Doppler Evaluation in RA Patients After Adalimumab.

Phase 4

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Biological: Adalimumab

• Registration Number: NCT01609205
• Lead Sponsor: Hamed Rezaei

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-29
• Study First Submitted QC: 2012-05-30
• Study First Posted: 2012-05-31
• Study Start: 2012-10
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-24
• Last Update Posted: 2018-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Adalimumab	Adalimumab

Primary Outcome Measures

Name	Time	Method
The proportion of different clinical (EULAR) response	6 months from BL	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.

Secondary Outcome Measures

Name	Time	Method
The proportion of patients with good response to add-on therapy	6 and 12 months from BL	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.

Trial Locations

Locations (2)

Linköping University Hospital; 🇸🇪 Linköping, Sweden

The karolinska Institute; 🇸🇪 Stockholm, Sweden