STRategies in Early Arthritis Management
| ISRCTN | ISRCTN56637846 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56637846 |
| Secondary identifying numbers | N/A |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 17/12/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
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 single blind active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | STREAM |
| Study objectives | 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(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Adalimumab, methotrexate, sulfasalazine, hydroxychloroquine, prednisone |
| Primary outcome measure | Progression of radiographic damage score after 2 years. |
| Secondary outcome measures | 1. Functional capacity 2. Quality of life 3. Disease activity |
| Overall study start date | 01/07/2004 |
| Completion date | 01/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 |
| Key inclusion criteria | 1. Aged 18+ years 2. Symptom duration less than 3 years 3. Swelling in two to five joints |
| Key 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 |
| Date of first enrolment | 01/07/2004 |
| Date of final enrolment | 01/07/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Jan van Breemen Instituut
Amsterdam
1056 AB
Netherlands
1056 AB
Netherlands
Sponsor information
Jan van Breemen Institute (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
Industry
Abbott (Netherlands) - study is investigator driven
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 |
