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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 19 March 2012
Main ID:  EUCTR2007-002976-32-NL
Date of registration: 30/08/2007
Prospective Registration: Yes
Primary sponsor: TIPharma
Public title: COBRA-light study, an open randomised trial comparing a modified COBRA therapy with the COBRA therapy according to BeSt in early rheumatoid arthritis.
Scientific title: COBRA-light study, an open randomised trial comparing a modified COBRA therapy with the COBRA therapy according to BeSt in early rheumatoid arthritis.
Date of first enrolment: 06/09/2007
Target sample size:
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-002976-32
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: combination therapy with less prednisone  
Phase: 
Countries of recruitment
Netherlands
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
Active RA according to ACR criteria
>6 swollen joints or >6 painful joints
Disease duration < 2jr
ESR > 28mm
VAS > 20
Age > 18 years

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Patients with early rheumatoid arthritis wil be treated with a combination therapy: COBRA according to BEST or a modified COBRA schedule (COBRA-light).
Intervention(s)

Trade Name: Prednisone
Pharmaceutical Form: Tablet

Trade Name: Methotrexate
Pharmaceutical Form: Tablet

Trade Name: Sulphasalazine
Pharmaceutical Form: Tablet

Primary Outcome(s)
Main Objective: Are there differences is efficacy, side effects, tolerance en costs in patients with early RA in treatment with COBRA-light compared with COBRA according to BeSt?
Primary end point(s): Difference in delta DAS compared at baseline between the both treatment strategies after 6 months.
Secondary Objective: Secundary parameters:
- Difference in delta DAS compared with baseline between the treatment strategies 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 radiologic 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 PET-scan, ultrasound and MRI.

Tertiary parameters:
-Bone and cartilage
-Cardiovascular
-Gastro-intestinal
-Infections
-Proteomics
-Costs
Secondary Outcome(s)
Secondary ID(s)
unknown
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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