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

ISRCTN	ISRCTN21334657
DOI	https://doi.org/10.1186/ISRCTN21334657
Protocol serial number	NTR73
Sponsor	Leiden University Medical Center (LUMC) (Netherlands)
Funder	Dutch Arthritis Association (Reumafonds) (Netherlands)

Submission date: 12/09/2005
Registration date: 12/09/2005
Last edited: 19/08/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof T.W.J. Huizinga
Scientific

Leiden University Medical Center
Department of Rheumatology
Albinusdreef 2
Leiden
2333 ZA
Netherlands

Phone	+31 (0)71 5263598
Email	T.W.J.Huizinga@lumc.nl

Study information

Primary study design	Interventional
Study design	Multicentre randomised double blind placebo controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	Probaat / PROMPT
Study objectives	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(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Methotrexate
Primary outcome measure(s)	Diagnosis after phasing out the study medication: rheumatoid arthritis, persisting undifferentiated arthritis or remission.
Key secondary outcome measure(s)	1. (Progression of) joint damage of hands and feet 2. Disease activity 3. Functional capacity
Completion date	01/06/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	110
Key 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
Key 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
Date of first enrolment	01/03/2001
Date of final enrolment	01/06/2005

Locations

Countries of recruitment

Netherlands

Study participating centre

Leiden University Medical Center

Leiden
2333 ZA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2007		Yes	No