Contact information
Type
Scientific
Primary contact
Prof T.W.J. Huizinga
ORCID ID
Contact details
Leiden University Medical Center
Department of Rheumatology
Albinusdreef 2
Leiden
2333 ZA
Netherlands
+31 (0)71 5263598
T.W.J.Huizinga@lumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR73
Study information
Scientific title
Acronym
Probaat / PROMPT
Study hypothesis
We 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.
Ethics approval
Received from local medical ethics committee
Study design
Multicentre randomised double blind placebo controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Undifferentiated arthritis, probable rheumatoid arthritis according to ACR-1958 criteria
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Methotrexate
Primary outcome measures
Diagnosis after phasing out the study medication: rheumatoid arthritis, persisting undifferentiated arthritis or remission.
Secondary outcome measures
1. (Progression of) joint damage of hands and feet
2. Disease activity
3. Functional capacity
Overall trial start date
01/03/2001
Overall trial end date
01/06/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
110
Participant 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
Recruitment start date
01/03/2001
Recruitment end date
01/06/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Center
Leiden
2333 ZA
Netherlands
Funders
Funder type
Charity
Funder name
Dutch Arthritis Association (Reumafonds) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17469099
Publication citations
-
Results
van Dongen H, van Aken J, Lard LR, Visser K, Ronday HK, Hulsmans HM, Speyer I, Westedt ML, Peeters AJ, Allaart CF, Toes RE, Breedveld FC, Huizinga TW, Efficacy of methotrexate treatment in patients with probable rheumatoid arthritis: a double-blind, randomized, placebo-controlled trial., Arthritis Rheum., 2007, 56, 5, 1424-1432, doi: 10.1002/art.22525.