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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)?
ISRCTN ISRCTN70365169
DOI 10.1186/ISRCTN70365169
ClinicalTrials.gov identifier
EudraCT number
Public title 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)?
Scientific title
Acronym CAMERA-II
Serial number at source N/A
Study hypothesis Prednisone inhibits progression of joint damage in early RA-patients, even when intensive treatment, according to a strict computer-assisted protocol, is applied.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Netherlands
Disease/condition/study domain Rheumatoid arthritis (RA)
Participants - inclusion criteria 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
Participants - exclusion criteria 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
Anticipated start date 01/04/2003
Anticipated end date 01/04/2007
Status of trial Completed
Patient information material
Target number of participants 220
Interventions 10 mg of prednisolone daily versus placebo in addition to DMARDs. Two year study.
Primary outcome measure(s) Radiologic joint damage of hands and feet according to the van der Heijde modification of the Sharp scoring method.
Secondary outcome measure(s) 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
Sources of funding University Medical Center Utrecht (UMCU), Abbott
Trial website
Publications 1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22393128
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/22807253
Contact name Dr  A.C.A.  Marijnissen
  Address University Medical Center Utrecht (UMCU)

Department of Rheumatology and Clinical Immunology

F02.127

P.O. Box 85500
  City/town Utrecht
  Zip/Postcode 3508 GA
  Country Netherlands
  Tel +31 (0)30 2509758
  Email a.c.a.marijnissen@umcutrecht.nl
Sponsor University Medical Center Utrecht (The Netherlands)
  Address P.O. Box 85500
  City/town Utrecht
  Zip/Postcode 3508 GA
  Country Netherlands
Date applied 28/03/2006
Last edited 21/03/2013
Date ISRCTN assigned 29/03/2006
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