ARA290 will reduce disease activity in rheumatoid arthritis.
ID
Bron
Verkorte titel
Aandoening
rheumatoid arthritis
reumatoide artritis
reuma
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Weekly measurements of:<br>
1. Disease activity, measured by the disease activity score: 'original DAS';<br>
2. Functionaly ability, measured by the Health Assessment Questionaire (HAQ) disability index;<br>
3. Systemic inflammation: ESR, CRP.
Achtergrond van het onderzoek
ARARA 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.
Doel van het onderzoek
ARA290 will reduce disease activity in rheumatoid arthritis.
Onderzoeksopzet
1. 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.
Onderzoeksproduct en/of interventie
Thrice or once (depending on randomization) weekly intravenous dose of study drug ARA 290, 2 mg bolus, for 4 weeks.
Algemeen / deelnemers
Department of Rheumatology,
C1-39,
P.O. Box 9600
C.F. Allaart
Leiden 2300 RC
The Netherlands
+31 (0)71 5263598
c.f.allaart@lumc.nl
Wetenschappers
Department of Rheumatology,
C1-39,
P.O. Box 9600
C.F. Allaart
Leiden 2300 RC
The Netherlands
+31 (0)71 5263598
c.f.allaart@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2460 |
| NTR-old | NTR2577 |
| Ander register | METC LUMC : P10.236 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |