Primary prevention of rheumatoid arthritis.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26301

Enrollment

Registered

2005-08-23

Start date

2005-10-01

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

rheumatoid arthritis

Interventions

1-2 intramuscular injections with 100 mg dexamethason with 6 weeks interval (2nd injection with verum depends on response to first injection) or twice placebo.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18-70 years for RF+, 18+ for aCCP+; 2. Twice increased IgM-RF and/or anti-CCP with 4+ weeks interval; 3. HLA-DR SE positive.

Exclusion criteria

Exclusion criteria: Situations with possible false positive RF: 1. Auto-immune diseases; 2. Active infection with hepatitis C or Ebstein Barr virus; 3. Recent chemotherapy; 4. Comorbidity with decreased life expectancy; 5. Corticosteroid use for another disease; 6. Contra-indications for corticosteroids: diabetes mellitus, osteoporosis; 7. Pregnancy or lactation.

Design outcomes

Primary

Measure	Time frame
50% reduction of the concentration of the increased antibodies after 6 months compared to no treatment.	—

Secondary

Measure	Time frame
Frequency of rheumatoid arthritis after 5 years compared to no treatment.	—

Contacts

Public ContactD. Schaardenburg, van

Jan van Breemen Institute, Dr. Jan van Breemenstraat 2

d.v.schaardenburg@janvanbreemen.nl+31 (0)20 5896589

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)