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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 DMARDs?


- candidate number2026
- NTR NumberNTR626
- ISRCTNISRCTN70365169
- Date ISRCTN created29-mrt-2006
- date ISRCTN requested24-mrt-2006
- Date Registered NTR23-mrt-2006
- Secondary IDsN/A 
- Public TitleComputer Assisted Management of Early Rheumatoid Arthritis-II: Does prednisone inhibit progression of joint damage if early RA is treated very intensively with DMARDs?
- Scientific TitleComputer Assisted Management of Early Rheumatoid Arthritis-II.
- ACRONYMCAMERA-II
- hypothesisPrednisone inhibits progression of joint damage in early RA-patients, even when intensive treatment, according to a strict computer-assisted protocol, is applied.
- Healt Condition(s) or Problem(s) studiedRheumatoid arthritis
- Inclusion criteria1. 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.
- Exclusion criteria1. Abnormal renal function (Cockroft < 75 ml/min);
2. Abnormal liver function (ASAT/ALAT > 2* 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 conception, 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 into another clinical trial;
10. Osteoporotic vertebral fractures.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2003
- planned closingdate1-apr-2007
- Target number of participants220
- Interventions10 mg of prednisolone daily vs placebo in addition to DMARDs. Two year study.
- Primary outcomeRadiologic joint damage of hands and feet according to the van der Heijde modification of the Sharp scoring method.
- Secondary outcomeNumber 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 ESR< 20 mm/hr1st;
2.c VAS general well being < 20 mm.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. A.C.A. Marijnissen
- CONTACT for SCIENTIFIC QUERIESDr. J.W.G. Jacobs
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU), Abbott
- PublicationsResearch based on:
Everdingen AA van, Jacobs JWG, Reesema DR van, Bijlsma JWJ. Low-dose prednisone therapy for patients with early active rheumatoid arthritis: clinical efficacy, disease-modifying properties, and side effects. A randomized, double-blind placebo-controlled clinical trial. Ann Intern Med 2002: 136: 1-12.
- Brief summaryIf early RA is treated very intensively with DMARDs according to modern clinical standards, does prednisone 10 mg daily inhibit progression of joint damage according to the van der Heijde modification of the Sharp scoring method?
- Main changes (audit trail)
- RECORD23-mrt-2006 - 16-nov-2009


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