No registrations found.
ID
Source
Brief title
Health condition
Rheumatoid Arthritis, recent onset arthritis
Sponsors and support
Department of Rheumatologie
Intervention
Outcome measures
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;
3. Costs.
Background 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.
Study objective
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.
Study design
N/A
Intervention
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;
HP-group:
1. MTX+SSZ+HCQ+1 single dose cortocisteroid intramuscular;
2. MTX+SSZ+HCQ+prednisone;
3. MTX+prednison.
IP-group:
1. MTX;
2. HCQ;
3. Prednisone.
LP-group:
1. Naproxen;
2. HCQ;
3.1 singel dose corticosteroids intramuscular.
Antwoordnummer 55
J.M.W. Hazes
Rotterdam 3000 WB
The Netherlands
+31 10-4633311
j.hazes@erasmusmc.nl
Antwoordnummer 55
J.M.W. Hazes
Rotterdam 3000 WB
The Netherlands
+31 10-4633311
j.hazes@erasmusmc.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL990 |
| NTR-old | NTR1019 |
| Other | : N/A |
| ISRCTN | ISRCTN26791028 |