STRategies in Early Arthritis Management

ISRCTN	ISRCTN56637846
DOI	https://doi.org/10.1186/ISRCTN56637846
Protocol serial number	N/A
Sponsor	Jan van Breemen Institute (Netherlands)
Funder	Abbott (Netherlands) - study is investigator driven

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

Dr D. van Schaardenburg
Scientific

Jan van Breemen Instituut
Dr. Jan van Breemenstraat 2
Amsterdam
1056 AB
Netherlands

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

Primary study design	Interventional
Study design	Randomised single blind active controlled parallel group trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Adalimumab, methotrexate, sulfasalazine, hydroxychloroquine, prednisone
Primary outcome measure(s)	Progression of radiographic damage score after 2 years.
Key secondary outcome measure(s)	1. Functional capacity 2. Quality of life 3. Disease activity
Completion date	01/07/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Jan van Breemen Instituut

Amsterdam
1056 AB
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan