Skip to content

Treatment in the Rotterdam Early Arthritis CoHort. A stratified, randomised clinical trial in patients with recent-onset arthritis.

Treatment in the Rotterdam Early Arthritis CoHort. A stratified, randomised clinical trial in patients with recent-onset arthritis.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23237
Enrollment
810
Registered
2007-07-11
Start date
2007-07-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis, recent onset arthritis

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 includi
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
3.1 singel dose corticosteroids intramuscular.

Sponsors

Erasmus medical Centre Rotterdam Department of Rheumatologie
Lead Sponsor

Eligibility

Inclusion criteria

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

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. Thrombopenia150 umol/l.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. ACR arthritis core-set; 2. Quality of Life, as measured with, SF-36, EuroQol; 3. Costs.

Contacts

Public ContactJ.M.W. Hazes

Erasmus MC. Afdeling Reumatologie Ee 959 Antwoordnummer 55

j.hazes@erasmusmc.nl+31 10-4633311

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)