| - candidate number | 2599 |
|
| - NTR Number | NTR986 |
|
| - ISRCTN | incomplete |
|
| - Date ISRCTN created | 23-mei-2007 |
|
| - date ISRCTN requested | |
|
| - Date Registered NTR | 23-mei-2007 |
|
| - Secondary IDs | |
|
| - Public Title | Treatment in the Rotterdam Early Arthritis Cohort. |
|
| - Scientific Title | N/A |
|
| - ACRONYM | (T)REACH |
|
| - hypothesis | Can an early, intensive and efficient treatment prevent the cause of a persistent chronic arthritis (erosive or non-erosive) in patients who recently developed an arthritis? |
|
| - Healt Condition(s) or Problem(s) studied | Rheumatoid arthritis |
|
| - Inclusion criteria | 1. Informed consent;
2. Objectivated arthrites in at least 1 joint
and at least 2 of the following criteria:
a. Morningstifness>60 min;
b. spec sumpt. in hand and feet;
c. unexpalined shoeproblems;
d. unexplained ringproblems;
e. tangential pressure pain in MCP/MTP;
f. pos familyanamneses;
g. symm. presentation(50% of the joints);
h. unexplained fatigue. |
|
| - Exclusion criteria | 1. Complaints existing >1 year;
2. Complaints after trauma or overburden;
3. None-rheumatic inflammatoire or systemic desease;
4. Non-communicable. |
|
| - mec approval received | yes |
|
| - multicenter trial | yes |
|
| - randomised | yes |
|
| - masking/blinding | Single |
|
| - control | Not applicable |
|
| - group | Parallel |
|
| - Type | 2 or more arms, randomized |
|
| - Studytype | intervention |
|
| - planned startdate | 15-jun-2007 |
|
| - planned closingdate | 15-jul-2011 |
|
| - Target number of participants | 810 |
|
| - Interventions | High probability (chance pers arthr >70%):
groupe 1: MTX+SSZ+HCQ+1xcorticosteroids intramusc;
groupe 2:
MTX+SSZ+HCQ+corticosteroids; groupe 3:
MTX+corticosteroids.
Intermediate prob.(chance pers arthr <=30. |
|
| - Primary outcome | N/A |
|
| - Secondary outcome | N/A |
|
| - Timepoints | N/A |
|
| - Trial web site | N/A |
|
| - status | open: patient inclusion |
|
| - CONTACT FOR PUBLIC QUERIES | Prof. dr. J.T. Dissel, van |
|
| - CONTACT for SCIENTIFIC QUERIES | Prof. dr. J.T. Dissel, van |
|
| - Sponsor/Initiator | |
|
- Funding
(Source(s) of Monetary or Material Support) | |
|
| - Publications | N/A |
|
| - Brief summary | N/A |
|
| - Main changes (audit trail) | |
|
|
| - RECORD | 23-mei-2007 - 28-apr-2008 |