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van CCT (UK)

A study of ARA 290 for treating rheumatoid arthritis.

- candidate number8573
- NTR NumberNTR2577
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-okt-2010
- Secondary IDsP10.236 METC LUMC
- Public TitleA study of ARA 290 for treating rheumatoid arthritis.
- Scientific TitleA phase II study of ARA 290 as therapeutic strategy in rheumatoid arthritis.
- hypothesisARA290 will reduce disease activity in rheumatoid arthritis.
- Healt Condition(s) or Problem(s) studiedRheumatoid arthritis
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2011
- planned closingdate1-jan-2012
- Target number of participants14
- InterventionsThrice or once (depending on randomization) weekly intravenous dose of study drug ARA 290, 2 mg bolus, for 4 weeks.
- Primary outcomeWeekly 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 outcomeWeekly assessment of:
Tolerability, using blood investigation and physical examination.
- Timepoints1. Weekly assessment of disease activity, functional ability, systemic inflammation and tolerability from start treatment until one week after end of treatment;
2. Extra assessment of all primary outcomes one month after end of treatment and when disease activity flares.
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsBrines M, Cerami A. Discovering erythropoietin's extra-hematopoietic functions: biology and clinical promise. Kidney Int 2006; 70(2):246-50.
- Brief summaryARARA is an open label phase II study investigating the effect of ARA290 on disease activity, functional ability and systemic inflammation in patients with active rheumatoid arthritis. Twelve patients will receive an intravenous dose (2mg) of ARA290 once or thrice weekly depending on randomization, during 4 weeks. During treatment, they will also continue the use of their own disease modifying anti rheumatic drug (DMARD). Previous or current use of a biologic agent will not be allowed. Efficacy and tolerability will be evaluated weekly.
- Main changes (audit trail)
- RECORD21-okt-2010 - 1-mei-2011

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