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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26545

Enrollment

160

Registered

2008-02-28

Start date

2008-02-01

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

Interventions

The study design randomizes the two treatment strategies, ie COBRA or a modified COBRA schedule. In the first year patients will be seen frequently in order to follow disease-activity, side effects an

Eligibility

Inclusion criteria

Inclusion criteria: 1. Active RA according to ACR criteria, 2. >6 swollen joints or >6 painful joints, 3. Disease duration 28mm, 5. VAS > 20, 6. Age > 18 years

Exclusion criteria

Exclusion criteria: 1. Prior treatment DMARDs (except hydroxychloroquine). 2. Insulin-dependent Diabetes mellitus. 3. Uncontrollable non-insuline dependent diabetes mellitus. 4. Heart failure NYHA class 3-4. 5. Uncontrollable hypertension. 6. ALAT/ASAT > 3 times normal values. 7.Reduced renal function (serum creat > 15mcmol). 8. Contra-indications for methotrexate, sulphasalazine or prednisolone. 9. 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
-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 <2,4) - HAQ - delta Sharp van der Heijde score - % patients with radiological remission - number of patients started with anti-TNF - patients in clinical remission after six or twelve months will be tested for subclinical synovitis with a PETscan, ultrasound and MRI Tertiary outcome: bone and cartilage metabolism, cardiovascular and endocrine parameters	—

Measure

Time frame

-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 <2,4) - HAQ - delta Sharp van der Heijde score - % patients with radiological remission - number of patients started with anti-TNF - patients in clinical remission after six or twelve months will be tested for subclinical synovitis with a PETscan, ultrasound and MRI Tertiary outcome: bone and cartilage metabolism, cardiovascular and endocrine parameters

—

Contacts

Public ContactW.F. Lems

VU Medical Center depatment of rheumatology 4a-42 Boelelaan 1117

wf.lems@vumc.nl+31 20-4443432

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)