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Early treatment of patients with undifferentiated arthritis (UA) with Methotrexate (MTX).


- candidate number0
- NTR NumberNTR73
- ISRCTNISRCTN21334657
- Date ISRCTN created12-sep-2005
- date ISRCTN requested15-aug-2005
- Date Registered NTR27-jun-2005
- Secondary IDsN/A 
- Public TitleEarly treatment of patients with undifferentiated arthritis (UA) with Methotrexate (MTX).
- Scientific TitleEarly treatment of patients with undifferentiated arthritis (UA) with Methotrexate (MTX); a double blind placebo controlled randomised clinical trial.
- ACRONYMPROMPT/Probaat
- hypothesisWe hypothesized that patients treated with Methotrexate (MTX) will have less duration and less severe arthritis, will not or less evolve into RA, will develop less radiographic progression in joint damage, and are more likely to go into remission.
- Healt Condition(s) or Problem(s) studiedRheumatoid arthritis, Undifferentiated arthritis, ACR-1958 criteria
- Inclusion criteria1. Diagnosis probable RA according to the ACR-1958 criteria;
2. Aged 18 years or older;
3. Less than 2 years of complaints;
4. No DMARD use in the past (except Prednisone, maximal 3 months);
5. Signed informed consent.
- Exclusion criteria1. Diagnosis RA according to the ACR-1987 criteria;
2. Kidney disorder: creatinine >150umol/l or estimated clearance < 75;
3. Liver function disorder: ASAT, ALAT > 3x normal values;
4. Alcoholism;
5. Bone marrow insufficiency;
6. Pregnant or pregnancy wish during study or 3 months thereafter;
7. No adequate method of birth control.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2001
- planned closingdate1-jun-2005
- Target number of participants110
- InterventionsThe patients started with either 15 mg MTX or 6 placebo tablets. Every three months the medication was increased with 5 mg or 2 tablets respectively if the disease activity score (DAS) was higher than 2,4. After 12 months, the study medication was phased out. If a patient is diagnosed with RA during the follow up, the treatment was continued with verum MTX. In case of side effects that might be related to MTX, the treatment was adjusted. Patients were followed up for 18 months. At inclusion, 3, 6, 9, 12 and 18 months a tender and swollen joint count and health assessment questionnaires were performed and blood was donated for clinical and scientific research. Every 6 months radiographs of hands and feet were taken.
- Primary outcomeThe primary outcome is diagnosis after phasing out the study medication:
rheumatoid arthritis, persisting undifferentiated arthritis or remission.
- Secondary outcomeSecondary outcome values are (progression of) joint damage of hands and feet, disease activity and functional capacity.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESProf. Dr. T.W.J. Huizinga
- CONTACT for SCIENTIFIC QUERIESProf. Dr. T.W.J. Huizinga
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Dutch Arthritis Association (Reumafonds)
- PublicationsArthritis Rheum. 2007 May;56(5):1424-32.
- Brief summaryIn patients with RA many studies have demonstrated the benefit of early initiation of Disease Modifying Anti-Rheumatic Drugs (DMARDs), resulting in a better prognosis. Patients included in these studies generally fulfilled the 1987 ACR classification criteria for RA. Although RA patients benefit from early aggressive treatment, it is unknown whether UA patients who might evolve into RA will also benefit from such a treatment strategy. In the present study, patients with undifferentiated arthritis fulfilling the ACR 1958 criteria for probable RA were treated with either methotrexate or placebo. We hypothesized that patients treated with MTX will have less duration and less severe arthritis, will not or less evolve into RA, will develop less radiographic progression in joint damage, and are more likely to go into remission.
- Main changes (audit trail)
- RECORD8-aug-2005 - 9-jul-2008


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