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

Conditions: Rheumatoid arthritis
MedDRA version: 12.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis
MedDRA version: 12.1Level: PTClassification code 10039073Term: Rheumatoid arthritis

Registration Number: EUCTR2010-023469-22-NL

Lead Sponsor: MC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 12

Inclusion Criteria

1) Diagnosis of RA, classified by ARA (American Rheumatism Association) 1987 revised criteria.
2) Active disease at screening and baseline: 6/68 tender and 6/66 swollen joints and either an erythrocyte sedimentation rate (ESR) of >=28 mm/hr or C-reactive protein (CRP)> 10 mg/l
3) Written informed consent

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

1) Current or previous treatment with biological agent
2) Clinically relevant abnormal laboratory results, ECG, vital signs, or physical findings other than conditions related to rheumatoid arthritis (as judged by the investigator)
3) Pregnancy or wish to become pregnant during the study, or childbearing potential without adequate contraception
4) 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
5) Use of erythropoietin
6) Inability to follow the protocol and to comply with the follow up requirements
7) 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To test whether ARA290 reduces 1) diseae activity, 2) disability and 3) systemic inflammation in patients with active RA. ;Secondary Objective: Tolerability of ARA290;Primary end point(s): Safety and tolerability parameters:<br>1) General safety measurements<br>2) 12-lead ECG <br>3) Blood Hematology<br>4) Blood Biochemistry<br>5) Adverse Event monitoring<br>Efficacy parameters: <br>1) Circulating inflammatory markers (CRP, TNF, IL-1, IL-6, IL10)<br>2) Disabilty (measured with the Health assessment questionnaire disability index)<br>3) Disease Activity (measured with the Disease Activity Score: composite index including number of swollen and tender joints, patient's assessment of global health on a visual analogue scale and ESR) <br>

Secondary Outcome Measures