Condition category
Musculoskeletal Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
18/03/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.janvanbreemen.nl

Contact information

Type

Scientific

Primary contact

Dr D. van Schaardenburg

ORCID ID

Contact details

Jan van Breemen Instituut
Dr. Jan van Breemenstraat 2
Amsterdam
1056 AB
Netherlands
+31 (0)20 5896589
d.v.schaardenburg@janvanbreemen.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR133

Study information

Scientific title

Acronym

Study hypothesis

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

Ethics approval received from the local medical ethics committee

Study design

Randomised, double blinded, placebo controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Dexamethasone

Primary outcome measures

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 trial start date

01/10/2005

Overall trial end date

01/04/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant 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

Recruitment start date

01/10/2005

Recruitment end date

01/04/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Jan van Breemen Instituut
Amsterdam
1056 AB
Netherlands

Sponsor information

Organisation

Jan van Breemen Instituut (Netherlands)

Sponsor details

Dr. Jan van Breemenstraat 2
Amsterdam
1056 AB
Netherlands

Sponsor type

Research organisation

Website

http://www.janvanbreemen.nl

Funders

Funder type

Research organisation

Funder name

The Netherlands Organization for Health Research and Development (ZonMw) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19363022

Publication citations

  1. Results

    Bos WH, Dijkmans BA, Boers M, van de Stadt RJ, van Schaardenburg D, Effect of dexamethasone on autoantibody levels and arthritis development in patients with arthralgia: a randomised trial., Ann. Rheum. Dis., 2010, 69, 3, 571-574, doi: 10.1136/ard.2008.105767.

Additional files

Editorial Notes