Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2012-10-31
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Arm 1
Adalimumab
Adalimumab
Adalimumab 40 mg eow (totally 27 doses/patient) manufactured by Abbott will be distributed as add-on therapy to DMARD
Interventions
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Adalimumab
Adalimumab 40 mg eow (totally 27 doses/patient) manufactured by Abbott will be distributed as add-on therapy to DMARD
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Rheumatoid arthritis according to the 1987 ACR or 2010 EULAR/ACR classification criteria
* Moderate to high disease activity
* Ongoing anti-rheumatic treatment with DMARD, with stable dosage during the last 3 months, and being a candidate for anti-TNF add-on therapy OR ongoing treatment with first anti-TNF therapy and being a candidate for switch to another anti-TNF therapy
* Women with child-bearing potential: use of an adequate method of contraception to avoid pregnancy throughout the study
* Signed Informed Consent \*Signed Informed Consent must be obtained before any study specific procedures take place.
Exclusion Criteria
* Two or more ongoing biologic treatments before inclusion
* Treatment with other biologic treatment than anti-TNF therapy before inclusion
* Any contraindication for treatment with Adalimumab
* Intraarticular corticosteroid injection during the last 4 weeks before each follow-up visit
* Positive for tuberculosis or hepatitis B.
* Ongoing pregnancy or lactation
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Hamed Rezaei
OTHER
Responsible Party
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Hamed Rezaei
Chief Arthritis, Inflammation department
Principal Investigators
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Monica Rydén Aulin, Phd
Role: STUDY_CHAIR
Karolinska Institutet
Locations
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Linköping University Hospital
Linköping, , Sweden
The karolinska Institute
Stockholm, , Sweden
Countries
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Other Identifiers
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2012-002573-62
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ClinTrid-US-1201
Identifier Type: -
Identifier Source: org_study_id
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