COBRA-light study, an open randomised trial comparing a modified COBRA therapy with the COBRA therapy according to BeSt in early rheumatoid arthritis.

COBRA-light study, an open randomised trial comparing a modified COBRA therapy with the COBRA therapy according to BeSt in early rheumatoid arthritis. - COBRA-light study.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37036

Enrollment

160

Registered

2007-08-08

Start date

2008-03-17

Completion date

Unknown

Last updated

2024-06-18

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

Conditions

Rheumatoid Arthritis

Interventions

COBRA light: Week 1: Pred 30mg Week 2: Pred 20mg MTX 10mg Week 3: Pred 15mg MTX 10mg Week 4: Pred 10mg MTX 10mg Week 5: Pred 10mg MTX 17,5mg Week 6: Pred 10mg MTX 17,5mg Week 7: Pred 10mg MTX 1

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Active RA according to ACR criteria >6 swollen joints or >6 painful joints Disease duration 28mm VAS > 20 Age > 18 years

Exclusion criteria

Exclusion criteria: Prior treatment DMARDs (except hydroxychloroquine) Insulin-dependent Diabetes mellitus Uncontrolable non-insuline dependent diabetes mellitus Decompensatio cordis class 3-4 Uncontrolable hypertension ALAT/ASAT > 3 times normal values Reduced renal function (serum creat > 15mcmol) Contra-indications for methotrexate, sulfasalzine or prednisolone Indications of probable tuberculosis

Design outcomes

Primary

Measure	Time frame
Difference in delta DAS compared at baseline between the both treatment strategies after 6 months.	—

Secondary

Measure	Time frame
Secundary parameters: - Difference in delta DAS compared with baseline between the treatmentstrategies after 12 months - % patients with ACR 20, 50, 70 response - Low disease status (DAS 44	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)