the subject.
Current or previous TBC infection

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Efficacy parameters:<br /><br>- Circulating inflammatory markers (CRP, if this is elevated possibly TNF,<br /><br>IL-1, IL-6, IL10)<br /><br>- Health assessment questionnaire disability index (HAQ)<br /><br>- Patient's assessment of pain on a visual analogue scale (0mm=no pain, 100mm=<br /><br>worst pain possible).<br /><br>- Functional health and well being (Short Form-36 questionnaire)<br /><br>- Symptoms of depression (Beck Depression Inventory-II questionnaire)<br /><br>- Disease activity, measured with the Disease Activity Score, a composite index<br /><br>calculated with the number of painfull joints (of 53 joints) and the number of<br /><br>swollen joints (of 44 joints), Erythrocyte Sedimentation Rate and patient's<br /><br>assessment of general health on a visual analogue scale (0mm= best possible,<br /><br>100mm= worst possible).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety and tolerability parameters:<br /><br>•General safety measurements<br /><br>•12-lead ECG<br /><br>•Blood Hematology<br /><br>•Blood Biochemistry<br /><br>•Adverse Event monitoring</p><br>