EUCTR2012-002573-62-SE
Active, not recruiting
Phase 1
Doppler quantitative evaluation and follow-up over 12 months in RA patients with moderate and high disease activity who are candidates for biologic add-on therapy with Adalimumab
The Karolinska Institute, ClinTRID0 sites120 target enrollmentAugust 14, 2012
ConditionsRheumatoid arthritis (RA)MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
DrugsHumira
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Rheumatoid arthritis (RA)
- Sponsor
- The Karolinska Institute, ClinTRID
- Enrollment
- 120
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult patient (\> 18 years of age), male or female
- •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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •Biologic treatment with Adalimumab before inclusion
- •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
Outcomes
Primary Outcomes
Not specified
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