No registrations found.
ID
Source
Brief title
Health condition
Rheumatoid Arthritis
Sponsors and support
Intervention
Outcome measures
Primary outcome
Radiologic joint damage of hands and feet according to the van der Heijde modification of the Sharp scoring method.
Secondary outcome
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 ESR< 20 mm/hr1st;
2.c VAS general well being < 20 mm.
Background summary
If 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?
Study objective
Prednisone inhibits progression of joint damage in early RA-patients, even when intensive treatment, according to a strict computer-assisted protocol, is applied.
Study design
N/A
Intervention
10 mg of prednisolone daily vs placebo in addition to DMARDs. Two year study.
P.O. Box 85500
A.C.A. Marijnissen
Utrecht 3508 GA
The Netherlands
+31 (0)30 2509758
a.c.a.marijnissen@umcutrecht.nl
P.O. Box 85500
A.C.A. Marijnissen
Utrecht 3508 GA
The Netherlands
+31 (0)30 2509758
a.c.a.marijnissen@umcutrecht.nl
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.
Exclusion criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL570 |
| NTR-old | NTR626 |
| Other | : N/A |
| ISRCTN | ISRCTN70365169 |
Summary results
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.