No registrations found.
ID
Source
Brief title
Health condition
All patients continue treatment according to the treatment group they were allocated to at the beginning of the BeSt trial. All treatment adjustments will continue to be based on threemonthly DAS measurements, aiming at DAS =<2.4 (or <1.6 before medication may be stopped altogether).
Sponsors and support
Centocor
Intervention
Outcome measures
Primary outcome
1. Functional ability as measured by HAQ;
2. Radiological damage as measured by Sharp/van der Heijde score of hands and feet;
3. Side effects and extra-articular manifestations (as reported and as monitored through laboratory assessments, X-rays, DEXAs).
Secondary outcome
1. Quality of life;
2. Utilities;
3. Work participation;
4. Costs.
Background summary
N/A
Study objective
1. Earlier identified differences in functional ability and radiological damage progression are maintained in the next ten years;
2. Early suppression of disease activity results in long term improvement in functional ability and suppression of joint damage progression;
3. Clinical remission can be maintained after discontinuation of all antirheumatic drugs in identifiable patients;
4. There is a clinically and statistically significant difference in extra-articular manifestations and side effects of medication between patients in the various treatment groups.
Intervention
Continued treatment with established antirheumatic drugs according to accepted treatment strategies, with threemonthly treatment adjustments dictated by the height of the DAS: if DAS>2.4, than medication will be increased or changed, if, for at least 6 months DAS <2.4, medication will be tapered, if, for at least 6 months DAS <1.6, medication will be stopped.
Department of Rheumatology,
C1-39,
P.O. Box 9600
C.F. Allaart
Leiden 2300 RC
The Netherlands
+31 (0)71 5263598
c.f.allaart@lumc.nl
Department of Rheumatology,
C1-39,
P.O. Box 9600
C.F. Allaart
Leiden 2300 RC
The Netherlands
+31 (0)71 5263598
c.f.allaart@lumc.nl
Inclusion criteria
All patients who completed participation in the first 2 years of BeSt.
Exclusion criteria
N/A
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 | NL227 |
| NTR-old | NTR265 |
| Other | : N/A |
| ISRCTN | Follow-up of ISRCTN32675862 |