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ISRCTN
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ISRCTN70365169
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ClinicalTrials.gov identifier
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Public title
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Computer Assisted Management of Early Rheumatoid Arthritis-II: Does prednisone inhibit progression of joint damage if early RA is treated very intensively with disease modifying antirheumatic drugs (DMARDs)?
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Scientific title
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Acronym
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CAMERA-II
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Serial number at source
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N/A
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Study hypothesis
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Prednisone inhibits progression of joint damage in early RA-patients, even when intensive treatment, according to a strict computer-assisted protocol, is applied.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Rheumatoid arthritis (RA)
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Participants - inclusion criteria
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1. Rheumatoid Arthritis, defined according to the revised American College of Rheumatology (ACR) criteria for Rheumatoid Arthritis
2. A disease duration of less than 1 year, estimated by the rheumatologist
3. Age >18 years
4. No previous treatment with DMARDs or oral glucocorticoids
5. Written informed consent by the patient
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Participants - exclusion criteria
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1. Abnormal renal function (Cockroft <75 ml/min)
2. Abnormal liver function (aspartate aminotransferase [ASAT]/alanine aminotransferase [ALAT] >2 x normal), active or recent hepatitis, cirrhosis
3. Major co-morbidities like malignancies, severe diabetic mellitus, severe infections, severe cardio and/or respiratory diseases
4. Leukopenia and/or thrombocytopenia
5. Inadequate birth control contraception, pregnancy, and/or breastfeeding
6. Treatment with cytoxic or immunosuppressive drugs within a period of 3 months prior to the study
7. Alcohol intake >2 units per day or drug abuse, presently or in the past
8. Psychiatric or mental disorders which makes adherence to the study protocol impossible
9. Taking part in another clinical trial
10. Osteoporotic vertebral fractures
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Anticipated start date
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01/04/2003
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Anticipated end date
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01/04/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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220
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Interventions
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10 mg of prednisolone daily versus placebo in addition to DMARDs. Two year study.
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Primary outcome measure(s)
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Radiologic joint damage of hands and feet according to the van der Heijde modification of the Sharp scoring method.
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Secondary outcome measure(s)
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Number of patients in remission, in which remission is defined as:
1. Number of swollen joints = 0
2. Plus at least two out of three following criteria:
2.a. Number of swollen joints <3
2.b. Erythrocyte sedimentation rate (ESR) <20 mm/1st hour
2.c. Visual analogue scale (VAS) of general well being <20 mm
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Sources of funding
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University Medical Center Utrecht (UMCU), Abbott
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Trial website
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Publications
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1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22393128
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Contact name
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Dr
A.C.A.
Marijnissen
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Address
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University Medical Center Utrecht (UMCU)
Department of Rheumatology and Clinical Immunology
F02.127
P.O. Box 85500
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City/town
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Utrecht
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Zip/Postcode
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3508 GA
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Country
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Netherlands
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Tel
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+31 (0)30 2509758
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Email
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a.c.a.marijnissen@umcutrecht.nl
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Sponsor
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University Medical Center Utrecht (The Netherlands)
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Address
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P.O. Box 85500
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City/town
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Utrecht
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Zip/Postcode
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3508 GA
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Country
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Netherlands
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Date applied
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28/03/2006
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Last edited
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13/03/2012
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Date ISRCTN assigned
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29/03/2006
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