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 purpose is 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. The purpose is also to compare the Doppler quantification with conventional clinical methods and semiquantitative Doppler assessment.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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 proportion of different clinical (EULAR) response [ Time Frame: 6 months from BL ] [ Designated as safety issue: No ]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 6 months follow-up visit in patients with activity versus in those without activity measured by Doppler ultrasound at baseline.
- The proportion of patients with good response to add-on therapy [ Time Frame: 6 and 12 months from BL ] [ Designated as safety issue: No ]The 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.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
Adalimumab 40 mg eow (totally 27 doses/patient) manufactured by Abbott will be distributed as add-on therapy to DMARD
Other Name: Humira
|Contact: Ronald van Vollenhoven, MD, Prof.||+46 8 517 email@example.com|
|Linköping University Hospital||Not yet recruiting|
|Contact: Michael Ziegelasch, MD +46 (0)10 103 21 86 firstname.lastname@example.org|
|Principal Investigator: Michael Ziegelasch, MD|
|The karolinska Institute||Not yet recruiting|
|Stockholm, Sweden, 171 76|
|Contact: Hamed Rezaei, MD +46 (0)8 517 70489 email@example.com|
|Principal Investigator: Ronald van Vollenhoven, MD, Prof.|
|Sub-Investigator: Hamed Rezaei, MD|