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AMC STOP study.


- candidate number8673
- NTR NumberNTR2611
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-nov-2010
- Secondary IDs010/220 METC AMC
- Public TitleAMC STOP study.
- Scientific TitleSTOP-study: Prospective study on the effects of withdrawal of anti-TNF therapy in patients with rheumatoid arthritis who are in remission.
- ACRONYMAMC STOP
- hypothesisBiomarkers of successful cessation of TNF blockade.
- Healt Condition(s) or Problem(s) studiedRheumatoid arthritis
- Inclusion criteria1. Men/women suffering from rheumatoid arthritis, based on the 2010 American College of Rheumatology/ European league Against Rheumatism (ACR/EULAR) classification criteria for RA will be included in this study;
2. Patients in ARA functional classes I, II, and III may be included;
3. In addition, patients must fulfill the following criteria at baseline:
A. DAS 28 ≤ 2.6 for the duration of a minimum of 24 weeks;
B. Be > 18 years of age and ≤ 85 years;
C. Stable use of concomitant DMARDs and TNF antagonists for the duration of 24 weeks before baseline.
- Exclusion criteria1. The use of oral/ intra-articular corticosteroids within 6 months prior to baseline;
2. Pregnancy;
3. Breastfeeding;
4. Subjects who are impaired, incapacitated, or incapable of completing study related assessments;
5. Subjects who meet diagnostic criteria for any other rheumatic disease (e.g., lupus erythematous);
6. Subjects with active vasculitis of a major organ system with the exception of rheumatoid nodules;
7. Subjects with current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease, or other medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study;
8. Subjects who have clinically significant drug or alcohol abuse;
9. Inability to give informed consent;
10. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-nov-2010
- planned closingdate1-nov-2014
- Target number of participants40
- InterventionsAt baseline they will stop using their current TNF-blocker.
- Primary outcome1. The percentage of patients that sustain drug-free remission 24 months after the cessation of TNF-antagonists;
2. Predictors (e.g. clinical parameters, serological and immunological markers) of sustained drug-free remission.
- Secondary outcome1. The difference in genetic markers/ epigenetic markers (e.g. genetic polymorphisms/ methylation status) in TNF-alpha genes that predict sustained drug-free remission in the individual patient;
2. Explore new markers, e.g. by micro-array analysis, distinguishing patients with sustained drug-free remission from patients who relapse;
3. Determine the percentage of patients with subclinical synovitis as determined by ultrasound in this group of patients in clinical remission.
- TimepointsBaseline, 3, 6, 9, 12, 15, 18, 21 and 24 months after baseline.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. P.P. Tak
- CONTACT for SCIENTIFIC QUERIESProf. Dr. P.P. Tak
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryCountries of recruitment: The Netherlands.
- Main changes (audit trail)
- RECORD16-nov-2010 - 3-dec-2010


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