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
- Conditions
- Rheumatoid 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]
- Registration Number
- EUCTR2012-002573-62-SE
- Lead Sponsor
- The Karolinska Institute, ClinTRID
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
• 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
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To study the relationship between RA disease activity based on Doppler quantification and the subsequent clinical response (EULAR response) to treatment with Adalimumab during 12 months.<br>;Secondary Objective: To compare the Doppler quantification with conventional clinical methods and semiquantitative Doppler assessment.;Primary end point(s): The primary endpoint will be the proportion of different clinical (EULAR) response (good, moderate, no response) to add-on therapy with anti-TNF treatment at <br>6 months follow-up visit in patients with activity versus in those without activity measured by Doppler ultrasound at baseline.<br>;Timepoint(s) of evaluation of this end point: 6 months after baseline
- Secondary Outcome Measures
Name Time Method Secondary end point(s): A. Proportion of patients with good response to add-on therapy (measured by both Doppler and clinical assessment) at 6 and 12 months follow-up visits in two groups of patients, those who achieve low disease activity according to Doppler assessment at 3 months visit versus those who did not.<br><br>B. Proportion of patients with/without activity measured by Doppler assessment who discontinue treatment because of treatment failure.<br><br>C. To compare Doppler quantification with conventional clinical methods and semi-quantitative Doppler assessment to measure disease activity and evaluation of treatment efficacy.<br>;Timepoint(s) of evaluation of this end point: A. 6 and 12 months after baseline<br>