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

Early treatment of patients with undifferentiated arthritis (UA) with Methotrexate (MTX); a double blind placebo controlled randomised clinical trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23294

Enrollment

110

Registered

2005-06-27

Start date

2001-03-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Diagnosis RA according to the ACR-1987 criteria; 2. Kidney disorder: creatinine >150umol/l or estimated clearance 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.

Design outcomes

Primary

Measure	Time frame
The primary outcome is diagnosis after phasing out the study medication: rheumatoid arthritis, persisting undifferentiated arthritis or remission.	—

Secondary

Measure	Time frame
Secondary outcome values are (progression of) joint damage of hands and feet, disease activity and functional capacity.	—

Contacts

Public ContactT.W.J. Huizinga

Leiden University Medical Center (LUMC), P.O. Box 9600

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

Outcome results