rheumatoid arthritis reumatoide artritis reuma
Conditions
Interventions
Thrice or once (depending on randomization) weekly intravenous dose of study drug ARA 290, 2 mg bolus, for 4 weeks.
Sponsors
Leiden University Medical Center
Eligibility
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.
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 |
|---|---|
| Weekly measurements of: 1. Disease activity, measured by the disease activity score: 'original DAS'; 2. Functionaly ability, measured by the Health Assessment Questionaire (HAQ) disability index; 3. Systemic inflammation: ESR, CRP. | — |
Secondary
| Measure | Time frame |
|---|---|
| Weekly assessment of: Tolerability, using blood investigation and physical examination. | — |
Contacts
Public ContactC.F. Allaart
Leiden University Medical Center (LUMC), Department of Rheumatology, C1-39, P.O. Box 9600
Outcome results
None listed