|- candidate number||2660|
|- NTR Number||NTR1019|
|- Date ISRCTN created||23-aug-2007|
|- date ISRCTN requested||13-aug-2007|
|- Date Registered NTR||11-jul-2007|
|- Secondary IDs||N/A |
|- Public Title||Treatment in the Rotterdam Early Arthritis CoHort. A stratified, randomised clinical trial in patients with recent-onset arthritis.
|- Scientific Title||Treatment in the Rotterdam Early Arthritis CoHort. A stratified, randomised clinical trial in patients with recent-onset arthritis.
|- hypothesis||In each stratum of probability there is a clinically and statistacally significant difference in the functional ability and disease activity score over time (area under the curve) and progression of radiological joint damage after 1 year of follow-up in recent-onset arthritia patients who were having induction treatment with divergent intansity.|
|- Healt Condition(s) or Problem(s) studied||Rheumatoid arthritis, Recent onset arthritis|
|- Inclusion criteria||1. Participant of the REACH cohort (patients with inflammatory joint complaints less then 1 year);|
2. All patients must at least have one (out of 66) swollen joint.
|- Exclusion criteria||1. Definite diagnosis of crystal arthropathy, (post)infective arthritis or autoimmune rheumatic disorder; |
2. Previous therapy with DMARD's or corticosteroids;
3. Pregnancy or wish to become pregnant during the study, or childbearing potential without adequate contraception;
4. Concomittant treatment with an other experimental drug;
5. History or presence of malignancy wthin the last five years;
6. Elevated hepetatic enzyme levels (ASAT,ALAT>2times normal value);
7. Thrombopenia<150x10-9 /l 7. Leucopenia<3.0x10-9 /l;
8. Serum creatinine level>150 umol/l.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2007|
|- planned closingdate||15-nov-2007|
|- Target number of participants||810|
|- Interventions||Three monthly evalutions of disease activity score and safety. Medication adjustments by ptotocol, based on DAS calculations. If DAS.2.4 medication will be switched to more intensive treatment including biologicals (initial biological will be etanersept). If DAS< 1.6 is achieved for at least 6 months, patients will start to taper and finally stop all medication.
Inductiontherapy for the three strata will be;|
1. MTX+SSZ+HCQ+1 single dose cortocisteroid intramuscular;
3.1 singel dose corticosteroids intramuscular.
|- Primary outcome||1. Functional ability as measured by HAQ and disease activity score (DAS) over time (area under the curve);|
2. Progression of radiological joint damage as measured by Sharp/van der Heijde score.
|- Secondary outcome||1. ACR arthritis core-set;|
2. Quality of Life, as measured with, SF-36, EuroQol;
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Prof. J.M.W. Hazes|
|- CONTACT for SCIENTIFIC QUERIES||Dr. A.E.A.M. Weel|
|- Sponsor/Initiator ||Erasmus Medical Center, Department of Rheumatology|
(Source(s) of Monetary or Material Support)
|Wyeth Pharmaceuticals BV|
|- Brief summary||In patient with recent-onset arthritis treatment strategies will be initiated according to their probability to develop persistent arthritis based on the Visser-model. For each stratum of probability (high probability, intermediate probability(IP), low probability(LP), the efficacy of induction therapy with divergaet intensity will be compared.|
If after 3 months a low disease activity (DAS<2.4)is not achieved, patients will receive more intensive treatment including biologicals(initial biological will be etanercept) If a DAS<1.6 is achieved for at lleast 6 months, patients will start to taper and finally stop all medication. Study outcomes after 1 year treatment are:
Functional ability (HAQ) and disease activity score (DAS) over time (area under the curve) and progression of radiological joint damage as measured by Sharp/ van der Heijde score.
|- Main changes (audit trail)|
|- RECORD||11-jul-2007 - 13-jan-2010|