Early treatment of patients with undifferentiated arthritis (UA) with Methotrexate (MTX)
| ISRCTN | ISRCTN21334657 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21334657 |
| Secondary identifying numbers | NTR73 |
- 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
Not provided at time of registration
Contact information
Prof T.W.J. Huizinga
Scientific
Scientific
Leiden University Medical Center
Department of Rheumatology
Albinusdreef 2
Leiden
2333 ZA
Netherlands
| Phone | +31 (0)71 5263598 |
|---|---|
| T.W.J.Huizinga@lumc.nl |
Study information
| Study design | Multicentre randomised double blind placebo controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study 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(s) | Received from local medical ethics committee |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Methotrexate |
| Primary outcome measure | 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 study start date | 01/03/2001 |
| Overall study end date | 01/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 110 |
| 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 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
Study participating centre
Leiden University Medical Center
Leiden
2333 ZA
Netherlands
2333 ZA
Netherlands
Sponsor information
Leiden University Medical Center (LUMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands
"ROR" |
https://ror.org/05xvt9f17 |
|---|
Funders
Funder type
Charity
Dutch Arthritis Association (Reumafonds) (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
