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

Hamed Rezaei2 sites in 1 country60 target enrollmentOctober 2012

ConditionsRheumatoid Arthritis

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Rheumatoid Arthritis
Sponsor: Hamed Rezaei
Enrollment: 60
Locations: 2
Primary Endpoint: The proportion of different clinical (EULAR) response
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2012

End Date

September 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hamed Rezaei

Responsible Party

Sponsor Investigator

Principal Investigator

Hamed Rezaei

Chief Arthritis, Inflammation department

Karolinska Institutet

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.

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

The proportion of different clinical (EULAR) response

Time Frame: 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.