Rheumatoid arthritis MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis MedDRA version: 12.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis
Conditions
Interventions
Product Name: ARA290
Product Code: ARA290
Pharmaceutical Form: Solution for infusion
Sponsors
LUMC
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: 1) General safety measurements 2) 12-lead ECG 3) Blood Hematology 4) Blood Biochemistry 5) Adverse Event monitoring Efficacy parameters: 1) Circulating inflammatory markers (CRP, TNF, IL-1, IL-6, IL10) 2) Disabilty (measured with the Health assessment questionnaire disability index) 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) | — |
Countries
Netherlands
Outcome results
None listed