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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR73 |
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Date of registration:
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27/06/2005 |
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Primary sponsor: |
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Public title:
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Early treatment of patients with undifferentiated arthritis (UA) with Methotrexate (MTX).
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Scientific title:
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Early treatment of patients with undifferentiated arthritis (UA) with Methotrexate (MTX); a double blind placebo controlled randomised clinical trial. - PROMPT/Probaat |
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Date of first enrolment:
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1/3/2001 |
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Target sample size:
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110 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=73 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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T.W.J.
Huizinga |
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Address:
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Leiden University Medical Center (LUMC),
P.O. Box 9600
, Albinusdreef 2
2300 RC
Leiden
The Netherlands |
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Telephone:
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+31 (0)71 5263598 |
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Email:
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T.W.J.Huizinga@lumc.nl |
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Affiliation:
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Name:
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T.W.J.
Huizinga |
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Address:
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Leiden University Medical Center (LUMC),
P.O. Box 9600
, Albinusdreef 2
2300 RC
Leiden
The Netherlands |
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Telephone:
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+31 (0)71 5263598 |
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Email:
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T.W.J.Huizinga@lumc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. 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 criteria: 1. 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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Rheumatoid arthritis, Undifferentiated arthritis, ACR-1958 criteria
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Intervention(s)
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The 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.
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Primary Outcome(s)
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The primary outcome is diagnosis after phasing out the study medication:
rheumatoid arthritis, persisting undifferentiated arthritis or remission.
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Secondary Outcome(s)
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Secondary outcome values are (progression of) joint damage of hands and feet, disease activity and functional capacity.
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Secondary ID(s)
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ISRCTN21334657
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N/A
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Source(s) of Monetary Support
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Dutch Arthritis Association (Reumafonds)
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