Primary prevention of rheumatoid arthritis
| ISRCTN | ISRCTN73232918 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73232918 |
| Secondary identifying numbers | NTR133 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 18/03/2010
- 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
Dr D. van Schaardenburg
Scientific
Scientific
Jan van Breemen Instituut
Dr. Jan van Breemenstraat 2
Amsterdam
1056 AB
Netherlands
| Phone | +31 (0)20 5896589 |
|---|---|
| d.v.schaardenburg@janvanbreemen.nl |
Study information
| Study design | Randomised, double blinded, 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 objectives | 1 - 2 intramuscular injections with 100 mg dexamethasone in persons without arthritis but with elevated serum levels of Rheumatoid Factor (RF) and or anti-Cyclic Citrullinated Peptide (aCCP) will lead to a reduction in antibody concentrations after 6 months and possibly to a lower frequency of rheumatoid arthritis after 5 years, in comparison to no treatment. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Rheumatoid arthritis |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Dexamethasone |
| Primary outcome measure | 50% reduction of the concentration of the increased antibodies after 6 months compared to no treatment. |
| Secondary outcome measures | Frequency of rheumatoid arthritis after 5 years compared to no treatment. |
| Overall study start date | 01/10/2005 |
| Completion date | 01/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 |
| Key inclusion criteria | 1. Age 18 - 70 years for RF+, 18+ for aCCP 2. Twice increased Immunoglobulin M (IgM)-RF and/or aCCP with 4+ weeks interval 3. Human Leukocyte Antigen (HLA)-DR Shared Epitope (SE) positive |
| Key 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. Co-morbidity with decreased life expectancy 5. Corticosteroid use for another disease 6. Contra-indications for corticosteroids: diabetes mellitus, osteoporosis 7. Pregnancy or lactation |
| Date of first enrolment | 01/10/2005 |
| Date of final enrolment | 01/04/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Jan van Breemen Instituut
Amsterdam
1056 AB
Netherlands
1056 AB
Netherlands
Sponsor information
Jan van Breemen Instituut (Netherlands)
Research organisation
Research organisation
Dr. Jan van Breemenstraat 2
Amsterdam
1056 AB
Netherlands
| Website | http://www.janvanbreemen.nl |
|---|---|
"ROR" |
https://ror.org/00bp9f906 |
Funders
Funder type
Research organisation
The Netherlands Organization for Health Research and Development (ZonMw) (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 | 01/03/2010 | Yes | No |
