Condition category
Musculoskeletal Diseases
Date applied
12/09/2005
Date assigned
12/09/2005
Last edited
19/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Leiden University Medical Center (LUMC) (Netherlands)

Sponsor details

Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

  1. 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.

Additional files

Editorial Notes