Condition category
Musculoskeletal Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
17/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

N/A

Study information

Scientific title

Acronym

STREAM

Study hypothesis

After 2 years of treatment with a combination of anti-rheumatic drugs including adalimumab with the aim of achieving and maintaining remission in patients with mild arthritis, there is less radiographic progression than in patients treated with usual care.

Ethics approval

Received from the local medical ethics committee

Study design

Randomised single blind active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Polyarthritis/rheumatoid arthritis

Intervention

Methotrexate, in case of insufficient response followed by adalimumab, and then by a combination of methotrexate, sulfasalazine, hydroxychloroquine and prednisone depending on achievement of remission versus usual care according to preference physician.

Intervention type

Drug

Phase

Not Specified

Drug names

Adalimumab, methotrexate, sulfasalazine, hydroxychloroquine, prednisone

Primary outcome measures

Progression of radiographic damage score after 2 years.

Secondary outcome measures

1. Functional capacity
2. Quality of life
3. Disease activity

Overall trial start date

01/07/2004

Overall trial end date

01/07/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18+ years
2. Symptom duration less than 3 years
3. Swelling in two to five joints

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Earlier treatment with disease modifying antirheumatic drugs except hydroychloroquine
2. Prednisone use within 3 months
3. Bacterial arthritis, crystal induced arthritis, reactive arthritis, sarcoidosis, osteoarthritis or systemic autoimmune disease other than rheumatoid arthritis (RA)
4. Pregnancy
5. Erosive disease

Recruitment start date

01/07/2004

Recruitment end date

01/07/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Jan van Breemen Instituut
Amsterdam
1056 AB
Netherlands

Sponsor information

Organisation

Jan van Breemen Institute (Netherlands)

Sponsor details

Dr. Jan van Breemenstraat 2
Amsterdam
1056 AB
Netherlands

Sponsor type

Research organisation

Website

http://www.janvanbreemen.nl

Funders

Funder type

Industry

Funder name

Abbott (Netherlands) - study is investigator driven

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

Publication citations

Additional files

Editorial Notes